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Rapid Self-test Kit For Twelve (12) Drugs

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Accuracy

Rapid Self-test Kit For Twelve (12) Drugs 1

Eighty (80) clinical urine specimens underwent analysis using GC/MS and the GenaCheckTM Rapid Self-Test Kit for Twelve (12) Drugs. Each test was conducted by three operators. The samples were categorized by concentration into five groups: drug-free, less than half the cut-off, near cut-off negative, near cut-off positive, and high positive. The obtained relative sensitivity and specificity results are outlined in below table.

Rapid Self-test Kit For Twelve (12) Drugs

Analytical Sensitivity/precision

Sensitivity and precision studies were conducted using spiked samples, targeted at concentrations of -100% cut-off, -75% cut-off, -50% cut-off, -25% cut-off, cut-off, +25% cut-off, +50% cut-off, +75% cut-off, and +100% cut-off. These samples were aliquoted into containers and blind-labeled before testing. Testing was performed by three operators twice a day for 25 days. Data obtained from all operators indicated >99% correlation at +/-50% of each assay cut-off.

Effect Of Urinary Specific Gravity

Fifteen (15) urine samples representing normal, high, and low specific gravity ranging from 1.000 to 1.035 were spiked with drugs at concentrations 25% below and 25% above cut-off levels. GenaCheckTM Rapid Self-Test Kit for Twelve (12) Drugs was tested in duplicate using ten drug-free urine and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity do not impact the test results.

Effect Of Urinary PH

The pH of a negative urine pool aliquot was adjusted within the range of 4.00 to 9.00 in 1 pH unit increments and spiked with the target drug at concentrations 25% below and 25% above the cut-off levels. The spiked, pH-adjusted urine was then tested using GenaCheckTM Rapid Self-Test Kit for Twelve (12) Drugs. The results confirm that varying pH ranges do not interfere with the test’s performance.

Cross-reactivity

A comprehensive study was conducted to assess the cross-reactivity of the test with compounds found in drug-free urine or positive urine for Amphetamine, Buprenorphine, Cocaine, Ecstasy, EDDP (Methadone Metabolite), Marijuana, Methadone, Methamphetamine, Morphine, Oxazepam, Oxycodone, Phencyclidine, Propoxyphene, Secobarbital, and Tricyclic Antidepressants. The following compounds exhibited no interference when tested with GenaCheckTM Rapid Self-Test Kit for Twelve (12) Drugs at a concentration of 100 µg/ml.