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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 phenobarbital in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Phenobarbital antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug-conjugate to the antibody on the microparticles and is inhibited by the presence of phenobarbital in the sample. A competitive reaction takes place between the drug conjugate and phenobarbital in the serum sample for binding to the phenobarbital antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

2.4‑60 µg/mL (10.3‑258.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM I diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 1.2 µg/mL (5.2 µmol/L)

Limit of Detection

= 2.4 µg/mL (10.3 µmol/L)

Limit of Quantitation

= 3.0 µg/mL (12.9 µmol/L)

The Limit of Blank, the Limit of Detection and the 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 concentration 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 concentration samples.

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

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

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

Expected values

The therapeutic range of phenobarbital is correlated with seizure control as well as the absence of toxic effects, and is generally accepted to be between 10 and 30 µg/mL (43.1 and 129 µmol/L). Variation in metabolism and absorption of the drug may cause levels to rise above 40 µg/mL (172 µmol/L) or fall below 15 µg/mL (64.7 µmol/L). The most frequent dose-related side effect is sedation, to which a tolerance usually develops. Phenobarbital serum levels above 40 µg/mL (172 µmol/L) are often associated with nystagmus, ataxia, and dysarthria.

LREFKutt H, Penry JK. Usefulness of blood levels of anti-epileptic drugs. Arch Neurol 1974;31:283-288.
,
LREFMorselli PL. Antiepileptic Drugs in Drug Disposition During Development. Morselli PL, ed. New York, NY: Spectrum 1971;311-360.
At high doses, phenobarbital can even cause an increase in seizure frequency.

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 phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).

Serum/Plasma

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 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 600. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL (11.3 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 200 IU/mL.

Total protein: No significant interference from total protein up to a concentration of 14 g/dL.

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

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

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

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

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

08058580 190

ONLINE TDM Phenobarbital (200 tests)

System‑ID 2097 001

cobas c 503

Materials required (but not provided):

03375790 190

Preciset TDM I
CAL A‑F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20691‑20696

04521536 190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)

Code 20310
Code 20311
Code 20312

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

System information

PHNO2: ACN 20970

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

800/600 nm

Reagent pipetting

Diluent (H2O)

R1

65 µL

R3

65 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.4 µL

Decreased

1.4 µL

Increased

1.4 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:

Do not freeze.

90 days

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

Calibration

Calibrators

S1‑6: Preciset TDM I

Calibration mode

Non‑linear

Calibration frequency

Full calibration
- after reagent lot change
- every 6 weeks
- 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 USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.

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

Specific performance data

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

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

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

Precision

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

Serum/plasma

Repeatability

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1a)

10.5

0.3

3.2

TDMC2b)

26.1

0.7

2.8

TDMC3c)

46.5

1.2

2.6

Human serum 1

3.81

0.26

6.7

Human serum 2

10.8

0.3

3.0

Human serum 3

20.5

0.3

1.6

Human serum 4

31.1

0.6

1.9

Human serum 5

53.7

1.4

2.5

Intermediate precision

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1

FREFTDM Control Set Level I

10.5

0.5

4.3

TDMC2

FREFTDM Control Set Level II

26.1

0.8

3.1

TDMC3

FREFTDM Control Set Level III

46.5

1.2

2.6

Human serum 1

3.81

0.34

9.0

Human serum 2

10.8

0.6

5.1

Human serum 3

20.8

0.6

2.8

Human serum 4

31.3

0.8

2.6

Human serum 5

53.7

1.4

2.6

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

Method comparison

Serum/plasma

Phenobarbital 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) = 73

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 = 1.000x + 0.400 µg/mL

y = 0.998x + 0.487 µg/mL

τ = 0.971

r = 0.999

The sample concentrations were between 2.60 and 58.5 µg/mL.

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

Summary

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects.

