DOA THC One Step Marijuana rapid Test with CE certificate uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The THC One Step Marijuana Test is a rapid chromatographic immunoassay for the detection of 11-nor-D⁹ -THC-9 COOH (THC metabolite) in human urine at a cut-off concentration of 50 ng/mL.

Analytical Specificity

The following table lists compounds and their respective concentrations in urine that yield a positive result in the THC One Step Marijuana Test at 5 minutes.

Compound Concentration (ng/mL)

Cannabinol 20,000

11-nor-D⁸-THC-9 COOH 30

11-nor-D⁹-THC-9 COOH 50

D^8--THC 15,000

D⁹-THC 15,000

Precision

A study was conducted at 3 physicians’ offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing, according to GC/MS, no THC, 25% THC above and below the cut-off, and 50% THC above and below the 50 ng/mL cut-off was provided to each site. For the specimens below the 25 % cut-off concentration, the 3 sites demonstrated 98% agreement with each other. For the –25% to +25% cut-off specimens, the 3 sites demonstrated 83% agreement with each other. For specimens above the 25% cut-off concentration, the 3 sites demonstrated 100% agreement with each other. For all results, the 3 sites were found to have a 92% agreement with each other.