Drug Abuse Test Kit ACL Rapid Test 3mm strip ,high sensitivity cut-off 300ng/ml

Product Name

ACL Rapid Diagnostic Test

Specimen: Urine

Background

aminoclonazepam is the major metabolite of clonazepam. Clonazepam sold under the brandname Klonopin among others, is a medication used to prevent and treat seizures, panic disorder, and for the movement disorder known as akathisia. It is a type of benzodiazepine. As a major metabolite, 7-aminoclonazepam may be used to monitor use of the parent drug, clonazepam. Clonazepam, marketed as Klonopin and Rivotril, is a long-acting benzodiazepine with anxiolytic, anticonvulsant, muscle relaxant, and hypnotic properties. The ACL Rapid Test Cassette (Urine) is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of 7-aminoclonazepam in urine. The ACL Rapid Test Cassette (Urine) yields a positive result when the 7-aminoclonazepam in urine exceed the cut-off level.

Test Principle

The ACL Rapid Test Cassette (Urine) 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. 7-Aminoclonazepam, if present in the urine specimen below the cut-off level, will not saturate the binding sites of the antibody in the test. The antibody coated particles will then be captured by immobilized 7-Aminoclonazepam -protein 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 7-Aminoclonazepam level exceeds the cut-off level, because it will saturate all the binding sites of anti-7-Aminoclonazepam antibody. 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.

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