INTENDED USE
The OneStep Marijuana drug test (THC) assay is a rapid, qualitative, competitive binding immunoassay for the determination of Cannabinoids and its metabolites (THC) in urine. This test is not intended to be used in monitoring cannabinoid levels.
Note: The test provides only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
SUMMARY AND EXPLANATION OF THE Marijuana Drug Test
The OneStep Marijuana Drug Test (THC) is an easy, fast, qualitative, visually read competitive binding immunoassay method for screening without the need of instrumentation. The method employs unique mixture of monoclonal and polyclonal antibodies to selectively identify Cannabinoids and its metabolites in test samples with a high degree of sensitivity.
Cannabinoids are central nervous system stimulants that alter mood and sensory perceptions, produce loss of coordination, impair short term memory, produce symptoms of anxiety, paranoia, depression, confusion, hallucination, and increased heart rate. Large doses of Cannabinoids could develop tolerances and physiological dependency and lead to its abuse.
The prominent D 9 THC metabolite, 11-nor-D-9 THC-9-carboxylic acid (D-9 COOH-THC), is the primary urinary marker for detecting marijuana use. Urine screening for drugs of abuse usually detects the presence of the parent compounds and metabolites of the drug9. All forms of Cannabinoids (Marijuana, Hashish) are controlled substances where the recommended cutoff level for Cannabinoids screening tests is set at 50 ng/ml in urine by the National Institute on Drug Abuse6.
PRINCIPLE OF THE TEST
The OneStep Marijuana Drug Test consists of a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane for limited antibody sites. As the test sample flows up through the absorbent device, the free drug in the specimen competes with immobilized antigen conjugate in the test zone by binding to the antibody-dye conjugate forming an antibody-antigen complex and preventing the formation of a rose-pink color band when the drug is at or above the detection level of 50 ng/ml.
In the case where free drug in the sample is below the detection level of 50 ng/ml, antibody-dye conjugate is free to bind to the immobilized antigen in the test zone, producing a rose-pink color band. Furthermore, unbound dye conjugate binds to the reagent in the control zone, producing a rose-pink color band, demonstrating that the reagents and device are functioning correctly.
A NEGATIVE specimen produces two distinct color bands in both the test zone and control zone.
A POSITIVE specimen produces only one color band in the control zone.
REAGENTS AND MATERIALS PROVIDED
1. Marijuana drug test Cassette The test device containing membrane-immobilized reagents in a protein matrix containing sodium azide.
2. Test Instructions
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or timer.
2. Specimen collection containers.
WARNINGS AND PRECAUTIONS
1. Do not use the test strip beyond the expiration date.
2. Urine specimens may be infectious; properly handle and dispose of all used reaction devices in the biohazard container.
3. Visually inspect the foil package to insure it is intact. If the package is not intact, discard the device.
STORAGE AND STABILITY
Store test kit below 28°C; do not freeze. Refer to the expiration date for stability.
SAMPLE COLLECTION AND PREPARATION
The sample must be collected in a clean, dry container, either plastic or glass, without any preservatives. Urine specimens may be refrigerated (2° -8°C) and stored up to 48 hours, or frozen (-20°C or below) prior to assaying. If samples are refrigerated or frozen, they should be allowed to come to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged, or allow to settle so that clear aliquots can be obtained for testing.
TEST PROCEDURE
1. Bring the test components and urine sample to room temperature (15-28ºC). Do not open the foil pouch until ready to begin testng.
2. Open the foil pouch at the notch and remove the test device. Place the device on a clean, flat surface.
3. Holding the dropper vertically as shown, add 4 drops (~ 120 ml) of urine to the sample well "S."
4. Read the result at 5 minutes.
IMPORTANT: Do not interpret a test result after more than five minutes. Waiting longer than five minutes may cause inaccurate interpretation. To avoid confusion, discard the test device after reading the result at five minutes.
INTERPRETATION OF RESULTS
1. Positive. One rose-pink color band appears in the Control Zone ("C"), but not in the Test Zone ("T"). A positive result indicates that benzoyl ecgonine levels are at or above 300 ng/ml.
2. Negative. Two rose-pink color bands appear-- one in the Control Zone ("C") and one in the Test Zone ("T"). A negative result indicates that benzoyl ecgonine levels are below 300 ng/ml.
3. Invalid. No rose-pink color bands appear, or a band appears in the Test Zone ("T"), but not in the Control Zone ("C"). An invalid result may be due to improper testing procedures or deterioration of the kit components. Repeat the assay sequence using a new device.
Note: There is no meaning attributed to line color intensity or width.
QUALITY CONTROL
An internal procedure control has been incorporated into the test to ensure proper kit performance and reliability.
