Dengue Antigen Rapid Test Uncut Sheet
Dengue Antigen Rapid Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of dengue virus in human serum, plasma or whole blood. This test is intended for professional use to aid in the presumptive diagnosis between primary and secondary dengue infection.
Product Overview
Dengue Antigen Rapid Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of dengue virus in human serum, plasma or whole blood. This test is intended for professional use to aid in the presumptive diagnosis between primary and secondary dengue infection. This test provides only a preliminary test result. Therefore, isolation of virus, antigen detection in fixed tissues, RT-PCR and serological test like haemagglutination-inhibition test, more specific alternative diagnosis method must be used in order to obtain a confirmation of dengue virus infection.
Product Parameters
| Parameter | Specification |
|---|---|
| Code | RUDE9 |
| Specimen | Human serum, plasma or whole blood |
| Format | Rapid Test Uncut Sheet |
Summary and Explanation
Dengue viruses, transmitted by the mosquito, Aedes aegypti and Aedes albopictus mosquitoes, are widely distributed throughout the tropical and subtropical areas of the world. There are four known distinct serotypes (dengue virus 1,2,3 and 4). In children, infection is often subclinical or causes a self-limited febrile disease. However, if the patient is infected second times with a different serotype, a more severe disease, dengue hemorrhagic fever or dengue shock syndrome, is more likely to occur. Dengue is considered to be the most important arthropod-borne viral disease due to the human morbidity and mortality it causes.
Traditionally, the serological diagnosis of an acute dengue virus infection has relied on showing a 4-fold or greater rise in anti-dengue virus antibody between paired acute- and convalescent-phase sera from a patient. The haemagglutination-inhibition test has been the most commonly used serological assay for dengue diagnosis.
Rapid and reliable tests for primary and secondary infections of dengue are essential for patient management. Primary Dengue infection is associated with mild to high fever, headache, muscle pain and skin rash. Secondary infections often result in high fever and in many cases with haemorrhagic events and circulatory failure.
Test Procedure
Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30"C) prior to testing.
1.Bring the pouch to room temperature before opening. Remove the test cassette from the
sealed pouch and use it within one hour.
2.Place the test cassette on a clean and level surface
For Serum or Plasma Specimens
Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul) to the sample well and start the timer. Avoid trapping air bubbles in the sample well.
For Whole Blood Specimens
Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul), then add 1 drop of buffer(approximately 25ul)to the sample well and start the timer. Avoid trapping air bubbles in the sample well.
3. Wait for the colored line(s)to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
Result Interpretation
Negative result: if there is only a quality control line C, the detection line is colorless, indicating that Dengue antigen has not been detected and the result is negative.
Positive result: if both the quality control line C and the detection line appear, Dengue antigen has been detected and the result is positive.
Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line, and the test shall be conducted again.