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Accuracy
A side-by-side comparison was conducted using the One Step Single Drug Test Strip and commercially available drug rapid tests. Testing was performed on approximately 300 specimens per drug type previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results 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:
|
% Agreement with Commercial Kit |
||||||
| AMP | BAR | BZO | COC | THC | MTD | |
| Positive Agreement | 97% | >99% | 90% | 95% | 98% | 99% |
| Negative Agreement | 100% | >99% | 97% | >99% | 100% | >99% |
| Total Results | 98% | 99% | 94% | 98% | 99% | >99% |
| mAMP | MDMA | MOP | OPI | PCP | TCA* | |
| Positive Agreement | 98% | 100% | 100% | >99% | 98% | 95%5 |
| Negative Agreement | 100% | 99% | 100% | >99% | 100% | >99% |
| Total Results | 99% | 99% | 100% | >99% | 99% | 99% |
|
% Agreement with GC/MS |
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| AMP | BAR | BZO | COC | THC | MTD | |
| Positive Agreement | 97% | >99% | 96% | 96% | 97% | 99% |
| Negative Agreement | 95% | >99% | 96% | >90% | 88% | >94% |
| Total Results | 96% | 99% | 96% | 93% | 91% | >96% |
|
% Agreement with GC/MS |
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| mAMP | MDMA | MOP | OPI | PCP | TCA* | |
| Positive Agreement | 99% | 96% | 100% | >99% | 100% | >99% |
| Negative Agreement | 94% | 98% | 94% | >90% | 97% | 89% |
| Total Results | 96% | 97% | 97% | >95% | 96% | 91% |
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 HPLC data.
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