LREFJohannessen SI. Antiepileptic drugs: pharmacokinetic and clinical aspects. Thera Drug Monit 1981;3(1):17-37.
,
LREFKoch-Weser J. Serum drug concentrations in clinical perspective. Ther Drug Monit 1981;3(1):3-16.
,
LREFBuchthal F, Lennox-Buchthal MA. In: Antiepileptic Drugs. Woodbury DM, Penry JK, Schmidt RP, eds. New York, NY: Raven Press 1972;193-209.
,
LREFBuchthal F, Svensmark O. Serum concentration of diphenylhydantion (phenytoin) and phenobarbital and their relation to therapeutic and toxic effects. Psychiatr Neurol Neurochir 1971;74:117-136.
,
LREFBooker HE, Hosokowa K, Burdette RD, et al. A clinical study of serum primidone levels. Epilepsia 1970;11:395-402.
,
LREFLund L. Anti-convulsant effect of diphenylhydantoin relative to plasma levels. Arch Neurol 1974;31:289-294.
,
LREFSherwin AD, Robb JP, Lechter M. Improved control of epilepsy by monitoring plasma ethosuximide. Arch Neurol 1973;28:178-181.
,
LREFPenry JK, Smith LD, White BG. Clinical Value and Methods. DHEW Publication No 73-396 (NIH) USGPO, Washington, DC 1972.
,
LREFTroupin A, Ojemann LM, Halpern L, et al. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977;27:511-519.
As with other anti-convulsant drugs, it is imperative that each patient’s dosage be individualized.
LREFPippenger CE. Effective Seizure Control Requires Drug Monitoring. Battaglia BJ, ed. Clin Chem. New Special Section. Washington, DC: American Association of Clinical Chemistry 1980:1s and 10s.

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

Reagents - working solutions

R1

Phenobarbital conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.85; preservative; stabilizer

R3

Anti‑phenobarbital antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.4; 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.

Warning: This reagent contains phenobarbital, a substance known to the State of California to cause cancer or reproductive harm.

", "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 90 days.

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: K2‑ or K3‑EDTA, lithium or sodium heparin.

Stability:

7 days capped at 25 °C or 2‑8 °C
1 year capped at -20 °C

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;866.

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.

Do not induce foaming of specimens.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108058580190c503", "ProductName": "PHNO2", "ProductLongName": "ONLINE TDM Phenobarbital", "Language": "en", "DocumentVersion": "6", "DocumentObjectID": "FF00000005A4DA0E", "DocumentOriginID": "FF00000004D51E0E", "MaterialNumbers": [ "08058580190" ], "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 phenobarbital in serum and plasma on cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Phenobarbital antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug-conjugate to the antibody on the microparticles and is inhibited by the presence of phenobarbital in the sample. A competitive reaction takes place between the drug conjugate and phenobarbital in the serum sample for binding to the phenobarbital antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

2.4‑60 µg/mL (10.3‑258.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM I diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 1.2 µg/mL (5.2 µmol/L)

Limit of Detection

= 2.4 µg/mL (10.3 µmol/L)

Limit of Quantitation

= 3.0 µg/mL (12.9 µmol/L)

The Limit of Blank, the Limit of Detection and the 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 concentration 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 concentration samples.

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

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

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

Expected values

The therapeutic range of phenobarbital is correlated with seizure control as well as the absence of toxic effects, and is generally accepted to be between 10 and 30 µg/mL (43.1 and 129 µmol/L). Variation in metabolism and absorption of the drug may cause levels to rise above 40 µg/mL (172 µmol/L) or fall below 15 µg/mL (64.7 µmol/L). The most frequent dose-related side effect is sedation, to which a tolerance usually develops. Phenobarbital serum levels above 40 µg/mL (172 µmol/L) are often associated with nystagmus, ataxia, and dysarthria.

LREFKutt H, Penry JK. Usefulness of blood levels of anti-epileptic drugs. Arch Neurol 1974;31:283-288.
,
LREFMorselli PL. Antiepileptic Drugs in Drug Disposition During Development. Morselli PL, ed. New York, NY: Spectrum 1971;311-360.
At high doses, phenobarbital can even cause an increase in seizure frequency.

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 phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).

Serum/Plasma

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 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 600. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL (11.3 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 200 IU/mL.

Total protein: No significant interference from total protein up to a concentration of 14 g/dL.

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

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

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

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

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

08058580190

ONLINE TDM Phenobarbital (200 tests)

System‑ID 2097 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375790190

Preciset TDM I
CAL A‑F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20691‑20696

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)


Code 20310
Code 20311
Code 20312

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

System information

PHNO2: ACN 20970

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

800/600 nm

Reagent pipetting

Diluent (H2O)

R1

65 µL

R3

65 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.4 µL

Decreased

1.4 µL

Increased

1.4 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:

Do not freeze.

