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One step Marijuana test card

　

　

Intended use

The marijuana test is an easy to use immunoassay intended for use in the qualitative analysis for marijuana and its metabolite in human urine. It should not be used without proper supervision and is not intended for sale to the general public.the marijuana provides only a preliminary screening test result; a more specific alternate chemical method must be used in order to confirm the analytical result. Gas chromatography/ mass spectrometry (gc/ms) is the preferred confirmatory method(i). Clinical considerations and professional judgment should be applied to any drug of abuse analysis, particularly when positive results are indicated (2,3).

Summary and explanation of test

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 form one to ten days.

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) allpresumptive positive results must be confirmed at a cutoff concentration of 15ng/ml of 11-no-n9-tetrahydrocannabinol-9-carboxylic acid.

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

Principles of procedure

The marijuana is an one step membrane immuno-chromatographic test (6)based on antigen/antibody complexation and is used for the analysis of marijuana and its metabolite present in the test sample.the assay is based on the competition between the drug or drug metabolite in the sample and a drug conjugate immobilized on a porous membrane support for limited antibody sites on the colored microsphers. Test urine is delivered into a sample site located at one end of the porous membrane.when the drug is present in the urine test sample, the drug or drug metabolite competes for the limited antibody sites on the microspheres.when an adequate amount of drug is present attachment of the colored microspheres to the probe site on the membrane. Therefore, a positive urine sample will inhibit the formation of a precipitin line at the probe area. A reference or control line with a secondary antibody raction is added to the membranes test to indicate that the test is viable. This control line should always be present before making any test interpretation. Normally, a negative urine sample will produce two colored lines (the formation of a visble precipitin at the test zone in addition to the control line) and a positive urine sample will show only one line(the control live).

　

Reagents

Each marijuana test is individually sealed in a foil pouch.

Each test contains a membrane strip with a defined amount of antibodies(sheep) in dry chemical form as absorbed in pad.a secondary polyclonal antiboday(goat anti-mouse igg) is used to form the reference line. Also, an antigenic drug conjugate an animal serum are adsorbed onto the membrane. The entire membrane is then dried before assembly and is used in the dry form. All necessary reagents for performing the test are performulated and included in each indivdual test. No addiional reagents are required. One needs only to add the test sample.

 

Storage

The components of this kit are stable until the marked expiration date when stored in the sealed pouch at 2℃-30℃.

      1.   The test must be brought to room temperature prior to use.do not allow test to be subjected to below freezing or above 30℃ temperatures

         2.   Urine samples if not used immediately after collection should be stored refrigerated(2℃-8℃).for store longer than3 days. The samples should be frozen(﹤-20℃).

　

Test procedure

1.Remove the test device from its foil wrapper by tearing along the slice.

   2.Using the sample dispenser,withdraw the urine sample from the specimen cup and slowly dispense 3 drops(approximately 120ul) into the circular sample well being careful not to overfill the    absorbent pad.

    

3.Read results within five minutes.do not interpret result after 10 minutes.

　

Standard of interpretation

      1. Positive: one pink-rose color band appear in the control zone and no band appears in the test zone. A positive result indicateds the THC level is 50ng/ml or higher.

      2. Negative: two pink-rose color bands appear, one in the control region and one in the test region. A negative result indicates that THC level is below the detection sensitivity of 50ng/ml

      3 If there are no distinct color band visible in both the test zone and the control zone or if there is a visible band in the test zone but not in the control zone, then the test is invalid. In this  instance, retesting of the speciman is recommended.

　

	POSITIVE The control line appears in the test window, but the test line is not visible. Amphetamine concentration in the test sample is 500 ng/ml or more.
	NEGATIVE Two pink-rose lines (bands) are visible in the control ("C") and test ("T") areas of the test window. Amphetamine level in the urine sample is below the Test Amphetamine sensitivity of 500 ng/ml.
	INVALID The test is invalid if the control line is not visible at five minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device.