ACL Rapid Test Cassette (Urine), 7-Aminoclonaz/epam (Major Metabolite) In Urine, DOA Test Kit

ACL Rapid Test Cassette (Urine), 7-AminoClona/zepam (major metabolite) in urine, DOA Test Kit

A rapid test for the qualitative detection of 7-AminoClona/zepam in human urine.

For medical and other professional in vitro diagnostic use only.

INTENDED USE

The ACL Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of 7-AminoClona/zepam (major metabolite) in urine at a cut-off concentration of 300ng/ml. This test will detect other related compounds, please refer to the 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.

SUMMARY

7-aminoClona/zepam is the major metabolite of Clona/zepam. Clona/zepam 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-aminoClona/zepam may be used to monitor use of the parent drug, Clona/zepam. Clona/zepam, 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-aminoClona/zepam in urine. The ACL Rapid Test Cassette (Urine) yields a positive result when the 7-aminoClona/zepam in urine exceed the cut-off level.

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-AminoClona/zepam, 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-AminoClona/zepam -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-AminoClona/zepam level exceeds the cut-off level, because it will saturate all the binding sites of anti-7-AminoClona/zepam 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.

REAGENTS

The test contains mouse monoclonal anti-7-AminoClona/zepam antibody coupled particles and 7-AminoClona/zepam -protein conjugate. A goat antibody is employed in the control line system.

PRECAUTIONS

For medical and other professional in vitro diagnostic use only. Do not use after the expiration date.

The test should remain in the sealed pouch until use.

All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

The used test should be discarded according to local regulations.

DIRECTIONS FOR USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the Test Cassette from the sealed pouch and use it within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S).

3. Wait for the color line(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes

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.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and to verify proper test performance.

Order Information

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.