CE ISO13485 marked Drug Abuse Rapid Test Kit Serun/Plasma Strip/cassette/Device
Drug Abuse Rapid Test Kit Serun/Plasma
INTRODUCTION
The one step Cassette Style Drug test is a rapid test based on the principle of immunoassay combined with conjugated colloid gold technology. The tests are designed to obtain a visual , qualitative result and are intended for professional use only . They are not intented for quantitative results ,nor for over-the-counter sale.
The Drug Test provides only preliminary analytical data , A more specific ,alternative method is required to obtain a confirmed analytical result .SAMHSA has established gas chromatography / mass spectrometry (GC/MS) as the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result ,particularly when preliminary positive Results are indicated.
Product principle:
The Drug Test is a competitive ,IVD, immunochromatographic ,urinary assay in which a chemically modified and bound drug conjugate competes with urinary MED for limited ,specific drug antibody binding sites. The one step Cassette Style Drug Test have five strips ,Each test stip contain a sample reaction unit , a pink-colored , antibody-colloidal gold conjugate unit pre-labeled with specific antibody ,and a chromatographic membrane pre-coated with drug conjugate in the device test region .
When free drug is absent from urine or at concentration lower than the urinary detection cut-off level, the pink-colored ,antibody-colloidal gold conjugate is free to bind to the immobilized drug conjugate pre-coated on the chromatographic membrane test region .Consequently ,a pink-colored band will form in the test region indicating a negative result .When drug is present in urine at concentrations at or exceeding the detection cut-off level, it will bind to limited epitopes on the pink-colored, antibody-colloidal gold conjugate , completely competing with drug conjugate in the test region .In such cases , no band forms in the test region ,indicating a positive result.
The one step Cassette Style Drug test also provide a built-in process control . A pink-colored band should always appear in the control region , regardless of the presence of any urinary MED . This pink-colored control band verifies that :1) sufficient urine volume was added, and 2) proper flow was obtained. If the control band is missing , the test was not performed correctly or failed to function correctly. In summary , negative urine will produce two pink-colored bands, one in the control region and one in the test region .Positive urine will produce one pink-colored band in the control region only .
Indication:
The Drug abuse rapid test for the qualitative detection of drug in human urine. For healthcare professional including professionals at point of care sites. For in vitro diagnostic use only.
Test Procedure:
1. The test kit and soecimen should be brout to room temperature prior to use.
2. Remove the Strip/cassette/Device from foil pouch.
3. Using the plastic pipettor provided draw 2-3 drops of specimens(approx 60-90ul) into thespecimen well, Use a separate pipette and device for each sample or control
4. Read result within 5minutes
5. For more detailed information please refer to the instruction
Storage:
The test kit can be stored at temperatures from 2 to 30 in the sealed pouch up to date of expiration. The test kit should be kept away from direct sunlight and moisture. Do not freeze the test kit.
