TAP-Tapentadol Rapid Test Dipstick , detection of Tapentadol in human urine, drugs of abuse

Application

The TAP Rapid Test Dipstick (Urine) is a rapid chromatographic immunoassay for the detection of Tapentadol in human urine at a cut-off concentration of 1000 ng/mL. This test will detect other related compounds, please refer to the Analytical Specificity table in this package insert.

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.

PRINCIPLE

The TAP Rapid Test Dipstick (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.

PRECAUTIONS

• For professional in vitro diagnostic use only. Do not use after the expiration date.

• The test should remain in the sealed pouch until use.

• All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.

• The used test should be discarded according to local regulations.

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 or canister to room temperature before opening it. Remove the test dipstick from the sealed pouch or closed canister and use it within one hour.

2. With arrows pointing toward the urine specimen, immerse the test dipstick vertically in the urine specimen for at least 10-15 seconds. Do not pass the maximum line (MAX) on the test dipstick when immersing the strip. See the illustration below.

3. Place the test dipstick on a non-absorbent flat surface, start the timer and 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.

EXPECTED VALUES

This negative result indicates that the Tapentadol concentration is below the detectable level of 1000 ng/mL. Positive result means the concentration of Tapentadol is above the level of 1000 ng/mL. The TAP Rapid Test Dipstick (Urine) has a sensitivity of 1000 ng/mL.

The Tapentadol (TAP) Rapid Test 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.

CITEST DIAGNOSTICS INC., an emerging In Vitro Diagnostics company based in Canada, is experiencing growth on a global scale, engaging in multinational operations. CITEST was founded by highly experienced IVD industry professionals with proven track records building and growing successful companies.

CITEST manufactures its IVD products in ISO13485:2016 accredited manufacturing facilities under strict quality assurance systems. Our innovative products are developed using industry-leading design control systems, which ensures consistent product quality and performance.

Our products are used in the clinical market to help people live more healthy lives. When you select CITEST products, you can be assured of high performance and accuracy along with a dedicated customer support team.