CE ISO13485 marked Drug Abuse Rapid Test Kit Serun/Plasma
Drug Abuse Rapid Test Kit Serun/Plasma
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.
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 .
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.
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
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.