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

Getachew Ferede , Moges Tiruneh , Ebba Abate , Yitayih Wondimeneh , Endalamaw Gadisa , Rawleigh Howe , Abraham Aseffa , Belay Tessema
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DOI: https://doi.org/10.20372/ejhbs.v11i01.267
Submitted: 2021-08-27 12:31:22
Published: 2021-11-26

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.

 

Keywords

Dengue virus infection, SD-Bioline test, ELISA, Performance, Ethiopia

Authors

Getachew Ferede
Moges Tiruneh
Ebba Abate
Yitayih Wondimeneh
Endalamaw Gadisa
Rawleigh Howe
Abraham Aseffa
Belay Tessema

How to Cite

Getachew Ferede, Moges Tiruneh, Ebba Abate, Yitayih Wondimeneh, Endalamaw Gadisa, Rawleigh Howe, Abraham Aseffa, Belay Tessema (2021-11-26). Evaluation of the Performance of the SD Bioline Dengue Rapid Test For the Detection of Anti-Dengue IgM Antibody in Northwest Ethiopia. Ethiopian Journal of Health and Biomedical Sciences, Vol. 11 No. 1 (2021), 37-43. https://doi.org/10.20372/ejhbs.v11i01.267

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Copyright © 2021 The Author(s)

Copyright & Licensing © Year The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0) , which permits unrestricted use; sharing (copying and redistributing the material in any medium or format); and adaptation (remixing, transforming, and building upon the material for any purpose), provided the original author(s) and the source are properly cited/credited and a link to the license is provided. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/

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