A rapid test for the qualitative detection of Desmethylcitalopram
in human urine.
For professional in vitro diagnostic use only.
INTENDED USE
The CIT Rapid Test Cassette (Urine) is a rapid chromatographic
immunoassay for the detection of Desmethylcitalopram in urine at a cut-off
concentration of 500ng/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
Citalopram, an antidepressant of the selective serotonin reuptake
inhibitor (SSRI) type, is only available as a racemic drug. Its metabolism occurs, partially,
by N-demethylation to demethylcitalopram (DCIT) and didemethylcitalopram (DDCIT), but
also by deamination to a propionic acid derivative (CIT-PROP) and by N-oxidation to
CIT-N-oxide (NO-CIT).
CIT has equal affinity for 5-HTT and dopamine transporters. Studies
have shown that compared with healthy subjects, the binding potential of thalamus
and brainstem binding area in patients with depression who take 20-60 mg citalopram every
day is reduced by 50% .
It is supplied as the free base in 20 mg tablets oral
administration; daily oral dose for adults usually range from 20-60 mg. The common adverse reactions
were nausea, dry mouth and drowsiness. The rare adverse reactions were agitation,
income and anxiety. The oral bioavailability of citalopram is about 80%. 15% of
citalopram is excreted by kidney, and 12%-23% of citalopram in daily dose is excreted in
original form from urine.
PRINCIPLE
The CIT 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. Desmethylcitalopram, 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 Citalopram-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 Desmethylcitalopram level exceeds the cut-off level, because it
will saturate all the
binding sites of anti-citalopram 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.
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 cassette on a clean and level surface. Hold the
dropper vertically and transfer
3 full drops of urine (approx. 120l) to the specimen well(S) of
the cassette, and then start the timer. Avoid trapping air bubbles in the specimen
well(S).
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 apparent colored line should be in the test
line region (T). This negative result indicates that the Citalopram 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
Desmethylcitalopram 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 |
| DCIT-102 | CIT Rapid Test Cassette | Urine | 40T |
| DCIT-114 | CIT Rapid Test Panel | Urine | 40T |
| DCIT-101/111 | CIT Rapid Test Dipstick | Urine | 50T |
