CAF Rapid Test Cassette (Urine),Cut-Off Concentration Of 1000ng/ML,Detection Of Caffeine
|Dipstick, Cassette, Panel, Cup
CAF Rapid Test Cassette (Urine), cut-off concentration of 1000ng/mL,Detection of Caffeine
A rapid test for the qualitative detection of caffeine in human urine. For medical and other professional in vitro diagnostic use only.
The CAF Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of caffeine in urine at a cut-off concentration of 1000ng/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.
Caffeine, is a central nervous system (CNS) stimulant of the methylxanthine class. It is the world's most widely consumed psychoactive drug. It is found in the seeds, nuts, or leaves of a number of plants native to South America and East Asia and confers on them several survival and reproductive benefits.
Caffeine can produce a mild form of drug dependence – associated with withdrawal symptoms such as sleepiness, headache, and irritability – when an individual stops using caffeine after repeated daily intake. After intravenous administration of caffeine the urine level of the drug is approximately the same in each of the first 4 hourly specimens. Blood samples taken 10 and 70 minutes after injection of the drug were analyzed and showed 0.29 and 0.28mg. per 100 cc. respectively. There are to be contrasted with the 1st hour urine which contained 0.73mg.per 100 cc., essentially 3 times that in the blood. After oral administration of caffeine to the horse the concentration of caffeine in the urine rose progressively during the first 3 hours, remained relatively constant through the 8th hours.
At 48 hours, a urine specimen contained approximately 0.17mg. per 100 cc. of caffeine. In addition, flu-like symptoms, nausea/vomiting, and muscle pain/stiffness were judged likely to represent valid symptom categories. In experimental studies, the incidence of headache was 50% and the incidence of clinically significant distress or functional impairment was 13%. Typically, onset of symptoms occurred 12-24 h after abstinence, with peak intensity at 20-51 h, and for a duration of 2-9 days.3 1% to 3% of caffeine is excreted unchanged in the urine. The rate of caffeine metabolism is variable, with a half-life of 4 to 6h.
The CAF 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. Caffeine, 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 Caffeine-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 caffeine level exceeds the cut-off level, because it will saturate all the binding sites of anti-caffeine 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-caffeine antibody coupled particles and caffeine-protein conjugate. A goat antibody is employed in the control line system.
• 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.
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 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). This negative result indicates that the caffeine 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 caffeine 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.
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.
This negative result indicates that the caffeine concentration is below the detectable level of1000ng/mL. Positive result means the concentration of caffeine is above the level of 1000ng/mL. The CAF Rapid Test Cassette has a sensitivity of 1000ng/mL.
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