One Step Salmonella Rapid Test Device , for the qualitative detection of Salmonella typhi , quick and easily

Product Name: One Step Salmonella Rapid Test Device

Accessories:

Intended Use:

The S.typhi Antigen Rapid Test Cassette (Feces) is a rapid chromatographic immunoassay for the qualitative detection of Salmonella typhi antigens in human feces specimens to aid in the diagnosis of Salmonella typhi infection.

Test Principle:

The S. typhi Antigen Rapid Test Cassette (Feces) is a qualitative, lateral flow immunoassay for the detection of S. typhi antigens in human feces. In this test, the membrane is pre-coated with anti-S. typhi antibodies on the test line region of the test. During testing, the specimen reacts with the particle coated with anti- S. typhi antibodies. The mixture migrates upward on the membrane by capillary action to react with anti- S. typhi 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.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

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 2-8℃ if not tested within 6 hours. For long term storage, specimens should be kept below -20℃.

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.

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.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent 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 TP antibodies 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.

PERFORMANCE CHARACTERS:

Sensitivity and Specificity

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

Relative Sensitivity: 96.2% (95%CI*: 87.0%-99.5%) *Confidence Interval

Relative Specificity: 99.2% (95%CI*: 95.7%-100%)

Accuracy: 98.3% (95%CI*: 95.2%-99.7%)