Benzo Serum

en
09P53
Serum Benzodiazepines Reagent Kit G91119R06
B9P530
Revised November 2019.

09P5320

Instructions must be carefully followed. Reliability of assay results ll

REAGENTS
cannot be guaranteed if there are any deviations from these
instructions.
Kit Contents
Alinity c Serum Benzodiazepines Reagent Kit 09P53
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NAME Volumes (mL) listed in the table below indicate the volume per
Alinity c Serum Benzodiazepines Reagent Kit (also referred to as cartridge.
Benzo Serum)
09P5320
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INTENDED USE Tests per cartridge 200
The Alinity c Serum Benzodiazepines assay is used for the Number of cartridges per kit 2
qualitative and semiquantitative determination of benzodiazepines Tests per kit 400
in human serum or plasma with a 50 ng/mL cutoff on the Alinity c 32.1 mL
analyzer.
The assay provides only a preliminary analytical test result. A 13.6 mL
more specific alternate chemical method must be used to obtain a  Active ingredients: Anti-benzodiazepine polyclonal antibodies
confirmed analytical result. Gas Chromatography/Mass Spectrometry (goat) (≤ 1.7 mg/mL), G6P (≤ 0.0062 g/mL), NAD (≤ 0.0076 g/mL).
(GC/MS) is the preferred confirmatory method.1, 2 Clinical Inactive ingredients: TRIS buffer and bovine serum albumin (BSA).
consideration and professional judgment should be applied to any Preservative: sodium azide (< 0.1%).
drug of abuse test result, particularly when preliminary positive
results are used.  Active ingredient: Benzodiazepine derivative labeled with G6PDH
(≤ 1.0 mg/mL). Inactive ingredients: TRIS buffer and bovine serum
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SUMMARY AND EXPLANATION OF THE TEST albumin (BSA). Preservative: sodium azide (< 0.1%).
Benzodiazepines are sedative-hypnotic drugs which are subject to
abuse. Benzodiazepines include a wide variety of structurally similar Warnings and Precautions
drugs such as alprazolam, chlordiazepoxide, diazepam, lorazepam, •
oxazepam, and triazolam. Therapeutic serum concentrations and • For In Vitro Diagnostic Use
toxic levels for each benzodiazepine are different. In addition, •
patients who have used benzodiazepines habitually, particularly
Safety Precautions
those who are addicted to such agents, may tolerate far larger
dosages than persons who are not habitual users. Because of CAUTION: This product requires the handling of human specimens.
the wide variations in individual tolerance and variation in toxic It is recommended that all human-sourced materials be considered
levels associated with each benzodiazepine, serum toxicology potentially infectious and handled in accordance with the OSHA
immunoassays are primarily useful to establish the presence of the Standard on Bloodborne Pathogens. Biosafety Level 2 or other
agent. An alternative chemical method should be used to determine appropriate biosafety practices should be used for materials that
the identity and concentration of the specific benzodiazepine. contain or are suspected of containing infectious agents.4-7
Being able to determine the type of benzodiazepine ingested will The following warnings and precautions apply to:
facilitate an effective course of treatment for benzodiazepine
Contains sodium azide.
intoxication. Although detection of benzodiazepines in urine can be
EUH032 Contact with acids liberates very toxic gas.
used as an indicator of benzodiazepine use, the Alinity c Serum
Benzodiazepines assay is critical in emergency situations where a P501 Dispose of contents / container in
urine sample may be difficult to obtain. accordance with local regulations.