90 days

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

Calibration

Calibrators (full calibration)

S1‑6: Preciset TDM I calibrators

Calibrators (2‑point calibration)

S2: Preciset TDM I‑B
S5: Preciset TDM I‑E

Calibration mode

Non‑linear

Calibration frequency
cobas c 303 analyzer

2‑point calibration
- every 2 days on‑board

Full calibration
- after reagent lot change
- every 6 weeks during shelf life
- as required following quality control procedures

Calibration frequency
cobas c 503 analyzer

Full calibration
- after reagent lot change
- every 6 weeks during shelf life
- 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 USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.

", "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.

Serum/plasma

Repeatability

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1a)

10.5

0.3

3.2

TDMC2b)

26.1

0.7

2.8

TDMC3c)

46.5

1.2

2.6

Human serum 1

3.81

0.26

6.7

Human serum 2

10.8

0.3

3.0

Human serum 3

20.5

0.3

1.6

Human serum 4

31.1

0.6

1.9

Human serum 5

53.7

1.4

2.5

Intermediate precision

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1

FREFTDM Control Set Level I

10.5

0.5

4.3

TDMC2

FREFTDM Control Set Level II

26.1

0.8

3.1

TDMC3

FREFTDM Control Set Level III

46.5

1.2

2.6

Human serum 1

3.81

0.34

9.0

Human serum 2

10.8

0.6

5.1

Human serum 3

20.8

0.6

2.8

Human serum 4

31.3

0.8

2.6

Human serum 5

53.7

1.4

2.6

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

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

Method comparison

Serum/plasma

Phenobarbital 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) = 73

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 = 1.000x + 0.400 µg/mL

y = 0.998x + 0.487 µg/mL

τ = 0.971

r = 0.999

The sample concentrations were between 2.60 and 58.5 µg/mL.

Phenobarbital 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) = 89

Passing/Bablok

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

Linear regression

y = 0.989x - 0.251 µg/mL

y = 0.990x - 0.290 µg/mL

τ = 0.973

r = 0.998

The sample concentrations were between 3.40 and 59.7 µg/mL.

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

Summary

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects.

LREFJohannessen SI. Antiepileptic drugs: pharmacokinetic and clinical aspects. Thera Drug Monit 1981;3(1):17-37.
,
LREFKoch-Weser J. Serum drug concentrations in clinical perspective. Ther Drug Monit 1981;3(1):3-16.
,
LREFBuchthal F, Lennox-Buchthal MA. In: Antiepileptic Drugs. Woodbury DM, Penry JK, Schmidt RP, eds. New York, NY: Raven Press 1972;193-209.
,
LREFBuchthal F, Svensmark O. Serum concentration of diphenylhydantion (phenytoin) and phenobarbital and their relation to therapeutic and toxic effects. Psychiatr Neurol Neurochir 1971;74:117-136.
,
LREFBooker HE, Hosokowa K, Burdette RD, et al. A clinical study of serum primidone levels. Epilepsia 1970;11:395-402.
,
LREFLund L. Anti-convulsant effect of diphenylhydantoin relative to plasma levels. Arch Neurol 1974;31:289-294.
,
LREFSherwin AD, Robb JP, Lechter M. Improved control of epilepsy by monitoring plasma ethosuximide. Arch Neurol 1973;28:178-181.
,
LREFPenry JK, Smith LD, White BG. Clinical Value and Methods. DHEW Publication No 73-396 (NIH) USGPO, Washington, DC 1972.
,
LREFTroupin A, Ojemann LM, Halpern L, et al. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977;27:511-519.
As with other anti-convulsant drugs, it is imperative that each patient’s dosage be individualized.
LREFPippenger CE. Effective Seizure Control Requires Drug Monitoring. Battaglia BJ, ed. Clin Chem. New Special Section. Washington, DC: American Association of Clinical Chemistry 1980:1s and 10s.

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

Reagents - working solutions

R1

Phenobarbital conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.85; preservative; stabilizer

R3

Anti‑phenobarbital antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.4; 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.

", "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 90 days.

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: K2‑ or K3‑EDTA, lithium or sodium heparin.

Stability:

7 days capped at 25 °C or 2‑8 °C
1 year capped at -20 °C

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;866.

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.

