Pregabalin PGB Rapid Test Dipcard (Urine) For Professional IVD Use, CE ISO Certified Screening

The test is used to obtain visual qualitative result and is intended for health care professionals use including professionals at point of care sites to assist in the determination of drug compliance. It is not

intended for over the counter sale to non-professionals. This assay provided only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/ Mass Spectrometry (GC/MS) or Liquid Chromatography/ Mass Spectrometry (LC/MS) are 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.

The PGB Rapid Test Dipcard (Urine) detects Pregabalin through visual interpretation of color development on the device. Drug conjugates are immobilized on the test region of the membrane. During testing, the specimen reacts with antibodies conjugated to colored particles and precoated on the sample pad. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there are insufficient drug molecules in the specimen, the antibody-colored particle conjugate will bind to the drug conjugates, forming a colored band at the test region of the membrane. Therefore, a colored band appears in the test region when the urine is negative for the drug. If drug molecules are present in the urine above the cut-off concentration of the test, they compete with the immobilized drug conjugate on the test region for limited antibody binding sites. This will prevent attachment of the antibody-colored particle conjugate to the test region. Therefore, the absence of a colored band at the test region indicates a positive result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.