A comprehensive analysis of 80 clinical urine specimens was conducted by using GC/MS in conjunction with the GenaCheck™ Rapid Self-Test Kit for Cannabis. Each test was administered by three skilled operators.
The samples were categorized based on their concentration into five distinct groups: drug-free, below half the cut-off point, near cut-off negative, near cut-off positive, and high positive. The results were exception- ally consistent, demonstrating an impressive 95.8% agreement among positive results and a perfect 100% agreement among negative results.
We conducted testing on a total of 150 samples, thoughtfully distributed into five concentration categories: -50% Cut-Off, -25% Cut-Off, Cut-Off, +25% Cut-Off, and +50% Cut-Off. This rigorous testing was carried out using three separate lots of each device and managed by three distinct operators.
The results were consistent and reassuring. All samples at and above +25% Cut-Off displayed positive results for Cannabis, affirming the device’s reliability in detecting concentrations above the verified cut-off value of 50 ng/mL. Similarly, all samples at and below -25% Cut-Off yielded negative results, showcasing the device’s precision in detecting concentrations below this threshold.
The following table lists compounds that are positively detected in urine by the
GenaCheck™Rapid Self-Test Kit for Cannabis Dip Card Device.
This study was conducted over a course of 25 days for each format, with two runs performed daily. The study involved three different lots and engaged three operators, each of whom was unaware of the sample number system. Every operator conducted two runs per day, testing two aliquots at each concentration for each lot. This resulted in a total of 50 determinations made by each operator at each concentration.
The following table lists compounds that are positively detected in urine by the
GenaCheck™Rapid Self-Test Kit for Cannabis Dip Card Device.
In another study, we assessed the effect of urinary pH on test performance. We adjusted the pH of a negative urine pool within the range of 4.00 to 9.00 in 1 pH unit increments. The urine was spiked with the target drug at levels 25% below and 25% above the cut-off values. The GenaCheck™ Rapid Self-Test Kit for Cannabis Dip card was employed for testing. The results unequivocally indicate that variations in pH within this range do not interfere with the test’s accuracy.
When tested with the GenaCheck™ Rapid Self-Test Kit for Cannabis Dip card at a concentration of 100 µg/mL, the following compounds exhibited no cross-reactivity with the test.
