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|Parameter:||THC, MET,COC,BUP,BZO,AMP,etc||Certification:||CE,FDA 510k, CLEARED, CLIA WAVIED|
|Quality Management:||ISO 13485 By TUV||Specimen:||Urine|
|Shelf Life:||24months||Cut Off:||Diversity|
3 Flat Sides Screening Cup for Drug Abuse Testing from Chinese factory
Urine based Drug tests for multiple drugs of abuse range from simple immunoassay tests to complex analytical procedures. The speed and sensitivity of immunoassays have made them the most widely accepted method to screen urine for multiple drugs of abuse.
A competitive immunoassay that is used to screen for the presence of various drugs and drug 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.
Test must be in room temperature (15ºC to 30ºC)
1. After the urine has been collected, tighten lid, and place the test cup on a flat surface.
2. Read temperature immediately to verify that urine temperature is within the acceptable range. 90 – 100 o F (32 – 38 o C)
3. Peel off label and read the results. The drug test results should be read at 5 minutes. The drug test results remain stable for up to thirty minutes.
See the illustration below.
When the test is activated, the urine is absorbed into each test strip 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 strip. This produces a colored Test line in the Test Region (T) of the strip, 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 each strip, if the test has been performed properly.
Note: This assay provides only a 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.
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