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 uncut sheet
| Product Name | KET One Step Ketamine rapid test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Urine |
| Read Time | 5 minutes |
| Shelf life | 2 years |
| Package | uncut sheet |
| 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 |
Analytical Specificity
The following table lists compounds that are positively detected in urine by the KET One Step Ketamine Test at 5 minutes.
| Compound | Concentration (ng/mL) |
| Ketamine | 1,000 |
| Pentobarbital | 50,000 |
| Secobarbital | 100,000 |
| Norketamine | 50,000 |