Assessment and Comparison of Two Serological Approaches for the Surveillance of Health Workers Exposed to SARS-CoV-2

Infect Drug Resist. 2020 Dec 17:13:4501-4507. doi: 10.2147/IDR.S282652. eCollection 2020.

Abstract

Background and aim: The aim of the present study was to assess the diagnostic performance of an LFA compared with an ELISA test in a cohort of HWs operating in a COVID-19 unit of a teaching hospital in southern Italy.

Methods: We performed an observational, prospective, interventional study including 65 COVID-19 unit personnel. On a total of 196 serum samples (at least 2 serum samples for each HW), LFA and ELISA tests for SARS-COV-2 IgG and IgM were performed. Also, 32 serum samples of SARS-CoV-2 RNA positive patients at least 21 days before sampling, and 30 serum samples of patients obtained up to November 2019, before COVID-19 outbreak in China, were used as positive and negative controls, respectively.

Findings: Of the 65 HWs enrolled, 6 were positive in LFA; overall, of the 196 serum samples, 20 were positive in LFA. All ELISA tests performed on serum samples collected from HWs were negative. The specificity of LFAs was 90.77% considering the 65 HWs and 89.80% considering all the 196 health workers serum samples analyzed. Considering the data on HWs, ELISA test for SARS-COV-2 antibodies showed a specificity of 100%, including all the 196 serum samples collected, and 100% including the 65 HWs. The ELISA and LFAs performed after 21 days last COVID-19 patient was discharged were all negative.

Conclusion: LFAs compared to ELISA tests result in less specificity, considering COVID-19 negative personnel and patients. Thus, LFAs seem to be not adequate in the active surveillance of HWs.

Keywords: COVID-19; SARS-CoV-2; active surveillance; anti-IgG SAR-COV-2; health workers.

Grants and funding

“POR Campania FESR 2014-2020-Avviso per l’acquisizione di manifestazioni di interesse per la realizzazione di servizi di ricerca e sviluppo per la lotta contro il Covid-19” (DGR n. 140 del 17 marzo 2020), Project: “IDENTIFICAZIONE DEI FATTORI DEMOGRAFICI, CLINICI, VIROLOGICI, GENETICI, IMMUNOLOGICI E SIEROLOGICI ASSOCIATI AD OUTCOME SFAVOREVOLE NEI SOGGETTI CON COVID-19”, Regione Campania, Italy.