Do not induce foaming of specimens.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208058580190c503", "ProductName": "PHNO2", "ProductLongName": "ONLINE TDM Phenobarbital", "Language": "en", "DocumentVersion": "4", "DocumentObjectID": "FF00000005AF380E", "DocumentOriginID": "FF000000050EA80E", "MaterialNumbers": [ "08058580190" ], "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 phenobarbital in serum and plasma on cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Phenobarbital antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug-conjugate to the antibody on the microparticles and is inhibited by the presence of phenobarbital in the sample. A competitive reaction takes place between the drug conjugate and phenobarbital in the serum sample for binding to the phenobarbital antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

2.4‑60 µg/mL (10.3‑258.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM I diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 1.2 µg/mL (5.2 µmol/L)

Limit of Detection

= 2.4 µg/mL (10.3 µmol/L)

Limit of Quantitation

= 3.0 µg/mL (12.9 µmol/L)

The Limit of Blank, the Limit of Detection and the 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 concentration 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 concentration samples.

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

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

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

Expected values

The therapeutic range of phenobarbital is correlated with seizure control as well as the absence of toxic effects, and is generally accepted to be between 10 and 30 µg/mL (43.1 and 129 µmol/L). Variation in metabolism and absorption of the drug may cause levels to rise above 40 µg/mL (172 µmol/L) or fall below 15 µg/mL (64.7 µmol/L). The most frequent dose-related side effect is sedation, to which a tolerance usually develops. Phenobarbital serum levels above 40 µg/mL (172 µmol/L) are often associated with nystagmus, ataxia, and dysarthria.

LREFKutt H, Penry JK. Usefulness of blood levels of anti-epileptic drugs. Arch Neurol 1974;31:283-288.
,
LREFMorselli PL. Antiepileptic Drugs in Drug Disposition During Development. Morselli PL, ed. New York, NY: Spectrum 1971;311-360.
At high doses, phenobarbital can even cause an increase in seizure frequency.

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 phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).

Serum/Plasma

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 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 600. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 1000 mg/dL (11.3 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 200 IU/mL.

Total protein: No significant interference from total protein up to a concentration of 14 g/dL.

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

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

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

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

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

08058580190

ONLINE TDM Phenobarbital (200 tests)

System‑ID 2097 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375790190

Preciset TDM I
CAL A‑F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20691‑20696

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)

Code 20310
Code 20311
Code 20312

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

System information

For cobas c 303 analyzer:
PHNO2X: ACN 20971

For cobas c 503 analyzer:
PHNO2: ACN 20970

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

800/600 nm

Reagent pipetting

Diluent (H2O)

R1

65 µL

R3

65 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.4 µL

Decreased

1.4 µL

Increased

1.4 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:

Do not freeze.

90 days

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

Calibration

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

Non‑linear

Calibration frequency

cobas c 303 analyzer

Full calibration
- after reagent lot change
- every 2 days on-board
- every 6 weeks during shelf life
- as required following quality control procedures

cobas c 503 analyzer

Full calibration
- after reagent lot change
- every 6 weeks during shelf life
- 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 USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.

", "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.

Serum/plasma

Repeatability

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1a)

10.5

0.3

3.2

TDMC2b)

26.1

0.7

2.8

TDMC3c)

46.5

1.2

2.6

Human serum 1

3.81

0.26

6.7

Human serum 2

10.8

0.3

3.0

Human serum 3

20.5

0.3

1.6

Human serum 4

31.1

0.6

1.9

Human serum 5

53.7

1.4

2.5

Intermediate precision

Mean

SD

CV

µg/mL

µg/mL

%

TDMC1

FREFTDM Control Set Level I

10.5

0.5

4.3

TDMC2

FREFTDM Control Set Level II

26.1

0.8

3.1

TDMC3

FREFTDM Control Set Level III

46.5

1.2

2.6

Human serum 1

3.81

0.34

9.0

Human serum 2

10.8

0.6

5.1

Human serum 3

20.8

0.6

2.8

Human serum 4

31.3

0.8

2.6

Human serum 5

53.7

1.4

2.6

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

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

Method comparison

Serum/plasma

Phenobarbital 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) = 73

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 = 1.000x + 0.400 µg/mL

y = 0.998x + 0.487 µg/mL

τ = 0.971

r = 0.999

The sample concentrations were between 2.60 and 58.5 µg/mL.

Phenobarbital 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) = 89

Passing/Bablok

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

Linear regression

y = 0.989x - 0.251 µg/mL

y = 0.990x - 0.290 µg/mL

τ = 0.973

r = 0.998

The sample concentrations were between 3.40 and 59.7 µg/mL.

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

Summary

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects.

