tetano
Editor, Senior Moderator
Eur J Clin Microbiol Infect Dis
. 2021 Mar 17.
doi: 10.1007/s10096-021-04220-7. Online ahead of print.
Evaluation of 18 commercial serological assays for the detection of antibodies against SARS-CoV-2 in paired serum samples
Dani?lle A T Hanssen[SUP] #[/SUP][SUP] 1 [/SUP], Michiel Slaats[SUP] #[/SUP][SUP] 1 [/SUP], Marlies Mulder[SUP] #[/SUP][SUP] 1 [/SUP], Paul H M Savelkoul[SUP] 1 2 [/SUP], Inge H M van Loo[SUP] 3 4 [/SUP]
Affiliations
Abstract
A variety of serological tests have been developed to detect the presence of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the performance of 18 commercially available SARS-CoV-2 antibody assays. Early (6-8 days after the start of symptoms) and late sera (>14 days) from ICU patients (n=10 and n=16, respectively) and healthcare workers (n=5 and n=9, respectively) were included. Additionally, 22 sera were included to detect potential cross-reactivity. Test characteristics were determined for the 18 assays. In >14 days samples, the Vircell IgG and Wantai Ig ELISAs had superior sensitivity compared to the other ELISAs (96%). Furthermore, the Roche Ig, the Epitope Diagnostics IgM, Wantai IgM, Euroimmun IgG, and IgA all showed a specificity of 100%. The POCTs of Boson Biotech and ACRO Biotech showed the highest sensitivities: 100% and 96% (83.5-99.8), respectively. The POCT of Orient Gene Biotech, VOMED Diagnostics, and Coris-Bioconcept showed highest specificities (100%). For the IgM and IgA assays, the Euroimmun IgA test showed the highest sensitivity in early samples: 46.7% (23.5-70.9) to 53.3% (29.1-76.5). In general, all tests performed better in patients with severe symptoms (ICU patients). We conclude that the Wantai Ig and Vircell IgG ELISAs may be suitable for diagnostic purposes. The IgM/IgA tests performed poorer than their IgG/Ig counterparts but may have a role in diagnoses of SARS-CoV-2 in a population in which the background seroprevalence of IgG high, and IgM and/or IgA may distinguish between acute or past infection.
Keywords: Antibody testing; ECLIA; ELISA; POCT; SARS-CoV-2; serology.
. 2021 Mar 17.
doi: 10.1007/s10096-021-04220-7. Online ahead of print.
Evaluation of 18 commercial serological assays for the detection of antibodies against SARS-CoV-2 in paired serum samples
Dani?lle A T Hanssen[SUP] #[/SUP][SUP] 1 [/SUP], Michiel Slaats[SUP] #[/SUP][SUP] 1 [/SUP], Marlies Mulder[SUP] #[/SUP][SUP] 1 [/SUP], Paul H M Savelkoul[SUP] 1 2 [/SUP], Inge H M van Loo[SUP] 3 4 [/SUP]
Affiliations
- PMID: 33733395
- DOI: 10.1007/s10096-021-04220-7
Abstract
A variety of serological tests have been developed to detect the presence of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). We evaluated the performance of 18 commercially available SARS-CoV-2 antibody assays. Early (6-8 days after the start of symptoms) and late sera (>14 days) from ICU patients (n=10 and n=16, respectively) and healthcare workers (n=5 and n=9, respectively) were included. Additionally, 22 sera were included to detect potential cross-reactivity. Test characteristics were determined for the 18 assays. In >14 days samples, the Vircell IgG and Wantai Ig ELISAs had superior sensitivity compared to the other ELISAs (96%). Furthermore, the Roche Ig, the Epitope Diagnostics IgM, Wantai IgM, Euroimmun IgG, and IgA all showed a specificity of 100%. The POCTs of Boson Biotech and ACRO Biotech showed the highest sensitivities: 100% and 96% (83.5-99.8), respectively. The POCT of Orient Gene Biotech, VOMED Diagnostics, and Coris-Bioconcept showed highest specificities (100%). For the IgM and IgA assays, the Euroimmun IgA test showed the highest sensitivity in early samples: 46.7% (23.5-70.9) to 53.3% (29.1-76.5). In general, all tests performed better in patients with severe symptoms (ICU patients). We conclude that the Wantai Ig and Vircell IgG ELISAs may be suitable for diagnostic purposes. The IgM/IgA tests performed poorer than their IgG/Ig counterparts but may have a role in diagnoses of SARS-CoV-2 in a population in which the background seroprevalence of IgG high, and IgM and/or IgA may distinguish between acute or past infection.
Keywords: Antibody testing; ECLIA; ELISA; POCT; SARS-CoV-2; serology.