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PRINCIPLES OF THE PROCEDURE The following warnings and precautions apply to:
The Alinity c Serum Benzodiazepines assay is a homogeneous WARNING: Contains tromethamine hydrochloride*,
enzyme immunoassay using ready-to-use liquid reagents.3 The tris hydroxymethyl aminomethane* and
assay uses polyclonal antibodies that detect most benzodiazepines sodium azide.
in serum. The assay is based on the competition between an H316* Causes mild skin irritation.
enzyme‑labeled drug and the drug from the serum or plasma for EUH032 Contact with acids liberates very toxic gas.
a fixed number of specific antibody binding sites. In the absence Response
of drug from the sample, the specific antibody binds to the drug P332+P313* If skin irritation occurs: Get medical
labeled with glucose-6‑phosphate dehydrogenase (G6PDH) and advice / attention.
the enzyme activity is inhibited. This phenomenon creates a direct Disposal
relationship between the drug concentration in the serum or plasma P501 Dispose of contents / container in
and the enzyme activity. The G6PDH enzyme activity is determined accordance with local regulations.
spectrophotometrically at 340/416 nm by measuring its ability to
convert nicotinamide adenine dinucleotide (NAD) to NADH. * Not applicable where regulation EC 1272/2008 (CLP) or OSHA
Methodology: Enzyme Immunoassay Hazard Communication 29 CFR 1910.1200 (HCS) 2012 have been
For additional information on system and assay technology, refer to implemented.
the Alinity ci-series Operations Manual, Section 3.

1
For the most current hazard information, see the product Safety Data Alternate Result Units
Sheet. Edit assay parameter "Result Units" to select an alternate unit.
Safety Data Sheets are available at www.abbottdiagnostics.com or Conversion formula:
contact your local representative. (Concentration in Default result unit) x (Conversion factor) =
For a detailed discussion of safety precautions during system (Concentration in Alternate result unit)
operation, refer to the Alinity ci-series Operations Manual, Section 8. Default Result Unit Conversion Factor Alternate Result Unit
Reagent Handling ng/mL 0.0035* μmol/L
• Reagents are shipped refrigerated or on cold packs.
* The conversion factor is based on diazepam.8
• Upon receipt, place reagent cartridges in an upright position for
8 hours before use to allow bubbles that may have formed to ll
SPECIMEN COLLECTION AND PREPARATION
dissipate. FOR ANALYSIS
• If a reagent cartridge is dropped, place in an upright position for Specimen Types
8 hours before use to allow bubbles that may have formed to The specimen types listed below were verified for use with this
dissipate. assay.
• Reagents are susceptible to the formation of foam and bubbles. Other specimen types, collection tube types, and anticoagulants
Bubbles may interfere with the detection of the reagent level in have not been verified with this assay.
the cartridge and cause insufficient reagent aspiration that may
Specimen Type Collection Vessel Special Conditions
adversely affect results.
Serum Serum tubes Gel barrier tubes were
For a detailed discussion of reagent handling precautions during
not tested.
system operation, refer to the Alinity ci-series Operations Manual,
Section 7. Plasma Collection tubes Heparinized gel barrier
Acceptable tubes were not tested.
Reagent Storage anticoagulants are:
Storage Maximum Additional Storage Sodium citrate
Temperature Storage Time Instructions
Heparin
Unopened 2 to 8°C Until Store in upright position.
