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elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of cholinesterase in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Colorimetric assay

CHE

butyrylthiocholine + H2O

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured photometrically.

To determine the dibucaine number (DN), cholinesterase activity is measured with and without enzyme inhibitor dibucaine. The dibucaine number is calculated as follows:

DN = 100 –

CHE activity with inhibitor

x 100

CHE activity without inhibitor

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

CHET2: 100‑14000 U/L (1.67‑234 µkat/L)

CHED2: 250‑7000 U/L (4.18‑117 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test:

CHET2: 100 U/L (1.67 µkat/L)

CHED2: 250 U/L (4.18 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

Values below the lower detection limit (< 100 U/L) will not be flagged by the instrument.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.
,a)

Children, men, women (aged 40 years or more): 5320‑12920 U/L (89‑215.3 µkat/L)

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 4260‑11250 U/L (71‑187 µkat/L)

Women aged 18‑41 years, pregnant or taking contraceptives: 3650‑9120 U/L (61‑152 µkat/L)

Dibucaine number

Dibucaine number for the cholinesterase variants U (usual) and A (atypical):

Normal individuals

UU

Dibucaine Number

≥ 73

Heterozygous individuals

UA

Dibucaine Number

72‑57

Homozygous individuals

AA

Dibucaine Number

≤ 50

DN results below 57 should be considered to indicate a potentially high risk of succinyldicholine sensitivity.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

a) Calculated with a temperature conversion factor of 1.52 (25 → 37 °C)

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

CHET2

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 5000 U/L (83.5 µkat/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 700 (approximate hemoglobin concentration: 435 µmol/L or 700 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

CHED2

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 1250 U/L (20.9 µkat/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and 40 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL; approximate unconjugated bilirubin concentration: 684 µmol/L or 40 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 200 (approximate hemoglobin concentration: 124 µmol/L or 200 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

05168503 190*

Cholinesterase Gen.2 (650 tests)

System‑ID 05 6842 1

Roche/Hitachi cobas c 701/702

05168503 214*

Cholinesterase Gen.2 (650 tests)

System‑ID 05 6842 1

Roche/Hitachi cobas c 701/702

Materials required (but not provided):

Order information

05168511 190

Dibucaine**(13.5 mL)

System‑ID 03 7458 8

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149435 160

Precinorm U plus (10 x 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

12149443 160

Precipath U plus (10 x 3 mL, for USA)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

05172152 190

Diluent NaCl 9 % (119 mL)

System‑ID 08 6869 3

* Some kits shown may not be available in all countries.

** The value presented on the instrument inventory screen is around 9 mL to account for the dead volume of the containers. This corresponds to 400 tests.

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CHET2: ACN 8534, total cholinesterase

CHED2: ACN 8434, inhibited cholinesterase

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Total cholinesterase CHET2

cobas c 701/702 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 25‑31

Wavelength (sub/main)

700/415 nm

Reaction direction

Decrease

Units

U/L (µkat/L, kU/L)

Reagent pipetting

Diluent (H2O)

R1

120 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2 µL

Decreased

10 µL

15 µL

135 µL

Increased

4 µL

Inhibited cholinesterase CHED2

cobas c 701/702 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 25‑31

Wavelength (sub/main)

700/415 nm

Reaction direction

Decrease

Units

U/L (µkat/L, kU/L)

Reagent pipetting

Diluent (H2O)

R1

100 µL

R2 (Special Reagent)

20 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2 µL

Decreased

2 µL

Increased

4 µL

Calculated test definition for dibucaine number

Abbreviated calculated test name CHE2R

Equation 100 – (CHED2/CHET2) x 100

Use a predefined profile for simultaneous order entry of CHET2, CHED2 and CHE2R tests from the same sample. The ratio for dibucaine number will automatically be calculated after results of both tests are available.

Please refer to Operator Manual, section profile and calculated test.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

CHE2

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

DIBU

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

Diluent NaCl 9  %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

On‑board on the Reagent Manager:

24 hours

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

CHET2:

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
- after reagent lot change
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test has been standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (IlI) method on a manual photometer and the published molar absorptivity ε of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

CHED2:

Calibrator

Transfer of blank and k‑factor from CHET2

Calibration frequency

- update of blank and k‑factor after each CHET2 calibration
- after lot change

Note:For the very first calibration of CHET2 set CHED2 inactive. After completion of the CHET2-calibration, set CHED2 again to active and transfer the blank and k‑factor to CHED2.

For further measurements only CHET2 has to be calibrated with calibrator C.f.a.s. and H2O. For CHED2 calibration always use the blank and calibration factor obtained in the CHET2 calibration.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

3118 (52.1)

19 (0.3)

0.6

Precipath U

4912 (82.0)

25 (0.4)

0.5

Human serum A

3047 (50.9)

27 (0.5)

0.9

Human serum B

5422 (90.5)

23 (0.4)

0.4

Human serum C

11785 (197)

50 (1)

0.4

Intermediate precision

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

4707 (78.6)

49 (0.82)

1.0

Precipath U

4838 (80.8)

45 (0.75)

0.9

Human serum 3

1002 (16.7)

26 (0.43)

2.6

Human serum 4

6683 (112)

74 (1.24)

1.1

Results for intermediate precision were obtained on the master system cobas c 501 analyzer.

