A rapid, one step test for the qualitative detection of Salmonella typhi and paratyphi B
antigen in human feces.
For professional in vitro diagnostic use only.
【INTENDED USE】
The Salmonella typhi and paratyphi B antigen Combo Rapid Test is an in-vitro diagnostic
rapid chromatographic immunoassay for the qualitative detection of Salmonella typhi and
paratyphi B antigen in human feces as an aid in the diagnostic of Salmonella typhi and
paratyphi B infections.
【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 water.1 Worldwide an estimated 21 million cases
and 222,000 associated deaths occur annually.2 The majority of infections are cause by S.
typhi with infections by S. paratyphi, B and C being more rare.2
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 B Antigen Combo Rapid Test is a rapid
chromatographic immunoassay for the qualitative detection of Salmonella typhi and
Salmonella paratyphi B antigens in human fecal specimens, providing results in 5
minutes.
【PRINCIPLE】
The Salmonella typhi and paratyphi B Antigen Combo Rapid Test is a qualitative, lateral
flow immunoassay for the detection of S. typhi and S. paratyphi B antigens in human
feces. In this test, the membrane is pre-coated with anti-S. typhi antibodies or anti-S.
paratyphi B 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 B
antibodies. The mixture migrates upward on the membrane by capillary action to react
with anti-S. typhi antibodies or anti-S. paratyphi B 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 contains monoclonal anti-S. typhi and anti-S. paratyphi B antibodies coated
particles and monoclonal anti-S. typhi and anti-S. paratyphi B antibodies coated on the
membrane.
【PRECAUTIONS】
Please read all the information in this package insert before performing the test.
• For professional in vitro diagnostic use only.
• Do not use after the expiration date. Do not reuse the test.
• Store in a dry place at 2-30 °C (36-86 °F), avoiding areas of excess moisture. If the foil
packaging is damaged or has been opened, please do not 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.
• The used test should be discarded according to local regulations.
• Humidity and temperature may adversely affect results.
• Wash hands thoroughly before and after handling.
• Any serious incident that has occurred in relation to the device shall be reported to the
manufacturer and the competent authority.
• Use the test only once. Keep the test upright while testing. Do not move or turn
the test upside down.
• Keep out of the reach of children.
• The kit must not be frozen or used after the expiration date printed on the package.
• Components provided in the kit are approved for use in the Salmonella typhi and
paratyphi B antigen Combo Rapid Test. Do not use any other commercial kit
component.
【STORAGE AND STABILITY】
The kit can be stored 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.
Note: It is suggested to use the test within one hour after removing it from the foil pouch.
【SPECIMEN COLLECTION AND PREPARATION】
• The fecal specimen must be collected in a clean, dry, waterproof container containing
no detergents, preservatives or transport media.
• No dietary restrictions are necessary before using the Salmonella typhi and paratyphi
B antigen Combo Rapid Test.
• Bring the necessary reagents and fecal specimen to room temperature before use.
• If specimens are to be shipped, they should be packed in compliance with local
regulations covering the transportation of etiologic agents.
【MATERIALS】
Materials Provided
• Test Cups (with dilution buffer)
• Package Insert
• Droppers
Materials Required but Not Provided
• Specimen collection containers
• Pipette
• Centrifuge
• Timer
【DIRECTIONS FOR USE】
Before performing the test, allow the test specimen to reach room temperature
(15-30 °C), stool samples must be collected following the instruction below.
1. Wash your hands with soap and rinse with clear water.
2. Collect fecal specimens:
Collect sufficient quantity of feces (1-2 mL or 1-2 g) 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.
3. Bring the pouch to room temperature before opening it. Remove the test cup from the
foil pouch and use it as soon as possible. Best results will be obtained if the test is
performed immediately after opening the foil pouch.
4. Process fecal specimens:
• For Solid Specimens:
Unscrew the cap of the test cup and take out the specimen collection applicator, then
randomly stab the specimen collection applicator into the fecal specimen in at least 3
different sites to collect approximate 50 mg 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 of the
liquid specimen (approximately 80 μL) into the test cup containing the dilution buffer.
5. Insert the specimen collection applicator back into the test cup and tighten the cap.
6. Shake the test cup for about 10-15 seconds to mix well. Leave the cup for reaction for
2 minutes.
7. Remove the plastic limit strip of the test cup.
8. Put the test cup on a clean and level surface, press the cup body from the top to the
bottom and start the timer.
Note: Keep the test cup upright during the test developing. Do not move or turn the
test cup upside down.
9. Read results at 5 minutes. Do not read results after 15 minutes.
NOTE: If the specimen does not migrate (presence of particles), open a new test cup,
repeat step 4 and centrifuge the diluted specimen contained in the test cup with a clean
tube. Pipette 1-1.5 mL of supernatant, dispense into the test cup and insert the
specimen collection applicator back into the test cup and tighten the cap. Continue
from step 7-8 onwards in the above instructions for use and start the timer.