expiration Potassium oxalate
date EDTA
Onboard System 55 days • The instrument does not provide the capability to verify specimen
Temperature types. It is the responsibility of the operator to verify that the
Opened 2 to 8°C Until Store in upright position. correct specimen types are used in the assay.
expiration Do not reuse original Specimen Conditions
date reagent caps or
• For accurate results, serum and plasma specimens should be
replacement caps due to
free of fibrin, red blood cells, and other particulate matter. Serum
the risk of contamination
specimens from patients receiving anticoagulant or thrombolytic
and the potential to
therapy may contain fibrin due to incomplete clot formation.
compromise reagent
• For accurate results, plasma specimens should be free of
performance.
platelets and other particulate matter. Ensure centrifugation is
Reagents may be stored on or off the system. If removed from the adequate to remove platelets.
system, store reagents with new replacement caps in an upright • To prevent cross contamination, use of disposable pipettes or
position at 2 to 8°C. For reagents stored off the system, it is pipette tips is recommended.
recommended that they be stored in their original trays or boxes to
Preparation for Analysis
ensure they remain upright.
• Follow the tube manufacturer’s processing instructions for
For information on unloading reagents, refer to the Alinity ci-series
collection tubes. Gravity separation is not sufficient for specimen
Operations Manual, Section 5.
preparation.
Indications of Reagent Deterioration • Specimens should be free of bubbles. Remove bubbles with an
Deterioration of the reagents may be indicated when a calibration applicator stick before analysis. Use a new applicator stick for
error occurs or a control value is out of the specified range. each specimen to prevent cross contamination.
Associated test results are invalid, and samples must be retested. To ensure consistency in results, recentrifuge specimens prior to
Assay recalibration may be necessary. testing if
For troubleshooting information, refer to the Alinity ci-series • they contain fibrin, red blood cells, or other particulate matter.
Operations Manual, Section 10. NOTE: If fibrin, red blood cells, or other particulate matter are
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INSTRUMENT PROCEDURE observed, mix by low speed vortex or by inverting 10 times prior to
The Alinity c Serum Benzodiazepines assay file must be installed on recentrifugation.
the Alinity c analyzer prior to performing the assay. Specimen Storage
For qualitative analysis, the assay file SerBENZQ is required. Maximum Storage
For semiquantitative analysis, the assay file SerBENZSQ is required. Specimen Type Temperature Time
For detailed information on assay file installation and viewing and Serum/Plasma -20°C or colder 1 month9
editing assay parameters, refer to the Alinity ci-series Operations
Manual, Section 2. Avoid multiple freeze/thaw cycles.
For information on printing assay parameters, refer to the Alinity ci- Each laboratory may establish a range around -20°C from either the
series Operations Manual, Section 5. freezer manufacturer’s specifications or your laboratory standard
operating procedure(s) for specimen storage.
For a detailed description of system procedures, refer to the Alinity
ci-series Operations Manual. Stored specimens must be inspected for particulates. If present, mix
with a low speed vortex or by inversion and centrifuge the specimen
to remove particulates prior to testing.

