Fluoxetine Rapid Test Cassette (Urine), FLX detection kit,Prozac and Sarafem, DOA
A rapid test for the qualitative detection of Fluoxetine in human urine. For medical and other professional in vitro diagnostic use only.
| 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 |
97.00% |
| Specificity |
96.60% |
| Accuracy |
96.80% |
| Cut-Off |
500 ng/mL |
INTENDED USE
The FLX Rapid Test Cassette (Urine) is a rapid chromatographic immunoassay for the detection of Fluoxetine in urine at a cut-off concentration of 500 ng/mL.
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
Fluoxetine (FLX), also known by trade names Prozac and Sarafem, among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used for the treatment of major depressive disorder, obsessive–compulsive disorder (OCD), bulimia nervosa, panic disorder and premenstrual dysphoric disorder. It may decrease the risk of suicide in those over the age of 65. It has also been used to treat premature ejaculation.[1] Fluoxetine is taken by mouth.
Common side effects include trouble sleeping, sexual dysfunction, loss of appetite, dry mouth, rash and abnormal dreams. Serious side effects include serotonin syndrome, mania, seizures, an increased risk of suicidal behavior in people under 25 years old and an increased risk of bleeding. If stopped suddenly, a withdrawal syndrome may occur with anxiety, dizziness and changes in sensation.[1] It is unclear if it is safe in pregnancy. If already on the medication, it may be reasonable to continue during breastfeeding.[2] Its mechanism of action is not entirely clear but believed to be related to increasing serotonin activity in the brain.
The FLX Rapid Test Cassette (Urine) is a rapid urine-screening test that can be performed without the use of an instrument. The test utilizes the antibody to selectively detect elevated levels of Fluoxetine in urine. The FLX Rapid Test Cassette (Urine) yields a positive result when the Fluoxetine in urine exceeds the cut-off level.
PRINCIPLE
The FLX 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. Fluoxetine 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 Fluoxetine-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 Fluoxetine level exceeds the cut-off level, because it will saturate all the binding sites of anti-Fluoxetine 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.
REAGENTS
The test contains mouse monoclonal anti-Fluoxetine antibody coupled particles and Fluoxetine -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 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 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 Fluoxetine 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 Fluoxetine 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.
