DOA KET One Step Ketamine rapid Test with CE certificate
| Product Name | KET One Step Ketamine rapid test |
| Formats | Strip(3mm)Device(4mm) Multi panel |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | 25 device/box or 50 strip/Box |
| Storage | 2℃-30℃ |
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:
| Method | GC/MS | Total Results |
KET One Step Test | Results | Positive | Negative |
| Positive | 10 | 8 | 18 |
| Negative | 0 | 205 | 205 |
| Total Results | 10 | 213 | 223 |
| % Agreement | 100% | 96.2% | 96.4% |
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:
Ketamine Concentration (ng/mL) | Percent of Cut-off | n | Visual Result |
| Negative | Positive |
| 0 | 0 | 20 | 20 | 0 |
| 500 | -50% | 20 | 20 | 0 |
| 750 | -25% | 20 | 15 | 5 |
| 1,000 | Cut-off | 20 | 10 | 10 |
| 1,250 | +25% | 20 | 0 | 20 |
| 1,500 | +50% | 20 | 0 | 20 |
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.
