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).
