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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 γ‑glutamyltransferase (GGT) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

γ‑glutamyltransferase transfers the γ‑glutamyl group of L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to glycylglycine.

GGT

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide + glycylglycine

L‑γ‑glutamyl‑glycylglycine + 5‑amino‑2‑nitrobenzoate

The amount of 5‑amino‑2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance photometrically.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:11 dilution. Results from samples diluted using the rerun function are automatically multiplied by 11.

Lower limits of measurement

Lower detection limit of the test

3 U/L (0.05 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 (< 3 U/L) will not be flagged by the instrument.

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

Expected values

Standardized against Szasz (Persijn, van der Slik)

LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.

Men

8‑61 U/L

0.13‑1.02 µkat/L

Women

5‑36 U/L

0.08‑0.60 µkat/L

Standardized against IFCC

Reference Interval Study at 37 °C (corrected in 2005)

LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10‑71 U/L

0.17‑1.19 µkat/L

Women (n = 228)

6‑42 U/L

0.10‑0.70 µkat/L

Consensus values (IFCC)

LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005;29(5):301-308.

Men

< 60 U/L

< 1.00 µkat/L

Women

< 40 U/L

<  0.67 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.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a γ‑glutamyltransferase activity of 40 U/L (0.67 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 50 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 855 µmol/L or 50 mg/dL) and approximate unconjugated bilirubin concentration: 342 µmol/L or 20 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 700. 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)

Standardized against IFCC / Szasz

Order information

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

05168775 190*

γ‑Glutamyltransferase ver.2 (1200 tests)

System‑ID 03 6598 8

Roche/Hitachi cobas c 701/702

05168775 214*

γ‑Glutamyltransferase ver.2 (1200 tests)

System‑ID 03 6598 8

Roche/Hitachi cobas c 701/702

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

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.

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

System information

GGTI2: ACN 8220: assay standardized against IFCC

GGTS2: ACN 8480: assay standardized against Szasz

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

Reagent handling

Ready for use

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

Application for serum and plasma

cobas c 701/702 test definition

Assay type

Rate A

Reaction time / Assay points

10/25‑38

Wavelength (sub/main)

700/415 nm

Reaction direction

Increase

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

25 µL

75 µL

R3

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

3 µL

15 µL

150 µL

Increased

6 µL

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

Storage and stability

GGT‑2

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label.

On‑board in use and refrigerated on the analyzer:

2 weeks

On‑board on the Reagent Manager:

1 hour

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

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 method has been standardized against the original IFCC formulation (2002)

LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
and against the GGT method published by Persijn and van der Slik (1976)
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
, respectively.

Use the appropriate calibrator value for the corresponding application.

", "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

39.2 (0.655)

0.5 (0.008)

1.4

Precipath U

181 (3.02)

1 (0.02)

0.5

Human serum A

18.0 (0.301)

0.6 (0.010)

3.3

Human serum B

472 (7.88)

2 (0.03)

0.3

Human serum C

867 (14.5)

4 (0.1)

0.5

Intermediate precision

Mean

U/L (µkat/L)

SD

U/L (µkat/L)

CV

%

Precinorm U

44.1 (0.736)

0.8 (0.013)

1.8

Precipath U

221 (3.69)

4 (0.07)

1.7

Human serum 3

46.8 (0.782)

1.5 (0.025)

3.2

Human serum 4

256 (4.28)

9 (0.15)

3.7

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

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

Method comparison

γ‑glutamyltransferase 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 a Roche/Hitachi cobas c 501 analyzer (x).

Sample size (n) = 103

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 = 1.014x - 0.39 U/L

y = 1.017x - 0.474 U/L

τ = 0.992

r = 1.000

The sample activities were between 14.0 and 1168 U/L (0.234 and 19.5 µkat/L).

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

Summary

Summary
LREFThomas L, ed. Labor und Diagnose, 4th ed. Marburg: Die Medizinische Verlagsgesellschaft 1992.
,
LREFShaw LM. Keeping pace with a popular enzyme GGT Diagnostic Medicine 1982.
,
LREFSzasz G. A kinetic photometric method for serum γ-glutamyl-transferase. J Clin Chem 1969;15:124-136.
,
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
,
LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
,
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:907-909.

γ‑glutamyltransferase is used in the diagnosis and monitoring of hepatobiliary diseases. Enzymatic activity of GGT is often the only parameter with increased values when testing for such diseases, and is one of the most sensitive indicators known. γ‑glutamyltransferase is also a sensitive screening test for occult alcoholism. Elevated GGT activities are found in the serum of patients requiring long‑term medication with phenobarbital and phenytoin.

In 1969, Szasz published the first kinetic procedure for GGT in serum using γ‑glutamyl‑p‑nitroanilide as substrate and glycylglycine as acceptor. In order to circumvent the poor solubility of γ‑glutamyl‑p‑nitroanilide, Persijn and van der Slik investigated various derivatives and found the water‑soluble substrate L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to be superior in terms of stability and solubility. The results correlate with those derived using the original substrate.

