Development of ASSURE® dengue IgA rapid test for the detection of anti-dengue IgA from dengue infected patients

• Main Authors: Yun Ying Tan, Shamala D Sekaran, Seok Mui Wang, Firoz Ahmed, Anowar Hossain, Bijon Kumar Sil
• Format: Article
• Language: English
• Published: Wolters Kluwer Medknow Publications 2011-01-01
• Series: Journal of Global Infectious Diseases
• Subjects: Anti-dengue IgA; ASSURE® Dengue IgA Rapid Test; Dengue
• Online Access: http://www.jgid.org/article.asp?issn=0974-777X;year=2011;volume=3;issue=3;spage=233;epage=240;aulast=Tan

Background: Rapid and early dengue diagnosis is essential for patient management and early disease intervention. MP Diagnostics ASSURE® Dengue IgA Rapid Test (Dengue IgA RT) was developed for the rapid detection of anti-dengue IgA in patients′ biological samples. The performance of Dengue IgA RT was examined using multiple categories of well-characterized samples. Materials and Methods: Dengue IgA RT was designed and developed. Following characterization of samples by reference ELISAs, the performance of the kit was evaluated. Results: The overall sensitivity and specificity of Dengue IgA RT were 86.70% (n=233) and 86.05% (n=681) respectively; in which Dengue IgA RT detected 77.42% primary and 92.86% secondary cases; compared to 70.97% and 72.14% by IgM-Cap ELISA and 89.25% and 20% by Non-Structural Protein 1 (NS1) Ag ELISA respectively. Using 125 paired samples, Dengue IgA RT showed 84.80% sensitivity at acute phase and 99.20% sensitivity at convalescent phase; with 92% specificity at both phases. Dengue IgA RT also demonstrated a consistent performance (sensitivity: 85.53%, specificity: 80%) with 76 whole blood samples. In detecting all four serotypes of DENV (n=162), the performance of Dengue IgA RT was comparable with in-house IgM-Cap ELISA. Kinetics of anti-dengue IgA production was elucidated with 42.86% detection level as early as one-two days after fever onset, which increased to 83.33% between five and seven days after fever onset. Conclusion: Dengue IgA RT demonstrated a good performance and is applicable as one of the dengue early diagnostic tools at all levels of health care system.