Product Details
TAP Rapid Test Panel, Tapentadol abuse, Drugs of Abuse, detection
of Tapentadol in Urine
Tapentadol is an opioid pain medication used to treat mod-erate to
severe pain. It may be habit-forming, even at regular doses. A
rapid test for the qualitative detection of Tapentadol in human
urine.
For professional in vitro diagnostic use only
Product: | TAP Rapid Test Panel, Tapentadol Abuse, Drugs Of Abuse, Detection
Of Tapentadol In Urine |
Cat No.: | DTAP-114 |
Certificate: | CE |
Pack: | 40T |
Shelf Life: | 2 Years |
Specificity: | 98.20% |
Cut-Off: | 500 Ng/mL |
Brand: | Citest |
Principle: | Chromatographic Immunoassay |
Specimen: | Urine |
Reading Time: | 5 Minutes |
Storage Temperature: | 2-30°C |
Sensitivity: | 94.40% |
Accuracy: | 96.70% |
PRODUCT FEATURES: | Multiple Formats Available |
Application
The TAP Rapid Test Panel (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.
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.
SPECIMEN COLLECTION AND PREPARATION
Urine Assay
The urine specimen must be collected in a clean and dry container.
Urine collected at any time of the day may be used. Urine specimens
exhibiting visible particles should be centrifuged, filtered or
allowed to settle to obtain clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8 °C for up to 48 hours prior to
testing. For long-term storage, specimens may be frozen and stored
below -20 °C. Frozen specimens should be thawedand mixed before
testing.
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 panel from the sealed pouch and use it within one hour.
2. Remove the cap.
3. With the arrow pointing toward the urine specimen, immerse the
test panel vertically in the urine specimen for at least 10 to 15
seconds. Immerse the strip to at least the level of the wavy lines,
but do not touch the plastic device.
4. Replace the cap and place the test panel on a non-absorbent flat
surface.
5. Start the timer and wait for the colored line(s) to appear.
6. Read results at 5 minutes. Do not interpret the result after 10
minutes.
INTERPRETATION OF RESULTS
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.
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 Panel (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 Panel (Urine) yields a
positive result when
Tapentadol in urine exceed 1000 ng/mL.
Company Profile
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.