Performance evaluation of a rapid dengue NS1 antigen lateral flow immunoassay test with reference to dengue NS1 antigen-capture ELISA

Abstract

Background: Dengue, ranked as one of the most critical viral diseases, requires rapid, accurate, and early diagnosis for better patient care. Objectives: This study pertains to the development and clinical validation of an in house easy to do, affordable kit for the detection of dengue NS1 antigen based on lateral flow immunoassay in serum samples of patients. Study Design: Clinically uncharacterized serum specimens were obtained and analyzed using the developed NS1 detection kit and compared against the ELISA results. Results: The performance of the kit was evaluated with both positive and negative patients’ serum samples for NS1 antigen and found to be highly specific and sensitive. An overall sensitivity of 92.16 % and specificity of 97.25 % were recorded. Kit stability tests were also carried out and the performance of the kit was found to be similar to real time tests. Conclusion: The results indicate that the developed NS1 detection kit has good reliability with comparable performance to ELISA results.

Keywords

• Lateral flow assays
• Dengue NS1 tests
• Stability analysis
• Clinical validation