Salmonella Typhi Paratyphi Infectious Disease Test Kit Feces Specimen
Brand Name:Citest
Certification:CE
Model Number:ISTP-625
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
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Product Details
Salmonella typhi and paratyphi Antigen Combo Rapid Test, Infectious Disease Test Kit
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Feces |
| Certificate | CE |
| Reading Time | 5 minutes |
| Pack | 10 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
A rapid test for the qualitative detection of salmonella typhi and
salmonella paratyphi antigen in human feces.
For professional in vitro diagnostic use only.
INTENDED USE
The Salmonella typhi and paratyphi Antigen Combo Rapid Test
Cassette (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of Salmonella typhi and Salmonella paratyphi
antigens in human fecal specimens to aid in the diagnosis of
Salmonella typhi and 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.
After the S. typhi or S. paratyphi bacteria are ingested, they
enter the small intestine via the microfold cells through which the
bacteria migrate to the mesenteric lymph nodes and multiply.
CIinicaI onset of the disease presents with symptoms including
fever, nausea, constipation and diarrhea. The incubation period is
usually 8 to 14 days, but periods ranging from 3 days to more
than 60 days have been reported.
The Salmonella typhi and paratyphi Antigen Combo Rapid Test
Cassette (Feces) is a rapid chromatographic immunoassay for the
qualitative detection of Salmonella typhi and Salmonella paratyphi
antigens in human fecal specimens, providing results in 5 minutes.
PRINCIPLE
The Salmonella typhi and paratyphi Antigen Combo Rapid Test
Cassette (Feces) is a qualitative, lateral flow immunoassay for the
detection of S. typhi and S. paratyphi antigens in human feces. In
this test, the membrane is pre-coated with anti-S. typhi antibodies
or anti-S. paratyphi antibodies on the test line region of the
test. During testing, the specimen reacts with the particle
coated with anti-S. typhi antibodies or anti-S. paratyphi
antibodies.
The mixture migrates upward on the membrane by capillary action to
react with anti-S. typhi antibodies or 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.
REAGENTS
The test cassette contains monoclonal anti-S. typhi and anti-S.
paratyphi antibodies coated particles and monoclonal anti-S. typhi
and anti-S. paratyphi antibodies coated on the membrane.
PRECAUTIONS
• For professional in vitro diagnostic use only. Do not use after
expiration date.
• The test should remain in the sealed pouch until use.
• Do not eat, drink or smoke in the area where the specimens or
kits are handled.
• Handle all specimens as if they contain infectious agents.
Observe established precautions against microbiological hazards
throughout all procedures and follow the standard procedures for
proper disposal of specimens.
• Wear protective clothing such as laboratory coats, disposable
gloves and eye protection when specimens are assayed.
• The used test should be discarded according to local regulations.
• Humidity and temperature can adversely affect results
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 each 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.
INTERPRETATION OF RESULTS
(Please refer to the illustration 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. typhi or 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.
QUALITY CONTROL
Internal procedural controls are included in the test. A colored
line appearing in the control region (C) is an internal valid
procedural control. It confirms sufficient specimen volume and
correct procedural technique.
Control standards are not supplied with this kit; however, it is
recommended that positive and negative controls be tested as a good
laboratory practice to confirm the test procedure and to verify
proper test performance.
Order Information
| Cat. No. | Product | Specimen | Pack |
| ISTP-625 | Salmonella typhi and paratyphi Antigen Combo Rapid Test | Feces | 25 T |
Salmonella Typhi Paratyphi Infectious Disease Test Kit Feces Specimen
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