5 minutes Salmonella Paratyphi Antigen Rapid Test Cassette vitro diagnostic
Brand Name:Citest
Certification:CE
Model Number:ISPT-602
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
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Product Details
Salmonella paratyphi Antigen Rapid Test,diagnosis of Salmonella paratyphi infection
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Feces |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 25 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
A rapid test for the qualitative detection of salmonella paratyphi
antigen in human feces. For professional in vitro diagnostic use
only.
INTENDED USE
The Salmonella paratyphi Antigen Rapid Test Cassette (Feces) is a
rapid chromatographic immunoassay for the qualitative detection of
Salmonella paratyphi antigen in human fecal specimens to aid in the
diagnosis of Salmonella paratyphi infection.
SUMMARY
Typhoid fever and paratyphoid fever are bacterial infections caused
by SalmoneIIa typhi (S. typhi) and SaImonella paratyphi (S.
paratyphi) A, B and C, which is transmitted through the ingestion
of tainted food and water1 . Worldwide an estimated 21 million
cases and 222,000 associated deaths occur annually .
The majority of infections are cause by S. typhi with infections by
S. paratyphi, B and C being more rare. S. paratyphi, B (tartrate
negative), and C are bacteria that often cause a potentially severe
and occasionally life-threatening bacteremic illness. While fever
and gastrointestinal symptoms are common, the clinical presentation
varies, including mild and atypical infections. In the United
States, approximately 80 cases of paratyphoid fever caused by S.
paratyphi are reported each year, 90% of which are acquired during
international travel.
Cases of paratyphoid fever caused by serotypes S. paratyphi B
(tartrate negative) and C are reported much less frequently.
Ongoing surveillance of S. paratyphi infections is essential to
detect and control outbreaks, determine public health priorities,
monitor trends in illness, and assess effectiveness of public
health interventions.
The Salmonella paratyphi Antigen Rapid Test Cassette (Feces) is a
rapid chromatographic immunoassay for the qualitative detection of
Salmonella paratyphi antigen in human fecal specimens, providing
results in 5 minutes.
PRINCIPLE
The Salmonella paratyphi Antigen Rapid Test Cassette (Feces) is a
qualitative, lateral flow immunoassay for the detection of S.
paratyphi antigen in human feces. In this test, the membrane is
pre-coated with anti-S. paratyphi antibodies on the test line
region of the test.
During testing, the specimen reacts with the particle coated with
anti-S. paratyphi antibodies. The mixture migrates upward on the
membrane by capillary action to react with anti-S. paratyphi
antibodies on the membrane and generate a colored line. The
presence of this colored line in the test region indicates a
positive result, while its absence indicates a negative result. To
serve as a procedural control, a colored line will always appear in
the control line region indicating that proper volume of specimen
has been added and membrane wicking has occurred.
DIRECTIONS FOR USE
Allow the test, specimen, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. To collect fecal specimens:
Collect sufficient quantity of feces (1-2mL or 1-2g) in a clean,
dry specimen collection container. Best results will be obtained if
the assay is performed within 6 hours after collection.
Specimen collected may be stored for 3 days at 2-8°C if not tested
within 6 hours. For long term storage, specimens should be kept
below -20°C.
2. To process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the specimen collection tube,then randomly stab
the specimen collection applicator into the fecal specimen in at
least 3 different sites to collect approximately 50mg of feces
(equivalent to 1/4 of a pea). Do not scoop the fecal specimen.
• For Liquid Specimens:
Hold the dropper vertically, aspirate fecal specimens, and then
transfer 2 drops (approximately 100μL) into the specimen collection
tube containing the extraction buffer.
3. Tighten the cap onto the specimen collection tube, then shake
the specimen collection tube vigorously to mix the specimen and the
extraction buffer. Leave the tube alone for 2 minutes.
4. Bring the pouch to room temperature before opening it. Remove
the test cassette from the foil pouch and use it within one hour.
Best results will be obtained if the test is performed immediately
after opening the foil pouch.
5. Hold the specimen collection tube upright and open the cap onto
the specimen collection tube. Invert the specimen collection tube
and transfer 3 full drops of the extracted specimen (approximately
120μL) to specimen well (S) of the test cassette, then start the
timer. Avoid trapping air bubbles in the specimen well (S). See
illustration below.
6. Read results at 5 minutes after dispensing the specimen. Do not
read results after 15 minutes.
Note: If the specimen does not migrate (presence of particles),
centrifuge the extracted specimens contained in the extraction
buffer vial. Collect 120μL of supernatant, dispense into the
specimen well (S) of a new test cassette and start afresh following
the instructions mentioned above.
POSITIVE:* 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).
*NOTE: The intensity of the color in the test line region (T) will
vary depending on the concentration of S. paratyphi antigen present
in the specimen. Therefore, any shade of color in the test line
region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C).
No line appears in the test line region (T).
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
| Cat. No. | Product | Specimen | Pack |
| ISPT-602 | Salmonella paratyphi Antigen Rapid Test | Feces | 25 T |
5 minutes Salmonella Paratyphi Antigen Rapid Test Cassette vitro diagnostic
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