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

CHET2

Cholinesterase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer (y) were compared with those determined using the corresponding reagent on Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 83

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.989x + 24.4 U/L

y = 0.987x + 29.0 U/L

τ = 0.973

r = 0.999

The sample activities were between 1693 and 13586 U/L (28.3 and 227 µkat/L).

CHED2

Total and inhibited cholinesterase values, CHET2 (x) and CHED2 (y), for human serum and plasma samples obtained on a Roche/Hitachi cobas c 701 analyzer were compared.

Sample size (n) = 84

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.275x - 127 U/L

y = 0.273x - 102 U/L

τ = 0.954

r = 0.997

The sample activities were between 1699 and 13832 U/L (28.4 and 231 µkat/L).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In preoperative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

At least 6 different genetic variants of serum cholinesterase have been described (A, F, J, K, S and U). The normal most common phenotype is designated U. The atypical forms A, F and S are described by high resistance to dibucaine inhibition (A), increased resistance to fluoride inhibition (F), and absence of catalytic activity (S). The homozygous forms AA or FF are found in only 0.3 to 0.5 % of the caucasian population. The genotypes most susceptible to prolonged anesthesia and/or apnea after succinyldicholine administration are AA, AS, and SS (severe risk); AF, FS, and FF (moderate risk); and to some extent, UA (usually only during pregnancy). In such cases succinyldicholine anesthesia should be avoided. Measurements of total serum cholinesterase activity as well as determination of dibucaine number and fluoride number are needed to characterize cholinesterase variants fully. The dibucaine number indicates the percentage inhibition of enzyme activity in the presence of a standard concentration of dibucaine.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme. This assay is based on the method published by Schmidt et al.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

Cholinesterase Gen.2

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate (III): 2.4 mmol/L

R3

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

Dibucaine (for ACN 8434)

R2

Dibucaine: 2.6 mmol/L, pH 6.3

(Special Reagent)

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

CHET2

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Specimen collection and preparation
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C
7 days at 2‑8 °C
1 year at -20 °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208105561190c503", "ProductName": "CHE2", "ProductLongName": "Cholinesterase Gen.2", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF000000048CAA0E", "DocumentOriginID": "FF00000003E98C0E", "MaterialNumbers": [ "08105561190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of cholinesterase in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Colorimetric assay

butyrylthiocholine + H2O

CHE

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured photometrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

100‑14000 U/L (1.67‑234 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 100 U/L (1.67 µkat/L)

Limit of Detection

= 100 U/L (1.67 µkat/L)

Limit of Quantitation

= 100 U/L (1.67 µkat/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity cholinesterase samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.

Calculated with a temperature conversion factor of 1.52 (25 → 37 °C)

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

U/L

Children, men, women (aged 40 years or more): 5320‑12920 U/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 4260‑11250 U/L

Women aged 18‑41 years, pregnant or taking contraceptives: 3650‑9120 U/L

µkat/L*

Children, men, women (aged 40 years or more): 89‑215 µkat/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 71‑187 µkat/L

Women aged 18‑41 years, pregnant or taking contraceptives: 61‑152 µkat/L

*calculated by unit conversion factor

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

Roche has not evaluated reference ranges in a pediatric population.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 5000 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 700 (approximate hemoglobin concentration: 435 µmol/L or 700 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet. For further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105561190

Cholinesterase Gen.2 (1050 tests)

System‑ID 2037 001

cobas c 303,cobas c 503

10759350360

Calibrator f.a.s. (12 × 3 mL)

Code 20401

05947626160

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CHE2-T: ACN 20370

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

700/415 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

16 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.3 µL

Decreased

2.6 µL

20 µL

60 µL

Increased

1.3 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test has been standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (IlI) method on a manual photometer and the published molar absorptivity ε of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1 a)

5606

24.0

0.4

PCCC2 b)

9093

45.4

0.5

Human serum 1

245

14.4

5.9

Human serum 2

1990

14.8

0.7

Human serum 3

7260

49.9

0.7

Human serum 4

8871

49.4

0.6

Human serum 5

12278

60.3

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

5658

41.1

0.7

PCCC2

FREFPreciControl ClinChem Multi 2

9093

66.2

0.7

Human serum 1

245

14.4

5.9

Human serum 2

1990

17.7

0.9

Human serum 3

7260

56.7

0.8

Human serum 4

8871

60.9

0.7

Human serum 5

12272

76.0

0.6

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Cholinesterase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.026x - 77.4 U/L

y = 1.030x - 90.4 U/L

τ = 0.992

r = 1.000

The sample activities were between 264 and 13566 U/L.

Cholinesterase values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 77

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.995x + 27.7 U/L

y = 0.999x + 14.5 U/L

τ = 0.981

r = 0.999

The sample concentrations were between 187 and 13388 U/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In preoperative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme. This assay is based on the method published by Schmidt et al.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate (III): 2.4 mmol/L

R3

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and Warnings

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Specimen collection and preparation
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C
7 days at 2‑8 °C
1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008105561190c503", "ProductName": "CHE2", "ProductLongName": "Cholinesterase Gen.2", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF0000000483950E", "DocumentOriginID": "FF000000038DEC0E", "MaterialNumbers": [ "08105561190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of cholinesterase in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.
,
LREFGarry PJ. Serum cholinesterase variants: examination of differential inhibitors, salts, and buffers used to measure enzyme activity Clin Chem 1971;17:183-191.

