Abstract
The onset of the new SARS-CoV-2 coronavirus encouraged the development of new serologic tests that could be additional and complementary to real-time RT-PCR-based assays. In such a context, the study of performances of available tests is urgently needed, as their use has just been initiated for seroprevalence assessment. The aim of this study was to compare four chemiluminescence immunoassays and one immunochromatography test for SARS-Cov-2 antibodies for the evaluation of the degree of diffusion of SARS-CoV-2 infection in Salerno Province (Campania Region, Italy). A total of 3,185 specimens from citizens were tested for anti-SARS-CoV-2 antibodies as part of a screening program. Four automated immunoassays (Abbott and Liaison SARS-CoV-2 CLIA IgG and Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays) and one lateral flow immunoassay (LFIA Technogenetics IgG–IgM COVID-19) were used. Seroprevalence in the entire cohort was 2.41, 2.10, 1.82, and 1.85% according to the Liaison IgG, Abbott IgG, Siemens, and Roche total Ig tests, respectively. When we explored the agreement among the rapid tests and the serologic assays, we reported good agreement for Abbott, Siemens, and Roche (Cohen's Kappa coefficient 0.69, 0.67, and 0.67, respectively), whereas we found moderate agreement for Liaison (Cohen's kappa coefficient 0.58). Our study showed that Abbott and Liaison SARS-CoV-2 CLIA IgG, Roche and Siemens SARS-CoV-2 CLIA IgM/IgG/IgA assays, and LFIA Technogenetics IgG-IgM COVID-19 have good agreement in seroprevalence assessment. In addition, our findings indicate that the prevalence of IgG and total Ig antibodies against SARS-CoV-2 at the time of the study was as low as around 3%, likely explaining the amplitude of the current second wave.
Highlights
In December 2019, an outbreak of an unexplained pneumonia was reported in the city of Wuhan, Hubei province, China
In the present seroprevalence study, we evaluated the performance of one lateral flow assay (Technogenetics), two chemiluminescent assays testing for total SARS-CoV-2 antibodies against N protein (Roche) or against S1 (Siemens), and two chemiluminescent assays testing IgG antibodies against N protein (Abbott) and against S protein (DiaSorin)
More than 90% of the tested individuals were domiciled in municipalities of the Diano Valley of the Salerno Province, with 1,168, 622, 536, 369, and 285 individuals, respectively, domiciled in Sala Consilina, Polla, Caggiano, Atena Lucana, and Auletta, respectively
Summary
In December 2019, an outbreak of an unexplained pneumonia was reported in the city of Wuhan, Hubei province, China. A novel coronavirus was identified as the etiological agent (named severe acute respiratory syndrome coronavirus 2—SARS-CoV2), the associated disease defined as COVID-19 (COrona VIrus Disease, 19 stands for the year the virus was first detected). The exponential growth of affected individuals led the WHO to declare a global pandemic; since the virus has greatly impacted, infecting over 80 million worldwide with more than 1.5 million deaths. SARS-CoV-2 belongs to the coronavirus family; these are enveloped, single-stranded, positive-sense RNA viruses. Seven coronaviruses infect humans; those are classified in two genera: Alpha and Beta. NL63 and 229E are alphacoronaviruses distantly related to SARS-CoV-2 and cause cold-like illnesses
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