One-Step THC Rapid Test

INTENDED USE

THC Gold Rapid Screen Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine.

SUMMARY AND EXPLANATION OF THE TEST

THC Gold Rapid Screen Test is a fast and easy to read immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Marijuana in urine with a high degree of sensitivity. Marijuana is a hallucinogenic agent derived from the flowering portion of the hemp plant. The active ingredients in marijuana, THC and Cannabinol can be metabolized and excreted as 11-nor-D9-THC-9-COOH with a half-life of 24 hours. It can be detected for 1-5 days after use. Smoking is the primary method of use of marijuana/cannabis. 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. Marijuana is controlled substances. GC/MS or immunoassay method has been developed for the determination of 50ng/ml for Marijuana as set by the National Institute on Drug Abuse (NIDA).

PRINCIPLE

THC Gold Rapid Screen Test is a chromatographic absorbent device in which drug or drug metabolites in a sample compete with drug antigen immobilized on a porous membrane support for limited antibody sites. Labeled antibody-dye conjugate mixes with sample specimen and binds to the free drug presented in sample forming an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone immobilized antigen conjugate when the drug is presented in the sample urine above the detection levels (50ng/ml for marijuana). Unbound dye conjugate binds to the reagent in the control zone and produces a pink-rose color band, demonstrating that the reagents and device are functioning correctly.

A negative specimen produces two distinct color bands, one for the control in the “C” zone and one for marijuana in the “T” zone.

REAGENTS AND MATERIALS PROVIDED

1.Test Device                         

A pouched cassette contains a single test for marijuana

2. Dropper                              

A transfer pipette seal in foil pouch together with test device

3. Operation Instruction

MATERIALS REQUIRED BUT NOT PROVIDED

1.        Clock or Timer

2.        A container for specimen collection

WARNING 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 biohazard container.

STORAGE

The kits should be stored at temperature 4-30°C the sealed pouch for the duration of the shelf life (18 months).

SAMPLE COLLECTION AND PREPARATION

Collect a fresh urine sample in a clean, dry container, either plastic or glass, without any preservatives. Urine specimens may be refrigerated (2-8°C) and stored up to 48 hours 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 urine sample and test components to room temperature if refrigerated.

2.  When ready to test, open the pouch at the notch and remove the test device. Place the test device on a clean, flat surface.

3.   Fill the urine dropper with specimen. Holding the dropper vertically, dispense 2-3 drops (about 50-80 ml) of urine without air bubble into the sample well.

4.    Read the result in 5-10 minutes.