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 |
