DOA MOP One Step Morphine rapid Test with CE certificate urine uncut sheet
| Product Name |
MOP One Step Morphine 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 MOP One Step Morphine Test is a lateral flow chromatographic immunoassay for the detection of Morphine in human urine at the cut-off concentration of 300 ng/mL. This test will detect other compounds, please refer to Analytical Specificity table in this package insert.
Accuracy
A side-by-side comparison was conducted using the MOP One Step Morphine Test and a leading commercially available MOP rapid test. Testing was performed on 341 clinical specimens. Ten percent of the specimens employed were either at -25% or +25% level of the cut-off concentration of 300 ng/mL Morphine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:
| Method |
Other MOP Rapid Test |
Total Results |
|
MOP One Step
Test
|
Results |
Positive |
Negative |
| Positive |
159 |
0 |
159 |
| Negative |
0 |
182 |
182 |
| Total Results |
159 |
182 |
341 |
|
% Agreement with
this Rapid Test Kit
|
100% |
100% |
100% |
When compared to GC/MS at the cut-off of 300 ng/mL , the following results were tabulated:
| Method |
GC/MS |
Total Results |
|
MOP One Step
Test
|
Results |
Positive |
Negative |
| Positive |
159 |
10 |
169 |
| Negative |
0 |
172 |
172 |
| Total Results |
159 |
182 |
341 |
|
% Agreement with
GC/MS Analysis
|
100% |
94.5% |
97.1% |
Analytical Sensitivity
A drug-free urine pool was spiked with Morphine at the following concentrations: 0 ng/mL, 150 ng/mL, 225 ng/mL, 300 ng/mL, 375 ng/mL and 450 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
|
MOP
Concentration (ng/mL)
|
Percent of Cut-off |
n |
Visual Result |
| Negative |
Positive |
| 0 |
0 |
20 |
20 |
0 |
| 150 |
-50% |
20 |
20 |
0 |
| 225 |
-25% |
20 |
20 |
0 |
| 300 |
Cut-off |
20 |
12 |
8 |
| 375 |
+25% |
20 |
2 |
18 |
| 450 |
+50% |
20 |
0 |
20 |
Analytical Specificity
The following table lists compounds that are positively detected in urine by the MOP One Step Morphine Test at 5 minutes.
Compound Concentration (ng/mL)
| Codeine |
300 |
| Ethylmorphine |
6,250 |
| Hydrocodone |
50,000 |
| Hydromorphone |
3,125 |
| Levophanol |
1,500 |
| 6-Monoacethylmorphine |
400 |
| Morphine |
300 |
| Morphine 3-b-D-glucuronide |
1,000 |
| Norcodeine |
6,250 |
| Normorphone |
100,000 |
| Oxycodone |
30,000 |
| Oxymorphone |
100,000 |
| Procaine |
15,000 |
| Thebaine |
6,250 |
Cross-Reactivity
A study was conducted to determine the cross-reactivity of the test with compounds in either drug-free urine or Morphine positive urine. The following compounds show no cross-reactivity when tested with the MOP One Step Morphine Test at a concentration of 100 mg/mL.