Colorimetric assay

butyrylthiocholine + H2O

CHE

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured photometrically.

To determine the dibucaine number (DN), cholinesterase activity is measured with and without enzyme inhibitor dibucaine. The dibucaine number is calculated as follows:

DN = 100 −

CHE activity with inhibitor
CHE activity without inhibitor

× 100

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Total cholinesterase (CHE2‑T, ACN 20370)

100‑14000 U/L (1.67‑234 µkat/L)

Inhibited cholinesterase (CHE2‑D, ACN 20371)

250‑7000 U/L (4.18‑117 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Total cholinesterase (CHE2‑T, ACN 20370)

Limit of Blank

= 100 U/L (1.67 µkat/L)

Limit of Detection

= 100 U/L (1.67 µkat/L)

Limit of Quantitation

= 100 U/L (1.67 µkat/L)

Inhibited cholinesterase (CHE2‑D, ACN 20371)

Limit of Blank

= 250 U/L (4.18 µkat/L)

Limit of Detection

= 250 U/L (4.18 µkat/L)

Limit of Quantitation

= 250 U/L (4.18 µkat/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity cholinesterase samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.

Calculated with a temperature conversion factor of 1.52 (25 → 37 °C)

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

U/L

Children, men, women (aged 40 years or more): 5320‑12920 U/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 4260‑11250 U/L

Women aged 18‑41 years, pregnant or taking contraceptives: 3650‑9120 U/L

µkat/L*

Children, men, women (aged 40 years or more): 89‑215 µkat/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 71‑187 µkat/L

Women aged 18‑41 years, pregnant or taking contraceptives: 61‑152 µkat/L

*calculated by unit conversion factor

Dibucaine number

Dibucaine number (DN) for the cholinesterase variants U (usual) and A (atypical):

Normal individuals

UU

Dibucaine number

≥ 73

Heterozygous individuals

UA

Dibucaine number

72‑57

Homozygous individuals

AA

Dibucaine number

≤ 50

DN results below 57 should be considered to indicate a potentially high risk of succinyldicholine sensitivity.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Total cholinesterase (CHE2‑T, ACN 20370)

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 5000 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 700 (approximate hemoglobin concentration: 435 µmol/L or 700 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Inhibited cholinesterase (CHE2‑D, ACN 20371)

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 1250 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and 40 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL; approximate unconjugated bilirubin concentration: 684 µmol/L or 40 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 200 (approximate hemoglobin concentration: 124 µmol/L or 200 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105561 190

Cholinesterase Gen.2 (1050 tests)

System‑ID 2037 001

Roche/Hitachi cobas c 503

08105570 190

Dibucaine (1050 tests)

System‑ID 2038 001

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 × 3 mL)

Code 20401

10759350 360

Calibrator f.a.s. (12 × 3 mL, for USA)

Code 20401

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05947626 160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

Code 20391

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

05947774 160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

Code 20392

08063494 190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CHE2-T: ACN 20370, total cholinesterase

CHE2-D: ACN 20371, inhibited cholinesterase

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition Total cholinesterase (CHE2‑T, ACN 20370)

Reporting time

10 min

Wavelength (sub/main)

700/415 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

16 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.3 µL

Decreased

2.6 µL

20 µL

60 µL

Increased

1.3 µL

Test definition Inhibited cholinesterase (CHE2‑D, ACN 20371)

Reporting time

10 min

Wavelength (sub/main)

700/415 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R2 (Special Reagent)

15 µL

R3

18 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.5 µL

Decreased

1.5 µL

Increased

1.5 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Application for total cholinesterase (CHE2-T, ACN 20370)

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test has been standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (IlI) method on a manual photometer and the published molar absorptivity ε of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Application for inhibited cholinesterase (CHE2-D, ACN 20371)
Transfer of calibration from application for total cholinesterase (CHE2-T, ACN 20370).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

Total cholinesterase (CHE2-T, ACN 20370)

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

5606

24.0

0.4

PCCC2b)

9093

45.4

0.5

Human serum 1

245

14.4

5.9

Human serum 2

1990

14.8

0.7

Human serum 3

7260

49.9

0.7

Human serum 4

8871

49.4

0.6

Human serum 5

12278

60.3

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1a)

5658

41.1

0.7

PCCC2b)

9093

66.2

0.7

Human serum 1

245

14.4

5.9

Human serum 2

1990

17.7

0.9

Human serum 3

7260

56.7

0.8

Human serum 4

8871

60.9

0.7

Human serum 5

12272

76.0

0.6

Inhibited cholinesterase (CHE2-D, ACN 20371)

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

1463

22.6

1.5

PCCC2b)

2412

20.3

0.8

Human serum 1

482

25.4

5.3

Human serum 2

1889

23.3

1.2

Human serum 3

2293

25.2

1.1

Human serum 4

3189

40.3

1.3

Human serum 5

6034

45.1

0.7

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1463

25.2

1.7

PCCC2

FREFPreciControl ClinChem Multi 2

2363

29.7

1.3

Human serum 1

482

28.3

5.9

Human serum 2

1848

30.9

1.7

Human serum 3

2315

40.1

1.7

Human serum 4

3129

43.4

1.4

Human serum 5

6034

57.3

0.9

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Total cholinesterase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.026x - 77.4 U/L

y = 1.030x - 90.4 U/L

τ = 0.992

r = 1.000

The sample activities were between 264 and 13566 U/L.

