Class III Rapid Drug Test Strip Cassette Device COC One Step Test Cassette With

Product Specification

Rapid Drug Test Strip Cassette Device Coc One Step Test Cassette with CE

【INTENDED USE】

Rapid CocaineCOC Test is an immuno-chromatographic assay for the qualitative determination of the presence of CocaineCOC listed in the table below. Drug(Identifier) Calibrator Cut-off level CocaineCOC Benzoylecgonine 100 ng/mL This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to CocaineCOC of abuse test result, particularly when preliminary positive results are indicated.

【PRINCIPLE】

CocaineCOC Rapid Test is a competitive immunoassay that is used to screen for the presence of CocaineCOC and metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites. When the test is activated, the urine is absorbed into test by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug within the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test . This produces a colored Test line in the Test Region (T) of the test, which, regardless of its intensity, indicates a negative test result. When sample drug levels are at or above the detection level of the test, the free drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result. To serve as a procedure control, a colored line will appear at the Control Region (C) of test, if the test has been performed properly.

【CONTENTS】

• Drug Test.

• Desiccant

• Leaflet with instruction for use

【STORAGE AND STABILITY】

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.

• The test must remain in the sealed pouch until use.

• Keep away from direct sunlight, moisture and heat.

• Do not freeze.

• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.

【OPERATION】

Test must be in room temperature (15ºC to 30ºC)

1. Donor collects urine specimen in a urine cup.

2. Cassette and Strip Operation:

2.1 Cassette: Remove test device/cassette from the sealed pouch. Lay the cassette flat, add 2-3 drops of urine specimen by sample dropper into the sample well.

2.2 Distick Panel or Strip: Remove test strip from the sealed pouch. Dip the arrowed end of the test strip into the container with urine sample, take it out in 5seconds and lay flat.

3. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.