2
Specimen Shipping The operator must enter the dilution factor in the Specimen or
Package and label specimens in compliance with applicable state, Control tab of the Create Order screen. The system will use this
federal, and international regulations covering the transport of clinical dilution factor to automatically calculate the concentration of the
specimens and infectious substances. sample and report the result. The result should be > 10.0 ng/mL
(> 0.035 µmol/L) before the dilution factor is applied.
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PROCEDURE If the operator does not enter the dilution factor, the result must
Materials Provided be manually multiplied by the appropriate dilution factor before
09P53 Alinity c Serum Benzodiazepines Reagent Kit reporting the result. If a diluted sample result is less than 10.0 ng/mL
Materials Required but not Provided (0.035 µmol/L), do not report the result. Rerun using an appropriate
dilution.
• Alinity c Serum Benzodiazepines assay file
For detailed information on ordering dilutions, refer to the Alinity ci-
• 08P6801 Alinity c Tox Semiquant Calibrators
series Operations Manual, Section 5.
• 08P6802 Alinity c Tox Qual Calibrators
• 08P6810 Alinity c Tox Controls Calibration
For information on materials required for operation of the instrument, For instructions on performing a calibration, refer to the Alinity ci-
refer to the Alinity ci-series Operations Manual, Section 1. series Operations Manual, Section 5.
For information on materials required for maintenance procedures, Calibration is stable for approximately 14 days (336 hours), but is
refer to the Alinity ci-series Operations Manual, Section 9. required with each change in reagent lot number. Verify calibration
with at least 2 levels of controls according to the established quality
Assay Procedure control requirements for your laboratory. If control results fall outside
Qualitative Analysis acceptable ranges, recalibration may be necessary.
Use the following for qualitative analysis: This assay may require recalibration after maintenance to critical
Cutoff Calibrator parts or subsystems or after service procedures have been
Assay Value* Calibrators Controls performed.
SerBENZQ 50 ng/mL Alinity c Tox Alinity c Tox Quality Control Procedures
(0.175 µmol/L) Qual Calibrators Controls
As appropriate, refer to your laboratory standard operating
* Based on Diazepam. Determines the cutoff between “positive” and procedure(s) and/or quality assurance plan for additional quality
“negative” samples. control requirements and potential corrective actions.
Semiquantitative Analysis • Two levels of controls are to be run every 24 hours.
Use the following for semiquantitative analysis: • If more frequent control monitoring is required, follow the
Assay Calibrators Controls established quality control procedures for your laboratory.
SerBENZSQ Alinity c Tox Semiquant Alinity c Tox Controls • If quality control results do not meet the acceptance criteria
Calibrators* defined by your laboratory, sample results may be suspect.
Follow the established quality control procedures for your
* Based on Diazepam. laboratory. Recalibration may be necessary. For troubleshooting
For a detailed description of how to run an assay, refer to the Alinity information, refer to the Alinity ci-series Operations Manual,
ci-series Operations Manual, Section 5. Section 10.
• If using primary or aliquot tubes, refer to the Alinity ci-series • Review quality control results and acceptance criteria following a
Operations Manual, Section 4 to ensure sufficient specimen is change of reagent or calibrator lot.
present. Quality Control Guidance
• To minimize the effects of evaporation, verify adequate sample Refer to “Basic QC Practices” by James O Westgard, Ph.D. for
cup volume is present prior to running the test. guidance on laboratory quality control practices.10
• Minimum sample volume requirements: Verification of Assay Claims
–– Sample volume for single test: 3 µL. For protocols to verify package insert claims, refer to Verification of
NOTE: This amount does not include the dead volume Assay Claims in the Alinity ci-series Operations Manual.
plus the additional over-aspiration volume. For total sample
volume requirements, refer to the Alinity ci-series Operations
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RESULTS
Qualitative Results
Manual, Section 4.
A sample that exhibits a change in absorbance rate (ΔmAU/min)
• Refer to the Alinity c Tox Semiquant Calibrators package insert, equal to or greater than the value obtained with the cutoff calibrator
Alinity c Tox Qual Calibrators package insert, and/or Alinity c Tox is considered positive.
Controls package insert for preparation and usage.
A sample that exhibits a change in absorbance rate (ΔmAU/min)
• For general operating procedures, refer to the Alinity ci-series lower than that obtained with the cutoff calibrator is considered
Operations Manual, Section 5. negative.
• For optimal performance, it is important to perform routine For each specimen, a numeric result will print without units. The
maintenance as described in the Alinity ci-series Operations number does not represent an actual drug concentration and is
Manual, Section 9. Perform maintenance more frequently when interpreted relative to the cutoff calibrator. Each numeric result
required by laboratory procedures. will be reported with a text interpretation. “Positive” = The drug
Sample Dilution Procedures concentration in the specimen gave a reaction rate equal to or
Samples with a benzodiazepines value exceeding greater than that of the cutoff calibrator. “Negative” = The drug
100.0 ng/mL (0.350 µmol/L) are flagged with the code concentration in the specimen gave a reaction rate less than that of
"> 100.0 ng/mL" ("> 0.350 µmol/L") and may be diluted with the the cutoff calibrator.
Manual Dilution Procedure. The cutoff for the qualitative application is 50 ng/mL (0.175 μmol/L).
Manual Dilution Procedure Semiquantitative Results
Dilute the sample with the Alinity c Tox Semiquant Calibrator 1. An estimate of the drug concentration can be obtained by running a
standard curve with all calibrators and determining the concentration
from the standard curve.

