DOA MOP One Step Morphine rapid Test with CE certificate urine test
device
| Product Name | MOP One Step Morphine 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 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 |
SUMMARY
Opioid analgesics comprise a large group of substances which
control pain by depressing the central nervous system. Large doses
of Morphine can produce higher tolerance levels and physiological
dependency in users, and may lead to substance abuse. Morphine is
excreted unmetabolized, and is also the major metabolic product of
codeine and heroin. Morphine is detectable in the urine for several
days after an opiate dose. 1
The MOP One Step Morphine 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 Morphine in urine. The MOP One Step Morphine Test yields
a positive result when Morphine in urine reaches 300 ng/mL. This is
the suggested screening cut-off for positive specimens set by the
Substance Abuse and Mental Health Services Administration (SAMHSA,
USA).
