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 |
