China wholesale Ivd - S. Typhi / Paratyphi Combo Antigen Rapid Test Kit (Immunochromatographic Assay) – Bioantibody

Product details

Intended Use:

S. Typhi/Paratyphi Combo Antigen Rapid Test Kit (Immunochromatographic Assay) is an in vitro, rapid, lateral flow test, also known as a lateral flow immunochromatographic assay, intended for the qualitative detection of S. Typhi and Paratyphi antigens in fecal specimens from patients. Results from S. Typhi/Paratyphi Combo Antigen Rapid Test Kit should be interpreted in conjunction with the patient’s clinical evaluation and other diagnostic methods.

Test Principles:

S. Typhi/Paratyphi Combo Antigen Rapid Test Kit(Immunochromatographic Assay) is a lateral flow chromatographic immunoassay. It has three pre-coatedlines, “T1” S. Typhi Test line, “T2” Paratyphi Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-S. Typhi and anti-Paratyphi antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region.When the specimen is processed and added to the sample well, S. Typhi/Paratyphi antigens in the sample interact with the S. Typhi/Paratyphi Antibody-labeled conjugate forming antigen-antibody color particle complexes. The complexes migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-S. Typhi/Paratyphi antibodies. A colored T1 line is visible in the result window if S. Typhi antigens are present in the specimen and the intensity depends upon the amount of S. Typhi antigen. A colored T2 line is visible in the result window if Paratyphi antigens are present in the specimen and the intensity depends upon the amount of Paratyphi antigen. When the S.Typhi/Paratyphi antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T1 and T2) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid

Main Contents

Components provided are listed in the table.

Operation Flow

Step 1: Sample Preparation

1. Collect fecal specimens in clean, leak-proof containers.
2. Specimen Transport and Storage: Specimens may be kept at room temperature for 8 hours or refrigerated at 36°F to 46°F (2°C to 8°C) for up to 96 hours.
3. Fecal specimens that are stored frozen may be thawed up to 2 times at –10°C or below. If  using frozen specimens, thaw at room temperature. Do not allow the fecal specimens to remain in the diluent mixture for >2 hours.

Step 2: Testing

1. Please read the instructions carefully before testing. Before testing, allow the test cassettes, sample solution and samples to be balanced to room temperature (15-30℃ or 59-86 degrees Fahrenheit).

2. Remove a test cassette from the foil pouch and place on a flat surface.

3.Unscrew the sample bottle, use the attached applicator stick attached on the cap to transfer small piece of stool sample (3- 5 mm in diameter; approximately 30-50 mg) into the sample bottle containing specimen preparation buffer.

4. Replace the stick into the bottle and tighten securely. Mix stool sample with the buffer thoroughly by shaking the bottle for several times and leave the tube alone for 2 minutes.

5. Uncrew the sample bottle tip and hold the bottle in a vertical position over the sample well of the Cassette, deliver 3 drops (100 -120μL) of diluted stool sample to the sample well.

Step 3: Reading

Read the results in 15-20 minutes. The result explanation time is not more than 20 minutes

Interpreting the results

1. S. Typhi Positive Result

Colored bands appear at both test line (T1) and control line (C). It indicates positive result for the S. Typhi antigens in the specimen.

2. Paratyphi Positive Result

Colored bands appear at both test line (T2) and control line (C). It indicates positive result for the Paratyphi antigens in the specimen.

3. S. Typhi and Paratyphi Positive Result

Colored bands appear at both test line (T1), test line (T2) and control line (C). It indicates positive result for the S. Typhi and Paratyphi antigens in the specimen.

4. Negative Result

Colored band appear at control line (C) only. It indicates that the concentration of S. Typhi or Paratyphi antigens do not exist or below the detection limit of the test.

5. Invalid Result

No visible colored band appears at control line after performing the test. The directions may not have been followed correctly or the test may have deteriorated. It is recommended that the specimen be re-tested

Order Information