The use of external control procedures is recommended to verify proper test performance. Quality control samples should be tested according to quality control requirements established by the testing laboratory.
LIMITATIONS OF THE TEST
1. This product is designed to be used for the detection of THC in
human urine only.
2. Although the test is very accurate in detecting the urine Cannabinoids level, interfering substances in the urine and/or factors beyond the control of the manufacturer, e.g. technical or procedural errors associated with the testing, may lead to false results.
2. Marijuana drug test is a qualitative screening assay and is not suggested for determining the quantitative THC level in urine or the level of intoxication.
3. Adulterants, such as bleach or other strong oxidizing agents, if present in urine specimens, can produce erroneous test results regardless of the analysis method used. If adulteration is suspected, obtain another urine specimen and retest.
PERFORMANCE CHARACTERISTICS
1. Sensitivity. The OneStep Marijuana Drug Test(THC) Rapicard detects marijuana and the major metabolites of marijuana in urine at concentrations equal to or greater than 50 ng/ml, which is suggested by NIDA for the immunoassay method.
2. Specificity. A study was conducted with the OneStep Marijuana Drug Test (THC) Rapicard to determine the cross-reactivity of non-marijuana related compounds with the test at concentrations much higher than normally found in the urine of people using or abusing them. No cross-reactivity was detected with the substances listed in Table I.
A separate study was conducted to determine the cross-reactivity of marijuana-related compounds with the test. Substances listed in Table II produced results approximately equivalent to the cutoff level for marijuana.
Table I: Compounds that give negative results at concentrations up to 10 mg/ml:
Table II: Concentration of marijuana-related compounds showing a positive response approximately equivalent to the marijuana cut off set for the test.
Compound Concentration
11-nor-D -8-THC-9-COOH 50 ng/ml
11-nor-D -9-THC-9-COOH 50 ng/ml
D 8-THC 1 mg/ml
D 9-THC 4 mg/ml
Cannabinol 10 mg/ml
11-hydroxy-D 9-THC 10 mg/ml
3. Accuracy. An independent correlation study was performed using positive and negative urine specimens. Each urine specimen was tested with the Rapicard OneStep Marijuana Test and a commercially available test (Syva®EMIT II). Positive results were confirmed by GC/MS. The results are summarized as follows:
Syva EMIT II Positive Syva EMIT II Negative
Rapicard Positive 297 4
Rapicard Negative 4 259
When compared to EMIT II® the relative sensitivity was 98.67%. The relative specificity was 98.48%. The concordance of the combined data was 98.58%.
4. Precision. The precision was determined by replicate assays of three different patient urine samples with kits from three different production lots. The resultant data indicated 100% precision for the duplicates within each lot and no appreciable interlot variation when testing both positive and negative spiked samples across three (3) different lots of devices.
BIBLIOGRAPHY
1. Johansson, E., Gillespie, H.K., Halldin, M.M. J. Anal. Toxicol., 14:176-180 (1990).
2. El Sohly, M.A., Jones, A.B., El Sohly, H.N. J. Anal. Toxicol., 14:277-279 (1990).
3. Mandatory Guidelines for Federal Workplace Drug Testing Programs, Fed. Reg. 53(69): 11070-89 1988.
4. Wimbish, G.H., Johnson, K.D. J. Anal. Toxicol., 14:292-295 (1990).
5. Nakamura, G.R., Meeks, R.D., Stall, W.J. J. Forensic Sci., 35(4):792-796 (1990).
6. Urine Testing for Drugs of Abuse, National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986.
7. Hollister, L.E., Kanter, S.L., Board, R.D., Green, D.E. Res. Com. Chem. Pathol. Pharmacol., 8:579-584 (1974).
8. Federal Register 53: 11970-11983 (1988).
9. Foltz, R.L., Sunshine, I. J. Anal. Toxicol., 14:375-378 (1990).
10. Jenkins, A.J., Mills, L.C., Darwin, W.D., Huestis, M.A., Cone, E.J., Mitchell, J.M. J. Anal. Toxicol., 17:292-298 (1993).
11. Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publ., Davis, CA p. 488 (1982).
12. Blum, K., Handbook of Abuseable Drugs, Gardner Press, Inc., New York, NY 1st Ed., (1984).
13. Ellerbe, P., and Long, T., J. Anal Toxicol., 17: 165170 (1993).
14. Cody, J.T., and schwarzhoff, R., J. Anal. Toxicol., 17: 26-30 (1993).
15. Dasgupta, A., Saldana, s., Kinnaman, G., Smith, M., and Johansen, K., Slin. Chem., 39(1): 104-108 (1993).
16. Brettell, T.A., and Saferstein, R., Anal Chem., 61, 95R-109R (1989).
17. Department of Health and Human Services, Fed. Regist., 53(69):11970-89 (1988).
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