Hangzhou Aichek Medical Technology Co.,Ltd
Hangzhou Aichek Medical Technology Co.,Ltd
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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.
