TY - JOUR
T1 - Diagnostic Performance of Seven Commercial COVID-19 Serology Tests Available in South America
AU - UDLA COVID-19 team
AU - Rivera-Olivero, Ismar A
AU - Henríquez-Trujillo, Aquiles R
AU - Kyriakidis, Nikolaos C
AU - Ortiz-Prado, Esteban
AU - Laglaguano, Juan Carlos
AU - Vallejo-Janeta, Alexander Paolo
AU - Lozada, Tannya
AU - Garcia-Bereguiain, Miguel Angel
N1 - FTX; DOAJ; CC BY
PY - 2022
Y1 - 2022
N2 - BACKGROUND: Although 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.OBJECTIVE: To study the clinical performance of seven commercial serological tests for COVID-19 diagnosis available in South America.METHODS: We conducted a blind evaluation of five lateral-flow immunoassays (LFIA) and two enzyme-linked immunosorbent assays (ELISAs) for detecting anti-SARS-CoV-2 antibodies.RESULTS: We 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.CONCLUSION: The 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.
AB - BACKGROUND: Although 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.OBJECTIVE: To study the clinical performance of seven commercial serological tests for COVID-19 diagnosis available in South America.METHODS: We conducted a blind evaluation of five lateral-flow immunoassays (LFIA) and two enzyme-linked immunosorbent assays (ELISAs) for detecting anti-SARS-CoV-2 antibodies.RESULTS: We 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.CONCLUSION: The 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.
KW - Antibodies, Viral
KW - COVID-19/diagnosis
KW - COVID-19 Testing
KW - Enzyme-Linked Immunosorbent Assay
KW - Humans
KW - Immunoglobulin M
KW - SARS-CoV-2
KW - Sensitivity and Specificity
KW - Seroepidemiologic Studies
KW - Serologic Tests/methods
KW - South America
U2 - 10.3389/fcimb.2022.787987
DO - 10.3389/fcimb.2022.787987
M3 - A1: Web of Science-article
C2 - 35252025
SN - 2235-2988
VL - 12
JO - Frontiers in Cellular and Infection Microbiology
JF - Frontiers in Cellular and Infection Microbiology
M1 - 787987
ER -