Urine 5-Drug Card - COC/AMP/METH/THC/OPI

Urine Drug Card Test Accuracy

Accuracy

A side-by-side comparison was conducted using the One Step Multi-Drug Test Cassette and commercially available drug rapid tests. Testing was performed on approximately 1,000 specimens previously collected from subjects presenting for Drug Screen Testing. Some specimens in the +/-25% cut-off levels were prepared by diluting from the more concentrated clinical specimens with the neat urine. Presumptive positive results were confirmed by GC/MS. Negative urine samples were screened initially by Predicate test. Approximately 10% negative samples 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 Oxazepam, Nordiazepam, -OH-Alprazepam, Desaky-frazepam
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:

Method GC/MS
Multi-Drug
Single-Line
Test Card
Neg. Neg. (<-25% cutoff) Near cutoff neg. (-25% cutoff to cutoff) Near cutoff pos. (cutoff to +25% cutoff) Pos. (>25% cutoff) % agreement with GC/MS
AMP Positive 0 1 8 18 114 97%
Negative 149 1 5 4 0 95%
BAR Positive 0 0 4 5 117 92%
Negative 150 2 6 1 10 99%
BZO Positive 0 2 0 6 122 98%
Negative 150 9 2 2 1 98%
COC Positive 0 2 15 16 103 98%
Negative 150 5 7 1 1 91%
THC Positive 0 13 9 12 109 89%
Negative 150 6 0 0 1 99%
MTD Positive 0 0 0 2 118 93%
Negative 150 17 10 8 1 >99%
mAMP Positive 0 0 10 9 126 99%
Negative 150 0 4 1 0 94%
MDMA Positive 0 0 3 6 79 98%
Negative 150 0 2 0 2 98%
MOP Positive 0 1 4 4 115 98%
Negative 150 2 3 2 1 97%
OPI Positive 0 0 16 18 116 >99%
Negative 150 0 0 0 0 90%
OXY Positive 0   5 2 135 98%
Negative 147   8 2 1 97%
PCP Positive 0 0 6 10 40 >99%
Negative 150 6 0 0 0 96%
*TCA Positive 0 9 2 14 20 >99%
Negative 150 24 7 0 0 94%
PPX Positive 0 0 2 7 158 94%
Negative 152 5 18 10 0 99%
COT Positive 0 0 0 50 74 >99%
Negative 185 90 90 40 16 94%

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 HP/LC data.

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