One Step Drug Test: Overview

Summary and Benefits

  • Speed. 
    Test is performed in 1 step with results displayed in seconds.
  • Low Cost. 
    Each test costs a fraction of the price of a standard lab test.
  • Outstanding Performance. 
    The One Step Drug Tests perform admirably when compared to the GC/MS lab testing method. See Specifications for individual test specifications and performances.
  • Consistency. 
    Each test configuration conforms to standard testing Cutoff Levels designated by SAMHSA (except where indicated).
  • FDA-Approved. 

Test Diagram and Explanation of Panels

Each One Step Drug Test card consists of one or more Panels. A panel represents one drug category detected. So a 1-Panel Drug Test detects 1 drug category (example: Marijuana); and a 2-Panel Drug Test detects 2 drug categories (example: Marijuana and Cocaine). A Multi-Panel Drug Test is another name for a drug test containing more than one panel.

Each drug test 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. A separate test result is displayed for each panel/drug category.

Drug Test Diagram

The 5-Panel One Step Drug Test, shown left, detects 5 drug categories. The absorbent Test Strips are dipped in urine and removed. Within 5 minutes, results are displayed in each of the test Results Windows.

2 Red Lines = Negative.

1 Red Line = Positive.

A Product Insert Sheet is included with each order, containing complete Instructions and Specifications.

Intended Use

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. 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

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.