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AlcoMate AL7000/6000/5000/Core/Plus (100 Mouthpcs)

AL7000/AL6000/AL5000/Core/Plus mouthpieces are lightweight and made of durable plastic. The breathalyzers use a semiconductor-oxide sensor that requires a mouthpiece.

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TEST COMPARISON 
TMS PACK LABORATORY SCREENING

Background/Description:

This study was conducted to compare the reliability/accuracy of Premier Laboratory Systems' TMS PACK Drugs of Abuse Tests vs. traditional, laboratory screening methods. The study was conducted at Clinical Reference Laboratory in Lenexa, KS. Forefront Diagnostics' TMS PACK 5-Panel (Methamphetamine) tests were compared to CRL's Hitachi Immunoassay Screening Instrument running DRI Liquid Reagents Screening Instrument running DRI Liquid Reagents. 196 samples (120 Random, 74 Screened Positives, 2 Controls) were tested via the Hitachi instrument. Samples were then tested using Premier Laboratory Systems' TMS PACK Drugs of Abuse Tests. All samples reported as positive by either TMS PACK or Hitachi were confirmed using GC/MS.

Test Summary:

TMS PACK    Hitachi-DRI 
Total Specimens   196 194
Total Correct 189 (96.4%) 179 (92.3%)
Total Errors   7 (3.5%) 15 (7.6%)
False Positive (%/#)   1.5% (3) 7% (14)
False Negative (%/#) 2.0% (4) 1% (1)
Failed/Test Not Performed  0% (0) 1% (3)

Description of False Positives:
TMS PACK              
1 - THC (Screened at 46 ng/ml) 
1 - THC (Sample Disposed. Could not Re-screen)
1 - OPI (Screened at 255 ng/ml) 
HITACHI (DRI Reagents)           
14 - Amphetamine (All were GC/MS Neg.)

Description of False Negatives:
 TMS PACK
1 - Methamphetamine (GC/MS = 2,596)
1 - Cocaine (GC/MS = 2116 ng & 351 ng) 
HITACHI - DRI
1 - THC (GG/MS = 85 ng)

Description of Failed/Test Not Performed:
 TMS PACK
All 196 tests were completed. No failed  tests.
HITACHI - DRI 
 1 - Test Not Performed (Dilute Specimen)
2 -Tests Not Performed (Nitrites - Both THC +)

Conclusion:
In this study, the TMS PACK Drugs of Abuse test kits were shown to have an "over-all" accuracy rate greater than that obtained using traditional laboratory screening methods. Additionally, the TMS PACK tests had a lower false positive rate than laboratory screening. Although the false negative rate was greater than that of the laboratory screening method, the rate of 2% was well within acceptable limits for a screening test.


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