LREFJohannessen SI. Antiepileptic drugs: pharmacokinetic and clinical aspects. Thera Drug Monit 1981;3(1):17-37.
,
LREFKoch-Weser J. Serum drug concentrations in clinical perspective. Ther Drug Monit 1981;3(1):3-16.
,
LREFBuchthal F, Lennox-Buchthal MA. In: Antiepileptic Drugs. Woodbury DM, Penry JK, Schmidt RP, eds. New York, NY: Raven Press 1972;193-209.
,
LREFBuchthal F, Svensmark O. Serum concentration of diphenylhydantion (phenytoin) and phenobarbital and their relation to therapeutic and toxic effects. Psychiatr Neurol Neurochir 1971;74:117-136.
,
LREFBooker HE, Hosokowa K, Burdette RD, et al. A clinical study of serum primidone levels. Epilepsia 1970;11:395-402.
,
LREFLund L. Anti-convulsant effect of diphenylhydantoin relative to plasma levels. Arch Neurol 1974;31:289-294.
,
LREFSherwin AD, Robb JP, Lechter M. Improved control of epilepsy by monitoring plasma ethosuximide. Arch Neurol 1973;28:178-181.
,
LREFPenry JK, Smith LD, White BG. Clinical Value and Methods. DHEW Publication No 73-396 (NIH) USGPO, Washington, DC 1972.
,
LREFTroupin A, Ojemann LM, Halpern L, et al. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977;27:511-519.
As with other anti-convulsant drugs, it is imperative that each patient’s dosage be individualized.
LREFPippenger CE. Effective Seizure Control Requires Drug Monitoring. Battaglia BJ, ed. Clin Chem. New Special Section. Washington, DC: American Association of Clinical Chemistry 1980:1s and 10s.

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

Reagents - working solutions

R1

Phenobarbital conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.85; preservative; stabilizer

R3

Anti‑phenobarbital antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.4; 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.

Warning: This reagent contains phenobarbital, a substance known to the State of California to cause cancer or reproductive harm.

", "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 90 days.

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: K2‑ or K3‑EDTA, lithium or sodium heparin.

Stability:

7 days capped at 25 °C or 2‑8 °C
1 year capped at -20 °C

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;866.

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.

Do not induce foaming of specimens.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004490924190c501", "ProductName": "PHNO2", "ProductLongName": "ONLINE TDM Phenobarbital", "Language": "en", "DocumentVersion": "9", "DocumentObjectID": "FF0000000469950E", "DocumentOriginID": "FF000000011A5E0E", "MaterialNumbers": [ "04490924190", "05027446190" ], "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 phenobarbital in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Phenobarbital antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug-conjugate to the antibody on the microparticles and is inhibited by the presence of phenobarbital in the sample. A competitive reaction takes place between the drug conjugate and phenobarbital in the serum sample for binding to the phenobarbital antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

2.4‑60 µg/mL (10.3‑258.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM I diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test

1.2 µg/mL (5.2 µmol/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the 0 µg/mL calibrator (standard 1 + 2 SD, repeatability, n = 21).

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

Expected values

The therapeutic range of phenobarbital is correlated with seizure control as well as the absence of toxic effects, and is generally accepted to be between 10 and 30 µg/mL (43.1 and 129 µmol/L). Variation in metabolism and absorption of the drug may cause levels to rise above 40 µg/mL (172 µmol/L) or fall below 15 µg/mL (64.7 µmol/L). The most frequent dose-related side effect is sedation, to which a tolerance usually develops. Phenobarbital serum levels above 40 µg/mL (172 µmol/L) are often associated with nystagmus, ataxia, and dysarthria.

LREFKutt H, Penry JK. Usefulness of blood levels of anti-epileptic drugs. Arch Neurol 1974;31:283-288.
,
LREFMorselli PL. Antiepileptic Drugs in Drug Disposition During Development. Morselli PL, ed. New York, NY: Spectrum 1971;311-360.
At high doses, phenobarbital can even cause an increase in seizure frequency.

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 phenobarbital levels of approximately 15 and 40 µg/mL (65 and 172 µmol/L).

Serum/Plasma

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 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 600. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

No significant interference from triglycerides up to 1000 mg/dL (11.3 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to 200 IU/mL.

Total protein: No interference from total protein up to 14 g/dL.

