Salmonella Typhi Antigen Rapid Test Typhoid Causes

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HSTY069G
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The Salmonellla Typhi Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Salmonellla Typhi Antigens in human stool specimens to aid in the diagnosis of Salmonellla Typhi infection.

MATERIALS
Materials Provided

Individually packed test devices	Package insert
Specimen collection tubes with extraction buffer	Droppers
Materials Required but Not provided
Specimen collection containers	Timer

 

TEST PROCEDURE

Allow the test, reagents, swab specimen, and/or controls to reach room temperature (15-30°C) prior to testing.

1. To collect fecal specimens:

Collect sufficient quantity of feces (1-2 mL or 1-2 g) in a clean, dry specimen collection container to obtain maximum antigens (if present). Best results will be obtained if the assay is performed within 6 hours after collection. Specimen collected may be stored for 3 days at 2-8ºC if not tested within 6 hours. For long term storage, specimens should be kept below -20ºC.

1. 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.
Tighten the cap onto the specimen collection tube, then shake the specimen collection tube vigorously to mix the specimen and the extraction buffer.

1. 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.
2. 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 the specimen well (S) of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
3. 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            

    

• POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).
  NEGATIVE: Only one colored band appears in the control region (C). No apparent colored band appears in the test region (T).
  INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.
  NOTE:
• The intensity of color in the test region (T) may vary depending on the concentration of analytes present in the specimen. Therefore, any shade of color in the test region should be considered positive. Note that this is a qualitative test only, and cannot determine the concentration of analytes in the specimen.
• Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The Salmonellla Typhi Antigen Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. The result shows that the sensitivity of the Salmonellla Typhi Antigen Rapid Test is 96.2% and the specificity is 99.2% relative to other Rapid Test Cassette.

Method		Other Test Cassette		Total Result
Salmonellla Typhi Antigen Rapid Test	Results	Positive	Negative
	Positive	103	2	105
	Negative	3	124	127
Total Result		106	126	232

Relative Sensitivity: 97.2% (95%CI: 87.0%-99.5%)  
Relative Specificity: 98.4% (95%CI: 95.7%-100%)
Accuracy: 97.8% (95%CI: 95.2%-99.7%)
Cross-Reactivity
Cross reactivity with following organisms has been studied at 1.0E+09 organisms/ml. The following organisms were found negative when tested with the Salmonellla Typhi Antigen Rapid Test:

Candida albicans	Group B Streptococcus	Branhamella catarrhalis
E.coli	Klebsiella pneumonia	Enterococcus faecium
Proteus vulgaris	Proteus mirabilis	Gardnerella vaginalis
Chlamydia trachomatis	Rotavirus	Group C Streptococcus
Enterococcus faecalis	Adenovirus	Neisseria gonorrhea

Detection Of Limit
The detection limit of Salmonellla Typhi was studied by rapid detection of Salmonellla Typhi antigen. According to the test results, the lowest detection limit of this product is 2x10⁷ CFU/ml.
Hook Effect
The Salmonellla Typhi Antigen Rapid Test was used to study the hooking effect of strongly positive samples at different dilution concentrations. The hook effect of the product was 2×10⁸CFU/ml by rapid detection of
Candida albicans antigen.