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SUBJECT:
Evaluation of TMS Pack On-site Drugs of Abuse Test
SUMMARY:
The study was conducted to evaluate the accuracy of the TMS Pack On-Site Drugs of Abuse Test. The
TMS Pack test is a compact, easy to use device for the detection of Drugs of Abuse in Urine.
STUDY DESIGN:
Samples were screened using the TMS Pack on-site DOA test and a Hitachi 717 analyzer running
CEDIA Reagents. Samples screening negative by both methods were deemed to be TRUE NEGATIVES.
Samples screening positive by either method were confirmed using GC/MS analysis. Samples with a
GC/MS
value equal to or greater than the confirmation cut-off were determined to be TRUE POSITIVES. Samples with
a GC/MS value less than the confirmation cut-off were determined to be TRUE NEGATIVES.
RESULTS: 309 TOTAL SAMPLES
| TRUE NEGATIVE |
FALSE NEGATIVE |
TRUE POSITIVE |
FALSE POSITIVE |
|
| HITACHI | 294 | 1 | 14 | 0 |
| PREMIER CHEK | 292 | 0 | 15 | 2 (.006%)** |
NOTE - - One sample screened positive for AMP. This sample did not confirm by GC/MS and as such is determined to be a False Positive. The second sample screened positive for THC. The sample confirmed as positive for THC at 10ng/ml, under the rules of this study was considered a false positive because it was found to have drug below the study confirmation cutoff level of 15 ng/mL.
CONCLUSIONS:
In summarizing the findings, "The results are very reliable The
quantitative performance of the PREMIER CHEK™ was also very good. In 100 blind challenges, the analyst was able to
determine the drug present every time.... In conclusion, the TMS Pack is a small, easy-to-use-testing
device well suited for use in an on-site drug-screening program. Reliable test results can be obtained in a short
time by an operator with minimal training and experience, without any equipment or reagents. The zero false
negative rate found in this study proves that the TMS Pack effectively identifies positive samples. The
<1% false positive rate is also well within acceptable limits for a screening test".

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