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Calculation Within-Run Within-Laboratory
The Alinity c Serum Benzodiazepines assay utilizes the Linear data Mean (Repeatability) (Total)a
reduction method to generate a calibration and results. Sample n (ng/mL) SD %CV SD %CV
For information on alternate result units, refer to the INSTRUMENT Tox Control 1 120 38.4 0.97 2.5 1.50 3.9
PROCEDURE, Alternate Result Units section of this package insert. Tox Control 2 120 94.9 1.00 1.1 2.17 2.3
Flags Tox Semiquant 120 49.1 0.91 1.9 1.90 3.9
Calibrator 3
Some results may contain information in the Flags field. For a
description of the flags that may appear in this field, refer to the a Includes within-run, between-run, and between-day variability.
Alinity ci-series Operations Manual, Section 5. Within-Run Within-Laboratory
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LIMITATIONS OF THE PROCEDURE
Sample n
Mean
(μmol/L)
(Repeatability)
SD %CV SD
(Total)a
%CV
• The assay is designed for use with human serum or plasma only.
Tox Control 1 120 0.134 0.0034 2.6 0.0053 3.9
• A positive result indicates only the presence of benzodiazepines
Tox Control 2 120 0.332 0.0035 1.1 0.0076 2.3
and does not necessarily correlate with the extent of
Tox Semiquant 120 0.172 0.0032 1.8 0.0067 3.9
physiological and psychological effects. Calibrator 3
• A positive result by this assay should be confirmed by a
a Includes within-run, between-run, and between-day variability.
chemical method such as GC, Thin Layer Chromatography
(TLC), or GC/MS. Accuracy by Recovery
• It is possible that other substances and/or factors (e.g., technical Each level of the Alinity c Tox Semiquant Calibrators was diluted with
or procedural) not listed in the SPECIFIC PERFORMANCE an equal volume of the next higher level calibrator to yield mid-point
CHARACTERISTICS, Specificity section of this package insert, samples. The Alinity c Tox Semiquant Calibrators and the mid-point
may interfere with the test and cause false results. samples were analyzed in replicates of four using the Alinity c Serum
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EXPECTED VALUES Benzodiazepines assay. A mean of the replicates for each sample
was determined and percent recovery calculated.
The Alinity c Serum Benzodiazepines assay is designed to detect
a range of benzodiazepine drugs and their metabolites. Detection Mean Measured Target
of the drug is helpful in confirming clinical diagnosis and the Concentration Concentration
Sample No. n (ng/mL) (ng/mL) % Recoverya
selection of the appropriate treatment. lmmunoassays which produce
01 4 12.6 12.5 100.8
only a single result in the presence of a class of drugs such as
02 4 24.9 25.0 99.7
benzodiazepines cannot accurately quantitate the concentration of
03 4 37.5 37.5 99.9
each individual component. In addition, certain substances or factors
not included in the study may interfere with the test and cause false 04 4 49.9 50.0 99.9
result. 05 4 80.0 75.0 106.6
Analysis of urine for this family of drugs may also provide useful 06 4 100.2 100.0 100.2
information. a % Recovery = Mean Measured Concentration
x 100
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SPECIFIC PERFORMANCE CHARACTERISTICS Target Concentration
Representative performance data are provided in this section. Results Sensitivity
obtained in individual laboratories may vary. Sensitivity, defined as the lowest concentration that can be
The Alinity c analyzer and the ARCHITECT c System and AEROSET differentiated from the negative calibrator (0 ng/mL) with 95%
System utilize the same reagents and sample/reagent ratios. confidence, is 10.0 ng/mL (0.035 μmol/L).
Unless otherwise specified, all studies were performed on the Alinity
c analyzer.
Specificity
The following data were generated using the same reagent on a
Precision commercially available clinical chemistry analyzer.
Within-Laboratory Precision Various benzodiazepines and potentially interfering substances were
A study was performed based on guidance from CLSI EP05-A2.11 tested for cross-reactivity with the assay. The compounds listed
Qualitative Precision in the table below produced a result approximately equivalent to
Testing was conducted using 1 lot of the Alinity c Serum 50 ng/mL diazepam.
Benzodiazepines Reagent Kit, 1 lot of the Alinity c Tox Qual Compound Concentration Tested (ng/mL)
Calibrator, 1 lot of the Alinity c Tox Controls, and 1 instrument. Two Alprazolam 50
controls and 1 calibrator were assayed in a minimum of 2 replicates Bromazepam 4000
at 2 separate times per day on 20 different days. Chlordiazepoxide 20 000
Within-Run Within-Laboratory Clonazepam 1000
Mean (Repeatability) (Total)a Clorazepate 150
Sample n (∆mAU/min) SD %CV SD %CV Delorazepam 2000
Tox Control 1 120 384 1.7 0.4 2.3 0.6
Desalkylflurazepam 50
Tox Control 2 120 460 1.3 0.3 2.3 0.5
Diazepam 50
Tox Qual Calibrator 2 120 401 1.4 0.3 4.3 1.1
Flunitrazepam 50
a Within-Laboratory variability contains within-run, between-run, and Flurazepam 250
between-day variance components. Halazepam 125
Semiquantitative Precision Lorazepam 2000
Testing was conducted using 1 lot of the Alinity c Serum Medazepam 150
Benzodiazepines Reagent Kit, 1 lot of the Alinity c Tox Semiquant Nitrazepam 300
Calibrators, 1 lot of the Alinity c Tox Controls, and 1 instrument. Two Norchlordiazepoxide 20 000
controls and 1 calibrator were assayed in a minimum of 2 replicates Nordiazepam 100
at 2 separate times per day on 20 different days.

