CAT Rapid Test Cassette (Urine), chromatographic
immunoassay,150ng/ml cut-off, Cathine
| Principle | Chromatographic Immunoassay |
| Format | Dipstick, Cassette, Panel, Cup |
| Specimen | Urine |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 40T/50T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
| Sensitivity | 90.50% |
| Specificity | 97.30% |
| Accuracy | 95.80% |
| Cut-Off | 150 ng/mL* |
A rapid test for the qualitative detection of Cathine in human
urine. For medical and other professional in vitro diagnostic use only.
INTENDED USE
The CAT Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Cathine in urine at a cut-off concentration of 150ng/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
Cathinone, also known as benzoylethanamine, or β-keto-amphetamine
is a monoamine alkaloid found in the shrub Catha edulis (CAT) and is chemically similar to
ephedrine, Cathinone, methCathinone and other amphetamines. It with amphetamine, ephedrine, methamphetamine
and mephedrone belongs to excitatory amphetamines psychiatric drugs, has the strong central
excitement and suppress appetite, has been widely applied in the depression, fatigue, obesity,
gastric ulcer, etc. The earliest found in Arab tea, because of its structure and pharmacological activities are
similar to amphetamines, so called "natural amphetamine. [1]It has approximately 10-14% the potency of
amphetamine.
S-(-)-Cathinone (S-(-)-alpha-aminopropiophenone) is the major
active principle of khat leaves (Catha edulis), which are widely used in East Africa and the Arab
peninsula as an amphetamine-like stimulant.
After oral administration of synthesized cathinone (isomers,
racemate), 22-52% was recovered in 24 h urine samples mainly as aminoalcohol metabolites. With GC/MS, HPLC
and CD, the main metabolite of S-(-)-cathinone was identified as R/S-(-)-norephedrine and the
main metabolite of R-(+)-cathinone as R/R-(-)-norpseudoephedrine. Both aminoalcohols are formed by a
stereospecific keto reduction.
Use too much Cathinone can cause loss of appetite, anxiety,
irritability, insomnia, illusion and panic attacks. Abusers have for a long time for the development of
personality disorder and continuing the risk of myocardial infarction. The World Anti-Doping Agency's list
of prohibited substances (used for the Olympic Games among other athletic events) bars cathine in
concentrations of over 5 micrograms per milliliter in urine. Cathine is a Schedule III drug under the
Convention on Psychotropic Substances.
PRINCIPLE
The CAT 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. Cathine, if present in the urine specimen below the cut-off level, will not saturate the binding
sites of the antibody in the test. The antibody coated particles will then be captured by immobilized
Cathinone-protein 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 (+)-Norpseudoephedrine HCl level exceeds the cut-off
level, because it will saturate all the binding sites of anti- Cathine antibody.
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 occurred.
The test contains mouse monoclonal anti-Cathine antibody coupled
particles and Cathine-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 particles
should be centrifuged, filtered, or allowed to settle to obtain a clear specimen for testing.
Specimen Storage
Urine specimens may be stored at 2-8°C for up to 48 hours prior to
testing. For prolonged storage, specimens may be frozen and stored below -20°C. Frozen specimens
should be thawed and mixed.
DIRECTIONS FOR USE
Allow the 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 cassette 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 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 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 Cathine concentration is below the detectable cut-off level.
*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 Cathine
concentration exceeds the detectable cut-off level.
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 with a new test. If the problem persists, discontinue using the test kit 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 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 |
| DCA-102 | Cathine (CAT) Rapid Test Cassette | Urine | 40T |
| DCA-114 | Cathine (CAT) Rapid Test Panel | Urine | 40 T |
| DCA-101 | Cathine (CAT) Rapid Test Dipstick | Urine | 50 T |
