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Accuracy
A side-by-side comparison was conducted using the One Step Multi-Drug Test Cassette and commercially available drug rapid tests. Testing was performed on approximately 1,000 specimens previously collected from subjects presenting for Drug Screen Testing. Some specimens in the +/-25% cut-off levels were prepared by diluting from the more concentrated clinical specimens with the neat urine. Presumptive positive results were confirmed by GC/MS. Negative urine samples were screened initially by Predicate test. Approximately 10% negative samples were confirmed by GC/MS. The following compounds were quantified by GC/MS and contributed to the total amount of drugs found in presumptive positive urine samples tested.
| Test | Compounds Contributed to the Totls of GC/MS |
| AMP | Amphetamine |
| BAR |
Secobarbital, Butalbital, Phenobarbital, Pentobarbital |
| BZO |
|
| COC |
Benzoylecgonine |
| THC |
11-nor-9-carboxy-delta-9-tetrahydrocanabinol |
| MTD |
Methadone |
| mAMP |
Methamphetamine |
| MDMA | Methylenedioxymethamphetamine, Methylenedioxyamphetamine |
| MOP | Morphine, Codeine |
| OPI |
Morphine, Codeine |
| OXY | Oxycodone |
| PCP |
Phencyclidine |
| TCA |
Amitriptyline, Desipramine, Doxepin, Imipramine, Nortriptyline, Desmethyldoxepin |
| COT | Cotinine, Nicotine |
| PPX | Propoxyphene, Norpropoxyphene |
The following results are tabulated from these clinical studies:
| Method | GC/MS | ||||||
| Multi-Drug Single-Line Test Card |
Neg. | Neg. (<-25% cutoff) | Near cutoff neg. (-25% cutoff to cutoff) | Near cutoff pos. (cutoff to +25% cutoff) | Pos. (>25% cutoff) | % agreement with GC/MS | |
| AMP | Positive | 0 | 1 | 8 | 18 | 114 | 97% |
| Negative | 149 | 1 | 5 | 4 | 0 | 95% | |
| BAR | Positive | 0 | 0 | 4 | 5 | 117 | 92% |
| Negative | 150 | 2 | 6 | 1 | 10 | 99% | |
| BZO | Positive | 0 | 2 | 0 | 6 | 122 | 98% |
| Negative | 150 | 9 | 2 | 2 | 1 | 98% | |
| COC | Positive | 0 | 2 | 15 | 16 | 103 | 98% |
| Negative | 150 | 5 | 7 | 1 | 1 | 91% | |
| THC | Positive | 0 | 13 | 9 | 12 | 109 | 89% |
| Negative | 150 | 6 | 0 | 0 | 1 | 99% | |
| MTD | Positive | 0 | 0 | 0 | 2 | 118 | 93% |
| Negative | 150 | 17 | 10 | 8 | 1 | >99% | |
| mAMP | Positive | 0 | 0 | 10 | 9 | 126 | 99% |
| Negative | 150 | 0 | 4 | 1 | 0 | 94% | |
| MDMA | Positive | 0 | 0 | 3 | 6 | 79 | 98% |
| Negative | 150 | 0 | 2 | 0 | 2 | 98% | |
| MOP | Positive | 0 | 1 | 4 | 4 | 115 | 98% |
| Negative | 150 | 2 | 3 | 2 | 1 | 97% | |
| OPI | Positive | 0 | 0 | 16 | 18 | 116 | >99% |
| Negative | 150 | 0 | 0 | 0 | 0 | 90% | |
| OXY | Positive | 0 | 5 | 2 | 135 | 98% | |
| Negative | 147 | 8 | 2 | 1 | 97% | ||
| PCP | Positive | 0 | 0 | 6 | 10 | 40 | >99% |
| Negative | 150 | 6 | 0 | 0 | 0 | 96% | |
| *TCA | Positive | 0 | 9 | 2 | 14 | 20 | >99% |
| Negative | 150 | 24 | 7 | 0 | 0 | 94% | |
| PPX | Positive | 0 | 0 | 2 | 7 | 158 | 94% |
| Negative | 152 | 5 | 18 | 10 | 0 | 99% | |
| COT | Positive | 0 | 0 | 0 | 50 | 74 | >99% |
| Negative | 185 | 90 | 90 | 40 | 16 | 94% | |
Forty (40) clinical samples for each drug were run using each of The One Step Single Drug Test Strip by an untrained operator at a Professional Point of Care site. Based on GC/MS data, the operator obtained statistically similar Positive Agreement, Negative Agreement and Overall Agreement rates as trained laboratory personnel.
*Note: TCA was based on HP/LC data.
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