Dengue IgG/IgM Rapid assay is a side-flow chromatography immunoassay used to qualitatively detect dengue virus IgG/IgM antibodies in human serum, plasma, or whole blood.

Test material
1. Testing procedures and interpretation of test results must be closely followed when testing individual subjects for the presence of antibodies to dengue virus in serum, plasma or whole blood. Failure to follow this process may produce inaccurate results.

2. Rapid detection of dengue IgG/IgM combination is limited to qualitative detection of dengue virus antibodies in human serum, plasma or whole blood. There was no linear correlation between the strength of the test band and the antibody titer in the specimen.
3. The rapid dengue IgG/IgM combination test cannot be used to distinguish between primary and secondary infections. The test does not provide information on dengue serotype.

4. Serologic cross-reactivity with other flaviviruses (e.g., Japanese encephalitis, West Nile, yellow fever, etc.) is common, so patients infected with these viruses may show some degree of reactivity through this test.
5. Negative or non-reactive results in individual subjects indicate no detectable dengue virus antibodies. However, negative or non-reactive test results do not rule out the possibility of exposure or infection with dengue virus.

6. If the number of dengue virus antibodies present in the specimen is below the detection line, or if no detectable antibodies are present at the stage of disease at which the specimen was collected, a negative or non-reactive result may occur. Therefore, if clinical manifestations strongly suggest an infection or outbreak, follow-up tests or alternative tests, such as antigen tests or PCR test methods, are recommended.

7. If symptoms persist, despite negative or non-responsive results from the combined IgG/IgM rapid test for dengue, it is recommended that the patient be resambused a few days later or tested with alternative testing equipment.
8. Some specimens containing unusually high titers of heterophile antibodies or rheumatoid factors may affect the expected results.
9. The results obtained in this trial can only be interpreted in conjunction with other diagnostic procedures and clinical findings.