Urine MDA Rapid Diagnostic Drug Abuse Test Kit Rapid Chromatographic Immunoassay

Product Specification

Drug Abuse Test Kit MDA Rapid Test 3mm strip ,high sensitivity cut-off 400ng/ml

Product Name

MDA Rapid Diagnostic Test

Specimen: Urine

Background

The MDA Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of 3,4-Methylenedioxyamphetamine in human urine at a cut-off concentration of 500 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert. 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.

Test Principle

The MDA Rapid Test Cassette (Urine) is 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. 3,4-Methylenedioxy- amphetamine, if present in the urine specimen below 500 ng/mL, will not saturate the binding sites of the antibody coated particles in the test. The antibody coated particles will then be captured by immobilized 3, 4-Methylenedioxyamphetamine 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 Amphetamine level exceeds 500 ng/mL because it will saturate all the binding sites of anti-3,4-Methylenedioxyamphetamine antibodies. A drug-positive urine specimen will not generate a colored line in the test line region, 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.

SPECIMEN COLLECTION AND STORAGE

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing. Specimen.

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

STORAGE

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

LIMITATION

1. The 6-MAM Rapid Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method2.3.

2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

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