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 - cobas + Integra)

Order information

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

04490924 190

ONLINE TDM Phenobarbital (100 Tests)

System‑ID 07 6915 0

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

05027446 190

ONLINE TDM Phenobarbital (200 Tests)

System‑ID 07 6915 0

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

Materials required (but not provided):

03375790 190

Preciset TDM I calibrators
1) CAL A‑F (1 x 5 mL)
2) Diluent (1 x 10 mL)

System‑ID 07 6830 8
Codes 691‑696

04521536 190

TDM Control Set
1) Level I (2 x 5 mL)
2) Level II (2 x 5 mL)
3) Level III (2 x 5 mL)

Code 310
Code 311
Code 312

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

System information

For cobas c 311/501 analyzers:
PHNO2: ACN 508

For cobas c 502 analyzer:
PHNO2: ACN 8508

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

Reagent handling

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

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

Application for serum and plasma

Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.

cobas c 311 test definition

Assay type

2‑Point end

Reaction time /Assay points:

10 / 10‑49

Wavelength (sub/main)

800 /600 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

93 µL

R2

93 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

cobas c 501/502 test definition

Assay type

2‑Point end

Reaction time /Assay points:

10 / 16‑60

Wavelength (sub/main)

800 /600 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

93 µL

R2

93 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

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

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:
Do not freeze.

90 days

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

Calibration

Calibrators

S1‑6 Preciset TDM I calibrators

Calibration mode

RCM

Calibration frequency

6‑point calibration
- after reagent lot change
- every 6 weeks
- as required following quality control procedures

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.

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

Specific performance data

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 a modified NCCLS EP5‑T2 protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a cobas c 501 analyzer.

Serum/Plasma

Repeatability

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

9.8

42.2

0.5

2.1

5.0

Control 2

24.4

105

0.6

3

2.4

Control 3

45.1

194

0.8

3

1.8

HS 1

15.6

67.2

0.5

2.3

3.4

HS 2

37.8

163

1.0

4

2.7

Intermediate precision

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

9.8

42.2

0.5

2.3

5.4

Control 2

24.4

105

0.6

3

2.4

Control 3

45.1

194

0.9

4

2.0

HS 1

15.6

67.2

0.6

2.7

3.9

HS 2

37.8

163

1.2

5

3.0

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

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

Method comparison

Serum/plasma

Phenobarbital 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).

Roche/Hitachi 917

Sample size (n) = 53

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 = 0.998x - 0.206 µg/mL

y = 0.982x - 0.077 µg/mL

τ = 0.936

r = 0.996

The sample concentrations were between 2.91 and 57.7 µg/mL (12.5 and 249 µmol/L).

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

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

Summary

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects.

LREFJohannessen SI. Antiepileptic drugs: pharmacokinetic and clinical aspects. Thera Drug Monit 1981;3(1):17-37.
,
LREFKoch-Weser J. Serum drug concentrations in clinical perspective. Ther Drug Monit 1981;3(1):3-16.
,
LREFBuchthal F, Lennox-Buchthal MA. In: Antiepileptic Drugs. Woodbury DM, Penry JK, Schmidt RP, eds. New York, NY: Raven Press 1972;193-209.
,
LREFBuchthal F, Svensmark O. Serum concentration of diphenylhydantion (phenytoin) and phenobarbital and their relation to therapeutic and toxic effects. Psychiatr Neurol Neurochir 1971;74:117-136.
,
LREFBooker HE, Hosokowa K, Burdette RD, et al. A clinical study of serum primidone levels. Epilepsia 1970;11:395-402.
,
LREFLund L. Anti-convulsant effect of diphenylhydantoin relative to plasma levels. Arch Neurol 1974;31:289-294.
,
LREFSherwin AD, Robb JP, Lechter M. Improved control of epilepsy by monitoring plasma ethosuximide. Arch Neurol 1973;28:178-181.
,
LREFPenry JK, Smith LD, White BG. Clinical Value and Methods. DHEW Publication No 73-396 (NIH) USGPO, Washington, DC 1972.
,
LREFTroupin A, Ojemann LM, Halpern L, et al. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977;27:511-519.
As with other anti-convulsant drugs, it is imperative that each patient’s dosage be individualized.
LREFPippenger CE. Effective Seizure Control Requires Drug Monitoring. Battaglia BJ, ed. Clin Chem. New Special Section. Washington, DC: American Association of Clinical Chemistry 1980:1s and 10s.

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

Reagents - working solutions

R1

Phenobarbital conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.85; preservative; stabilizer

R2

Anti‑phenobarbital antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.4; 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.

Warning: This reagent contains phenobarbital, a substance known to the State of California to cause cancer or reproductive harm.

", "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: K2‑ or K3‑EDTA, lithium or sodium heparin.

Stability:

7 days capped at 25 °C or 2‑8 °C
1 year capped at -20 °C

LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;866.

