DOA KET One Step Ketamine rapid Test with CE certificate uncut sheet

For professional in vitro diagnostic use only.

INTENDED USE

The KET One Step Ketamine Test is a lateral flow chromatographic immunoassay for the detection of Ketamine in human urine at a cut-off concentration of 1,000ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

ACCURACY

A comparison was conducted using the KET One Step Ketamine Test and GC/MS at 1,000 ng/mL cut-off. The following results were tabulated:

Analytical Sensitivity

A drug-free urine pool was spiked with Ketamine at the following concentrations: 0 ng/mL, 500ng/mL, 750 ng/mL, 1,000 ng/mL, 1,250 ng/mL and 1,500 ng/mL.The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:

Analytical Specificity

The following table lists compounds that are positively detected in urine by the KET One Step Ketamine Test at 5 minutes.