DOA KET One Step Ketamine rapid Test with CE certificate

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:

SUMMARY

Ketamine is a dissociative anesthetic developed in 1963 to replace PCP (Phencyclidine). While Ketamine is still used in human anesthesia and veterinary medicine, it is becoming increasingly abused as a street drug.

Ketamine is molecularly similar to PCP and thus creates similar effects including numbness, loss of coordination, sense of invulnerability, muscle rigidity, aggressive / violent behavior, slurred or blocked speech, exaggerated sense of strength, and a blank stare. There is depression of respiratory function but not of the central nervous system, and cardiovascular function is maintained.

The effects of Ketamine generally last 4-6 hours following use. Ketamine is excreted in the urine as unchanged drug (2.3%) and metabolites (96.8%).¹

The KET One Step Ketamine Test is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Ketamine in urine. The KET One Step Ketamine Test yields a positive result when Ketamine in urine exceeds 1,000 ng/mL.