tetano
Editor, Senior Moderator
Pract Lab Med
. 2021 May;25:e00227.
doi: 10.1016/j.plabm.2021.e00227. Epub 2021 Apr 19.
Diagnostic performance of an automated chemiluminescence immunoassay for SARS-CoV-2 IgG and IgM antibodies detection: A real life experience
Danilo Villalta[SUP] 1 [/SUP], Paola Martelli[SUP] 1 [/SUP], Anna Moratto[SUP] 1 [/SUP], Valeria Salgarolo[SUP] 1 [/SUP], Elita Ligato[SUP] 1 [/SUP], Mariaelisabetta Conte[SUP] 1 [/SUP], Roberto Giacomello[SUP] 1 [/SUP], Tommaso Pellis[SUP] 2 [/SUP], Rita De Rosa[SUP] 3 [/SUP], Sergio Venturini[SUP] 4 [/SUP], Massimo Crapis[SUP] 4 [/SUP]
Affiliations
Abstract
Background: Recently many serological assays for detection of antibodies to SARS-COV-2 virus were introduced on the market. Aim of this study was to assess the diagnostic performance of an automated CLIA for quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies.
Methods: A total of 354 sera, 89 from consecutive patients diagnosed with COVID-19 (43 mild, 32 severe and 13 critical) and 265 from asymptomatic and negative on rRT-PCR testing healthcare workers, were evaluated for IgM and IgG anti-SARS-CoV-2 antibodies with MAGLUMI immunoassay.
Results: The overall sensitivity and specificity were 86.5% (95%CI: 77.6-92.8) and 98.5% (95%CI:96.2-99.6), respectively. PPV, PPN, LR+, LR- and OR were 95.1 (95%CI: 87.8-98.6), 95.6 (95%CI: 92.4-97.7), 57.3 (95%CI: 21.6-152.1), 7.3 (95%CI: 4.31-12.4) and 418.6 (95%CI: 131.2-1335.2), respectively. The levels of SARS-CoV-2 IgM and IgG antibodies were 1.22 ?? ?1.2 AU/mL and 15.86 ?? ?24.83 AU/mL, 2.86 ?? ?2.4 AU/mL and 69.3 ?? ?55.5 AU/mL, 2.47 ?? ?1.33 AU/mL and 83.9 ?? ?83.9 AU/mL in mild, severe and critical COVID-19 groups, respectively. A significant difference in antibody levels between mild and severe/critical subjects has been shown.
Conclusions: The CLIA assay showed good diagnostic performance and a significant association between antibody levels and severity of the disease was found.
Keywords: Anti-SARS-CoV ?2 antibodies; Antibody levels; Coronavirus infectious disease 2019 (COVID-19); Diagnostic accuracy; Serological diagnosis.
. 2021 May;25:e00227.
doi: 10.1016/j.plabm.2021.e00227. Epub 2021 Apr 19.
Diagnostic performance of an automated chemiluminescence immunoassay for SARS-CoV-2 IgG and IgM antibodies detection: A real life experience
Danilo Villalta[SUP] 1 [/SUP], Paola Martelli[SUP] 1 [/SUP], Anna Moratto[SUP] 1 [/SUP], Valeria Salgarolo[SUP] 1 [/SUP], Elita Ligato[SUP] 1 [/SUP], Mariaelisabetta Conte[SUP] 1 [/SUP], Roberto Giacomello[SUP] 1 [/SUP], Tommaso Pellis[SUP] 2 [/SUP], Rita De Rosa[SUP] 3 [/SUP], Sergio Venturini[SUP] 4 [/SUP], Massimo Crapis[SUP] 4 [/SUP]
Affiliations
- PMID: 33898690
- PMCID: PMC8054542
- DOI: 10.1016/j.plabm.2021.e00227
Abstract
Background: Recently many serological assays for detection of antibodies to SARS-COV-2 virus were introduced on the market. Aim of this study was to assess the diagnostic performance of an automated CLIA for quantitative detection of anti-SARS-CoV-2 IgM and IgG antibodies.
Methods: A total of 354 sera, 89 from consecutive patients diagnosed with COVID-19 (43 mild, 32 severe and 13 critical) and 265 from asymptomatic and negative on rRT-PCR testing healthcare workers, were evaluated for IgM and IgG anti-SARS-CoV-2 antibodies with MAGLUMI immunoassay.
Results: The overall sensitivity and specificity were 86.5% (95%CI: 77.6-92.8) and 98.5% (95%CI:96.2-99.6), respectively. PPV, PPN, LR+, LR- and OR were 95.1 (95%CI: 87.8-98.6), 95.6 (95%CI: 92.4-97.7), 57.3 (95%CI: 21.6-152.1), 7.3 (95%CI: 4.31-12.4) and 418.6 (95%CI: 131.2-1335.2), respectively. The levels of SARS-CoV-2 IgM and IgG antibodies were 1.22 ?? ?1.2 AU/mL and 15.86 ?? ?24.83 AU/mL, 2.86 ?? ?2.4 AU/mL and 69.3 ?? ?55.5 AU/mL, 2.47 ?? ?1.33 AU/mL and 83.9 ?? ?83.9 AU/mL in mild, severe and critical COVID-19 groups, respectively. A significant difference in antibody levels between mild and severe/critical subjects has been shown.
Conclusions: The CLIA assay showed good diagnostic performance and a significant association between antibody levels and severity of the disease was found.
Keywords: Anti-SARS-CoV ?2 antibodies; Antibody levels; Coronavirus infectious disease 2019 (COVID-19); Diagnostic accuracy; Serological diagnosis.