ELIPSE-COL: A novel ELISA test based on rational envisioned synthetic peptides for detection of SARS-CoV-2 infection in Colombia.

BackgroundCOVID-19 pandemic caused by infection with the betacoronavirus SARS-CoV-2 is the greatest public health defiant on a global scale in the last 100 years. Governments and health Institutes face challenges during the pandemic, related to the diagnosis, mitigation, treatment, and timely detection after the epidemic peak for the prevention of new infections and the evaluation of the real impact of the COVID-19 disease in different geographic areas. To develop a valuable tool to study the seroprevalence of SARS-CoV-2 infection in Colombia, an "in-house" ELISA was achieved for the detection of IgG anti-SARS-CoV-2 antibodies in serum. MethodsThe test was standardized using an antigenic epitope "Pool" of the synthetic peptide as antigen derived from antigenic regions of the spike, nucleocapsid, envelope, and membrane structural proteins, which were designed, based on the genomic information of SARS-CoV-2 circulating in Colombia. In the ELISA standardization process, 94 positive sera were used, including sera from asymptomatic and symptomatic patients (mild and severe) and 123 negative sera, including pre-pandemic historical negatives originating from patients living in arbovirus endemic areas or patients with a history of respiratory diseases and sera from patients with a negative rRT-PCR test for SARS-CoV-2. ResultsThe in-house peptide ELIPSE-COL test showed promising performance, being able to detect reactivity in sera from asymptomatic and symptomatic patients. The sensitivity and specificity of the assay were 91.4% and 83.7% respectively. ConclusionELIPSE-COL assay was developed as an ELISA test using synthetic peptides for the study of the seroprevalence of SARS-CoV-2 infection in Colombia. SUMMARY BOXO_LIDetection of IgG anti-SARS-CoV-2 antibodies is required for the evaluation of the pandemic impact and vaccination strategies. C_LIO_LIELIPSE-COL is an in-house test based on synthetic peptides as antigen derived from antigenic regions of the spike, nucleocapsid, envelope, and membrane structural proteins. C_LIO_LIThe sensitivity and specificity of the assay were 91.4% and 83.7% respectively suggesting a promising performance. C_LIO_LIELIPSE-COL test is a valuable tool for the study of seroprevalence in Colombia. C_LI