Accuracy
A comparison study was carried out to evaluate the performance of the MOP One Step Morphine Test and a popular commercially available MOP rapid test. The testing was conducted on a total of 341 clinical specimens, with 10% of the specimens having a concentration of morphine that was either -25% or +25% of the cut-off level of 300 ng/mL. Any presumptive positive results were further confirmed through the use of GC/MS. The results of the study are presented in the following table:| Method | Other MOP Rapid Test | Total Results | ||
| MOP One Step Test | Results | Positive | Negative | |
| Positive | 159 | 0 | 159 | |
| Negative | 0 | 182 | 182 | |
| Total Results | 159 | 182 | 341 | |
| % Agreement with this Rapid Test Kit | 100% | 100% | 100% | |
| Method | GC/MS | Total Results | ||
| MOP One Step Test | Results | Positive | Negative | |
| Positive | 159 | 10 | 169 | |
| Negative | 0 | 172 | 172 | |
| Total Results | 159 | 182 | 341 | |
| % Agreement with GC/MS Analysis | 100% | 94.5% | 97.1% | |
Analytical Sensitivity
A drug-free urine pool was spiked with Morphine at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL and 450 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:| MOP Concentration (ng/mL) | Percent of Cut-off | n | Visual Result | |
| Negative | Positive | |||
| 0 | 0 | 20 | 20 | 0 |
| 150 | -50% | 20 | 20 | 0 |
| 225 | -25% | 20 | 20 | 0 |
| 300 | Cut-off | 20 | 12 | 8 |
| 375 | +25% | 20 | 2 | 18 |
| 450 | +50% | 20 | 0 | 20 |
Analytical Specificity
The following table lists compounds that are positively detected in urine by the MOP One Step Morphine Test at 5 minutes.| Compound | Concentration (ng/mL) |
| Codeine | 300 |
| Ethylmorphine | 6,250 |
| Hydrocodone | 50,000 |
| Hydromorphone | 3,125 |
| Levophanol | 1,500 |
| 6-Monoacethylmorphine | 400 |
| Morphine | 300 |
| Morphine 3-b-D-glucuronide | 1,000 |
| Norcodeine | 6,250 |
| Normorphone | 100,000 |
| Oxycodone | 30,000 |
| Oxymorphone | 100,000 |
| Procaine | 15,000 |
| Thebaine | 6,250 |
