DOA THC One Step Marijuana rapid Test with CE certificate urine
test device
| Product Name | THC One Step Marijuana rapid Test |
| Formats | Strip(3mm)Device(4mm) Multi panel |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
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.
Accuracy
A three way side-by-side comparison was conducted using the THC One
Step Marijuana Test and a leading commercially available THC rapid
test. Testing was performed on specimens previously collected from
subjects presenting for Drug Screen Testing. Presumptive positive
results were confirmed by GC/MS. The following results were
tabulated:
Method | Other THC Rapid Test | Total Results |
THC One StepTest | Results | Positive | Negative |
Positive | 135 | 1 | 136 |
Negative | 0 | 201 | 201 |
Total Results | 135 | 202 | 337 |
% Agreement with this Rapid Test | 100% | 99.5% | 99.7% |
When compared to GC/MS at 50 ng/mL, the following results were
tabulated:
| Method | GC/MS | Total Results |
| THC One StepTest | Results | Positive | Negative |
| Positive | 109 | 21 | 130 |
| Negative | 2 | 205 | 207 |
| Total Results | 111 | 226 | 337 |
| % Agreement with GC/MS at 50 ng/mL | 98.2% | 90.7% | 93.2% |
Analytical Sensitivity
A drug-free urine pool was spiked with
11-nor-D9-Tetrahytrocannabinol-9-carboxylic acid at the following
concentrations: 75 ng/mL, 62.5 ng/mL, 37.5 ng/mL, 25 ng/mL, and 0
ng/mL. The result demonstrates 100% accuracy at 50% above and 50%
below the cut-off concentration. The data are summarized below:
THC Concentration (ng/mL) | Percent of Cut-off | n | Visual Result |
| Negative | Positive |
| 0 | 20 | 20 | 0 |
| 50% | 20 | 20 | 0 |
| 75% | 20 | 9 | 11 |
| Cut-off | 20 | 3 | 17 |
| 125% | 20 | 3 | 17 |
| 150% | 20 | 0 | 20 |
SUMMARY
THC (D9-tetrahydrocannabinol) is the primary active ingredient in
cannabinoids (Marijuana). When smoked or orally administered, it
produces euphoric effects. Users have impaired short term memory
and slowed learning. Users may also experience transient episodes
of confusion and anxiety. Long term relatively heavy use may be
associated with behavioral disorders. The peak effect of smoking
Marijuana 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 (D9-THC-COOH).
The THC One Step Marijuana Test is a rapid urine screening test
that can be performed without the use of an instrument. The test
utilizes a monoclonal antibody to selectively detect elevated
levels of Marijuana in urine. The THC One Step Marijuana Test
yields a positive result when the concentration of Marijuana 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).
