A rapid test for the qualitative detection of Cotinine (nicotine
metabolite) in human urine.
For determination of smoking status only. Not intended for medical
diagnostic use.
INTENDED USE
The COT Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Cotinine in human urine at a cut-off concentration of 30 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 preliminary analytical test result. A
more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas
chromatography and 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 | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Device, Cup |
| Specimen | Urine,Oral Fluid,Powder,WB/S/P,Hair |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 10T/25T/40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 97.50% |
| Accuracy | 97.20% |
| Cut-Off | 10 ng/mL, 50 ng/mL, 100 ng/mL, 200 ng/mL*, 500 ng/mL,20 ng/mL* ,0.2
ng/mg |
SUMMARY
Cotinine is the first-stage metabolite of nicotine, a toxic
alkaloid that produces stimulation of the autonomic ganglia and central nervous system when in humans.
Nicotine is a drug to which virtually every member of a tobacco-smoking society is exposed whether
through direct contact or second-hand inhalation. In addition to tobacco, nicotine is also commercially
available as the active ingredient in smoking replacement therapies such as nicotine gum, transdermal
patches and nasal sprays.
In a 24-hour urine, approximately 5% of a nicotine dose is excreted
as unchanged drug with 10% as cotinine and 35% as hydroxycotinine; the concentrations of other
metabolites are believed to account for less than 5%.1 While cotinine is thought to be an inactive
metabolite, it’s elimination profile is more stable than that of nicotine which is largely urine pH dependent.
As a result, cotinine is considered a good biological marker for determining nicotine use. The plasma
half-life of nicotine is approximately 60 minutes following inhalation or parenteral administration.2
Nicotine and cotinine are rapidly eliminated by the kidney; the window of detection for cotinine in urine at a
cutoff level of 30 ng/mL is expected to be up
to 2-3 days after nicotine use.
The COT 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 Cotinine in urine. The COT Rapid Test Cassette (Urine) yields a
positive result when the Cotinine in urine exceeds 30 ng/mL.
PRINCIPLE
The COT Rapid Test Cassette (Urine) is an 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. Cotinine, if present in the urine specimen below 30 ng/mL, will not saturate the binding sites of
antibody coated particles in the test . The antibody coated particles will then be captured by immobilized
Cotinine 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 Cotinine level exceeds 30 ng/mL because it will saturate all the
binding sites of anti-Cotinine 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 that
proper volume of specimen has been added and membrane wicking has occurred.
REAGENTS
The test contains mouse monoclonal anti-Cotinine antibody-coupled
particles and Cotinine-protein conjugate. A goat antibody is employed in the control line system.
PRECAUTIONS
For medical and other 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 either 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.
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 precipitates
should be centrifuged, filtered, or allowed settle to obtain a clear supernatant for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior to
assay. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens
should be thawed and mixed before testing.
DIRECTIONS FOR USE
Allow test, urine specimen, and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove
the test device from the sealed pouch and use it within one hour.
2. Place the test device on a clean and level surface. Hold the
dropper vertically and transfer 3 full drops of urine (approx. 120 uL) to the specimen well (S) of the
test device, 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. The result should be
read at 5 minutes. It is important that the background is clear before the result is read. Do not interpret the
result after 10 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE:* Two lines appear. One colored line should be in the
control line region (C), and another apparent colored line should be in the test line region (T). This
negative result indicates that the Cotinine concentration is below the detectable level (30 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). This positive result indicates that the Cotinine
concentration exceeds the detectable level (30 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 lot
immediately and contact your 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 positive 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.
Order Information
| DCT-102 | Cotinine (COT) Rapid Test Cassette | Urine | 40T |
| DCT-114 | Cotinine (COT) Rapid Test Panel | Urine | 40 T |
| DCT-101 | Cotinine (COT) Rapid Test Dipstick | Urine | 50 T |
| DCT-802 | Cotinine (COT) Rapid Test Cassette | Oral Fluid | 25 T |
| DCT-803 | Cotinine (COT) Rapid Test Device | Oral Fluid | 25 T |
| DCT-402 | Cotinine (COT) Rapid Test Cassette | WB/S/P | 40 T |
| DCT-X14 | Cotinine (COT) Rapid Test Panel | Powder | 25 T |
| DCT-H902 | Cotinine (COT) Rapid Test Cassette | Hair | 10 T |
