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One Step Drug Test:  Product Overview

Key Advantages

  • Speed. 
    Test is performed in 1 step with results obtained in 5 minutes.
  • Low Cost. 
    Each test costs a fraction of the price of a standard lab test.
  • Outstanding Performance. 
    See Available Tests for individual test specifications and performance.
  • Consistency. 
    Conforms to standard testing Cutoff Levels designated by SAMHSA.
  • FDA-Approved. 

Test Diagram and Explanation

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Each One Step Drug Test card consists of one or more Panels. Each Panel contains a test Results Window and a Test Strip for absorbing the urine sample and transporting it to the Results Window for a reading. Each Panel detects a specific drug or drug category. A separate test result is shown for each Panel. See example below.

Drug Test Diagram

The 5-Panel One Step Drug Test card, shown left, detects 5 different drug categories, displaying 5 separate results. The absorbent Test Strips are dipped in urine and removed. Within 5 minutes, results are displayed in each of 5 Results Windows. 2 Red Lines = Negative. 1 Red Line = Positive.

Complete Instructions and Specifications are included. To view Test Preparation and Procedure, see Instructions.

Intended Use

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The One Step Drug Screen Test Card is a lateral flow chromatographic immunoassay for the qualitative detection of drugs and/or drug metabolites in human urine at specified cut-off concentrations. (See Available Tests for drugs/metabolites detected and test cut-offs.) For healthcare professionals including professionals at point of care sites. For in vitro diagnostic use only.

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 indicated.

Principle

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The One Step Drug Screen Test Card is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody.

During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region.

A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen will generate a line in the test line region because of the absence of drug competition.

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.