Abstract
IntroductionIn this work, six SARS-CoV-2-specific antibody assays were evaluated, namely, two pan-immunoglobulin (pan-Ig) assays [Roche Elecsys Anti-SARS-CoV-2 (named "Elecsys" in this study) and the PerkinElmer SuperFlex™ Anti-SARS-CoV-2 Ab Assay (SuperFlex_Ab)], two IgM assays [SuperFlex™ Anti-SARS-CoV-2 IgM Assay (SuperFlex_IgM) and YHLO iFlash-SARS-CoV-2 IgM (iFlash_IgM)], and two IgG assays [SuperFlex™ Anti-SARS-CoV-2 IgG Assay (SuperFlex_IgG) and iFlash-SARS-CoV-2 IgG (iFlash_IgG)]. Combination assays of SuperFlex™ (SuperFlex_any) and iFlash (iFlash_any) were also evaluated.MethodsA total of 438 residual serum samples from 54 COVID-19 patients in the COVID-19 group and 100 samples from individuals without evidence of SARS-CoV-2 infection in the negative control group were evaluated.ResultsIn the early stage of COVID-19 infection, within 14 days of symptom onset, the seropositive rate was lower than that of the late stage 15 days after onset (65.4% vs 99.6%). In the total period, the pan-Ig and IgG assays had higher sensitivity (90.8–95.3%) than the IgM assays (36.5–40.7%). SuperFlex_Ab and SuperFlex_any had higher sensitivity than Elecsys and SuperFlex_IgG (p < 0.05). The specificity of all the assays was 100%, except for SuperFlex_IgM (99.0%). The concordance rate between each assay was higher (96.4–100%) in the late stage than in the early stage (77.4–98.1%).ConclusionFor the purpose of COVID-19 diagnosis, antibody testing should be performed 15 days after onset. For the purpose of epidemiological surveillance, highly sensitive assays should be used as much as possible, such as SuperFlex_Ab, iFlash_IgG and their combination. IgM assays were not suitable for these purposes.
Highlights
In this work, six SARS-CoV-2-specific antibody assays were evaluated, namely, two pan-immunoglobulin assays [Roche Elecsys Anti-SARS-CoV-2 and the PerkinElmer SuperFlexTM Anti-SARS-CoV-2 Ab Assay (SuperFlex_Ab)], two IgM assays [SuperFlexTM Anti-SARS-CoV-2 IgM Assay (SuperFlex_IgM) and YHLO iFlash-SARS-CoV-2 IgM], and two IgG assays [SuperFlexTM Anti-SARS-CoV-2 IgG Assay (SuperFlex_IgG) and iFlash-SARS-CoV-2 IgG]
Since the start of the coronavirus disease 2019 (COVID19) pandemic and its worldwide spread, the gold standard for diagnosis has been the identification of viral RNA by reverse-transcription polymerase chain reaction (RT-PCR) from nasal swabs, nasopharyngeal swabs, or saliva [1]
We compared six assays and two combination assays, including one assay approved under emergency use authorization (EUA) by the Food and Drug Administration (FDA), with the goal of identifying the assay(s) with the highest sensitivity and specificity
Summary
Six SARS-CoV-2-specific antibody assays were evaluated, namely, two pan-immunoglobulin (pan-Ig) assays [Roche Elecsys Anti-SARS-CoV-2 (named "Elecsys" in this study) and the PerkinElmer SuperFlexTM Anti-SARS-CoV-2 Ab Assay (SuperFlex_Ab)], two IgM assays [SuperFlexTM Anti-SARS-CoV-2 IgM Assay (SuperFlex_IgM) and YHLO iFlash-SARS-CoV-2 IgM (iFlash_IgM)], and two IgG assays [SuperFlexTM Anti-SARS-CoV-2 IgG Assay (SuperFlex_IgG) and iFlash-SARS-CoV-2 IgG (iFlash_IgG)]. Because seroconversion is generally observed 3 to 14 days after symptom onset, antibody testing is not suitable for the early diagnosis of COVID-19 [3]. Many antibody assays for COVID-19 are available and have been authorized by the U.S Food and Drug Administration (FDA) under emergency use authorization (EUA) [5]. These assays have good sensitivity and specificity (87.9–100% sensitivity and 95.0–100% specificity for IgG), the sensitivity and specificity values are mainly determined 14 days from symptom onset or later. We compared six assays and two combination assays, including one assay approved under EUA by the FDA, with the goal of identifying the assay(s) with the highest sensitivity and specificity
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