Presumptive positive result

D. Interference testing
AccuTest™ THC Test Cassette
The AccuTest™ THC test strip performance at cut 1. Urine testing for drugs of abuse, NIDA Research not affected when pH and Specific Gravity ranges of urine 2. Steven B. Karch, Drugs of abuse hand book, CRC specimen are at 4.5 to 9.0 and 1.005 to 1.035. FOR THE QUALITATIVE ASSESSMENT OFTHCL AND The following substances were tested and confirmed did not 3. Ray H. Liu and Bruce A. Goldberger, Handbook of interfere with the AccuTest™ THC test strip at the listed workplace drug testing, AACC Press, Washington 4. Stephenson, R.L., Department of Health and Human 5. U.S. Department of Transportation, Drug Testing For in vitro Diagnostic and Forensic Use
Procedures Handbook. p.22, Superintendent of Documents, INTENDED USE
E. Specificity
The AccuTest™ THC test strip is an immunochromatography based The specificity for adding various drugs, drug metabolites 6. Lafolie, P., Beck, O., Blennow, G., et al., Importance one step in vitro test. It is designed for qualitative determination of tested the AccuTest™ THC test strip, and other compounds of Creatinine Analyses of Urine When Screening for drug substances in human urine specimens. This assay may be used that are likely to be present in urine. All compounds were Abused Drugs. Clinical Chemistry; 37:1927-31, in the point of care setting. The cut-off concentration using our test is prepared in drug -free normal human urine. The following table lists compounds that are detected by the 7. Goldberger, B.A., Loewenthal, B., Darwin, W.D., AccuTest™ THC test strip, which produced positive results and E.J. Cone, Intrasubject Variation of Creatinine Cannabinoid (THC) 50 ng/ml of 11-nor- 9-THC-9-COOH when tested at levels equal or greater than the concentrations and Specific Gravity Measurements in Consecutive This assay provides only a preliminary analytical test result. A more Compounds
8. Needleman, S.B., Porvaznik, M., Ander, D., specific alternative chemical method must be used in order to obtain a Creatinine Analysis in Single Collection Urine confirmed analytical result. The Substance Abuse Mental Health Specimens. Journal of Forensic Science; 37: 1125- chromatography/ mass spectrometry (GC/MS) as the preferred 9. Mayer, B and Hemphill, G., Evaluation of Urine confirmatory method. Clinical consideration and professional judgment Creatinine as a Marker to Identify Dilute Specimens should be applied to any drug of abuse test result, particularly when Being Analyzed for Drugs of Abuse. Abstract 313. preliminary positive results are indicated. The following compounds show no cross-reactivity at Note: It is not for use in diagnosing disease or illness; it is for
concentration up to 100 µg/ml unless specified. Association of Clinical Chemistry, July 1992. investigational use only.
10. Young, D.S., et al., Clinical Chemistry; 21 (9), 1975. 11. Friedman, R.B., et al., Clinical Chemistry; 26 (4), SUMMARY AND EXPLANATION
THC The agents of Marijuana that cause various biological effects in
humans are called cannabinoid. Cannabinoid is a central nervous stimulant that alters mood and sensory perceptions, produces loss of coordination, impairs short term memory, and produces symptoms of 1066E Beaufort Street, Unit 6-7, Bedford WA 6052 anxiety, paranoia, depression, confusion, hallucination, and increased heart rate. Large doses of cannabinoid could cause the development of tolerances and physiological dependency and lead to abuse. A tolerance to the cardiac and psychotropic effects can occur and withdrawal syndrome produces restlessness, insomnia, anorexia and -THC is the primary active ingredient in cannabinoids. The main metabolite excreted in the urine is 11-nor - which are found within hours of exposure and remain detectable in the PRINCIPLE
The test strip is based on the principle of specific immunochemical reaction between antibodies and antigen to analyze particular compound in human urine specimen. The assay relies on the competition for binding antibody. When drug is present in the urine specimen, it competes with drug conjugate for the limited amount of antibody dye conjugate. When the amount of drug is equal or more than the cut-off, it will prevent the binding of drug conjugate to the antibody. Therefore, a positive urine specimen will not show a colored band on the test line zone, indicating a positive result, while the presence of a colored band indicates a negative result. A control line is present in the test window to work as procedural control. This colored band should always the presence of drug or metabolite. If the control line does not LIMITATION OF PROCEDURE
appear on the control line zone if the test device is stored in appear, the test device should be discarded and the obtained The assay is designed for use with human urine only. A positive result good condition and the test is performed appropriately. result is invalid. The presence of this control band in the control with any of the tests indicates only the presence of a drug/metabolite MATERIAL PROVIDED
region serve as 1) verification that sufficient volume is added, 2) and does not indicate or measure intoxication. There is a possibility that technical or processed urine error as well other substances in The amount of each coated antigen and/or antibody on the certain foods and medicines may interfere with the test and cause false results. Please refer “SPECIFICITY” secti strip is less than 1.0 mg for antigen conjugate and is less PROCEDURE
