Drug Abuse Test Kit Methaqualone Rapid Test 4mm cassette ,high sensitivity cut-off 300ng/ml
Product Name
MQL ( Methaqualone) Rapid Diagnostic Test
Specimen: Urine
Intended Use
The MQL Rapid Test Panel (Urine) is a rapid chromatographic
immunoassay for the qualitative detection of Methaqualone in human
urine at a cut-off concentration of 300 ng/mL.
This assay provides only a preliminary analytical test result. A
more specific alternate chemical method must be used in order to
obtain a confirmed analytical result. Gas chromatography/mass
spectrometry (GC/MS) is the preferred confirmatory method. Clinical
consideration and professional judgment should be applied to any
drug of abuse test result, particularly when preliminary positive
results are used.
| Parameter | Calibrator | Cut-off (ng/mL) |
| MQL | Methaqualone | 300 |
Test Principle
The MQL Rapid Test Panel (Urine) is a a rapid chromatographic
immunoassay based on the principle of competitive binding. Drugs
which may be present in the urine specimen compete against the drug
conjugate for binding sites on the antibody.
During testing, a urine specimen migrates upward by capillary
action. Methaqualone, if present in the urine specimen below 300
ng/mL, will not saturate the binding sites of antibody-coated
particles in the Test Panel. The antibody-coated particles will
then be captured by immobilized Methaqualone conjugate and a
visible colored line will show up in the test line region. The
colored line will not form in the test line region if the
Methaqualone level exceeds 300 ng/mL because it will saturate all
the binding sites of anti-Methaqualone antibodies.
A drug-positive urine specimen will not generate a colored line in
the test line region because of drug competition, while a
drug-negative urine specimen or a specimen containing a drug
concentration less than the cut-off will generate a line in the
test line region.
To serve as a procedural control, a colored line will always appear
at the control line region, indicating that proper volume of
specimen has been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
Using the provided disposable pipette, transfer 3 drops of specimen
(approximately 120 µL) to the specimen well (S) of the device and
start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add
any solution to the result area.
As the test begins to work, color will migrate across the membrane.
Wait for the colored band(s) to appear. The result should be read
at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
NEGATIVE:* A colored line appears in the Control region (C) and colored lines
appears in the Test region (T). This negative result means that the
concentrations in the urine sample are below the designated cut-off
levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line
appears in the Test region (T). The positive result means that the
drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen
volume or incorrect procedural techniques are the most likely
reasons for Control line failure. Read the directions again and
repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
QUALITY CONTROL
A procedural control is included in the test. A colored line
appearing in the control line region (C) is considered an internal
procedural control. It confirms sufficient specimen volume,
adequate membrane wicking and correct procedural technique.
performance characteristics
A side-by-side comparison was conducted using the Rapid Test
Cassette (Urine) and GC/MS. The following results were tabulated:
Table 1: Specimen Correlation
| Method | | GC/MS | Total |
| | Results | Positive | Negative | Results |
| MQL Rapid Test Panel | | Positive | 79 | 11 | 90 |
| | Negative | 9 | 151 | 160 |
| Total Results | | | 88 | 162 | 250 |
| % Agreement with GC/MS | 89.8% | 93.2% | 92.0% |
| | Analytical | Sensitivity | | |
| ORIENT NEW LIFE MEDICAL CO., LTD. |
| Contact: | Jerry Meng |
| Email: | Jerry @ newlifebiotest .com |
| Tel. | +86 18657312116 |
| SKYPE | enetjerry |
