20.500.12556/RUL-138695 Head-to-head comparison of two rapid high-throughput automated electrochemiluminescence immunoassays targeting total antibodies to the SARS-CoV-2 nucleoprotein and spike protein receptor binding domain Background: Accurate anti-SARS-CoV-2 assays are needed to inform diagnostic, therapeutic, and public health decisions. The first manufacturer-independent head-to-head comparison of two rapid high-throughput automated electrochemiluminescence double-antigen sandwich immunoassays targeting total anti-SARS-CoV-2 antibodies against two different viral proteins, Elecsys Anti-SARS-CoV-2 (Elecsys-N) and Elecsys Anti-SARS-CoV-2 S (Elecsys-S) (Roche Diagnostics), was performed in a routine setting during the exponential growth phase of the epidemic’s second wave. Methods: The diagnostic specificity of Elecsys-N and Elecsys-S was initially evaluated on a panel of 572 pre−COVID-19 samples, showing 100 % specificity of both assays. Elecsys-N/Elecsys-S head-to-head comparison used 3,416 consecutive blood samples from individuals that were tested for the presence of anti-SARS-CoV-2 within commercial out-of-pocket serologic testing. Results: Elecsys-N/Elecsys-S head-to-head comparison showed overall agreement of 98.68 % (3,371/3,416; 95 % CI, 98.23–99.03 %), positive agreement of 95.16 % (884/929; 95 % CI, 93.52–96.41 %), and a high kappa value of 0.996 (95 % CI, 0.956–0.976). Previous SARS-CoV-2 PCR positivity was identified in 14/24 (58.3 %) Elecsys-N negative/Elecsys-S positive individuals and in 4/21 (19.0 %) Elecsys-N positive/Elecsys-S negative individuals. Conclusion: The first Elecsys-N/Elecsys-S head-to-head comparison showed excellent agreement of two highly specific and rapid high-throughput automated anti-SARS-CoV-2 assays. An important question is whether laboratories offering two different antibody assays could benefit from combining the assays; if so, should use be concomitant or sequential—and, in the latter case, in which order? Based on our results, we favor concomitant over sequential Elecsys-N/Elecsys-S use when testing individuals for anti-SARS-CoV-2 antibodies in high-incidence settings; for example, during the exponential or stationary growth phase of the COVID-19 epidemic. SARS-CoV-2 immunoassay antibody COVID-19 electrochemiluminescence SARS-CoV-2 imunski test protitelesa true false true Angleški jezik Slovenski jezik Članek v reviji 2022-08-09 15:00:24 2022-08-09 15:00:31 2022-09-15 04:17:04 0000-00-00 00:00:00 2021 0 0 5 str. Vol. 137, art. 104784 2021 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.9 1873-5967 10.1016/j.jcv.2021.104784 61796611 1-s2.0-S1386653221000512-main.pdf 1-s2.0-S1386653221000512-main.pdf 1 A75F6B415EA1C316DF69ECB4129F58A4 326d85fa77408f2a50f36621212800239d517f07ba68c280ac5e38ebe7bd494b 50d0ff6b-17e3-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159103 https://www.sciencedirect.com/science/article/pii/S1386653221000512 0 f6610c4a-17e2-11ed-8aca-00155dcfd717 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=159102 Medicinska fakulteta 0 0 0