Accuracy
A side-by-side comparison was conducted using the MET One Step Methamphetamine Test and a leading commercially available MET rapid test. Testing was performed on 234 clinical specimens. Ten percent of the specimens employed were either at -25% or +25% level of the cut-off concentration of 1,000 ng/mL Methamphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:| Method | Other MET Rapid Test | Total Results | ||
| MET One Step Test Device | Results | Positive | Negative | |
| Positive | 99 | 0 | 99 | |
| Negative | 1 | 134 | 135 | |
| Total Results | 100 | 134 | 234 | |
| % Agreement with this Rapid Test Kit | 99.0% | 100% | 99.6% | |
| Method | GC/MS | Total Results | ||
| MET One Step Test Device | Results | Positive | Negative | |
| Positive | 89 | 6 | 95 | |
| Negative | 1 | 138 | 139 | |
| Total Results | 90 | 144 | 234 | |
| % Agreement with GC/MS Analysis | 98.9% | 95.8% | 97.0% | |
Analytical Sensitivity
A drug-free urine pool was spiked with Methamphetamine at the following concentrations: 0 ng/mL, 500 ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:| MET Concentration (ng/mL) | Percent of Cut-off | n | Visual Result | |
| Negative | Positive | |||
| 0 | 0 | 20 | 20 | 0 |
| 500 | -50% | 20 | 20 | 0 |
| 750 | -25% | 20 | 14 | 6 |
| 1,000 | Cut-off | 20 | 10 | 10 |
| 1,250 | +25% | 20 | 1 | 19 |
| 1,500 | +50% | 20 | 0 | 20 |
Analytical Specificity
The following table lists compounds that are positively detected in urine by the MET One Step Methamphetamine Test at 5 minutes.| Compound | Concentration (ng/mL) |
| r-Hydroxymethamphetamine | 30,000 |
| D-Methamphetamine | 1,000 |
| L-Methamphetamine | 8,000 |
| (±)-3,4-Methylenedioxymethamphetamine | 2,000 |
| Mephentermine | 50,000 |
