COCAINE ONE STEP TEST

Cat. No. S7765

INTENDED USE

The Cocaine One Step Test is for the rapid determination of cocaine in human urine. The test is used to obtain a visual, qualitative result and is intended for professional use. The presence of cocaine or its metabolite in urine as low as 300 ng/ml can be detected in 3 to 10 minutes.

PRINCIPLE OF THE ASSAY

Derived from leaves of coca plant, cocaine is a potent central nervous system stimulant and a local anesthetic. Among the phychological effects induced by using cocaine are euphoria, confidence and sense of increased energy, accompanied by invreased heart rate, dilation of the pupils, fever, tremors and sweating. Cocaine is excreted in the urine primarily as benzoylecgonine in a short period of time. Benzoylecgonine has a biological hald-life of 5 to 8 hours, which is much longer than that of cocaine (0.5 to 1.5 hour), and can be generally detected for 24-60 hours after cocaine use or exposure.

The Cocaine One Step Test is based on the principle of the highly specific immunochemical reactions of antigens and antibodies which are used for the analysis  of specific compounds in biological fluids. The assay relies on the competition for binding antibody between drug conjugate and drug which may be present in the urine being tested. When cocaine or its metabolite is present in the urine sample, it competes with drug conjugate which is immobilized on the membrane. When the amount of cocaine or its metabolite in sample is equal to or more than the cut-off value, it will occupy all the anitbody binding sites and prevent the binding of drug conjugate to the antibody. Therefore, a positive urine sample will not show a color band on test region, while the presence of the color band on test region indicates a negative result.

PRECAUTION

1. For in vitro diagnostic use only.

2. Use a new specimen container and dropper for each test to avoid cross contamination of urine samples.

3. Handle urine samples carefully.

4. Test strips should remain sealed until ready for use.

5. Do not use after expiration date.

STORAGE AND STABILITY

The Cocaine One Step Test should be stored at 2ºC to 30ºC, in sealed pouch, and under dry condition.

ASSAY PROCEDURE

1. Bring up all reagents and specimens to room temperature.

2. Remove test device from the sealed pouch.

3. (A) For the Test Card: Dispense 100-150 ul specimen to the sample well with a transfer pipet.

(B) For the Test Strip: Prepare urine specimen with a clean, dry container; then dip the test strip into the urine sample with the arrow toward the specimen. the urine level should not be higher than the maximum level line marked on the strip.

NOTE: For the best performance, let the sample level be as close as possible to but not higher than the maximum line marked on the strip.

4. Read the result within 3 to 10 minutes; do not interpret result after 10 minutes.

INTERPRETATION OF RESULTS

1. Positive: Only one color band appears on the control region.

2. Negative: In addition to the control band, a distinct color band also appears in the test region.

3. Invalid: There is no color band shown in either control or test region.

LIMITATIONS

* The test is designed for use with human urine only.

* There is a possibility that factors such as technical or procedural errors, as well as additional substances in the urine sample that are not listed below, may interfere with the test and cause erroneous results.

* The test detects only the presence of oxazepam in urine; it does not provide any indication of intoxication.

* A test result read after 10 minutes may not be consistent with the original reading obtained within the 10 minute test period.

CHARACTERISTICS AND SPECIFICITY

NIDA has suggested that the screening cutoff for positive samples be 300 ng/ml for cocaine. The Cocaine One Step Test detects an average of 300 ng/ml benzoylecgonone and 500 ng/ml cocaine HCl in urine.

1. Compounds detected:

Benzoylecgonine :  300 ng/ml or greater

Cocaine HCl :  500 ng/ml or greater

2. Compounds not detected:

Acetaminophen

Acetylsalicylic Acid

Aminopyrine

Amitriptyline

Amorbarbital

Amphetaminesulfate

Ampicillin

Apomorphine

Ascorbic Acid

Atropine

Benzocaine

Butabarbital

Caffeine

Calcium hypochlorite

Chlordiazepoxide

Chloroquine

Codeine

Dextromethorphan

Dexropropoxiphene

Diazepam

Diphenylhydantoin

Epinephrine

Erythromycin

Estriol

Gentisic Acid

Gluthimide

Guaiacol glycerol ether

Hydrochlorothiazide

Imipramine

Lidocaine

Meperidine

Methadone

Methaqualone

Methamphetamine

Methyprylon

Morphine sulfate

Naproxen

Norethindrone

Penicillin

Pentobarbital

Phenobarbital

Phencyclidine

Phenolbutazone

Phenylpropanolamine

Procaine HCl

Secobarbital

9-Tetrahydrocannabinolcarb-

     oxylic Acid

Tetracycline

Tetrahydrozoline

Trifluoperazine

Zomepirac

REFERENCES

1. Stewart, D.J., Inoba, T., Ducassen, M., and Kalow, W., clin. Pharmacol. Ther. 25; 264-8(79).

2. Ambre, J., J. Anal. Toxicol. 9; 241-5(85)