SYNLAB Analytics and Services Germany GmbH, Berlin, Germany.
SYNLAB Global Diagnostics, Alcobendas, Madrid, Spain.
Diagn Microbiol Infect Dis. 2022 Feb;102(2):115587. doi: 10.1016/j.diagmicrobio.2021.115587. Epub 2021 Oct 29.
Reliable diagnostic technologies are pivotal to the fight against COVID-19. While real-time reverse transcription-polymerase chain reaction (rRT-PCR) remains the gold standard, commercial assays for antibodies against (SARS-CoV-2) have emerged. We sought to examine 5 widely used commercial methods. We measured antibodies against SARS-CoV-2 with assays, Abbott-IgG, Roche-IgT (total antibodies, isotype-unspecific), EUROIMMUN-IgG, EUROIMMUN-IgA, DiaSorin-IgG, in 191 serum samples from patients with rRT-PCR proven COVID-19 between days 0 and 47 after the onset of clinical symptoms and in biobank samples collected in 2018. The assays were calibrated using the manufacturers' instructions; results are in multiples of the assay specific cut-offs (Abbott, Roche, EUROIMMUN) or in arbitrary units (AU/mL, DiaSorin). The assays for IgG and IgT have approximately the same sensitivity and specificity for detecting seroconversion which starts at approximately day 3 after symptom onset, sensitivity reached 93% on day 16 and was 100% for each assay on day 20. The assay for IgA antibodies was superior in sensitivity and had a lower specificity than the others. Bivariate non-parametric correlation coefficients ranged between 0.738 and 0.991. Commercial assays for IgG or total antibodies against SARS-CoV-2 are largely equivalent for establishing seroconversion but differ at high antibody titres. Increased sensitivity to detect seroconversion is afforded by including IgA antibodies. Further international efforts to harmonise assays for antibodies against SARS-CoV-2 are urgently needed.
可靠的诊断技术是抗击 COVID-19 的关键。虽然实时逆转录聚合酶链反应（rRT-PCR）仍然是金标准，但针对（SARS-CoV-2）的抗体的商业检测方法已经出现。我们试图研究 5 种广泛使用的商业方法。我们使用 Abbott-IgG、Roche-IgT（总抗体，非特异性同种型）、EUROIMMUN-IgG、EUROIMMUN-IgA、DiaSorin-IgG 这 5 种商业方法在 191 份来自临床症状出现后 0 至 47 天的 rRT-PCR 确诊 COVID-19 患者的血清样本以及 2018 年收集的生物库样本中测量针对 SARS-CoV-2 的抗体。根据制造商的说明校准检测方法；结果以检测到血清转化的检测方法特定截止值的倍数（Abbott、Roche、EUROIMMUN）或任意单位（AU/mL、DiaSorin）表示。针对 IgG 和 IgT 的检测方法在检测血清转化方面具有相似的敏感性和特异性，血清转化大约在症状出现后第 3 天开始，在第 16 天达到 93%的敏感性，在第 20 天每个检测方法的敏感性均为 100%。针对 IgA 抗体的检测方法在敏感性方面具有优势，特异性低于其他检测方法。双变量非参数相关系数在 0.738 到 0.991 之间。用于确定血清转化的 IgG 或针对 SARS-CoV-2 的总抗体的商业检测方法在很大程度上是等效的，但在高抗体滴度时有所不同。通过包括 IgA 抗体，可以提高检测血清转化的敏感性。迫切需要进一步开展国际努力来协调针对 SARS-CoV-2 的抗体检测方法。
