The Marijuana test is a rapid, qualitative, competitive binding immunoassay for the detection of tetrahydrocannabinol (THC) metabolites in urine. The test provides only presumptive data that should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS) 1-6. Positive results should be justified with compelling clinical evidence and professional judgment.

 

SUMMARY AND EXPLANATION OF TEST

 

The Marijuana Test employs a unique monoclonal antibody set to selectively identify THC metabolites in urine with a high degree of sensitivity.

 

Marijuana is major drug of abuse. After smoking or oral administration, the major psychoactive compound, tetrahydrocannabinol, is extensively metabolized before excretion.7 The excretion half-life of cannabinoid metabolites in urine, estimated by different techniques, ranges from one to ten days. 1

 

For an initial immunoassay result, a cutoff value of 50ng/ml total cannabinoid metabolites is required by he mandatory reference guidelines from the U.S. Department of Health and Human Services.8 All presumptive positive results must be confirmed at a cutoff concentration of 15ng/ml of 11-nor-N9-tetrahydrocannabinol-9-carboxylic acid.

 

The Marijuana test is an easy, fast, and visually read screening test that does not require instrumentation.

 

PRINCIPLE OF THE TEST

 

The Marijuana test includes a chromatographic absorbent device in which the drug or drug metabolites in the sample compete with a THC derivative immobilized on the membrane for binding with antibody-dye conjugate. THC o its metabolites, if present in the test sample at a concentration of 50 ng/ml or higher, block the combining sites of dye-conjugated anti-THC antibodies. Thus, the conjugate is not captured by THC derivative immobilized in the test zone of the membrane and a visible pink-rose band does not form in the test zone. The pink-rose test band only forms in the test zone if the drug level in the sample is below the detection level of 50ng/ml.

The samples, regardless of drug content, produce a pink-rose band in the control zone as dye conjugate binds to the immobilized reagent demonstrating that the assay is functioning correctly.

 

REAGENTS AND MATERIALS SUPPLIED

 

1. Test dipstick, 25 pcs.-a test device containing membrane-immobilized reagents in a protein matrix containing sodium azide.

 

1. Test instructions.

 

MATERIALS REQUIRED, BUT NOT PROVIDED

 

1. Clock or timer.

 

WARNINGS AND PRECAUTIONS

 

1. For in vitro diagnostic use only.
2. Do not use kit beyond the expiration date.
3. Urine specimens may be infectious; properly handle and dispose of all used reaction devices in a biohazard container.

 

STORAGE

 

Store test kit below 280C; do not freeze. Refer to the expiration date for stability.

 

SAMPLE COLLECTION AND PREPARATION

 

Collect urine samples in clean, dry containers, either plastic or glass, without any preservatives. Urine specimens may be refrigerate (2-80C) and stored up to forty-eight hours. For longer storage, freeze samples (-200C or below). Bring frozen or refrigerated samples to room temperature before testing.

 

Urine samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle. Use only clear aliquots for testing.

 

ASSAY PROCEDURE

 

1. Bring the test components to room temperature before opening the pouch.
2. Remove the test dipstick from the foil wrapper by tearing along the “notch”.
3. Insert the test dipstick into the urine sample being careful not to exceed the maximum level indicated by the arrows.
4. Read the test result at five minutes.