Diagnostic Performance of SD Bioline Immunochromatography Test for the Detection of Rubella Specific IgM and Igg Antibodies in Resource Limited Settings

Abstract

Background: The diagnosis of rubella and congenital rubella syndrome (CRS) cases by only clinical parameters is unreliable. They are mostly confirmed by enzyme linked immunosorbent assay (ELISA). However, currently, there is a need of more rapid, cost effective and less complicated assays.

Objective: The main aim of this study was to evaluate the diagnostic performance of commercially available and newly developed Standard Diagnostic Bioline [SD Bioline] immunochromatographic (ICT) assay with the conventional ELISA method for the diagnosis of rubella IgM and IgG antibodies.

Method: A comparative cross-sectional study was conducted in Dessie, Felege-Hiwot and University of Gondar Referral Hospitals, from December 2015 to February 2017.  After obtaining written informed consent, blood sample was collected from each pregnant woman for the laboratory analysis of rubella antibodies using both ELISA and SD Bioline methods. 

Result: A total of 600 serum samples were analyzed by using ELISA and SD Bioline methods. For rubella IgM antibody determination, the sensitivity and specificity of SD Bioline against the ELISA method were 66.7% (95% CI: 52.9%-78.6%) and 98.9% (95% CI: 97.6%-99.6%), respectively (kappa=0.730, 95% CI: 0.62-0.83).  Similarly, sensitivity and specificity of the SD Bioline to diagnose rubella IgG antibody against the ELISA method were 82.1% (95% CI: 78.6%-85.3%) and 96.0% (95% CI: 88.6%-99.2%) (Kappa= 0.511, 95% CI: 0.43-0.59). These results indicated that the SD Bioline had a substantial and moderate agreement with conventional ELISA for the diagnosis of rubella IgM and IgG antibodies, respectively. 

Conclusion: The SD Bioline might be an alternative approach for the diagnosis of both rubella and CRS cases in the areas where ELISA or other advanced laboratory techniques are impractical.