4
Compound Concentration Tested (ng/mL) Qualitative
Oxazepam 1000 A comparison of 211 samples with Serum Benzodiazepines
Oxazolam 100 000 on the ARCHITECT c 8000 and the Alinity c analyzer found
Prazepam 50 98.58% agreement using the 50 ng/mL cutoff, demonstrating the
assays perform comparably. Two results were found to have an
Temazepam 100
interpretation of positive with the Alinity c Serum Benzodiazepines
Triazolam 150
assay and an interpretation of negative with the ARCHITECT
The following compounds do not cross-react at the concentrations Serum Benzodiazepines assay. One result was found to have an
listed below. interpretation of negative with the Alinity c Serum Benzodiazepines
Compound Concentration (μg/mL) assay and an interpretation of positive with the ARCHITECT Serum
Acetaminophen 1000 Benzodiazepines assay.
Acetylsalicylic acid 1000 Semiquantitative
Amitriptyline 100 A comparison of 211 samples with Serum Benzodiazepines on
d-Amphetamine 1000 the ARCHITECT c 8000 and the Alinity c analyzer found 99.53%
Caffeine 100 agreement using the 50 ng/mL cutoff, demonstrating the assays
Carbamazepine 100 perform comparably. One result was found to have an interpretation
Dextromethorphan 1000
of positive with the Alinity c Serum Benzodiazepines assay
and an interpretation of negative with the ARCHITECT Serum
Glutethimide 50
Benzodiazepines assay.
Imipramine 100
However, this study cannot be used to determine accuracy around
Meperidine 100
the cutoff as none of the samples were confirmed as positive or
Methadone 1000
negative by a reference method such as HPLC. For false positive and
Methaqualone 1000
false negative rates, see the accuracy data provided above.
Methsuximide 50
Morphine 200 ll
BIBLIOGRAPHY
Phencyclidine 1000 1. Hawks RL, Chiang CN, editors. Urine Testing for Drugs of Abuse.
NIDA Research Monograph 73. Rockville, MD: National Institute on
Phenobarbital 500
Drug Abuse (NIDA), Department of Health and Human Services;
Phenytoin 100 1986.
Primidone 100 2. Mandatory Guidelines for Federal Workplace Drug Testing Programs.
Propoxyphene 1000 National Institute on Drug Abuse. Federal Register Vol. 59, No. 110,
Secobarbital 1000 1994:29908.
3. Rubenstein KE, Schneider RS, EF Ullman. Homogeneous enzyme
Valproic acid 500
immunoassay: a new immunochemical technique. Biochem Biophys
Res Commun 1972;47:846.
Interference 4. US Department of Labor, Occupational Safety and Health
This study was performed on the AEROSET System. Administration, 29 CFR Part 1910.1030, Bloodborne pathogens.
Potentially Interferent Level Benzodiazepines 5. US Department of Health and Human Services. Biosafety in
Interfering Recovery (% of Microbiological and Biomedical Laboratories. 5th ed. Washington, DC:
Substance Default Units Alternate Units Target (ng/mL) Target) US Government Printing Office; December 2009.
6. World Health Organization. Laboratory Biosafety Manual. 3rd ed.
Bilirubin 40 mg/dL 684 μmol/L 38 101.0
Geneva: World Health Organization; 2004.
Hemoglobin 400 mg/dL 4.0 g/L 37 105.7 7. Clinical and Laboratory Standards Institute (CLSI). Protection
