High Sensitivity 6-Monoacetylmorphine (6-MAM) Rapid Diagnostic Test Cut-Off 10ng/Ml

Drug Abuse Test Kit 6-MAM Rapid Test 4mm cassette ,high sensitivity cut-off 10ng/ml

Product Name

6-Monoacetylmorphine (6-MAM) Rapid Diagnostic Test

Specimen: Urine

Intended Use

The 6-mono-aceto-morphine (6-MAM) Rapid Test Cassette is a rapid chromatographic immunoassay for the detection of 6-mono-aceto-morphine in human urine at the cut-off concentration of 10ng/ml. This test will detect other compounds, please refer to Analytical Specificity table in this package insert. This assay provides only a qualitative, 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.

Test Principle

The 6-MAM Rapid Test Cassette is an 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. 6-MAM, if present in the urine specimen below 10ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized 6-MAM 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 6-MAM level is at or above 10ng/mL because it will saturate all the binding sites of anti-6-MAM 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.

Analytical Sensitivity

A drug-free urine pool was spiked with 6-MAM at the following concentrations: 0 ng/mL, 5 ng/mL, 7.5ng/mL, 10ng/mL, 12.5ng/mL, 15ng/mL and 30ng/mL.The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below: