Pregabalin PGB Rapid Diagnostic Urine Drug Test Kits 4mm Card

Product Specification

Drug Abuse Test Kit PGB(Pregabalin) Rapid Test 4mm card , 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.

DIRECTIONS FOR USE

Remove the test from its sealed pouch, or remove one strip from the canister, and use it as soon as possible. For best results, the assay should be performed within one hour. Canisters should be closed tightly after removing strips.

Hold the strip by the end, where the product name is printed. To avoid contamination, do not touch the strip membrane.

Holding the strip vertically, dip the test strip in the urine specimen for at least 10-15 seconds. Do not immerse past the maximum line (MAX) on the test strip. After the test has finished running, remove the strip from the specimen and place it on a non-absorbent flat surface. Start the timer and wait for the colored band(s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF RESULTS

NEGATIVE:* A colored line appears in the Control region (C) and colored lines appears in the Test region (T). This negative result means that the concentrations in the urine sample are below the designated cut-off levels for a particular drug tested.

*NOTE: The shade of the colored lines(s) in the Test region (T) may vary. The result should be considered negative whenever there is even a faint line.

POSITIVE: A colored line appears in the Control region (C) and NO line appears in the Test region (T). The positive result means that the drug concentration in the urine sample is greater than the designated cut-off for a specific drug.

INVALID: No line appears in the Control region (C). Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for Control line failure. Read the directions again and repeat the test with a new test card. If the result is still invalid, contact your manufacturer.

QUALITY CONTROL

A procedural control is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

1. Analytical Sensitivity A drug-free urine pool was spiked with Pregabalin at the following concentrations: 0ng/mL, 500ng/mL, 750ng/mL, 1000ng/mL, 1250ng/mL, 1500ng/mL and 2000ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration.

C. Reproducibility The reproducibility of the PGB Rapid Test Strip (Urine) was verified by blind tests performed at four different locations. Samples with PGB concentrations at 50% of the cut-off were all determined to be negative, while samples with PGB concentrations at 200% of the cut-off were all determined to be positive.