PPX Rapid Test

PocTell^® One Step Propoxyphene PPX Rapid test Device (Urine) is a lateral flow chromatographic immunoassay for the qualitative detection of Propoxyphene in human urine at a cut-off concentration of 300 ng/mL. It is a prescription assay intended for use by healthcare professionals including those at point of care sites. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

This assay provides only a qualitative, 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..

PocTell^® One Step Propoxyphene PPX Rapid test Device (Urine) is an immunoassay based on the principle of competitive binding. Drugs which may be present in the urine specimen compete against the drug conjugate for binding sites on the antibody.

During testing, a urine specimen migrates upward by capillary action. Propoxyphene, if present in the urine specimen below 300ng/mL, will not saturate the binding sites of antibody-coated particles in the test. The antibody-coated particles will then be captured by immobilized Propoxyphene conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the Propoxyphene level exceeds 300ng/mL because it will saturate all the binding sites of anti-Propoxyphene antibodies.

A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region.

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..

Bring tests, specimens and/or controls to room temperature (15-30°C) before use.

1.Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.

2.Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 L) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).

3.Wait for the colored line(s) to appear. Read results at 5 minutes. Do not interpret the result after 10 minutes.

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