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.

Do not induce foaming of specimens.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0005842131190c701", "ProductName": "PHNO2", "ProductLongName": "ONLINE TDM Phenobarbital", "Language": "en", "DocumentVersion": "5", "DocumentObjectID": "FF0000000516110E", "DocumentOriginID": "FF000000009C630E", "MaterialNumbers": [ "05842131190" ], "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": "

Intended use

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

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

Test principle

The assay is based on the kinetic interaction of microparticles in a solution (KIMS). Phenobarbital antibody is covalently coupled to microparticles and the drug derivative is linked to a macromolecule. The kinetic interaction of microparticles in solutions is induced by binding of drug-conjugate to the antibody on the microparticles and is inhibited by the presence of phenobarbital in the sample. A competitive reaction takes place between the drug conjugate and phenobarbital in the serum sample for binding to the phenobarbital antibody on the microparticles. The resulting kinetic interaction of microparticles is indirectly proportional to the amount of drug present in the sample.

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

Limits and ranges

Measuring range

2.4‑60 µg/mL (10.3‑258.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM I Diluent (0 ng/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test:

1.2 µg/mL (5.2 µmol/L)

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the of the 0 µg/mL calibrator (standard 1 + 2 SD, repeatability, n = 21).

Functional sensitivity

2.4 µg/mL (10.3 µmol/L)

The functional sensitivity is calculated as the lowest concentration from clinical samples with a CV of ≤ 20 %.

Values below the functional sensitivity (< 2.4 µg/mL) will not be flagged by the instrument.

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

Expected values

The therapeutic range of phenobarbital is correlated with seizure control as well as the absence of toxic effects, and is generally accepted to be between 10 and 30 µg/mL (43.1 and 129 µmol/L). Variation in metabolism and absorption of the drug may cause levels to rise above 40 µg/mL (172 µmol/L) or fall below 15 µg/mL (64.7 µmol/L). The most frequent dose-related side effect is sedation, to which a tolerance usually develops. Phenobarbital serum levels above 40 µg/mL (172 µmol/L) are often associated with nystagmus, ataxia, and dysarthria.

LREFKutt H, Penry JK. Usefulness of blood levels of anti-epileptic drugs. Arch Neurol 1974;31:283-288.
,
LREFMorselli PL. Antiepileptic Drugs in Drug Disposition During Development. Morselli PL, ed. New York, NY: Spectrum 1971;311-360.
At high doses, phenobarbital can even cause an increase in seizure frequency.

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 phenobarbital levels of approximately 15 and 40 μg/mL (65 and 172 μmol/L).

Icterus:

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

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 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 600. 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.

Triglycerides: No significant interference from triglycerides up to 1000 mg/dL (11.3 mmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to 200 IU/mL.

Total protein: No interference from total protein up to 14 g/dL.

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, manual input is required in certain cases. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SmpCln1+2/SCCS Method Sheet and for further instructions refer to the operator’s manual.

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

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

OrderInformation (CC Reagents - cobas + Integra)

Order information

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

05842131190

ONLINE TDM Phenobarbital (200 tests)

System‑ID 03 6915 0

cobas c 701/702

Materials required (but not provided):

03375790190

Preciset TDM I calibrators
1) CAL A‑F (1 x 5 mL)
2) Diluent (1 x 10 mL)

System‑ID 07 6830 8
Codes 691-696

04521536190

TDM Control Set
1) Level I (2 x 5 mL)
2) Level II (2 x 5 mL)
3) Level III (2 x 5 mL)

Code 310
Code 311
Code 312

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

System information

PHNO2: ACN 8508

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

Reagent handling

Ready for use

Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.

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

Application for serum and plasma

Deselect Automatic Rerun for this application in the Utility menu, Application screen, Range tab.

cobas c 701/702 test definition

Assay type

2‑Point End

Reaction time / Assay points

10 / 11‑35

Wavelength (sub/main)

800 /600 nm

Reaction direction

Increase

Unit

µg/mL (µmol/L)

Reagent pipetting

Diluent (H2O)

R1

93 µL

R2

93 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

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

Storage and stability

Shelf life at 2 to 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

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM I calibrators

Calibration mode

RCM

Calibration frequency

6‑point calibration
- after cobas c pack change
- as required following quality control procedures

Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.

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

Specific performance data

Specific performance data
LREFData on file at Roche Diagnostics.