Cholinesterase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 503 analyzer using the application for inhibited cholinesterase CHE2‑D (y) were compared with those determined using the application for total cholinesterase CHE2‑T on the same analyzer (x).

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.259x + 37.4 U/L

y = 0.259x + 51.6 U/L

τ = 0.975

r = 0.998

The sample activities were between 279 and 13941 U/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFEvans RT. Cholinesterase phenotyping: clinical aspects and laboratory applications. CRC Crit Rev Clin Lab Sci 1986;23:35-64.
,
LREFGeorge PM, Joyce SL, Abernethy MH. Screening for plasma cholinesterase deficiency: an automated succinylcholine based assay. Clin Biochem 1988;21:159-162.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In preoperative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

At least 6 different genetic variants of serum cholinesterase have been described (A, F, J, K, S and U). The normal most common phenotype is designated U. The atypical forms A, F and S are described by high resistance to dibucaine inhibition (A), increased resistance to fluoride inhibition (F), and absence of catalytic activity (S). The homozygous forms AA or FF are found in only 0.3 to 0.5 % of the Caucasian population. The genotypes most susceptible to prolonged anesthesia and/or apnea after succinyldicholine administration are AA, AS, and SS (severe risk); AF, FS, and FF (moderate risk); and to some extent, UA (usually only during pregnancy). In such cases succinyldicholine anesthesia should be avoided. Measurements of total serum cholinesterase activity as well as determination of dibucaine number and fluoride number are needed to characterize cholinesterase variants fully. The dibucaine number indicates the percentage inhibition of enzyme activity in the presence of a standard concentration of dibucaine.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme. This assay is based on the method published by Schmidt et al.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

Cholinesterase Gen.2

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate (III): 2.4 mmol/L

R3

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

R1 is in position B and R3 is in position C.

Dibucaine (special reagent for ACN 20371)

R2

Dibucaine: 2.6 mmol/L, pH 6.3

R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and Warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Total cholinesterase (CHE2-T, ACN 20370)

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Specimen collection and preparation
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C
7 days at 2‑8 °C
1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108105561190c503", "ProductName": "CHE2", "ProductLongName": "Cholinesterase Gen.2", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF00000004E6730E", "DocumentOriginID": "FF00000004A8EF0E", "MaterialNumbers": [ "08105561190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of cholinesterase in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.
,
LREFGarry PJ. Serum cholinesterase variants: examination of differential inhibitors, salts, and buffers used to measure enzyme activity Clin Chem 1971;17:183-191.

Colorimetric assay

butyrylthiocholine + H2O

CHE

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured photometrically.

To determine the dibucaine number (DN), cholinesterase activity is measured with and without enzyme inhibitor dibucaine. The dibucaine number is calculated as follows:

DN = 100 −

CHE activity with inhibitor
CHE activity without inhibitor

× 100

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

Total cholinesterase (CHE2‑T, ACN 20370)

100‑14000 U/L (1.67‑234 µkat/L)

Inhibited cholinesterase (CHE2‑D, ACN 20371)

250‑7000 U/L (4.18‑117 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Total cholinesterase (CHE2‑T, ACN 20370)

Limit of Blank

= 100 U/L (1.67 µkat/L)

Limit of Detection

= 100 U/L (1.67 µkat/L)

Limit of Quantitation

= 100 U/L (1.67 µkat/L)

Inhibited cholinesterase (CHE2‑D, ACN 20371)

Limit of Blank

= 250 U/L (4.18 µkat/L)

Limit of Detection

= 250 U/L (4.18 µkat/L)

Limit of Quantitation

= 250 U/L (4.18 µkat/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the activity below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low activity samples.

The Limit of Detection corresponds to the lowest analyte activity which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte activity that can be reproducibly measured with a total error of 20 %. It has been determined using low activity cholinesterase samples.

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.

Calculated with a temperature conversion factor of 1.52 (25 → 37 °C)

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

U/L

Children, men, women (aged 40 years or more): 5320‑12920 U/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 4260‑11250 U/L

Women aged 18‑41 years, pregnant or taking contraceptives: 3650‑9120 U/L

µkat/L*

Children, men, women (aged 40 years or more): 89‑215 µkat/L

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 71‑187 µkat/L

Women aged 18‑41 years, pregnant or taking contraceptives: 61‑152 µkat/L

*calculated by unit conversion factor

Dibucaine number

Dibucaine number (DN) for the cholinesterase variants U (usual) and A (atypical):

Normal individuals

UU

Dibucaine number

≥ 73

Heterozygous individuals

UA

Dibucaine number

72‑57

Homozygous individuals

AA

Dibucaine number

≤ 50

DN results below 57 should be considered to indicate a potentially high risk of succinyldicholine sensitivity.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Total cholinesterase (CHE2‑T, ACN 20370)

