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.
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 Five (5) Drugs. The results
confirm that varying pH ranges do not interfere with the test’s performance
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 Five (5) Drugs at a concentration of
100 µg/ml.