than 1.0 mg for goat anti- mouse IgG antibody. substances that will produce either positive results, or that do not 1. Bring all materials and specimens to room temperature. Test zone: contains drug bovine protein antigen conjugates interfere with test performance. If a drug/metabolite is found present in 2. Remove the test cassette and pipette from sealed foil Control zone: contains Goat anti-mouse IgG antibody the urine specimen, the assay does not indicate frequency of drug use Conjugate pad: contains mice monoclonal anti-drug antibody. or distinguish between drug of abuse and certain foods and 3. Place the cassette kit onto a flat surface, face up. 4. Suck up the urine specimen with the pipette. EXPECTED RESULTS
5. Holding the dropper vertically, dispense 3 drops (110µL) The AccuTest™ THC test strip is a qualitative assay. It identifies the MATERIAL REQUIRED BUT NOT PROVIDED
drug in human urine at its cut-off concentration or higher. The concentration of the drug cannot be determined by this assay. The test is intended to distinguish negative result from presumptive WARNINGS AND PRECAUTIONS
positive result. All positive results must be confirmed using an 1. For in vitro diagnostic and professional use only. 2. Do not use the test strip beyond the expiration date. PERFORMANCE CHARACTERISTICS
3. Urine specimens may be infectious; properly handle and A. Accuracy
dispose of all used reaction devices in a biohazard The accuracy of the AccuTest™ THC test strip was evaluated in comparison to GC/MS method at the following concentration: 11-nor- 4. Visually inspect the foil package to insure it is intact. If the 9-THC-9-COOH 50ng/ml (THC). The results of the component strip is package is not intact, the integrity of the device might be 6. Read the result after 3 minutes but within 10 minutes. Do not interpret the result after 10 minutes. Waiting more
THC The accuracy of the THC test was evaluated in comparison to 5. Use a new urine specimen cup for each sample to avoid than ten minutes may cause the reading to be inaccurate.
GC/MS at a cut-off of 50 ng/ml of 11-nor-?9-THC-9-COOH. Eighty- To avoid confusion, discard the test cassette after
eight (88) urine specimens with GC/MS confirmed 11-nor-?9-THC-9- STORAGE AND STABILITY
interpreting the result.
COOH concentration were evaluated in this study. The results are The test device should be stored at 2°C to 28°C; do not
freeze and will be effective until the expiration date stated on
Positive % agreement: 95, Negative % agreement: 100 the package. The product is humidity-sensitive and should be Two colored bands form on any strip of the card. The Two specimens were found discrepant between the Rapid THC and used immediately after being open. Any improperly sealed appearance of two colored bands, one in test line zone and the GC/MS method. When compared those data, 50% (1 out of 2) of the other in control line zone, indicates negative result for that discrepancy specimens were found between –25% and cut-off SPECIMEN COLLECTION AND PREPARATION
particular test(s). The negative result does not indicate the Fresh urine does not require any special handling or absence of drug in the specimen; it only indicates the level of B. Sensitivity
pretreatment. Specimen should be collected in a clean, dry, tested drug in the specimen is less than cut-off level.
The cut-off concentrations (sensitivity level) of AccuTest™ THC test plastic or glass container. If the assay is not performed Positive:
immediately, urine specimen may be refrigerated at 2- 8 °C or One colored band appears in control line zone. No coloured frozen up to 7 days. Specimens should be brought to room band is found in test line zone. This is an indication the level of C. Precision
temperature before testing. Urine specimens exhibiting a tested drug(s) in the specimen is above the cut- off level. The precision of the AccuTest™ THC test strip was determined by large amount of precipitate or turbidity should be centrifuged Invalid:
conducting the test with spiked controls and interpreted the results by or allowed to settle before testing. Avoid contact with skin by If there is no colored band in control line zone of any strip, the three individuals to verify the random error of visual interpretation. The wearing gloves and proper laboratory attire. test result is invalid. Retest the sample with a new device. results of 50% above and 50% below cut-off specimens are 100% QUALITY CONTROL
Good Laboratory practice recommends the daily use of control materials to validate the reliability of device. Control materials should be assayed as clinical specimen and Concentration
challenging to the assay cutoff concentration, e.g., 25% Corrected
above and below cutoff concentration. If control values do not fall within establish range, assay results are invalid. Control materials that are not provided with this test kit are The Rapid Drugs of Abuse Test provides a built-in process control with a different antigen/antibody reaction at the control Note: A borderline (+/-) in test line zone should be
region (C). This control line should always appear regardless considered negative result.


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