Diagnostic performance of an automated chemiluminescence immunoassay for SARS-CoV-2 IgG and IgM antibodies detection: A real life experience

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 immunoasay. 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.

Evaluation of the analytical performance of three chemiluminescence serological assays for detecting anti-SARS-CoV-2 antibodies

“…CLIA has several advantages over ELISA, such as full automation, cost-effectiveness, reproducibility, fast and precise measurement. Additionally, literature evidence shows that CLIA immunoassays have high diagnostic sensitivity and specificity for detecting anti-SARS-CoV-2 antibody levels [ 5 , 15 , 16 ].…”

A Rolling Circle-Amplified G-Quadruplex/Hemin DNAzyme for Chemiluminescence Immunoassay of the SARS-CoV-2 Protein

“…The general detection methods of SARS-CoV-2 include real-time polymerase chain reaction (RT-PCR) for the virus gene and immunoassay for SARS-CoV-2-related proteins. The latter can be performed with enzyme-linked immunosorbent assay (ELISA), gold immunochromatographic assay (GICA), and chemiluminescence immunoassay (CLIA) . Although RT-PCR is a current standard method for SARS-CoV-2 diagnosis due to its high precision and specificity, , some data indicate that this detection technique is not suitable for all cases with clinical features of SARS-CoV-2, and serologic assay has become an indispensable tool as a complementary method for accurate diagnosis .…”

“…The latter can be performed with enzyme-linked immunosorbent assay (ELISA), 5 gold immunochromatographic assay (GICA), 6 and chemiluminescence immunoassay (CLIA). 7 Although RT-PCR is a current standard method for SARS-CoV-2 diagnosis due to its high precision and specificity, 8,9 some data indicate that this detection technique is not suitable for all cases with clinical features of SARS-CoV-2, and serologic assay has become an indispensable tool as a complementary method for accurate diagnosis. 10 In serologic assay, commercially available ELISA is considered as a reliable detection method, but its efficiency is limited by laborious and time-consuming operation.…”