Typhoid IgG/IgM Rapid Test
For the qualitative detection of Typhoid IgG/IgM Antibody in serum/ plasma/whole blood
Typhoid IgG/IgM Combo Rapid Diagnostic Kit High Accurate Home Use Infectious Disease Typhoid Fever
Intended Use
The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human serum or plasma.
It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with alternative testing method(s).
Principle
Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi.
Evidence of H. pylori infection also presents an increase risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gallbladder.
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 time-consuming 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 thus to aid in the determination of current or previous exposure to the S.typhi.
Reagents and Materials Provided
☀ Individual pouched cassette with desiccant and a disposable plastic pipett.
☀ Operating instruction.
Materials Required But Not Provided
☀ Stop watch.
☀ Disposable gloves. Disinfectant solution.
Specimen Collection and Handling
Consider any materials of human origin as infectious and handle them using standard biosafety procedures.
Plasma
☀ Collect blood specimen into a lavender, blue or green top collection tube by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma into new pre-labeled tube.
Serum
☀ Collect blood specimen into a red top collection tube by veinpuncture.
☀ Allow the blood to clot.
☀ Separate the serum by centrifugation.
☀ Carefully withdraw the serum into a new pre-labeled tube.
Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if not tested immediately.
Assay Procedure
☀ Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
☀ When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
☀ Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about 30-45 µL) of specimen into the sample well making sure that there are no air bubbles. Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.
☀ Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.
Interpretation of Result
Negative: If only the C band presents, the absence of any burgundy color in the both test bands (M and G) indicates that no anti-S. typhi antibody is detected in the specimen. The result is negative or non-reactive.
IgG Positive: In addition to the presence of C band, if only G band is developed, the test indicates for the presence of anti- S. typhi IgG in the specimen. The result is IgG positive or reactive.
IgM Positive: In addition to the presence of C band, if only M band is developed, the test indicates for the presence of anti- S. typhi IgM in the specimen. The result is IgM positive or reactive.
IgM and IgG Positive: In addition to the presence of C band, both M and G bands are developed, the test indicates for the presence of anti-S. typhi IgG and IgM in the specimen. The result is both IgG and IgM positive or reactive.
Invalid: The test results are INVALID, if no control line is visible, regardless of the presence or absence of lines in the IgG or IgM test zone of the strip. Repeat the test using a new cassette.
Storage
Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.
Warning and Precautions
☀ For in vitro diagnostic uses only.
☀ All patient samples should be treated as if capable of transmitting diseases.
☀ Do not use test kit beyond expiration date.
☀ Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.
Limitation
☀ The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to S. typhi in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.
☀ The Typhoid IgG/IgM Rapid Test is limited to the qualitative detection of antibodies to S. typhi in human serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.
☀ The Typhoid IgG/IgM Rapid Test also detects para-typhi antibodies.
☀ A negative result for an individual subject indicates absence of detectable anti-S. typhi antibodies. However, a negative test result does not preclude the possibility of exposure to S. typhi.
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