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.
