Abstract
BackgroundAlthough RT-qPCR remains the gold-standard for COVID-19 diagnosis, anti-SARS-CoV-2 serology-based assays have been widely used during 2020 as an alternative for individual and mass testing, and are currently used for seroprevalence studies.ObjectiveTo study the clinical performance of seven commercial serological tests for COVID-19 diagnosis available in South America.MethodsWe conducted a blind evaluation of five lateral-flow immunoassays (LFIA) and two enzyme-linked immunosorbent assays (ELISAs) for detecting anti-SARS-CoV-2 antibodies.ResultsWe found no statistically significant differences among ELISA kits and LFIAs for anti-SARS-CoV-2 IgG sensitivity (values ranging from 76.4% to 83.5%) and specificity (100% for the seven serological assays). For anti-SARS-CoV-2 IgM, the five LFIAs have a significantly higher sensitivity for samples collected 15 days after the first time RT-qPCR positive test, with values ranging from 47.1% to 88.2%; moreover, the specificity varied from 85% to 100%, but the only LFIA brand with a 100% specificity had the lowest sensitivity.ConclusionThe diagnostic performance of the seven serological tests was acceptable for the seven brands tested for anti-SARS-CoV-2 IgG detection for seroprevalence screening purposes. On the other hand, our results show the lack of accuracy of anti-SARS-CoV-2 IgM detection in LFIAs as a tool for SARS-CoV-2 acute-phase infection diagnosis.
Highlights
The detection of the novel coronavirus SARS-CoV-2 in the Chinese province of Hubei in December 2019 led to the Coronavirus Disease 2019 (COVID-19) outbreak that resulted in the World Health Organization (WHO) declaring a pandemic in March 11th 2020 (Gorbalenya et al, 2020; Zhou et al, 2020)
For anti-SARS-Cov-2 IgG detection, the overall specificity of the five brands was 100%, while the overall sensitivity ranged from 76.4% (68-85.5 IC 95%) to 80.3% (72.3-86.8 IC 95%), no statistically significant differences were found among the five lateral-flow immunoassays (LFIA) brands
This is the first report addressing the clinical performance of serological tests for COVID-19 diagnosis commercially available in Ecuador and other South American countries like Colombia and Peru
Summary
The detection of the novel coronavirus SARS-CoV-2 in the Chinese province of Hubei in December 2019 led to the Coronavirus Disease 2019 (COVID-19) outbreak that resulted in the World Health Organization (WHO) declaring a pandemic in March 11th 2020 (Gorbalenya et al, 2020; Zhou et al, 2020). By the end of September 2021, more than 230 million cases and 4.7 million deaths have been reported worldwide (https://coronavirus.jhu.edu/map.html). Current numbers of cases and deaths related to the COVID-19 pandemic worldwide would suggest that these control and prevention strategies have been hampered by a lack of massive testing in several regions of world, at low- and middle-income countries (Torres and Sacoto, 2020; Henriquez-Trujillo et al, 2021; Pullano et al, 2021). During the first semester of COVID19 pandemic, SARS-CoV-2 genomic material detection by RT-qPCR was the main gold standard method available for COVID-19 diagnosis worldwide This technique has significant logistic and capacity limitations like the need for sophisticated and expensive equipment, such as real time thermal cyclers, trained personnel, or permanent supply of expensive reagents. RT-qPCR remains the gold-standard for COVID-19 diagnosis, anti-SARS-CoV-2 serology-based assays have been widely used during 2020 as an alternative for individual and mass testing, and are currently used for seroprevalence studies
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