DOA PPX One Step Propoxyphene Test with CE Certificate Urine uncut sheet

DOA PPX One Step Propoxyphene Test with CE certificate urine uncut sheet

One Step Propoxyphene Test is a rapid one step test for the qualitative detection of Propoxyphene and its principal metabolites in human urine at specified cut-off level.

For in vitro diagnostic use only. For healthcare professional use only.

INTENDED USE

The One Step Propoxyphene Test is a lateral flow chromatographic immunoassay for the detection of Propoxyphene in human urine at the cut-off concentration of 300 ng/ml. 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.

PERFORMANCE CHARACTERISTICS

A. Sensitivity

One Step Propoxyphene Test has set the screen cut-off for positive specimens at 300 ng/mL for Propoxyphene as a calibrator. The test device has been proved to detect above 300 ng/mL of Propoxyphene in urine at 5 minutes.

B. Specificity and cross reactivity

To test the specificity of the test, the test device was used to test Propoxyphene, its metabolites and other components of the same class that are likely to be present in urine, All the components were added to drug-free normal human urine. These concentrations below also represent the limits of detection for the specified drugs or metabolites.

Component Concentration (ng/ml)

d-Propoxyphene 300

d-Norpropoxyphene 300

C. Interfering substances

Considering the complexity of clinical urine specimens and the possibility that various urine specimens contain potentially interfering substances, for example Acetoacetic Aci, Acetone, Albumin etc., we simulated above situations by adding the potentially interfering substances to a certain concentration as specimen. The following components show no cross-reactivity when tested with One Step Propoxyphene Test at a concentration of100 µg/ml.

SUMMARY

Propoxyphene, a synthetic opiate agonist, is structurally similar to methadone. Propoxyphene is a narcotic analgesic used to relieve mild to moderate pain. The principal metabolites are nordextropropoxyphene. The combination usage of propoxyphene, aspirin, acetaminophen or other sedatives can lead cooperative interaction. Abuse of propoxyphene can lead nausea, vomit, astriction, illusion, hallucination, heart poisoning, lung dropsy and even death. Propoxyphene is metabolized in the liver and excreted in urine as nordextropropoxyphene. Thus the presence of the propoxyphene or its metabolites in the urine indicates propoxyphene use.

DOA PPX One Step Propoxyphene Test with CE Certificate Urine uncut sheet Images