Introduction: Serological detection of antibodies against SARS-CoV-2 has become an essential tool to test vaccine efficacy and epidemiological surveillance of COVID-19. There have been limited published studies documenting the performance of SARS-CoV-2 antibody assays within hispanic populations. Materials and methods: We evaluated the diagnostic performance of a chemiluminescence enzyme immunoassay (CLIA) on a set of 1,035 samples including pre-pandemic samples, healthcare workers (HCW), blood donors (BD) and COVID-19 positive confirmed by RT-PCR collected from April to December 2020. Results: Through a ROC curve the CLIA test had a high diagnostic performance, with an AUC of 0.9854 (CI95% 95.68-100), P<0.0001. The analysis yielded a cut-off point 0.1950, sensitivity of 98.4% (CI95% 95 91.54-99.9), and specificity of 93.8% (CI95% 79.8 - 98.9). The diagnostic performance was also evaluated comparing the results with those obtained using other diagnostic techniques. Substantial agreement with the lateral flow chromatography and RT-PCR tests was found, and a high level of agreement with ELISA, with %PPA of 91.3 (CI95% 84.0-95.5), %NPA of 97.7 (CI95% 96.3-98.6), %OPA of 97.7 (CI95% 96.3-98.6) and Cohens kappa value of 90.4 (CI95% 85.8-94.9). A logistic regression was used to determine which of the independent variables predicted reactivity to CLIA test. A higher age was associated with an odds ratio (OR) of 1.043 (CI95% 1.022-1.065), while the presence of at least one chronic disease was associated with an OR of 5.649 (CI95% 3.089-10.329) greater likelihood of reactivity. Conclusions: CLIA test exhibited excellent performance making it a suitable test for seroprevalence surveillance at the community level.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.