Tapentadol (TAP) Rapid Test Cassette (Urine specimen), tapentadol-O-glucuronide,Durgs of Abuse

Application

PRINCIPLE

The TAP Rapid Test Cassette (Urine) is a rapid chromatographic 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. Tapentadol, if present in the urine specimen below 1000 ng/mL, will not saturate the binding sites of the antibody coated particles in the test. The antibody coated particles will then be captured by immobilized Tapentadol 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 Tapentadol level exceeds 1000 ng/mL because it will saturate all the binding sites of anti-Tapentadol antibodies. A drug-positive urine specimen will not generate a colored line in the test line region, 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.

STORAGE AND STABILITY

Store as packaged in the sealed pouch 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.

DIRECTIONS FOR USE

Allow the test, urine specimen, and/or controls to reach room temperature (15-30 ºC) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it within one hour.

2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer

3 full drops of urine (approx. 120 μL) to the specimen well (S) of the test cassette, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See the illustration below.

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

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. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as good laboratory testing practice to confirm the test procedure and

to verify proper test performance.

Order Information

Cat. No.	Product	Specimen	Pack
DTAP-102	TAP Rapid Test Cassette	Urine	40T
DTAP-101/111	TAP Rapid Test Dipstick	Urine	50 T
DTAP-114	TAP Rapid Test Panel	Urine	40T

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