In vitro test for the quantitative determination of phenobarbital in serum and plasma on Roche/Hitachi cobas c systems.
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.
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.
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.
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).
Serum/Plasma
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
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
|
| 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 | Codes 20691‑20696 | |
04521536 190 | TDM Control Set | Code 20310 |
PHNO2: ACN 20970
Ready for use
Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.
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.
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 |
Calibrators | S1‑6: Preciset TDM I |
Calibration mode | Non‑linear |
Calibration frequency | Full calibration |
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.
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.
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:
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 |
Serum/plasma
Phenobarbital values for human serum and plasma samples obtained on a
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 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.
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.
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.
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.
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 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.
In vitro test for the quantitative determination of phenobarbital in serum and plasma on
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.
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.
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.
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).
Serum/Plasma
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
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.
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 | Codes 20691‑20696 | |
04521536190 | TDM Control Set |
|
PHNO2: ACN 20970
Ready for use
Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.
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.
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 |
S1‑6: Preciset TDM I calibrators | |
Calibrators (2‑point calibration) | S2: Preciset TDM I‑B |
Calibration mode | Non‑linear |
| 2‑point calibration Full calibration |
Calibration frequency | Full calibration |
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.
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.
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 | 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).
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. |
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.
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.
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 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.
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 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
Invert thawed specimens several times prior to testing.
In vitro test for the quantitative determination of phenobarbital in serum and plasma on
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.
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.
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.
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at phenobarbital concentrations of 15 and 40 µg/mL (65 and 172 µmol/L).
Serum/Plasma
Icterus:
Hemolysis:
Lipemia (Intralipid):
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.
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
|
| Analyzer(s) on which cobas c pack(s) can be used | |
08058580190 | ONLINE TDM Phenobarbital (200 tests) | System‑ID 2097 001 |
Materials required (but not provided):
03375790190 | Preciset TDM I | Codes 20691‑20696 | |
04521536190 | TDM Control Set | Code 20310 |
PHNO2X: ACN 20971
For cobas c 503 analyzer:
PHNO2: ACN 20970
Ready for use
Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.
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.
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 |
Calibrators | S1‑6: Preciset TDM I |
Calibration mode | Non‑linear |
cobas c 303 analyzer | Full calibration |
cobas c 503 analyzer | Full calibration |
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.
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.
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).
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 |
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. |
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. |
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.
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.
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.
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.
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 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.
In vitro test for the quantitative determination of phenobarbital in serum and plasma on Roche/Hitachi cobas c systems.
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.
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).
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.
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at phenobarbital levels of approximately 15 and 40 µg/mL (65 and 172 µmol/L).
Serum/Plasma
Hemolysis:
Lipemia (Intralipid):
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.
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.
|
| 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 | System‑ID 07 6830 8 | |
04521536 190 | TDM Control Set | Code 310 |
For cobas c 311/501 analyzers:
PHNO2: ACN 508
For cobas c 502 analyzer:
PHNO2: ACN 8508
Ready for use
Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.
Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.
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 | – | – |
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 | – | – |
Shelf life at 2‑8 °C: | See expiration date on cobas c pack label |
On‑board in use and refrigerated on the analyzer: | 90 days |
Calibrators | S1‑6 Preciset TDM I calibrators |
Calibration mode | RCM |
Calibration frequency | 6‑point calibration |
Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
Precision was determined using human samples and controls in a modified NCCLS EP5‑T2 protocol (
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 |
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 |
Serum/plasma
Phenobarbital values for human serum and plasma samples obtained on a Roche/Hitachi cobas c 501 analyzer (y) were compared
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). |
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.
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.
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.
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.
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: |
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.
In vitro test for the quantitative determination of phenobarbital in serum and plasma on Roche/Hitachi cobas c systems.
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.
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.
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.
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.
Criterion: Recovery within ± 10 % of initial value at phenobarbital levels of approximately 15 and 40 μg/mL (65 and 172 μmol/L).
Icterus:
Hemolysis:
Lipemia (Intralipid):
Drugs: No interference was found at therapeutic concentrations using common drug panels.
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.
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.
|
| Analyzer(s) on which cobas c pack(s) can be used | |
05842131190 | ONLINE TDM Phenobarbital (200 tests) | System‑ID 03 6915 0 |
Materials required (but not provided):
03375790190 | Preciset TDM I calibrators | System‑ID 07 6830 8 | |
04521536190 | TDM Control Set | Code 310 |
PHNO2: ACN 8508
Ready for use
Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.
Deselect Automatic Rerun for this application in the Utility menu, Application screen, Range tab.
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 | – | – |
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. |
Calibrators | S1‑6: Preciset TDM I calibrators |
Calibration mode | RCM |
Calibration frequency | 6‑point calibration |
Traceability: This method has been standardized against USP reference standards. The calibrators are prepared to contain known quantities of phenobarbital in normal human serum.
Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.
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 | SD | 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 | SD | 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.
Phenobarbital values for human serum and plasma samples obtained on a
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). |
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.
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.
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.
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.
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.
Phenobarbital
![](\"http://pim-media.roche.com/Images/REF_Frame_1_970150539_All.jpg\"/)
![](\"http://pim-media.roche.com/Images/CONTENT_Frame_1_970070027_All.jpg\"/)