Triglyceride 1000 mg/dL 10.0 g/L 37 96.0 of Laboratory Workers From Occupationally Acquired Infections;
Approved Guideline—Fourth Edition. CLSI Document M29-A4. Wayne,
This study was performed on the ARCHITECT c System. PA: CLSI; 2014.
The following drugs were tested for interference at the concentrations 8. Burtis CA, Ashwood ER, editors. Tietz Textbook of Clinical Chemistry,
indicated using an acceptance criteria of ± 10% from the target 2nd ed. Philadelphia, PA: WB Saunders; 1994:2213.
value. 9. Peters FT. Stability of analytes in biosamples—an important
issue in clinical and forensic toxicology? Anal Bioanal Chem
Potentially Interferent Level Benzodiazepines 2007;388(7):1505–1519.
Interfering Recovery (% of 10. Westgard JO. Basic QC Practices. 3rd ed. Madison, WI: Westgard
Substance Default Units Alternate Units Target (ng/mL) Target) Quality Corporation; 2010.
Sulfapyridine 300 mg/dL 1204.8 μmol/L 35 100.7 11. Clinical and Laboratory Standards Institute (CLSI). Evaluation of
Sulfasalazine 300 mg/dL 753.8 μmol/L 35 98.2 Precision Performance of Quantitative Measurement Methods;
Temozolomide 20 mg/dL 103.1 μmol/L 41.1 98.4 Approved Guideline—Second Edition. CLSI Document EP05-A2.
Wayne, PA: CLSI; 2004.
Accuracy 12. Clinical and Laboratory Standards Institute (CLSI). User Protocol for
Evaluation of Qualitative Test Performance; Approved Guideline—
One hundred nine clinical samples were assayed for Second Edition. CLSI Document EP12-A2. Wayne, PA: CLSI; 2008.
benzodiazepines on a commercially available system and an HPLC Note for number formatting:
technique. Eighty-five samples were positive and 12 were negative
• A space is used as thousands separator (example: 10 000
by both methods, whereas 12 samples were positive by HPLC
specimens).
method and negative by the Serum Benzodiazepines assay. The
• A period is used to separate the integer part from the fractional
concentration of the benzodiazepines in these 12 discrepant samples
part of a number written in decimal form (example: 3.12%).
was ≥ 10 ng/mL, but ≤ 50 ng/mL by HPLC.
System Comparison
Based on guidance from CLSI EP12-A212, a separate study was
performed on the Alinity c analyzer and ARCHITECT c System.
The qualitative analysis and the semiquantitative analysis was
evaluated based on a cutoff of 50 ng/mL (0.175 µmol/L).

5
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Key to Symbols
ISO 15223 Symbols
Consult instructions for use

Manufacturer

Sufficient for

Temperature limitation

Use by/Expiration date

Authorized Representative in the

European Community
In Vitro Diagnostic Medical
Device
Lot Number
List Number
Serial number
Other Symbols
Contains Sodium Azide. Contact
with acids liberates very toxic
gas.
Distributed by
Distributed in the USA by
Information needed for United
States of America only
Product of USA
Reagent 1
Reagent 2
For use by or on the order of a
physician only (applicable to USA
classification only).

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Laboratories in various jurisdictions. All other trademarks are property
of their respective owners.

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