In 2002, the International Federation of Clinical Chemistry (IFCC) recommended the standardized method for determining GGT including optimization of substrate concentrations, employment of NaOH, glycylglycine buffer and sample start. The GGT liquid reagent follows the formulation recommendation according to Szasz, but was optimized for performance and stability. The assay is optionally standardized against the original IFCC and Szasz methods. The performance claims and data presented here are independent from the standardization.

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

Reagents - working solutions

R1

TRIS: 492 mmol/L, pH 8.25; glycylglycine: 492 mmol/L; preservative; additive

R3

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide: 22.5 mmol/L; acetate: 10 mmol/L, pH 4.5; stabilizer; preservative

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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

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 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:

LREFSzasz G. Methods of Enzymatic Analysis. 2nd English ed. New York. Academic Press, Inc 1974;717.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;286.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "08542821001", "ProductName": "GGT-2", "ProductLongName": "γ-Glutamyltransferase ver.2", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF00000004AE970E", "DocumentOriginID": "FF000000028C2C0E", "MaterialNumbers": [ "05168775188" ], "InstrumentReferences": [ { "ID": "2492", "BrandName": "cobas c 702" }, { "ID": "310", "BrandName": "cobas c 701" } ], "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": "", "Language": "en" }, { "Name": "TestPrinciple", "Value": "", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "", "Language": "en" }, { "Name": "LimitationInterference", "Value": "", "Language": "en" }, { "Name": "OrderInformation", "Value": "", "Language": "en" }, { "Name": "SystemInformation", "Value": "", "Language": "en" }, { "Name": "Handling", "Value": "", "Language": "en" }, { "Name": "TestDefinition", "Value": "", "Language": "en" }, { "Name": "StorageStability", "Value": "", "Language": "en" }, { "Name": "Calibration", "Value": "", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "", "Language": "en" }, { "Name": "Precision", "Value": "", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "", "Language": "en" }, { "Name": "Reagents", "Value": "", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108057796190c503", "ProductName": "GGT-2", "ProductLongName": "γ-Glutamyltransferase ver.2 - Standardized against IFCC / Szasz", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF0000000499CC0E", "DocumentOriginID": "FF0000000468590E", "MaterialNumbers": [ "08057796190" ], "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 γ‑glutamyltransferase (GGT) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

γ‑glutamyltransferase transfers the γ‑glutamyl group of L‑γ‑glutamyl-3‑carboxy-4‑nitroanilide to glycylglycine.

L‑γ‑glutamyl-3-carboxy-4-nitroanilide + glycylglycine

GGT

L-γ-glutamyl-glycylglycine + 5-amino-2-nitrobenzoate

The amount of 5‑amino‑2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance photometrically.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:11 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 11.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 3 U/L (0.05 µkat/L)

Limit of Detection

= 3 U/L (0.05 µkat/L)

Limit of Quantitation

= 3 U/L (0.05 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 γ‑glutamyltransferase samples.

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

Expected values

U/L

Standardized against Szasz (Persijn, van der Slik)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.

Men

8-61 U/L

Women

5-36 U/L

Standardized against IFCC
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10-71 U/L

Women (n = 228)

6-42 U/L

Consensus values (IFCC)
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 60 U/L

Women

< 40 U/L

µkat/L

Standardized against Szasz (Persijn, van der Slik)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,*

Men

0.13-1.02 µkat/L

Women

0.08-0.60 µkat/L

Standardized against IFCC
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].
,*

Men (n = 216)

0.17-1.19 µkat/L

Women (n = 228)

0.10-0.70 µkat/L

Consensus values (IFCC)
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 1.00 µkat/L

Women

< 0.67 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.

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

Limitations - interferences

Criterion: Recovery within ± 10 % of initial value at a γ‑glutamyltransferase activity of 40 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 50 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 855 µmol/L or 50 mg/dL and approximate unconjugated bilirubin concentration: 342 µmol/L or 20 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 1500. 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 - Hitachi)

Order information

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

08057796190

γ‑Glutamyltransferase ver.2 (400 tests)

System‑ID 2060 001

cobas c 303, cobas c 503

Materials required (but not provided):

10759350190

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05117003190

PreciControl ClinChem Multi 1 (20 x 5 mL)

Code 20391

05947626190

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05117216190

PreciControl ClinChem Multi 2 (20 x 5 mL)

Code 20392

05947774190

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

GGT2-I: ACN 20600: assay standardized against IFCC

GGT2-S: ACN 20601: assay standardized against Szasz

", "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

19 µL

57 µL

R3

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.3 µL

Decreased

2.3 µL

10 µL

100 µL

Increased

2.3 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:

12 weeks

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Use the appropriate calibrator value for the corresponding application.

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

Traceability: This method has been standardized against the original IFCC formulation (2002)

LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
and against the GGT method published by Persijn and van der Slik (1976)
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
, respectively.