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 5000 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 700 (approximate hemoglobin concentration: 435 µmol/L or 700 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

Inhibited cholinesterase (CHE2‑D, ACN 20371)

Criterion: Recovery within ± 10 % of initial value at a cholinesterase activity of 1250 U/L.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated bilirubin and 40 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL; approximate unconjugated bilirubin concentration: 684 µmol/L or 40 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 200 (approximate hemoglobin concentration: 124 µmol/L or 200 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 500. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry-over is available via the cobas link. The latest version of the carry-over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08105561190

Cholinesterase Gen.2 (1050 tests)

System‑ID 2037 001

cobas c 303, cobas c 503

Materials required (but not provided):

08105570190

Dibucaine (1050 tests)

System‑ID 2038 001

10759350190

Calibrator f.a.s. (12 × 3 mL)

Code 20401

05117003190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

CHE2-T: ACN 20370, total cholinesterase

CHE2-D: ACN 20371, inhibited cholinesterase

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition Total cholinesterase (CHE2‑T, ACN 20370)

Reporting time

10 min

Wavelength (sub/main)

700/415 nm

Reagent pipetting

Diluent (H2O)

R1

78 µL

R3

16 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.3 µL

Decreased

2.6 µL

20 µL

60 µL

Increased

1.3 µL

Test definition Inhibited cholinesterase (CHE2‑D, ACN 20371)

Reporting time

10 min

Wavelength (sub/main)

700/415 nm

Reagent pipetting

Diluent (H2O)

R1

75 µL

R2 (Special Reagent)

15 µL

R3

18 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.5 µL

Decreased

1.5 µL

Increased

1.5 µL

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

26 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Application for total cholinesterase (CHE2-T, ACN 20370)

Calibrators

S1: H2O
S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Automatic full calibration
- after reagent lot change

Full calibration
- as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test has been standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (IlI) method on a manual photometer and the published molar absorptivity ε of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Application for inhibited cholinesterase (CHE2-D, ACN 20371)
Transfer of calibration from application for total cholinesterase (CHE2-T, ACN 20370).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

Total cholinesterase (CHE2-T, ACN 20370)

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

5606

24.0

0.4

PCCC2b)

9093

45.4

0.5

Human serum 1

245

14.4

5.9

Human serum 2

1990

14.8

0.7

Human serum 3

7260

49.9

0.7

Human serum 4

8871

49.4

0.6

Human serum 5

12278

60.3

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1a)

5658

41.1

0.7

PCCC2b)

9093

66.2

0.7

Human serum 1

245

14.4

5.9

Human serum 2

1990

17.7

0.9

Human serum 3

7260

56.7

0.8

Human serum 4

8871

60.9

0.7

Human serum 5

12272

76.0

0.6

Inhibited cholinesterase (CHE2-D, ACN 20371)

Repeatability

Mean
U/L

SD
U/L

CV
%

PCCC1a)

1463

22.6

1.5

PCCC2b)

2412

20.3

0.8

Human serum 1

482

25.4

5.3

Human serum 2

1889

23.3

1.2

Human serum 3

2293

25.2

1.1

Human serum 4

3189

40.3

1.3

Human serum 5

6034

45.1

0.7

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

1463

25.2

1.7

PCCC2

FREFPreciControl ClinChem Multi 2

2363

29.7

1.3

Human serum 1

482

28.3

5.9

Human serum 2

1848

30.9

1.7

Human serum 3

2315

40.1

1.7

Human serum 4

3129

43.4

1.4

Human serum 5

6034

57.3

0.9

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Total cholinesterase values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.026x - 77.4 U/L

y = 1.030x - 90.4 U/L

τ = 0.992

r = 1.000

The sample activities were between 264 and 13566 U/L.

Cholinesterase values for human serum and plasma samples obtained on a cobas c 503 analyzer using the application for inhibited cholinesterase CHE2‑D (y) were compared with those determined using the application for total cholinesterase CHE2‑T on the same analyzer (x).

Sample size (n) = 72

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.259x + 37.4 U/L

y = 0.259x + 51.6 U/L

τ = 0.975

r = 0.998

The sample activities were between 279 and 13941 U/L.

Total cholinesterase values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 77

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.995x + 27.7 U/L

y = 0.999x + 14.5 U/L

τ = 0.981

r = 0.999

The sample activities were between 187 and 13388 U/L.

Cholinesterase values for human serum and plasma samples obtained on a cobas c 303 analyzer using the application for inhibited cholinesterase CHE2‑D (y) were compared with those determined using the application for total cholinesterase CHE2‑T on the same analyzer (x).

Sample size (n) = 74

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.258x - 8.95 U/L

y = 0.255x + 24.1 U/L

τ = 0.937

r = 0.996

The sample activities were between 1219 and 13696 U/L.

