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.
