Evaluation of the Performance of the SD Bioline Dengue Rapid Test For the Detection of Anti-Dengue IgM Antibody in Northwest Ethiopia

Abstract

Background: Dengue is a rapidly emerging mosquito-borne viral disease that affects millions of individuals worldwide. A rapid, accurate, and cost-effective test  is essential for patient management. This study aimed to evaluate the performance of the rapid SD Bioline dengue test for point-of-care testing in resource-limited countries.

Method: This cross-sectional study was conducted from March 2016 to May 2017, in northwest Ethiopia. Blood samples were collected from febrile patients and serum was separated and tested for IgM antibodies against dengue virus by an enzyme-linked immunosorbent assay (ELISA) and the SD Bioline dengue rapid test. The sensitivity, specificity, and the kappa statistic value of the rapid test were calculated against the results of ELISA as the reference test.

Result: Six hundred serum samples were tested by anti-dengue virus IgM seropositivity. The sensitivity of the SD Bioline dengue rapid test was found to be 57.9% (95% CI = 48.3%-67.1%), with specificity of 92.8% (95% CI = 90.1%-94.9%), positive predictive value 65.4% (95% CI = 56.9%-72.9%), negative predictive value 90.4% (95% CI = 88.3%-92.1%), and accuracy of 86.2% (95% CI = 83.1%-88.8%). The kappa agreement of the SD Bioline test was 0.53.

Conclusion: This study showed that the SD Bioline test has high specificity for the diagnosis of dengue but has low sensitivity and moderate agreement with the reference assay. Hence, a rapid test kit with high sensitivity and better agreement needs to be considered for proper management of dengue patients in countries where a reference diagnostic test is limited.