MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or timer.
2. Specimen collection containers.
WARNINGS AND PRECAUTIONS
1. For in vitro diagnostic and professional use only.
2. Do not use the test device beyond the expiration date.
3. Urine specimens may be infectious; properly handle and dispose of all used reaction devices in a biohazard container.
4. Visually inspect the foil package to insure it is intact. If the package is not intact, the integrity of the device might be compromised.
Storage and stability
Store test kit below 28°C; do not freeze. Refer to the expiration date for stability.
Test procedure
1. Bring a urine sample and a foil test pouch to room temperature (15°-28°C).
2. Do not break the seal of the pouch until ready to begin testing.
3. Remove a Test Device from the foil pouch.
4. Remove the protective cap and place the revealed strips into the urine sample for 10 seconds. Do not allow the urine level to touch the plastic device.
5. Read the results at 5 minutes.
Note: The result must be interpreted at five minutes. Waiting more than five minutes may cause the reading to be inaccurate. To avoid confusion, discard the test device after interpreting the result.
INTERPRETATION OF RESULTS
POSITIVE NEGATIVE INVALID
Positive: A rose-pink band is visible in each control zone. No color band appearing in the appropriate test zone indicates a positive result for the corresponding drug of that specific test zone.
Negative: A rose-pink band is visible in each control zone and the appropriate test zone, indicating that the concentration of the corresponding drug of that specific test zone is below the detection limit of the test.
Invalid: If a color band is not visible in each of the control zones, the test is invalid. Another test should be run to re-evaluate the specimen.
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 an external control is recommended to verify proper kit 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 drugs of abuse and their metabolites in human urine only.
2. Although the test is very accurate, there is the possibility false results will occur due to the presence of interfering substances in the specimen sample.
3. The test is a qualitative screening assay and is not suggested for quantitative determination of drug levels in urine, or the level of intoxication.
4. Adulterants such as bleach or other strong oxidizing agents, when added to urine specimens can cause erroneous test results regardless of the analysis method used. If adulteration is suspected, obtain another urine specimen.
Performance characteristics
1. Sensitivity. The Multi-drug Test detects drugs of abuse and their major metabolites in urine at concentrations equal to or greater than the cut-off level for the specific drug, which is suggested by the National Institute on Drug Abuse (NIDA) for the immunoassay method.
2. Specificity. A study was conducted with the Multi-drug Test to determine the cross-reactivity of drug-related compounds with the test. Substances listed in Table I produced results approximately equivalent to the cutoff levels. A separate study was conducted to determine the cross-reactivity of non-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 II.
Table I: Concentrations of drug-related compounds showing positive response approximately equivalent to the cut-off set for the test:
The following Methamphetamine-related substances yield positive results for Methamphetamine:
(+) 3,4-Methylenedioxymethamphetamine (MDMA, Ecstacy) 500 ng/ml
d-Amphetamine 50,000 ng/ml
(+) 3,4-Methylenedioxyamphetamine (MDA) 50,000 ng/ml
(+) Methamphetamine 50,000 ng/ml
D, 1-amphetamine 10,000 ng/ml
Pseudoephedrine 1,000 ng/ml
Ephedrine 25,000 ng/ml
The following Marijuana-related substances yield positive results for Marijuana:
| 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 |
The following Cocaine-related substances yield positive results for Cocaine:
Benzoylecgonine 300 ng/ml
Cocaine 300 ng/ml
Isoxsurpine 1,500 ng/ml
Table II: Compounds tested and found not to cross-react with the test at a 10mg/ml concentration in urine.
The following compounds do not cross-react with Methamphetamine:
The following compounds do not cross-react with Phencyclidine:
3. Accuracy: The accuracy of the Multi-drug Multi-drug Test was first tested in urine samples in-house and subsequently in a clinical trial of urine samples submitted to a NIDA certified laboratory. In both cases the laboratories used EMIT II as their screening procedure. All positive samples by either screening method were confirmed by GC/MS. The data was combined and the results are summarized as follows:
Marijuana (THC)
Syva EMIT II Positive Syva EMIT II Negative
Positive 297 4
Negative 4 259
When compared to EMIT II the relative sensitivity between positive samples was 98.67%. The relative specificity between negative samples was 98.48%. The concordance of the combined data with respect to EMIT II was 98.58%.
Cocaine (BEG)
Syva EMIT II Positive Syva EMIT II Negative
Positive 194 1
Negative 0 212
When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 99.55%. The concordance of the combined data with respect to EMIT II was 99.75%.
Methamphetamine (MET)
Syva EMIT II Positive Syva EMIT II Negative
Positive 179 14
Negative 0 262
When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 94.9%. The concordance of the combined data with respect to EMIT II was 96.92%.
When compared to EMIT II the relative sensitivity between positive samples was 100%. The relative specificity between negative samples was 100%. The concordance of the combined data with respect to EMIT II was 100%.
Note: The above data for Methadone reflects the results of in-house urine sample testing only.
Bibliography
General
1. Baselt, R.C., Disposition of Toxic Drugs and Chemicals in Man, 2nd Ed., Biomedical Publ., Davis, CA, p.488 (1982).
2. Cody, J.T., Schwarzhoff, R., J. Anal. Toxicol., 17: 2630 (1993).
3. Urine Testing for Drugs of Abuse, NIDA Research Monograph 73, (1986).
4. Dasguspta, A., Saldana, S., Kinnaman, G., Smith M., Johansen, K., Clin. Chem., 39(1): 104-108 (1993).
5. Department of Health and Human Services, Fed. Regist., 53(69): 11970-11989 (1988), (1989).
6. FDA Guidence for Labeling Urine Drugs of Abuse Screening Testing, Kshitij Mohan, 7/21/1987. |
