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Saliva Confirm Oraline 4-Drug (THC/COC/MAMP/OPI)

SalivaConfirm-OraLine is much simpler to use, detects Marijuana at 4 ng/mL and Cocaine, Methamphetamines & Opiates at much lower levels than other saliva/urine based tests.

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TEST EVALUATION
TMS PACK vs. Laboratory Screening & GC/MS

EVALUATION OVERVIEW
This evaluation was conducted to compare the accuracy of the TMS PACK Drugs of Abuse Test Kits versus traditional laboratory screening methods. The evaluation was performed at a SAMSHA certified laboratory. 194 samples were initially screened by the laboratory using a HITACHI Analyzer, (DRI Liquid Reagents). These samples were then tested using the TMS PACK test kits. Positive samples, either HITACHI or TMS PACK were then tested using GC/MS. (Note: If the laboratory screen result and TMS PACK indicated a negative result, no further testing was conducted.)

TMS PACK TEST KITS

TOTAL SAMPLES	194
TOTAL CORRECT SAMPLES OVERALL ACCURACY	185 95.5%
TOTAL INCORRECT SAMPLES	9
TOTAL FALSE NEGATIVE SAMPLES FALSE NEGATIVE RATE	0 0%
TOTAL FALSE POSITIVE SAMPLES FALSE POSITIVE RATE	9** 4.5%

TMS PACK reported one sample to contain THC/COC. GC/MS determined that the sample contained 8 ngl/ml THC & 104 ng/ml COC. Five samples were reported as positive for Methamphetamine or Amphetamine, one sample was reported as positive for Morphine and Methamphetamine and one sample was reported as positive for Morphine. GC/MS determined these samples to be negative. The positive results for Methamphetamine/Amphetamine are believed to be the result of cross-reactivity with OTC products.

LABORATORY SCREENING

TOTAL SAMPLES	194
TOTAL CORRECT SAMPLES OVERALL ACCURACY	187 96.0%
TOTAL INCORRECT SAMPLES	7
TOTAL FALSE NEGATIVE SAMPLES FALSE NEGATIVE RATE	3** 1.5%
TOTAL FALSE POSITIVE SAMPLES FALSE POSITIVE RATE	4** 2.0%

Three samples screening negative for THC confirmed by GC/MS for THC. Four samples reported as positive for Methamphetamine or Amphetamine were negative when tested by GC/MS.

NOTE Screening results were adjusted to represent a Morphine cut-off level of 300 ngl/ml.

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