", "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
%

PCCC1a)

45.8

0.382

0.8

PCCC2b)

207

0.772

0.4

Human serum 1

8.57

0.449

5.2

Human serum 2

30.9

0.646

2.1

Human serum 3

62.7

0.679

1.1

Human serum 4

598

3.55

0.6

Human serum 5

1155

6.04

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

45.6

0.463

1.0

PCCC2

FREFPreciControl ClinChem Multi 2

207

1.67

0.8

Human serum 1

7.97

0.420

5.3

Human serum 2

30.6

0.703

2.3

Human serum 3

62.7

0.708

1.1

Human serum 4

598

3.69

0.6

Human serum 5

1161

10.6

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

γ‑glutamyltransferase 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) = 65

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 = 1.014x − 1.98 U/L

y = 1.023x − 1.96 U/L

τ = 0.981

r = 0.999

The sample activities were between 4.81 and 941 U/L.

γ‑glutamyltransferase 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) = 75

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 = 1.010x + 1.44 U/L

y = 1.019x + 0.534 U/L

τ = 0.982

r = 1.000

The sample activities were between 3.10 and 1001 U/L.

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

Summary

Summary
LREFThomas L, ed. Labor und Diagnose, 4th ed. Marburg: Die Medizinische Verlagsgesellschaft 1992.
,
LREFShaw LM. Keeping pace with a popular enzyme GGT. Diagnostic Medicine May/June 1982;1–8.
,
LREFSzasz G. A kinetic photometric method for serum γ-glutamyl-transferase. J Clin Chem 1969;15:124-136.
,
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
,
LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
,
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

γ‑glutamyltransferase is used in the diagnosis and monitoring of hepatobiliary diseases. Enzymatic activity of GGT is often the only parameter with increased values when testing for such diseases, and is one of the most sensitive indicators known. γ‑glutamyltransferase is also a sensitive screening test for occult alcoholism. Elevated GGT activities are found in the serum of patients requiring long-term medication with phenobarbital and phenytoin.

In 1969, Szasz published the first kinetic procedure for GGT in serum using γ‑glutamyl‑p‑nitroanilide as substrate and glycylglycine as acceptor. In order to circumvent the poor solubility of γ‑glutamyl‑p‑nitroanilide, Persijn and van der Slik investigated various derivatives and found the water‑soluble substrate L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to be superior in terms of stability and solubility. The results correlate with those derived using the original substrate.

In 2002, the International Federation of Clinical Chemistry (IFCC) recommended the standardized method for determining GGT including optimization of substrate concentrations, employment of NaOH, glycylglycine buffer and sample start. The GGT liquid reagent follows the formulation recommendation according to Szasz, but was optimized for performance and stability. The assay is optionally standardized against the original IFCC and Szasz methods. The performance claims and data presented here are independent from the standardization.

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

Reagents - working solutions

R1

TRIS: 492 mmol/L, pH 8.25; glycylglycine: 492 mmol/L; preservative; additive

R3

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide: 22.5 mmol/L; acetate: 10 mmol/L, pH 4.5; stabilizer; preservative

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

", "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 12 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

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 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:

LREFSzasz G. Methods of Enzymatic Analysis. 2nd English ed. New York. Academic Press, Inc 1974;717.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;286.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °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": "0208057796190c503", "ProductName": "GGT-2", "ProductLongName": "γ-Glutamyltransferase ver.2 - Standardized against IFCC / Szasz", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000005B5F50E", "DocumentOriginID": "FF00000005B5F50E", "MaterialNumbers": [ "08057796190" ], "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 γ‑glutamyltransferase (GGT) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

γ‑glutamyltransferase transfers the γ‑glutamyl group of L‑γ‑glutamyl-3‑carboxy-4‑nitroanilide to glycylglycine.

L‑γ‑glutamyl-3-carboxy-4-nitroanilide + glycylglycine

GGT

L-γ-glutamyl-glycylglycine + 5-amino-2-nitrobenzoate

The amount of 5‑amino‑2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance photometrically.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:11 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 11.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 3 U/L (0.05 µkat/L)

Limit of Detection

= 3 U/L (0.05 µkat/L)

Limit of Quantitation

= 3 U/L (0.05 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 γ‑glutamyltransferase samples.

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

Expected values

U/L

Standardized against Szasz (Persijn, van der Slik)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.

Men

8-61 U/L

Women

5-36 U/L

Standardized against IFCC
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10-71 U/L

Women (n = 228)

6-42 U/L

Consensus values (IFCC)
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 60 U/L

Women

< 40 U/L

µkat/L

Standardized against Szasz (Persijn, van der Slik)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,*

Men

0.13-1.02 µkat/L

Women

0.08-0.60 µkat/L

Standardized against IFCC
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].
,*

Men (n = 216)

0.17-1.19 µkat/L

Women (n = 228)

0.10-0.70 µkat/L

Consensus values (IFCC)
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 1.00 µkat/L

Women

< 0.67 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.

