New Drug Abuse Test Kit TML (Tramadol) Rapid Diagnostic Test
dipcard, cut-off 100ng/ml urine drug test, professional use
One Step TML (Tramadol) Rapid Diagnostic Test dipcard
|Product||Cat No||Specimen||Sensitivity||Format||Kit Size|
|TML||YD171S3||Urine||100 ng/mL||3mm Strip||100T|
The TML Rapid Test Cassette (Urine) is a rapid
immunochromatographic assay for the qualitative detection of
Tramadol in human urine at a cut-off concentration of 100 ng/mL.
This assay provides only a 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.
The TML Rapid Test Cassette (Urine) is a 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. Tramadol, if
present in the urine specimen below 100 ng/mL, will not saturate
the binding sites of antibody-coated particles in the test device.
The antibody-coated particles will then be captured by immobilized
Tramadol 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 Tramadol level exceeds 100 ng/mL because it will
saturate all the binding sites of anti-Tramadol antibodies. A
drug-positive urine specimen will not generate a colored line in
the test line region because of drug competition, 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
DIRECTIONS FOR USE
1. Bring tests, specimens, and/or controls to room temperature
(15-30°C) before use.
Remove the test from its sealed pouch, and place it on a clean,
level surface. Label the test with patient or control
identification. For best results, the assay should be performed
within one hour.
2. Using the provided disposable pipette, transfer 3 drops of
specimen (approximately 120 µL) to the specimen well (S) of the
device and start the timer.
3. Avoid trapping air bubbles in the specimen well (S), and do not
add any solution to the result area.
4. As the test begins to work, color will migrate across the
5. Wait for the colored band(s) to appear. The result should be
read at 5 minutes. Do not interpret the result after 8 minutes
INTERPRETATION OF RESULTS
NEGATIVE:* A colored line appears in the Control region (C) and colored lines
appears in the Test region (T). This negative result means that the
concentrations in the urine sample are below the designated cut-off
levels for a particular drug tested.
*NOTE: The shade of the colored lines(s) in the Test region (T) may
vary. The result should be considered negative whenever there is
even a faint line.
POSITIVE: A colored line appears in the Control region (C) and NO line
appears in the Test region (T). The positive result means that the
drug concentration in the urine sample is greater than the
designated cut-off for a specific drug.
INVALID: No line appears in the Control region (C). Insufficient specimen
volume or incorrect procedural techniques are the most likely
reasons for Control line failure. Read the directions again and
repeat the test with a new test card. If the result is still
invalid, contact your manufacturer.
A procedural control is included in the test. A line appearing in
the control 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 practice to confirm the test procedure
and to verify proper test performance.