2020 China New Design Human Use Coronavirus Disease Detection Kit - Testsea Disease Test TYP Typhoid IgG/IgM Rapid Test Kit – TESTSEA

The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and timeconsuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test3,4. 

In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen5 t in whole blood specimen thus aid in the determination of current or previous exposure to the S. typhi.

Allow the test, specimen, buffer and/or controls to reach room temperature 15-30℃ (59-86℉) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. For serum or plasma specimen: Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 100μl) to the specimen well(S) of the test device, then start the timer. See illustration below.
4. For whole blood specimens: Hold the dropper vertically and transfer 1 drop of whole blood(approximately 35μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 70μl) and start the timer. See illustration below.  
5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.  

Applying sufficient amount of specimen is essential for a valid test result. If migration (the wetting of membrane) is not observed in the test window after one minute, add one more drop of buffer (for whole blood) or specimen (for serum or plasma) to the specimen well.

Interpretation of Results

Positive: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the test line region.

Negative: One colored line appears in the control region(C).No apparent colored line appear in the test line region.

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 device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.