THC ONE STEP TEST

Cat. No. S7770

INTENDED USE

THC One Step Test is for the rapid determination of cannabinoids and its Metabolites (THC) in human urine. The test is used to obtain a visual, qualitative result and is intended for professional use.

PRINCIPLE OF THE ASSAY

Urine screening for drugs of abuse usually detect the presence of parent compounds and metabolites of the drugs. The THC One Step Test detects Cannabinoids of marijuana.

Marijuana is a hallucinogenic agent derived from the flowering portion of the hemp plant. Smoking is the primary method of use of marijuana/cannabis. Cannabinoids have been proposed for therapy for acute glaucoma and parsea due to  chemotherapy. Higher doses used by abusers produce central nervous system effects, altered mood and sensory perceptions, loss of coordination, impaired short term memory, anxiety, paranoia, depression, confusion, hallucinations and increased heart rate. A tolerance to the cardiac and psychotropic effects can occur, and withdrawal syndrome produces restlessness, insomnia, anorexia and nausea.

When marijuana is ingested, the drug is metabolized by the liver, the primary urinary metabolite of marijuana is 11-nor-  -9-tetrahydrocannabinol-9-carboxylic acid and its glucuronide. This means that the presence of detected Cannabinoids, including the primary carboxyl metabolite, in the urine indicate marijuana/cannabis use.

The THC One Step Test is a homogeneous immunochromatographic assay based on the principle of 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 conjugates and drugs which may be present in the urine being tested. When THC is present in the urine, it competes for limited antibody sites between the drug or its metabolite in the sample and a drug conjugate immobilized on a porous solid phase. When a sufficient amount of drug is present, it will prevent the binding of dye-antibody conjugate to the drug conjugate on the membrane. Therefore a positive result, 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 THC One Step Test should be stored at 4ºC 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 cannabinoids and its metabolites 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 50 ng/ml for the qualitative screening of marijuana metabolites. The THC One Step Test detects an average of 50 ng/ml for cannabinoid metabolites in urine.

1. Compounds detected:

11-nor-  -9-tetrahydrocannabinol-9-carboxylic acid 0.1 ug/ml

 -9-tetrahydrocannabinol 500 ug/ml

Cannabinol 500 ng/ml

2. Compounds not detected:

Acetaminophen

Acetylsalicylic Acid

Ampicillin

Benzoic Acid

Benzoylecgonine HCl

Caffeine

Chlorpheniramine

Chlorpromazine HCl

Cimetidine

Codeine

Dextromethorphan

Dithylpropion

Diphenylhydantoin

Doxylamine

Ecgonine HCl

Ecgonine Methyl Ester

Hydrocodone

Hydromorphone

Indomathacin Ketoprofen

Levorphanol

Meperidine

Morphine Glucuronide

Morphine Sulfate

Methylphenidate

Methodone

Methaqualone

Oxycodone

Propraanollol

d-Propoxyphene Hydrochlorothiazide

Penicillin G

Pentobarbital

Phenobarbial

Phencyclidine

Phenylpropanolamine

Pendimetrazine

Phentermine

L-Phenylephrine

Quinine

Ranitidine

REFERENCES

1. Urine TEsting for Drugs of Abuse, National Institute on Drug Abuse (NIDA), Research Monograph 73, 1986.

2. T.A. Brettell and R. Saferstein, Anal Chem. (1989), 61,95R-109R.

3. Mandatory Guidelines for Federal Workplace Drug Testing Programs, D\Fed. Register (1988), 53

4. A.J. McBay, Clin. Chem. (1987), 33, 33B-40B.

5. Cocaine: Determinaiton in Human Body Fluids, J. Anal. Toxicology, Preston Publ., Niles, Il., 1988.