METHOD VALIDATION OF SD BIOSENSOR???S STANDARD??? F PLATFORM FOR THE RAPID DETECTION AND DIFFERENTIATION OF DENGUE NS1 ANTIGEN, DENGUE IgM/IgG, ZIKA ANTIGEN AND ZIKA IgM/IgGANTIBODIES IN HUMAN PLASMA AND WHOLE BLOOD SAMPLESAuthor(s): Blair Steele
Method Validation Of SD Biosensor’s STANDARD™ F Platform For The Rapid Detection And Differentiation Of Dengue NS1 Antigen, Dengue IgM/IgG, Zika Antigen and Zika IgM/IgGAntibodies In Human Plasma And Whole Blood Samples Blair Steele This retrospective observational study attempted is to evaluate SD BIOSENSOR’s STANDARD™ F Fluorescent Immunoassay for the rapid detection and differentiation of Zika virus (ZIKV) Antigen/IgM/IgG and dengue virus (DENV) IgM/IgG and Non-Structural Protein 1 (NS1) antigen. These arboviruses share factors that complicate definitive diagnosis, in light of their tendency to cause concurrent arboviral infections in this region. Whole blood/serum/plasma samples – previously tested by reference/gold standard tests (Enzyme-linked Immunosorbent Assay - ELISA) and Polymerase chain reaction - PCR) were retested with the SD Biosensor STANDARD™ F Fluorescent Immunoassay. Samples were selected between January 2016 and March 2019, from the Laboratory Information System (LIS) at the Virology Laboratory, Department of Microbiology University of the West Indies. The dengue IgG test component of the SD Biosensor Standard™ F kit had the highest individual positive percent agreement (83.33%) when compared to the reference test (ELISA) for the diagnosis of dengue in Jamaica. It was also the most accurate of the SD Biosensor STANDARD™ F tests. Zika IgG detection using this platform had the lowest (0%) individual positive percent agreement. Zika antigen testshowed a positive percent agreementof only 2.17%. This is stark contrast to the proven accuracy, sensitivity and specificity provided by the gold standard tests currently in use at this facility. Although the SD Biosensor Standard™ F was indeed able to detect viruses more rapidly, it failed to prove its efficiency as an alternative to the use of gold standard tests in this setting.