DOA THC One Step Marijuana rapid Test with CE certificate uncut sheet
| Product Name | THC One Step Marijuana rapid Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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 |
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
D8--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.
