Detection of Specific Anti-Dengue IgM and IgG Antibodies Differentiate Primary from Secondary Infection

Background: The incidence of dengue fever has increased dramatically worldwide in recent decades. Most cases are asymptomatic or mildly symptomatic and recover with self-management, so the actual number of dengue cases is greater than the number reported. Many cases have also been misdiagnosed as other febrile illnesses.

The number of dengue cases reported to World Health Organization (WHO) has increased more than seven-fold over the past 20 years, from 505,430 cases in 2000 to more than 2.4 million in 2010 and 5.2 million in 2019. The number of reported deaths increased from 960 to 4,032 between 2000 and 2015, mainly affecting younger age groups. Between 2020 and 2021, the total number of cases, as well as the number of reported deaths, appears to have decreased. However, data in this area are incomplete and the COVID-19 pandemic may also have hindered case reporting in several countries. Clinical presentations range from non-severe dengue fever to severe dengue fever, such as dengue haemorrhagic fever and dengue shock syndrome. Serologically, initial infection is characterized by elevated dengue virus-specific IgM antibodies within 4-5 days after the fever and elevated IgG antibodies 7-10 days later.

Therefore, the diagnosis of primary dengue within the first 5 days requires the application of polymerase chain reaction techniques (RT-PCR) or antigen detection, particularly for NS1 antigen, whereas secondary infections are identified by early elevated IgG antibody titers and lower titer IgM elevations. In addition, the early stages of secondary dengue fever also show PCR and NS1 positivity.

Objective: The main purpose of this evaluation report was to explore the reliability and performance of the CITEST Dengue Rapid Test Cassette for the qualitative detection of IgG and IgM antibodies to Dengue virus in human whole blood, serum, or plasma as an aid in the diagnosis of primary and secondary Dengue infections.

Method: Run a rapid in vitro diagnostic test device for the detection of antibodies (IgG and IgM) to Dengue virus in whole blood, serum, or plasma and compare with a leading commercial Dengue ELISA test for validation of the performance.

Results: The results show that the overall relative sensitivity for the primary and secondary infection of the Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is 94.3%, the relative specificity is 99.1%, and the relative accuracy is 98.3%.

Conclusion: CITEST Dengue Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test that utilizes a combination of Dengue antigen-coated colored particles for the detection of IgG and IgM Dengue antibodies in human whole blood, serum, or plasma. The product is simple to operate and has been validated against an industry leading commercial Dengue ELISA test to give results within 10 minutes of the sample being tested. A comparison of 429 samples showed an accuracy of 98.3% and an excellent specificity of 99.1%. Patients can use this test kit to obtain accurate results and to determine whether they have a primary or secondary dengue virus.

Keywords Anti-dengue; Primary infection; Secondary infection; Rapid test

Published Date: 2022-12-09; Received Date: 2022-11-11