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFEvans RT. Cholinesterase phenotyping: clinical aspects and laboratory applications. CRC Crit Rev Clin Lab Sci 1986;23:35-64.
,
LREFGeorge PM, Joyce SL, Abernethy MH. Screening for plasma cholinesterase deficiency: an automated succinylcholine based assay. Clin Biochem 1988;21:159-162.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In preoperative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

At least 6 different genetic variants of serum cholinesterase have been described (A, F, J, K, S and U). The normal most common phenotype is designated U. The atypical forms A, F and S are described by high resistance to dibucaine inhibition (A), increased resistance to fluoride inhibition (F), and absence of catalytic activity (S). The homozygous forms AA or FF are found in only 0.3 to 0.5 % of the Caucasian population. The genotypes most susceptible to prolonged anesthesia and/or apnea after succinyldicholine administration are AA, AS, and SS (severe risk); AF, FS, and FF (moderate risk); and to some extent, UA (usually only during pregnancy). In such cases succinyldicholine anesthesia should be avoided. Measurements of total serum cholinesterase activity as well as determination of dibucaine number and fluoride number are needed to characterize cholinesterase variants fully. The dibucaine number indicates the percentage inhibition of enzyme activity in the presence of a standard concentration of dibucaine.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme. This assay is based on the method published by Schmidt et al.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

Cholinesterase Gen.2

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate (III): 2.4 mmol/L

R3

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

R1 is in position B and R3 is in position C.

Dibucaine (special reagent for ACN 20371)

R2

Dibucaine: 2.6 mmol/L, pH 6.3

R2 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and Warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Total cholinesterase (CHE2-T, ACN 20370)

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 26 weeks. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Specimen collection and preparation
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C
7 days at 2‑8 °C
1 year at −20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004498577190COIN", "ProductName": "CHE2", "ProductLongName": "Cholinesterase Gen.2", "Language": "en", "DocumentVersion": "6", "DocumentObjectID": "FF0000000474F40E", "DocumentOriginID": "FF000000008A850E", "MaterialNumbers": [ "04498577190" ], "InstrumentReferences": [ { "ID": "302", "BrandName": "COBAS INTEGRA 400 plus" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of the catalytic activity of cholinesterase (EC 3.1.1.8; acylcholine acylhydrolase) in serum and plasma

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Method with butyrylthiocholine.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured at wavelengths between 405 and 415 nm.

butyrylthiocholine + H2O

CHE

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

200‑14000 U/L (3.34‑234 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test:
200 U/L (3.34 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of a zero sample (zero sample + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.
,*

Women aged 40 years or more, children, men:
5320‑12920 U/L (89‑215 µkat/L)

Women aged 16‑39 years, not pregnant, not using hormonal contraceptives:
4260‑11250 U/L (71‑187 µkat/L)

Women aged 18‑41 years, pregnant or taking contraceptives:
3650‑9120 U/L (61‑152 µkat/L)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

*Calculated with a temperature conversion factor of 1.52 (25 → 37 °C).

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Limitations - interference

Criterion: Recovery within ± 10 % of initial value.

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference.

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 350 (approximate hemoglobin concentration: 217 µmol/L or 350 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

Anticoagulants: Citrate and fluoride inhibit the reaction and must not be used.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on COBAS INTEGRA analyzers. Refer to the CLEAN Method Sheet for further instructions and for the latest version of the Extra wash cycle list.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

Orderinformation_INT

Order information

Analyzer(s) on which cobas c pack(s) can be used

04498577 190

Cholinesterase Gen.2 (200 tests)

System-ID 07 6842 1

COBAS INTEGRA 400 plus

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 × 3 mL)

System-ID 07 3718 6

10759350 360

Calibrator f.a.s. (12 × 3 mL, for USA)

System-ID 07 3718 6

12149435 122

Precinorm U plus (10 × 3 mL)

System-ID 07 7999 7

12149435 160

Precinorm U plus (10 × 3 mL, for USA)

System-ID 07 7999 7

12149443 122

Precipath U plus (10 × 3 mL)

System-ID 07 8000 6

12149443 160

Precipath U plus (10 × 3 mL, for USA)

System-ID 07 8000 6

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

System-ID 07 7469 3

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

System-ID 07 7469 3

05947626 160

PreciControl ClinChem Multi 1 (4 × 5 mL, for USA)

System-ID 07 7469 3

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

System-ID 07 7470 7

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

System-ID 07 7470 7

05947774 160

PreciControl ClinChem Multi 2 (4 × 5 mL, for USA)

System-ID 07 7470 7

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

Test CHE2, test ID 0‑021

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

Test definition

Measuring mode

Absorbance

Abs. calculation mode

Kinetic

Reaction mode

R1‑S‑SR

Reaction direction

Decrease

Wavelength A/B

409/659 nm

Calc. first/last

43/52

Unit

U/L

Pipetting parameters

Diluent (H2O)

R1

120 µL

Sample

2 µL

5 µL

SR

24 µL

Total volume

151 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C

See expiration date on cobas c pack label

On-board in use at 10‑15 °C

weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibration

Calibrator

Calibrator f.a.s.

Use deionized water as zero calibrator.

Calibration mode

Linear regression

Calibration replicate

Duplicate recommended

Calibration interval

Each lot

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test is standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (III) method on a photometer and the published molar absorptivity of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the COBAS INTEGRA analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (1 aliquot per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Intermediate precision

Sample

Mean

CV

Mean

CV

U/L

µkat/L

%

U/L

µkat/L

%

Human serum

6374

106

0.5

6675

111

1.4

Precinorm U

6263

105

0.6

6213

104

1.1

Precipath U

6015

100

0.6

5964

100

0.9

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

CHE values for human serum samples obtained on a COBAS INTEGRA 800 analyzer using the Roche CHE2 reagent (y) were compared with those determined using the Roche CHE reagent on the same analyzer (x).

