Cut - Off 1000ng/Ml Pregabalin Drug Abuse Test Kit 4mm Strip , Time 5 -15 M

Drug Abuse Test Kit PGB(Pregabalin) Rapid Test 4mm strip , cut-off 1000ng/ml, urine drug test

Product Name

PGB Rapid Diagnostic Test/ Pregabalin Rapid Diagnostic Test

Specimen: Urine

Intended Use

The PGB Rapid Test Strip (Urine) is a rapid visual immunoassay for the qualitative presumptive detection of PGB in human urine specimens at the cut-off concentrations listed below:

Test Principle

The PGB Rapid Test Strip (Urine) has been designed to detect PGB through visual interpretation of color development in the Device. The membrane was immobilized with PGB conjugates on the test region, and the sample pad was pre-coated with colored anti- PGB antibodies colloidal gold conjugates. After specimens were added, the gold-conjugates move along the membrane chromatographically by capillary action and antibodies get to the test region. If there is no drug molecule in the urine the antibody gold conjugate would attach to the drug conjugate to form a visible line. Therefore, the formation of a visible precipitant in the test region occurs when the urine is negative for the drug. If PGB are present in the urine, the drug antigen competes with the immobilized drug conjugate on the test region for limited antibody sites. In case of sufficient concentration of the drug, it fills the limited antibody binding sites. This will prevent attachment of the colored antibody-colloidal gold conjugate to the drug conjugate zone on the test region. Therefore, absence of the colored band on the test region indicates a positive result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND STORAGE

The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing. Specimen.

Urine specimens may be stored at 2-8°C for up to 48 hours prior to testing. For long-term storage, specimens may be frozen and stored below -20°C. Frozen specimens should be thawed and mixed before testing.

STORAGE

Store as packaged in the sealed pouch either at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

LIMITATION

1. The 6-MAM Rapid Test Cassette provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method2.3.

2. It is possible that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

3. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

4. A positive result indicates presence of the drug or its metabolites but does not indicate level of intoxication, administration route or concentration in urine.

5. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

performance characteristics

A side-by-side comparison was conducted using the Pregabalin Rapid Test Strip (Urine) and GC/MS. The following results were tabulated:

A. Accuracy Accuracy of the PGB Rapid Test Strip (Urine) was established by running urine sample against GC/MS specification.