TAP Rapid Test Cassette (Urine), Cut-Off Concentration Of 1000 Ng/ML, Analytical Specificity Table
| Principle |
Chromatographic Immunoassay |
| Format |
Dipstick, Cassette, Panel |
| Specimen |
Urine |
| Certificate |
CE |
| Reading Time |
5 minutes |
| Pack |
40T/50T |
| Storage Temperature |
2-30°C |
| Shelf Life |
2 Years |
| Sensitivity |
94.40% |
| Specificity |
98.20% |
| Accuracy |
96.70% |
| Cut-Off |
1000 ng/mL |
TAP Rapid Test Cassette (Urine), cut-off concentration of 1000 ng/mL, Analytical Specificity table
A rapid test for the qualitative detection of Tapentadol in human urine.
For professional in vitro diagnostic use only.
INTENDED USE
The TAP Rapid Test Cassette (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.
SUMMARY
Tapentadol is used to help relieve moderate to severe short-term pain such as pain from an injury or after surgery. It belongs to a class of drugs known as opioid analgesics. It works in the brain to change how the body feels and responds to pain.1 Tapentadol is mainly metabolized in the liver and is excreted by the kidneys in urine as well as in feces. The major pathway of metabolism is conjugation with glucuronic acid to produce glucuronides; tapentadol-O-glucuronide is the major metabolite. 2 For monitoring the intake regularly, Tapentadol is tested in human urine.
The TAP Rapid Test Cassette (Urine) is a rapid urine screening test that can be performed without the use of an instrument. The test utilizes a monoclonal antibody to selectively detect elevated levels of Tapentadol in urine. The TAP Rapid Test Cassette (Urine) yields a positive result when Tapentadol in urine exceed 1000 ng/mL.
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.
REAGENTS
The test contains mouse monoclonal anti-Tapentadol antibody coupled particles and Tapentadol-protein conjugate. A rabbit antibody is employed in the control line system.
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.
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.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two Colored lines appear. One colored line should be in the control line region (C), and another colored line should be in the test line region (T). A negative result indicates that the Tapentadol concentration is below the detectable level (1000 ng/mL).
*NOTE: The shade of color in the test line region (T) may vary, but it should be considered negative whenever there is even a faint colored line.
POSITIVE: One colored line appears in the control line region (C). No line appears in the test line region (T). A positive result indicates that the Tapentadol concentration exceeds the detectable level (1000 ng/mL).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test using a new test. If the problem persists, discontinue using the test kit immediately and contact local distributor.
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 |