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

Limitations - interferences

Criterion: Recovery within ± 10 % at a γ-glutamyltransferase activity of 40 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 50 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 855 µmol/L or 50 mg/dL and approximate unconjugated bilirubin concentration: 342 µmol/L or 20 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 1500. 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 - Hitachi)

Order information

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

08057796190

γ‑Glutamyltransferase ver.2 (400 tests)

System‑ID 2060 001

cobas c 303, cobas c 503

10759350360

Calibrator f.a.s. (12 x 3 mL)

Code 20401

05947626160

PreciControl ClinChem Multi 1 (4 x 5 mL)

Code 20391

05947774160

PreciControl ClinChem Multi 2 (4 x 5 mL)

Code 20392

08063494190

Diluent NaCl 9 % (123 mL)

System‑ID 2906 001

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

System information

GGT2-I: ACN 20600: assay standardized against IFCC

GGT2-S: ACN 20601: assay standardized against Szasz

", "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

19 µL

57 µL

R3

15 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.3 µL

Decreased

2.3 µL

10 µL

100 µL

Increased

2.3 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:

12 weeks

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

Calibration

Calibrators

S1: H2O

S2: C.f.a.s.

Calibration mode

Linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

Use the appropriate calibrator value for the corresponding application.

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

Traceability: This method has been standardized against the original IFCC formulation (2002)

LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
and against the GGT method published by Persijn and van der Slik (1976)
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
, respectively.

", "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
%

PCCC1a)

45.8

0.382

0.8

PCCC2b)

207

0.772

0.4

Human serum 1

8.57

0.449

5.2

Human serum 2

30.9

0.646

2.1

Human serum 3

62.7

0.679

1.1

Human serum 4

598

3.55

0.6

Human serum 5

1155

6.04

0.5

Intermediate precision

Mean
U/L

SD
U/L

CV
%

PCCC1

FREFPreciControl ClinChem Multi 1

45.6

0.463

1.0

PCCC2

FREFPreciControl ClinChem Multi 2

207

1.67

0.8

Human serum 1

7.97

0.420

5.3

Human serum 2

30.6

0.703

2.3

Human serum 3

62.7

0.708

1.1

Human serum 4

598

3.69

0.6

Human serum 5

1161

10.6

0.9

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

Method comparison

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

Sample size (n) = 65

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 = 1.014x − 1.98 U/L

y = 1.023x − 1.96 U/L

τ = 0.981

r = 0.999

The sample activities were between 4.81 and 941 U/L.

γ‑glutamyltransferase 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) = 75

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 = 1.010x + 1.44 U/L

y = 1.019x + 0.534 U/L

τ = 0.982

r = 1.000

The sample activities were between 3.10 and 1001 U/L.

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

Summary

Summary
LREFThomas L, ed. Labor und Diagnose, 4th ed. Marburg: Die Medizinische Verlagsgesellschaft 1992.
,
LREFShaw LM. Keeping pace with a popular enzyme GGT. Diagnostic Medicine May/June 1982;1–8.
,
LREFSzasz G. A kinetic photometric method for serum γ-glutamyl-transferase. J Clin Chem 1969;15:124-136.
,
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
,
LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
,
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

γ‑glutamyltransferase is used in the diagnosis and monitoring of hepatobiliary diseases. Enzymatic activity of GGT is often the only parameter with increased values when testing for such diseases, and is one of the most sensitive indicators known. γ‑glutamyltransferase is also a sensitive screening test for occult alcoholism. Elevated GGT activities are found in the serum of patients requiring long-term medication with phenobarbital and phenytoin.

In 1969, Szasz published the first kinetic procedure for GGT in serum using γ‑glutamyl‑p‑nitroanilide as substrate and glycylglycine as acceptor. In order to circumvent the poor solubility of γ‑glutamyl‑p‑nitroanilide, Persijn and van der Slik investigated various derivatives and found the water‑soluble substrate L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to be superior in terms of stability and solubility. The results correlate with those derived using the original substrate.

In 2002, the International Federation of Clinical Chemistry (IFCC) recommended the standardized method for determining GGT including optimization of substrate concentrations, employment of NaOH, glycylglycine buffer and sample start. The GGT liquid reagent follows the formulation recommendation according to Szasz, but was optimized for performance and stability. The assay is optionally standardized against the original IFCC and Szasz methods. The performance claims and data presented here are independent from the standardization.

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

Reagents - working solutions

R1

TRIS: 492 mmol/L, pH 8.25; glycylglycine: 492 mmol/L; preservative; additive

R3

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide: 22.5 mmol/L; acetate: 10 mmol/L, pH 4.5; stabilizer; preservative

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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "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 12 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

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 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:

LREFSzasz G. Methods of Enzymatic Analysis. 2nd English ed. New York. Academic Press, Inc 1974;717.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;286.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °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": "05402425001", "ProductName": "GGT-2 ", "ProductLongName": "γ-Glutamyltransferase ver.2", "Language": "en", "DocumentVersion": "7", "DocumentObjectID": "FF000000047BB90E", "DocumentOriginID": "FF00000000ADCA0E", "MaterialNumbers": [ "05401461190" ], "InstrumentReferences": [ { "ID": "307", "BrandName": "cobas c 111" } ], "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 γ‑glutamyltransferase in human serum and plasma on the cobas c 111 system.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

γ‑glutamyltransferase transfers the γ‑glutamyl group of L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to glycylglycine.

