Department of Pathology, University of Chicago, Chicago, IL, USA.
Department of Pathology and Genomic Medicine, Weill Cornell Medical College, New York, NY, USA.
Am J Clin Pathol. 2022 Jan 6;157(1):109-118. doi: 10.1093/ajcp/aqab092.
To analytically and clinically evaluate the semiquantitative Elecsys anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein antibody (S-Ab) assay on the Roche cobas e602 analyzer.
The S-Ab assay is a 1-step, double-antigen sandwich electrochemiluminescent immunoassay that semiquantitatively measures total IgG, IgM, and IgA antibodies specific for the receptor binding domain of SARS-CoV-2 spike protein in serum or plasma. The S-Ab assay was evaluated for precision, linearity, interference (by hemoglobin, bilirubin, triglycerides, and biotin), cross-reactivity, and clinical performance, and was compared to the qualitative Elecsys anti-nucleocapsid (N-Ab) immunoassay, a lateral flow device that qualitatively detects S-Ab and N-Ab, and an anti-spike enzyme-linked immunosorbent assay (ELISA).
S-Ab assay is precise, exhibits linearity from 0.4 to 250 U/mL, is unaffected by significant cross-reactivity or interferences, and qualitatively demonstrates greater than 90% concordance with N-Ab assay and lateral flow device. Readouts of S-Ab assay correlate with ELISA, which in turn correlates strongly with SARS-CoV-2 virus neutralization assay, and exhibit 100% sensitivity and specificity for COVID-19 patient samples obtained at or more than 14 days after PCR positivity.
The S-Ab assay is a robust clinical test for qualitative and semiquantitative detection of seropositivity following SARS-CoV-2 infection or spike-encoding mRNA COVID-19 vaccination.
分析并临床评估罗氏 cobas e602 分析仪上 Elecsys 抗严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）刺突蛋白抗体（S-Ab）分析的半定量检测。
S-Ab 分析是一种一步法、双抗原夹心电化学发光免疫分析法，半定量检测血清或血浆中针对 SARS-CoV-2 刺突蛋白受体结合域的总 IgG、IgM 和 IgA 抗体。评估 S-Ab 分析的精密度、线性、干扰（血红蛋白、胆红素、甘油三酯和生物素）、交叉反应性和临床性能，并与定性 Elecsys 抗核衣壳（N-Ab）免疫分析、定性检测 S-Ab 和 N-Ab 的侧向流动设备以及抗刺突酶联免疫吸附测定（ELISA）进行比较。
S-Ab 分析具有精密度，在 0.4 至 250 U/mL 之间具有线性，不受显著的交叉反应或干扰影响，与 N-Ab 分析和侧向流动设备定性相比，具有大于 90%的一致性。S-Ab 分析的读数与 ELISA 相关，而 ELISA 又与 SARS-CoV-2 病毒中和测定强烈相关，对于在 PCR 阳性后 14 天或更长时间获得的 COVID-19 患者样本，具有 100%的敏感性和特异性。
S-Ab 分析是一种可靠的临床检测方法，用于定性和半定量检测 SARS-CoV-2 感染或编码刺突 mRNA 的 COVID-19 疫苗接种后的血清阳性。
