Development of ASSURE Dengue IgA Rapid Test for the Detection of Anti-dengue IgA from Dengue Infected Patients.

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.