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide + glycylglycine

GGT

L‑γ‑glutamyl‑glycylglycine + 5‑amino‑2‑nitrobenzoate

The amount of 5‑amino‑2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance photometrically.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

Lower limits of measurement

Lower detection limit of the test:
3 U/L (0.05 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

Standardized against Szasz (Persijn, van der Slik)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.

Men

8‑61 U/L

(0.13‑1.02 µkat/L)

Women

5‑36 U/L

(0.08‑0.60 µkat/L)

Standardized against IFCC
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10‑71 U/L

(0.17‑1.19 µkat/L)

Women (n = 228)

6‑42 U/L

(0.10‑0.70 µkat/L)

Consensus values (IFCC)
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 60 U/L

(< 1.00 µkat/L)

Women

< 40 U/L

(< 0.67 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.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at a γ‑glutamyltransferase activity of 40 U/L (0.668 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 20 for conjugated bilirubin and 48 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 342 µmol/L or 20 mg/dL; approximate unconjugated bilirubin concentration: 821 µmol/L or 48 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 250 (approximate hemoglobin concentration: 402 µmol/L or 250 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 800. 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 the cobas c 111 analyzer. For information about test combinations requiring special wash steps, please refer to the latest version of the carry-over evasion list found with the CLEAN Method Sheet and the operator’s manual for further instructions.
Where required, special wash/carry-over evasion programming must be implemented prior to reporting results with this test.

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

OrderInformation_111 (CC Reagents - cobas + Integra)

Standardized against IFCC / Szasz
Order information

Analyzer(s) on which kit(s) can be used

05401461 190

γ-Glutamyltransferase ver.2 (2 × 100 tests)

cobasc 111

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 × 3 mL)

Code 401

10759350 360

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

Code 401

12149435 122

Precinorm U plus (10 × 3 mL)

Code 300

12149435 160

Precinorm U plus (10 × 3 mL, for USA)

Code 300

12149443 122

Precipath U plus (10 × 3 mL)

Code 301

12149443 160

Precipath U plus (10 × 3 mL, for USA)

Code 301

05117003 190

PreciControl ClinChem Multi 1 (20 × 5 mL)

Code 391

05947626 190

PreciControl ClinChem Multi 1 (4 × 5 mL)

Code 391

05947626 160

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

Code 391

05117216 190

PreciControl ClinChem Multi 2 (20 × 5 mL)

Code 392

05947774 190

PreciControl ClinChem Multi 2 (4 × 5 mL)

Code 392

05947774 160

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

Code 392

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

System information

GGTS2:

ACN 480

Szasz standardization

GGTI2:

ACN 220

IFCC standardization - Not for use in the US

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

Reagent handling

Ready for use

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

Application for serum and plasma

cobas c 111 test definition

Measuring mode

Absorbance

Abs. calculation mode

Kinetic

Reaction direction

Increase

Wavelength A/B

409/659 nm

Calc. first/last

26/38

Unit

U/L

Reaction mode

R1‑S‑SR

Pipetting parameters

Diluent (H2O)

R1

25 µL

35 µL

Sample

3 µL

20 µL

SR

20 µL

20 µL

Total volume

123 µL

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

Storage and stability

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on reagent

On-board in use and refrigerated on the analyzer:

3 weeks

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

Calibration

Calibration

Calibrators

Calibrator f.a.s.

Standard 2 is defined by a fixed value.

Calibration mode

Linear regression

Calibration interval

Each lot and as required following quality control procedures.

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

Traceability: This method has been standardized against the original IFCC formulation (2002)

LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
and against the GGT method published by Persijn and van der Slik (1976),
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
respectively.
Use the appropriate calibrator value for the corresponding application.

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

Specific performance data

Representative performance data on the cobas c 111 analyzer 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, 10 days). The following results were obtained:

Repeatability

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

44.2 (0.74)

0.6 (0.01)

1.4

Precipath U

221 (3.69)

1 (0.02)

0.4

Human serum 1

29.1 (0.49)

0.6 (0.01)

1.9

Human serum 2

481 (8.03)

2 (0.03)

0.4

Intermediate precision

Mean
U/L (µkat/L)

SD
U/L (µkat/L)

CV
%

Precinorm U

38.3 (0.64)

0.7 (0.01)

1.9

Precipath U

194 (3.24)

1 (0.02)

0.7

Human serum 3

18.1 (0.30)

0.6 (0.01)

3.5

Human serum 4

322 (5.38)

2 (0.03)

0.6

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

Method comparison

γ‑glutamyltransferase values for human serum and plasma samples obtained on a cobas c 111 analyzer (y) using the γ‑Glutamyltransferase ver.2 reagent (GGT‑2) and the application GGTS2 were compared with those determined using the corresponding reagent on a COBAS INTEGRA 400 analyzer (x).
Sample size (n) = 79

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 = 1.017× - 0.829 U/L

т = 0.982

y = 1.022× - 1.03 U/L

r = 1.00

The sample activities were between 8.00 and 1142 U/L (0.134 and 19.1 µkat/L).

