Salmonella typhi and paratyphi Antigen Combo Rapid Test, Infectious Disease Test Kit
A rapid test for the qualitative detection of salmonella typhi and salmonella paratyphi antigen in human feces.
For professional in vitro diagnostic use only.
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.
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.
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.
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.
• 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.
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.
|Salmonella typhi and paratyphi Antigen Combo Rapid Test