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Description: This test study was performed on February 1, 2001 using 155 patient samples. Samples were collected at an employment site with aliquots of each forwarded to Forefront Diagnostics and CRL for testing. Samples were tested using the TMS Pack 902C (THUCOUPCIPTMORMET/MTD/AIMP/ BAR/BZO) test kits. Samples forwarded to CRL for screen ing/confirmation testing were tested using DRI immunoassay reagents. GC/MS confirmation tests were performed on all samples screening positive by TMS Pack or DRI.
Results: Table 1 shows the final results for all of the TMS Pack tests. Table 2 indicates which samples, screened positive by TMS Pack were confirmed by CRL with their respective GC/MS value (screening values where noted).
Summary: Overall the TMS Pack tests performed extremely well when compared to laboratory testing (immunoassay screening and GC/MS confirmation). An overall accuracy rate of 99% is well within acceptable ranges for screening assays. The study results indicate that users can be confident of the results they obtain using the TMS Pack test kits, when used according to manufacturers directions.
Table 1
| Drug | PREMIER CHEK™ 730C |
CRL (GC/MS) |
Accuracy | Comments |
| THC | 99% | |||
| Positive | 13 | 11 | ||
| Negative | 142 | 144 | 1 - Dilute | |
| COCAINE | 100% | |||
| Positive | 3 | 3 | ||
| Negative | 152 | 152 | ||
| MORPHINE | 99% | |||
| Positive | 4 | 2 | ||
| Negative | 153 | 153 | ||
| PCP | 100% | |||
| Positive | 0 | 0 | ||
| Negative | 155 | 155 | ||
| METHAMPHETAMINE | 99% | |||
| Positive | 4 | 3 | ||
| Negative | 151 | 152 | ||
| AMPHETAMINE | 99% | |||
| Positive | 5 | 4 | ||
| Negative | 150 | 151 | ||
| BENZODIAZAPINES | 99% | |||
| Positive | 3 | 1 | ||
| Negative | 152 | 154 | ||
| BARBITURATES | 100% | |||
| Positive | 0 | 0 | ||
| Negative | 155 | 155 | ||
| METHADONE | 100% | |||
| Positive | 0 | 0 | ||
| Negative | 155 | 155 | ||
| Overall Test Accuracy | 99% |
1. Note: Insufficient sample, due to
leaking, resulted in several not being tested by CRL.
2. Note: CRL did not test for presence of Hydromorphone
or Hydrocodone.
Table 2
| Positive Results 730C |
Confirmed Y/N |
GC/MS Level (ng/ml) |
Comments |
| THC | Y | 399 | |
| THC | Y | 27 | |
| THC | N | Dilute | |
| THC | Y | 400 | |
| THC | Y | 60 | |
| THC | Y | 148 | |
| THC | Y | 25 | |
| THC | Y | 87 | |
| THC | Y | 33 | Subsequent GC/MS 19 |
| THC | Y | 32 | |
| THC | Y | 96 | |
| THC | Y | 57 | |
| THC | Y | 46 | |
| COC | Y | 499 | |
| COC | Y | 38485 | |
| COC | Y | 2461 | |
| MOR | N | 0 | |
| MOR | Y | 413 | |
| MOR | N | 0 | |
| MOR | Y | 1349 | |
| MET | Y | 3000 | |
| MET | Y | 8163 | |
| MET | N | 427 | |
| MET | Y | 1857 | |
| AMP | Y | 4692 | |
| AMP | Y | 1377 | |
| AMP | Y | 928 | |
| AMP | N | 316 | |
| AMP | Y | 829 | |
| BZO | Y | 2000 | |
| BZO | N | 244 | |
| BZO | N | 132 |
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