【INTENDED USE】

The Marijuana Rapid Test Strip/Card/Device is a lateral flow chromatographic immunoassay for the qualitative detection of 11-nor-Δ9-THC-9 COOH (THC metabolite) in human urine at the following cut-off concentration:

Test Calibrator Cut-off (ng/mL)

Marijuana (THC150) 11-nor-Δ9-THC-9 COOH 150

Marijuana (THC) 11-nor-Δ9-THC-9 COOH 50

Marijuana (THC 25) 11-nor-Δ9-THC-9 COOH 25

Marijuana (THC 20) 11-nor-Δ9-THC-9 COOH 20

This assay provides only a preliminary analytical test result.A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

【SUMMARY】

Marijuana (THC)

THC (D9-tetrahydrocannabinol) is the primary active ingredient in cannabis (marijuana). When smoked or orally administered,THC produces euphoric effects. Users have impaired short-term memory and slowed learning. They may also experience transient episodes of confusion and anxiety. Long-term, relatively heavy use may be associated with behavioral disorders. The peak effect of marijuana administered by smoking occurs in 20-30 minutes and the duration is 90-120 minutes after one cigarette.Elevated levels of urinary metabolites are found within hours of exposure and remain detectable for 3-10 days after smoking. The main metabolite excreted in

the urine is 11-nor-D9-tetrahydrocannabinol-9-carboxylic acid (THC-COOH).

The Marijuana Rapid Test Strip/Card/Device yields a positive result when the concentration of THC-COOH in urine exceeds 50 ng/mL. This is the suggested screening cut-off for positive specimens set by the Substance Abuse and Mental Health Services Administration (SAMHSA,

USA). 1

Marijuana (THC150)

The Marijuana Rapid Test Strip/Card/Device yields a positive result when the concentration of THC-COOH in urine exceeds 150 ng/mL.See Marijuana (THC 50)for the summary.

Marijuana (THC25)

The Marijuana Rapid Test Strip/Card/Device yields a positive result when the concentration of THC-COOH in urine exceeds 25 ng/mL. See Marijuana (THC 50) for the summary.

Marijuana (THC20)

The Marijuana Rapid Test Strip/Card/Device yields a positive result when the concentration of THC-COOH in urine exceeds 20 ng/mL. See Marijuana (THC 50)for the summary.

【DIRECTIONS FOR USE】

Allow the test card and/or test strip, urine specimen,and/or controls to reach room

temperature (15-30ºC) prior to testing.

For test device

1. Remove the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface.Hold the dropper vertically and transfer 3 full drops of urine (approx.100ul) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration above.

3. Wait for the colored line(s) to appear.It is important that the background is clear before the result is read.The result should be read at 5 minutes.Do not interpret the result after 10 minutes.