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

Summary

Summary
LREFThomas L, ed. Labor und Diagnose, 4th ed. Marburg: Die Medizinische Verlagsgesellschaft 1992.
,
LREFShaw LM. Keeping pace with a popular enzyme GGT. Diagnostic Medicine May/June 1982;1–8.
,
LREFSzasz G. A kinetic photometric method for serum γ-glutamyl-transferase. J Clin Chem 1969;15:124-136.
,
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
,
LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
,
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:907-909.

γ‑glutamyltransferase is used in the diagnosis and monitoring of hepatobiliary diseases. Enzymatic activity of GGT is often the only parameter with increased values when testing for such diseases, and is one of the most sensitive indicators known. γ‑glutamyltransferase is also a sensitive screening test for occult alcoholism. Elevated GGT activities are found in the serum of patients requiring long-term medication with phenobarbital and phenytoin.

In 1969, Szasz published the first kinetic procedure for GGT in serum using γ‑glutamyl‑p‑nitroanilide as substrate and glycylglycine as acceptor. In order to circumvent the poor solubility of γ‑glutamyl‑p‑nitroanilide, Persijn and van der Slik investigated various derivatives and found the water-soluble substrate L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to be superior in terms of stability and solubility. The results correlate with those derived using the original substrate.

In 2002, the International Federation of Clinical Chemistry (IFCC) recommended the standardized method for determining GGT including optimization of substrate concentrations, employment of NaOH, glycylglycine buffer and sample start. The GGT liquid reagent follows the formulation recommendation according to Szasz, but was optimized for performance and stability. The assay is optionally standardized against the original IFCC and Szasz methods. The performance claims and data presented here are independent from the standardization.

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

Reagents - working solutions

R1

TRIS: 492 mmol/L, pH 8.25; glycylglycine: 492 mmol/L; preservative; additive

SR

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide: 22.5 mmol/L; acetate: 10 mmol/L, pH 4.5; stabilizer; preservative

", "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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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

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, K3‑EDTA plasma.
Note: K3‑EDTA plasma values are approximately 6 % lower than serum values.

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:

LREFSzasz G. Methods of Enzymatic Analysis. 2nd English ed. New York. Academic Press, Inc 1974;717.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;286.

7 days at 20‑25 °C

7 days at 4‑8 °C

1 year at ‑20 °C

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0003002721122c501", "ProductName": "GGT-2", "ProductLongName": "γ-Glutamyltransferase ver.2 Standardized against IFCC / Szasz", "Language": "en", "DocumentVersion": "11", "DocumentObjectID": "FF0000000490230E", "DocumentOriginID": "FF000000003F1B0E", "MaterialNumbers": [ "03002721122" ], "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 γ‑glutamyltransferase (GGT) in human serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

γ‑glutamyltransferase transfers the γ‑glutamyl group of L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to glycylglycine.

GGT

L-γ-glutamyl-3-carboxy-4-nitroanilide + glycylglycine

L-γ-glutamyl-glycylglycine + 5-amino-2-nitrobenzoate

The amount of 5‑amino‑2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance photometrically.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20.0 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:11 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 11.

Lower limits of measurement

Lower detection limit of the test

3 U/L (0.05 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

Standardized against Szasz (Persijn, van der Slik)

LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.

Men

8-61 U/L

0.13-1.02 µkat/L

Women

5-36 U/L

0.08-0.60 µkat/L

Standardized against IFCC

Reference Interval Study at 37 °C (corrected in 2005)

LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10-71 U/L

0.17-1.19 µkat/L

Women (n = 228)

6-42 U/L

0.10-0.70 µkat/L

Consensus values (IFCC)

LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 60 U/L

< 1.00 µkat/L

Women

< 40 U/L

< 0.67 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.

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

Limitations - interferences

Criterion: Recovery within ± 10 % of initial value at a γ‑glutamyltransferase activity of 40 U/L (0.67 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 50 for conjugated and 20 for unconjugated bilirubin (approximate conjugated bilirubin concentration: 855 µmol/L or 50 mg/dL and approximate unconjugated bilirubin concentration: 342 µmol/L or 20 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 1500. 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 not required.