Sample size (n) = 51

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.970× + 128 (U/L)

т = 0.967

SD (md95) = 125

y = 0.965× + 153 (U/L)

r = 0.999

Sy.x = 37.1

The sample activities were between 1192 U/L and 14411 U/L (19.9‑241 µkat/L).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In pre‑operative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme.

This assay is based on the method published by Schmidt E et al. in 1992.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

Reagents - working solutions

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate : 2.4 mmol/L

SR

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

R1 is in position B and SR is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

Reference range

Precinorm U plus or PreciControl ClinChem Multi 1

Pathological range

Precipath U plus or PreciControl ClinChem Multi 2

Control interval

24 hours recommended

Control sequence

User defined

Control after calibration

Recommended

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable:
Serum: Collect serum using standard sampling tubes.
Plasma: Li‑heparin, K2‑EDTA or K3‑EDTA plasma.

Do not use citrate and fluoride plasma.

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

See the limitations and interferences section for details about possible sample interferences.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C

7 days at 2‑8 °C

1 year at ‑20 °C

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004498577190c501", "ProductName": "CHE2", "ProductLongName": "Cholinesterase Gen.2", "Language": "en", "DocumentVersion": "10", "DocumentObjectID": "FF0000000474DD0E", "DocumentOriginID": "FF0000000024C70E", "MaterialNumbers": [ "04498577190" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

In vitro test for the quantitative determination of cholinesterase in human serum and plasma on Roche/Hitachi cobas c systems.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

Test principle
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Colorimetric assay

CHE

butyrylthiocholine + H2O

thiocholine + butyrate

thiocholine + potassium hexacyanoferrate (III)

dithiobis(choline) + potassium hexacyanoferrate (II)

Cholinesterase catalyzes the hydrolysis of butyrylthiocholine to thiocholine and butyrate. Thiocholine instantaneously reduces the yellow hexacyanoferrate (III) to the almost colorless hexacyanoferrate (II). This decrease in color can be measured photometrically.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Limits and ranges

Measuring range

100‑14000 U/L (1.67‑234 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:2 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 2.

Lower limits of measurement

Lower detection limit of the test

100 U/L (1.67 µkat/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 3 standard deviations above that of the lowest standard (standard 1 + 3 SD, repeatability, n = 21).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

Expected values
LREFden Blaauwen DH, Poppe WA, Tritschler W.Cholinesterase (EC 3.1.1.8) mit Butyrylthiocholiniodid als Substrat:Referenzwerte in Abhängigkeit von Alter und Geschlecht unter Berücksichtigung hormonaler Einflüsse und Schwangerschaft. J Clin Chem Clin Biochem 1983;21:381-386.
,a

Children, men, women (aged 40 years or more): 5320‑12920 U/L (89‑215.3 µkat/L)

Women aged 16‑39 years, not pregnant, not taking hormonal contraceptives: 4260‑11250 U/L (71‑187 µkat/L)

Women aged 18‑41 years, pregnant or taking contraceptives: 3650‑9120 U/L (61‑152 µkat/L)

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

Roche has not evaluated reference ranges in a pediatric population.

a) Calculated with a temperature conversion factor of 1.52 (25 → 37 °C)

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

Criterion: Recovery within ± 10 % of initial values at a cholinesterase activity of 5000 U/L (83.5 µkat/L).

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 60 for conjugated and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 1026 µmol/L or 60 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 700 (approximate hemoglobin concentration: 435 µmol/L or 700 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Drugs: No interference was found at therapeutic concentrations using common drug panels.

LREFBreuer J. Report on the Symposium "Drug effects in Clinical Chemistry Methods". Eur J Clin Chem Clin Biochem 1996;34:385-386.
,
LREFSonntag O, Scholer A. Drug interference in clinical chemistry: recommendation of drugs and their concentrations to be used in drug interference studies. Ann Clin Biochem 2001;38:376-385.

In very rare cases, gammopathy, in particular type IgM (Waldenström’s macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med 2007;45(9):1240-1243.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is required in certain cases.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

04498577 190

Cholinesterase Gen.2 (200 tests)

System‑ID 07 6842 1

Roche/Hitachi cobas c 311, cobas c 501/502

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 x 3 mL)

Code 401

10759350 360

Calibrator f.a.s. (12 x 3 mL, for USA)

Code 401

12149435 122

Precinorm U plus (10 x 3 mL)

Code 300

12149435 160

Precinorm U plus (10 x 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 x 3 mL)

Code 301

12149443 160

Precipath U plus (10 x 3 mL, for USA)

Code 301

10171743 122

Precinorm U (20 x 5 mL)

Code 300

10171735 122

Precinorm U (4 x 5 mL)

Code 300

10171778 122

Precipath U (20 x 5 mL)

Code 301

10171760 122

Precipath U (4 x 5 mL)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 391

05947626 160

PreciControl ClinChem Multi 1 (4 x 5 mL, for USA)

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 392

05947774 160

PreciControl ClinChem Multi 2 (4 x 5 mL, for USA)

