The QuikScreen 5 ^TM is a immunochromatographic assay for rapid, qualitative detection of five drugs and their principal metabolites in urine at specified cut-off concentrations. A five drug combination is composed from the following drugs:

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 TEST

The QuikScreen 5 ^TM is an easy, fast, qualitative, visually read competitive binding immunoassay method for screening without the need of instrumentation. The method employs unique mixture of antibodies to selectively identify the drugs of abuse and their metabolites in test samples with a high degree of sensitivity.

Drug abuse remains a growing social and economical concern in many developed and developing countries throughout the world. The above stated drugs are among the most frequently abused illicit drugs, according to the U.S. Substance Abuse and Mental Health Services Administration. Opiates are among a class of heavily abused prescription drugs.

The sensitivity of QuikScreen 5 ^TM is set as required for the screening immunoassays of these drugs in the reference guidelines set by the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) and the U.S. Department of Health and Human Services.

PRINCIPLE OF THE TEST

The QuikScreen 5 is a competitive binding immunoassay in which drug and drug metabolites in a urine sample compete with immobilized drug conjugate for limited labeled antibody binding sites. By utilizing antibodies that are specific to different drug classes, the test permits independent, simultaneous detection of five drugs from a single sample. The approximate run time is 5 minutes.

In the assay procedure, urine mixes with labeled antibody-dye conjugate and migrates along a porous membrane. When the concentration of a given drug is below the detection limit of the test, unbound antibody-dye conjugate binds to antigen conjugate immobilized on the membrane, producing a rose-pink color band in the appropriate Test Zone for that drug. Conversely, when the drug level is at or above the detection limit, free drug competes with the immobilized antigen conjugate on the membrane by binding to antibody-dye conjugate, forming an antigen- antibody complex, preventing the development of a rose-pink color band.

Regardless of the drug levels in the sample, a rose-pink color band is produced in each Control Zone by a parallel immunochemical reaction. These bands serve as built-in quality control measures by demonstrating antibody recognition, verifying that the reagents are chemically active.

REAGENTS AND MATERIALS PROVIDED

MATERIALS REQUIRED BUT NOT PROVIDED

1. Clock or timer.

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 QuikScreen 5 ^TM might be compromised.

STORAGE AND STABILITY

Store test kit below 28°C (83°F); do not freeze. If stored at 2°-8°C (36°-46°F), allow the test kit to reach room temperature (15°-28°; 59°-83°F) before performing the test. Refer to the expiration date for stability.

SPECIMEN COLLECTION AND PREPARATION

Fresh urine specimens should be collected directly into the cup and do not require any special handling or pretreatment. No additives or preservatives are required. Note: Urine specimens can be transferred from a urine collection container into QuikScreen 5 ^TM, if necessary.

TEST PROCEDURE

1. Do not break the seal of the pouch until ready to begin testing.
2. Remove QuikScreen 5 ^TMfrom the foil pouch.
3. Collect a urine specimen directly into QuikScreen 5 ^TM. Ensure the sample is no less than 1/2 oz and does not exceed 2 oz., as indicated by the graduations on the side of QuikScreen 5 ^TM.
4. 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.

INTERPRETATIONS OF THE RESULTS

Confirm: A rose-pink band is visible in each control zone. No color band appearing in the appropriate test zone indicates a preliminary positive result for the corresponding drug of that specific test zone. Send urine specimen to a certified laboratory for confirmation.

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.

Retest: 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 QuikScreen 5 ^TM 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 U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) for the immunoassay method.
2. Specificity. A study was conducted with the QuikScreen 5 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 Opiates-related substances yield a positive result for Opiates:

Table II: Compounds tested and found not to cross-react with the test as a 1 mg/ml concentration in urine.

The following compounds do not cross-react with Phencyclidine:

The following compounds do not cross-react with Opiates:

The following compounds do not cross-react with Amphetamine:

The following compounds do not cross-react with Cocaine:

The following compounds do not cross-react with Marijuana:

3. Accuracy: The accuracy of the QuikScreen 5 was first tested in urine samples by D.F.E. 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:

   3.1 Marijuana (THC)

   	Syva EMIT II Positive	Syva EMIT II Negative
   QuikScreen 5 Positive	297	4
   QuikScreen 5 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%.

   3.2 Cocaine (BEG)

   	Syva EMIT II Positive	Syva EMIT II Negative
   QuikScreen 5 Positive	194	1
   QuikScreen 5 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%.

   3.3. Phencyclidine (PCP)

   	Syva EMIT II Positive	Syva EMIT II Negative
   QuikScreen 5 Positive	223	0
   QuikScreen 5 Negative	0	290

   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%.

   3.4. Opiates (OPI)

   	Syva EMIT II Positive	Syva EMIT II Negative
   QuikScreen 5 Positive	172	0
   QuikScreen 5 Negative	0	190

   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%.

   3.5 Amphetamine (AMP)

   	Syva EMIT II Positive	Syva EMIT II Negative
   QuikScreen 5 Positive	188	1
   QuikScreen 5 Negative	0	340

   When compared to EMIT II the relative sensitivity between positive samples was 100% . The relative specificity between negative samples was 99.7%. The concordance of the combined data with respect to EMIT II was 99.8%.

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).

Opiate Test

1. Huang, W., Andollo, W., Hearn W.L.J. Anal. Toxicol., 16: 307-310 (1992).
2. Cone, E.J., Dickerson, S., Paul, B.D., Mitchell, J.M., J. Anal. Toxicol., 17: 156-164 (1993).
3. Glare, P.A., Walsh, T.D., and Pippenger, C.E., Ther. Drug Monit., 13: 226-232 (1991).
4. Walsh, T.D., Cheater, F.M., Pharm. J., 10: 525-527 (1983).
5. Mitchell, J.M., Paul, B.D., Welch, P., Cone, E.J. J. Anal. Toxicol., 15: 49-53 (1991).

Phencyclidine/Amphetamine Test

1. Ellerbe, P., Long, T.,Welch, M.J., J. Anal. Toxicol., 17: 165-170 (1993).

Marijuana Test

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)14: 227-279 (1990).
3. Foltz, R.L., Sunshine, I.J. Anal. Toxicol., 14: 375-378 (1990).
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. 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).
7. Hollister, L.E., Kanter, S.L., Board, R.D., Green D.E. Res. Com. Chem. Pathol. 579-584 1974).

Cocaine Test

1. D.W. Hoyt et al. J. Am. Med. Assoc., Vol. 258 (1987), pp. 504-509.
2. R.R. MacGregor, J.S. Fowler, and A.P. Wolf. J. of Chromatography, Vol. 590 (1992), pp. 354-58.
3. E.J. Cone, D. Yousefnejad, and S.L. Dickerson. J. of Forensic Sciences, Vol. 35, No.4 (1990), pp. 786-91.
4. E.J. Cone et al. J. of Forensic Sciences, Vol. 34, No. 1 (1989), pp. 15-31.
5. B. Holmstedt and A. Fredga. J. of Ethnopharmacology, Vol. 3 (1981), pp. 113-47.
6. T. Inaba and J. Can. Physiol. Pharmacol., Vol. 67 (1989), pp. 1154-57
7. A.R. Jeffcoat et al. Drug Metabolism and Disposition, Vol. 17, No. 2 (1989), pp. 153- 59.
8. R.C. Baselt and R. Chang. J. Anal. Toxicol., Vol. 11 (1987), pp. 81-82.