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 - Hitachi)

Order information

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

03002721 122

γ‑Glutamyltransferase ver.2 400 tests

System‑ID 07 6598 8

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:

GGTI2: ACN 220: assay standardized against IFCC

GGTS2: ACN 480: assay standardized against Szasz

For cobas c 502 analyzer:

GGTI2: ACN 8220: assay standardized against IFCC

GGTS2: ACN 8480: assay standardized against Szasz

", "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 / 13‑42

Wavelength (sub/main)

700/415 nm

Reaction direction

Increase

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

25 µL

75 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

3 µL

15 µL

150 µL

Increased

3 µL

cobas c 501 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 19‑56

Wavelength (sub/main)

700/415 nm

Reaction direction

Increase

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

25 µL

75 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

3 µL

15 µL

150 µL

Increased

3 µL

cobas c 502 test definition

Assay type

Rate A

Reaction time / Assay points

10 / 19‑56

Wavelength (sub/main)

700/415 nm

Reaction direction

Increase

Units

U/L (µkat/L)

Reagent pipetting

Diluent (H2O)

R1

25 µL

75 µL

R2

20 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

3 µL

Decreased

3 µL

15 µL

150 µL

Increased

6 µL

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

Storage and stability

GGT‑2

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

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

Traceability: This method has been standardized against the original IFCC formulation (2002)

LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
and against the GGT method published by Persijn and van der Slik (1976)
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
, respectively.

Use the appropriate calibrator value for the corresponding application.

", "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

45.3 (0.757)

0.4 (0.007)

0.9

Precipath U

226 (3.77)

2 (0.03)

0.7

Human serum 1

34.0 (0.568)

0.3 (0.005)

0.9

Human serum 2

150 (2.51)

1 (0.02)

0.8

Intermediate precision

Mean

U/L (µkat/L)

SD

U/L (µkat/L)

CV

%

Precinorm U

44.1 (0.736)

0.8 (0.013)

1.8

Precipath U

221 (3.69)

4 (0.07)

1.7

Human serum 3

46.8 (0.782)

1.5 (0.025)

3.2

Human serum 4

256 (4.28)

9 (0.15)

3.7

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

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

Method comparison

γ‑glutamyltransferase 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 Roche/Hitachi 917 analyzer (x).

Sample size (n) = 113

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 - 0.428 U/L

y = 0.980x + 0.219 U/L

τ = 0.979

r = 1.000

The sample activities were between 4.50 and 1100 U/L (0.075 and 18.4 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
LREFThomas L, ed. Labor und Diagnose, 4th ed. Marburg: Die Medizinische Verlagsgesellschaft 1992.
,
LREFShaw LM. Keeping pace with a popular enzyme GGT. Diagnostic Medicine May/June 1982;1–8.
,
LREFSzasz G. A kinetic photometric method for serum γ-glutamyl-transferase. J Clin Chem 1969;15:124-136.
,
LREFPersijn JP, van der Slik W. A new Method for the Determination of γ-Glutamyltransferase. J Clin Chem Clin Biochem 1976;4:421.
,
LREFSchumann G, Bonora R, Ceriottiet F et al. IFCC Primary Reference Procedures for the Measurement of Catalytic Activity Concentrations of Enzymes at 37 °C – Part 6. Reference Procedure for the Measurement of Catalytic Activity Concentrations of gamma-glutamyltransferase. Clin Chem Lab Med 2002;40(7):734-738.
,
LREFKlauke R, Schmidt E, Lorentz K. Recommendations for carrying out standard ECCLS procedures (1988) for the catalytic concentrations of creatine kinase, aspartate aminotransferase, alanine aminotransferase and γ-glutamyltransferase at 37 °C. Eur J Clin Chem Clin Biochem 1993;31:901-909.

γ‑glutamyltransferase is used in the diagnosis and monitoring of hepatobiliary diseases. Enzymatic activity of GGT is often the only parameter with increased values when testing for such diseases, and is one of the most sensitive indicators known. γ‑glutamyltransferase is also a sensitive screening test for occult alcoholism. Elevated GGT activities are found in the serum of patients requiring long-term medication with phenobarbital and phenytoin.

In 1969, Szasz published the first kinetic procedure for GGT in serum using γ‑glutamyl‑p‑nitroanilide as substrate and glycylglycine as acceptor. In order to circumvent the poor solubility of γ‑glutamyl‑p‑nitroanilide, Persijn and van der Slik investigated various derivatives and found the water‑soluble substrate L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide to be superior in terms of stability and solubility. The results correlate with those derived using the original substrate.

In 2002, the International Federation of Clinical Chemistry (IFCC) recommended the standardized method for determining GGT including optimization of substrate concentrations, employment of NaOH, glycylglycine buffer and sample start. The GGT liquid reagent follows the formulation recommendation according to Szasz, but was optimized for performance and stability. The assay is optionally standardized against the original IFCC and Szasz methods. The performance claims and data presented here are independent from the standardization.

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

Reagents - working solutions

R1

TRIS: 492 mmol/L, pH 8.25; glycylglycine: 492 mmol/L; preservative; additive

R2

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide: 22.5 mmol/L; acetate: 10 mmol/L, pH 4.5; stabilizer; preservative

R1 is in position B and 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: For prescription use only.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H317

May cause an allergic skin reaction.