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 (n = 63). The following results were obtained:

Repeatability

Mean
µg/mL (µmol/L)

SD
µg/mL (µmol/L)

CV
%

Control 1

9.53 (41.1)

0.18 (0.8)

1.9

Control 2

25.1 (108)

0.3 (1)

1.2

Control 3

44.7 (193)

0.4 (2)

1.0

Human serum A

3.53 (15.2)

0.15 (0.6)

4.2

Human serum B

19.7 (84.9)

0.3 (1.2)

1.4

Human serum C

42.6 (184)

0.6 (3)

1.3

Intermediate precision

Mean
µg/mL (µmol/L)

SD
µg/mL (µmol/L)

CV
%

Control 1

9.8 (42.2)

0.5 (2.3)

5.4

Control 2

24.4 (105)

0.6 (3)

2.4

Control 3

45.1 (194)

0.9 (4)

2.0

Human serum 1

15.6 (67.2)

0.6 (2.7)

3.9

Human serum 2

37.8 (163)

1.2 (5)

3.0

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

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

Method comparison

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

Sample size (n) = 59

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 = 1.008x + 0.62 µg/mL

y = 1.006x + 0.75 µg/mL

τ = 0.979

r = 0.999

The sample concentrations were between 2.70 and 54.9 µg/mL (11.6 and 237 µmol/L).

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

Summary

Summary
LREFJohannessen SI. Antiepileptic drugs: pharmacokinetic and clinical aspects. Thera Drug Monit 1981;3(1):17-37.
,
LREFKoch-Weser J. Serum drug concentrations in clinical perspective. Ther Drug Monit 1981;3(1):3-16.
,
LREFBuchthal F, Lennox-Buchthal MA. In: Antiepileptic Drugs. Woodbury DM, Penry JK, Schmidt RP, eds. New York, NY: Raven Press 1972;193-209.
,
LREFBuchthal F, Svensmark O. Serum concentration of diphenylhydantion (phenytoin) and phenobarbital and their relation to therapeutic and toxic effects. Psychiatr Neurol Neurochir 1971;74:117-136.
,
LREFBooker HE, Hosokowa K, Burdette RD, et al. A clinical study of serum primidone levels. Epilepsia 1970;11:395-402.
,
LREFLund L. Anti-convulsant effect of diphenylhydantoin relative to plasma levels. Arch Neurol 1974;31:289-294.
,
LREFSherwin AD, Robb JP, Lechter M. Improved control of epilepsy by monitoring plasma ethosuximide. Arch Neurol 1973;28:178-181.
,
LREFPenry JK, Smith LD, White BG. Clinical Value and Methods. DHEW Publication No 73-396 (NIH) USGPO, Washington, DC 1972.
,
LREFTroupin A, Ojemann LM, Halpern L, et al. Carbamazepine - a double blind comparison with phenytoin. Neurology 1977;27:511-519.

Phenobarbital is one of the most commonly used drugs for the treatment of grand mal, psychomotor epilepsy, and other forms of focal epilepsy. Monitoring of the serum level of the drug is essential in order to achieve maximal seizure control while maintaining minimal blood levels to avoid negative side effects. As with other anti-convulsant drugs, it is imperative that each patient’s dosage be individualized.

LREFPippenger CE. Effective Seizure Control Requires Drug Monitoring. Battaglia BJ, ed. Clin Chem. New Special Section. Washington, DC: American Association of Clinical Chemistry 1980:1s and 10s.

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

Reagents - working solutions

R1

Phenobarbital conjugate; piperazine‑N,N'‑bis (ethanesulfonic acid) (PIPES) buffer, pH 7.85; preservative; stabilizer

R2

Anti‑phenobarbital antibody (mouse monoclonal); latex microparticle; 3‑(N‑morpholino) propane sulfonic acid (MOPS) buffer, pH 7.4; 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.

Warning: This reagent contains phenobarbital, a substance known to the State of California to cause cancer or reproductive harm.

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

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

Quality control

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

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

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

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

Specimen collection and preparation

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: K2 or K3-EDTA, lithium or sodium heparin.

Stability:

7 days capped at 25 °C or 2‑8 °C

LREFData on file at Roche Diagnostics.

1 year capped at -20 °C
LREFTietz NW, ed. Clinical Guide to Laboratory Tests, 3rd ed. Philadelphia, PA: WB Saunders Company 1995;866.

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.

Do not induce foaming of specimens.

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.

Invert thawed specimens several times prior to testing.

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

PHNO2

Phenobarbital

IVD For in vitro diagnostic use.
PHNO2

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