Code 392

04489357 190

Diluent NaCl 9 % (50 mL)

System‑ID 07 6869 3

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

For cobas c 311/501 analyzers:

CHE2: ACN 510

For cobas c 502 analyzer:

CHE2: ACN 8510

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for serum and plasma

cobas c 311 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 29‑40

Wavelength (sub/main)

700/415 nm

Reaction direction

Decrease

Units

U/L (µkat/L, kU/L)

Reagent pipetting

Diluent (H2O)

R1

120 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2 µL

Decreased

10 µL

15 µL

135 µL

Increased

2 µL

cobas c 501 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 44‑54

Wavelength (sub/main)

700/415 nm

Reaction direction

Decrease

Units

U/L (µkat/L, kU/L)

Reagent pipetting

Diluent (H2O)

R1

120 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2 µL

Decreased

10 µL

15 µL

135 µL

Increased

2 µL

cobas c 502 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 44‑54

Wavelength (sub/main)

700/415 nm

Reaction direction

Decrease

Units

U/L (µkat/L, kU/L)

Reagent pipetting

Diluent (H2O)

R1

120 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2 µL

Decreased

10 µL

15 µL

135 µL

Increased

4 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

CHE2

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

4 weeks

Diluent NaCl 9 %

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

12 weeks

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

2‑point calibration
• after reagent lot change
• as required following quality control procedures

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This test has been standardized against a reference method using a manual application of the butyrylthiocholine/hexacyanoferrate (IlI) method on a manual photometer and the published molar absorptivity ε of hexacyanoferrate (III).

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

Precision was determined using human samples and controls in an internal protocol with repeatability (n = 21) and intermediate precision (3 aliquots per run, 1 run per day, 21 days). The following results were obtained:

Repeatability

Mean

U/L (µkat/L)

SD

U/L (µkat/L)

CV

%

Precinorm U

4887 (81.6)

25 (0.4)

0.5

Precipath U

5331 (89.0)

27 (0.5)

0.5

Human serum 1

5916 (98.8)

28 (0.5)

0.5

Human serum 2

7313 (122)

38 (1)

0.5

Intermediate precision

Mean

U/L (µkat/L)

SD

U/L (µkat/L)

CV

%

Precinorm U

4707 (78.6)

49 (0.8)

1.0

Precipath U

4838 (80.8)

45 (0.8)

0.9

Human serum 3

1002 (16.7)

26 (0.4)

2.6

Human serum 4

6683 (112)

74 (1)

1.1

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "MethodComparison", "Value": "

Method comparison

Cholinesterase values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a COBAS INTEGRA 700 analyzer (x).

Sample size (n) = 89

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.019x - 177 U/L

y = 1.018x - 178 U/L

τ = 0.963

r = 0.999

The sample activities were between 2184 and 12525 U/L (36.5 and 209 µkat/L).

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

Summary
LREFMoss DW, Henderson AR, Kachmar JF. Enzymes. In: Tietz NW, ed. Fundamentals of Clinical Chemistry, 3rd ed. Philadelphia, PA: WB Saunders 1987;346-421.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

Cholinesterase (pseudocholinesterase or cholinesterase II) is found in the liver, pancreas, heart, serum and in the white matter of the brain. This enzyme must not be confused with acetylcholinesterase from erythrocytes (EC 3.1.1.7), which is also referred to as cholinesterase I.

The biological function of cholinesterase is unknown. Serum cholinesterase serves as an indicator of possible insecticide poisoning. It is measured as an index of liver function. In preoperative screening, cholinesterase is used to detect patients with atypical forms of the enzyme and hence avoid prolonged apnea caused by slow elimination of muscle relaxants.

Depressed cholinesterase levels are found in cases of intoxication with organophosphorus compounds and in hepatitis, cirrhosis, myocardial infarction, acute infections and atypical phenotypes of the enzyme. This assay is based on the method published by Schmidt et al.

LREFSchmidt E, Gerhardt W, Henkel E, et al. Proposal of Standard Methods for the Determination of Enzyme Catalytic Concentrations in Serum and Plasma at 37 °C. Eur J Clin Chem Clin Biochem 1992;30:163-170.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Pyrophosphate buffer: 92 mmol/L, pH 7.7; potassium hexacyanoferrate (III): 2.4 mmol/L

R3

GOOD's buffer: 10 mmol/L, pH 4.0; butyrylthiocholine: 46 mmol/L; stabilizers

R1 is in position B and R3 is in position C.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

Specimen collection and preparation
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.
Serum.
Plasma: Li‑heparin and K2‑EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

Stability:

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;132-133.
,
LREFUse of Anticoagulants in Diagnostic Laboratory Investigations. WHO Publication WHO/DIL/LAB/99.1 Rev. 2: Jan 2002.
,
LREFHuizenga JR, van der Belt K, Gips CH. The Effect of Storage at Different Temperatures on Cholinesterase Activity in Human Serum. J Clin Chem Clin Biochem 1985;24:283-385.

6 hours at 15‑25 °C

7 days at 2‑8 °C

1 year at -20 °C

", "Language": "en" } ] } } ] }

CHE2

Cholinesterase Gen.2

IVD For in vitro diagnostic use.
CHE2

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