Prevention:

P261

Avoid breathing dust/fume/gas/mist/vapours/spray.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves.

Response:

P333 + P313

If skin irritation or rash occurs: Get medical advice/attention.

P362 + P364

Take off contaminated clothing and wash it before reuse.

Disposal:

P501

Dispose of contents/container to an approved waste disposal plant.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

", "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

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 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:

LREFSzasz G. Methods of Enzymatic Analysis. 2nd English ed. New York. Academic Press, Inc 1974;717.
,
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia PA: WB Saunders Company 1995;286.

7 days at 15‑25 °C

7 days at 2‑8 °C

1 year at (-15)‑(-25) °C

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0103002721122COIN", "ProductName": "GGT-2", "ProductLongName": "γ-Glutamyltransferase ver.2 - Standardized against IFCC", "Language": "en", "DocumentVersion": "9", "DocumentObjectID": "FF00000004901D0E", "DocumentOriginID": "FF00000000A01C0E", "MaterialNumbers": [ "03002721122" ], "InstrumentReferences": [ { "ID": "304", "BrandName": "COBAS INTEGRA 800" }, { "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 GGT (EC 2.3.2.2; γ‑glutamyl peptide: amino acid γ‑glutamyltransferase) in human serum and plasma on COBAS INTEGRA systems.

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

Test principle

Test principle
LREFSzasz G, Weimann G, Stähler F, et al. New Substrates for measuring gamma-glutamyl-transpeptidase activity. Z Klin Chem Klin Biochem 1974;12:228-233.

Enzymatic colorimetric assay

Gamma‑glutamyltransferase transfers the γ‑glutamyl group of L-γ-glutamyl-3‑carboxy-4‑nitroanilide to glycylglycine.

L‑γ‑glutamyl‑3‑carboxy‑4‑nitroanilide + glycylglycine

GGT

L‑γ‑glutamyl‑glycylglycine + 5‑amino‑2‑nitrobenzoate

The amount of 5‑amino-2‑nitrobenzoate liberated is proportional to the GGT activity in the sample. It is determined by measuring the increase in absorbance at 409 nm.

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

Limits and ranges

Measuring range

3‑1200 U/L (0.05‑20 µkat/L)

Determine samples having higher activities via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted using the rerun function are automatically multiplied by a factor of 10.

Lower limits of measurement

Lower detection limit of the test:
3 U/L (0.05 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
Reference Interval Study at 37 °C (corrected in 2005)
LREFAbicht K, El-Samalouti V, Junge W, et al. Multicenter evaluation of new GGT and ALP reagents with new reference standardization and determination of 37 °C reference intervals. Clin Chem Lab Med 2001;39:Special Supplement pp S 346.
,
LREFKytzia H-J. Reference intervals for GGT according to the new IFCC 37°C reference procedure. Clin Chem Lab Med 2005;43:A69 [abstract].

Men (n = 216)

10‑71 U/L

(0.17‑1.19 µkat/L)

Women (n = 228)

6‑42 U/L

(0.10‑0.70 µkat/L)

Consensus values
LREFThomas L, Müller M, Schumann G, et al. Consensus of DGKL and VDGH for interim reference intervals on enzymes in serum. J Lab Med 2005; 29(5):301-308.

Men

< 60 U/L

(< 1.00 µkat/L)

Women

< 40 U/L

(< 0.67 µkat/L)

Conversion factors to other temperatures have been published

LREFZawta B, Klein G, Bablok W. Temperature Conversion in Clinical Enzymology? Klin Lab 1994;40:33-42.
but these have not been checked by Roche for the present reagent.

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

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 up to an I index of 48 for unconjugated bilirubin (approximate unconjugated bilirubin concentration: 821 µmol/L or 48 mg/dL). No significant interference with conjugated bilirubin.

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 550 (approximate hemoglobin concentration: 0.34 mmol/L or 550 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.

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 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

03002721 122

γ-Glutamyltransferase ver.2 (400 tests)

System-ID 07 6598 8

COBAS INTEGRA 400 plus
COBAS INTEGRA 800

Materials required (but not provided):

10759350 190

Calibrator f.a.s. (12 × 3 mL)

System-ID 07 3718 6

12149435 122

Precinorm U plus (10 × 3 mL)

System-ID 07 7999 7

12149443 122

Precipath U plus (10 × 3 mL)

System-ID 07 8000 6

10171743 122

Precinorm U (20 × 5 mL)

System-ID 07 7997 0

10171735 122

Precinorm U (4 × 5 mL)

System-ID 07 7997 0

10171778 122

Precipath U (20 × 5 mL)

System-ID 07 7998 9

10171760 122

Precipath U (4 × 5 mL)

System-ID 07 7998 9

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

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

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

System information

Test GGTI2, test ID 0‑498, standardized against IFCC

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

Reagent handling

Ready for use

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