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Evaluation of ASSURE® Dengue IgA Rapid Test using dengue-positive and dengue-negative samples
Firoz Ahmed1, Huzzatul Mursalin, Meer Taifur Alam
1International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh.
Insights
The ASSURE® Dengue IgA Rapid Test shows high accuracy in diagnosing dengue infections, detecting both primary and secondary cases effectively. This rapid test offers excellent sensitivity and specificity, making it a valuable tool for early dengue diagnosis, especially in resource-limited settings.
Area of Science:
- * Virology and Immunology
- * Infectious Disease Diagnostics
Background:
- * Dengue fever is a significant global health concern, necessitating accurate and rapid diagnostic tools.
- * Existing diagnostic methods for dengue virus (DENV) infection have limitations, particularly in early detection and in resource-limited areas.
Purpose of the Study:
- * To evaluate the diagnostic performance of the ASSURE® Dengue IgA Rapid Test.
- * To compare its accuracy against established reference enzyme-linked immunosorbent assays (ELISAs) for dengue infection.
Main Methods:
- * The study utilized archived sera from 204 patients during a dengue outbreak and 220 negative sera.
- * Performance was assessed by comparing the Dengue IgA Rapid Test results with reference NS1 Ag ELISA, IgM-Cap ELISA, and IgG-Cap ELISA.
- * Sensitivity and specificity were calculated, and performance was analyzed for primary and secondary infections.
Main Results:
- * The Dengue IgA Rapid Test demonstrated high sensitivity (99.4%) and specificity (99.2%).
- * It accurately detected 100% of primary and 99.2% of secondary dengue infections.
- * The test showed comparable performance to RT-PCR and outperformed in-house IgM ELISA in detecting DENV serotypes.
Conclusions:
- * The ASSURE® Dengue IgA Rapid Test is a highly sensitive and specific diagnostic tool for dengue infection.
- * Its ability to detect both primary and secondary infections early makes it suitable for widespread use.
- * The test is a valuable addition to the arsenal of dengue diagnostic tools, especially in areas with limited diagnostic facilities.
Abstract:
ASSURE® Dengue IgA Rapid Test, an immunochromatographic anti-Dengue IgA Rapid Test based on reverse flow technology, was evaluated using archived sera. The sera were obtained during hospital admission and discharge of 204 patients during 2000 to 2001 dengue outbreak in Bangladesh and 220 negative sera collected in 2009. Based on characterization by reference ELISA (nonstructural protein 1 [NS1] Ag ELISA, immunoglobulin M [IgM]-Cap ELISA, and immunoglobulin G [IgG]-Cap ELISA), 179 (87.7%) patients were positive for dengue infection, and the remaining 245 patients had nondengue febrile illness. The performance of Dengue IgA Rapid Test was compared to reference ELISA. Of 179 dengue-positive sera, 79 (44.1%) were positive by NS1 Ag ELISA, 174 (97.2%) were positive by IgM-Cap ELISA, and 142 (79.3%) were positive by IgG-Cap ELISA. Among 142 IgG-positive cases, 121 (85.2%) patients had shown high level of IgG (PanBio units ≥ 22, equivalent to hemagglutination inhibition (HI) titer ≥ 2560) during hospital admission, indicating secondary infections. Dengue IgA Rapid Test demonstrated 99.4% (178 of 179) sensitivity in diagnosing dengue infection with the ability to detect 100% primary (58 of 58) and 99.2% (120 of 121) secondary infections, and the specificity was found 99.2% (2 of 245). The capability of Dengue IgA Rapid Test in detecting dengue infection in terms of day of illness was comparable to reverse transcriptase polymerase chain reaction and was found better than in-house IgM ELISA. Compared with in-house IgM ELISA, Dengue IgA Rapid Test also detected similar number of dengue virus (DENV) 1, DENV 2, and more DENV 3 and DENV 4 cases. The overall performance thus suggested its usefulness as one of the dengue early diagnostic tools where diagnostic facility is limited.
