Papenburg Jesse, Cheng Matthew P, Corsini Rachel, Caya Chelsea, Mendoza Emelissa, Manguiat Kathy, Lindsay L Robbin, Wood Heidi, Drebot Michael A, Dibernardo Antonia, Zaharatos Gerasimos, Bazin Reneé, Gasser Romain, Benlarbi Mehdi, Gendron-Lepage Gabrielle, Beaudoin-Bussières Guillaume, Prévost Jérémie, Finzi Andrés, Ndao Momar, Yansouni Cedric P
Division of Pediatric Infectious Diseases, Department of Pediatrics, Montreal Children's Hospital, Montreal, Quebec, Canada.
Division of Microbiology, Department of Clinical Laboratory Medicine, Optilab Montreal - McGill University Health Centre, Montreal, Quebec, Canada.
Open Forum Infect Dis. 2021 Apr 30;8(6):ofab220. doi: 10.1093/ofid/ofab220. eCollection 2021 Jun.
Severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) surrogate neutralization assays that obviate the need for viral culture offer substantial advantages regarding throughput and cost. The cPass SARS-CoV-2 Neutralization Antibody Detection Kit (GenScript) is the first such commercially available assay that detects antibodies that block receptor-binding domain (RBD)/angiotensin-converting enzyme (ACE)-2 interaction. We aimed to evaluate cPass to inform its use and assess its added value compared with anti-RBD enzyme-linked immunosorbent assays (ELISAs).
Serum reference panels comprising 205 specimens were used to compare cPass to plaque-reduction neutralization test (PRNT) and a pseudotyped lentiviral neutralization (PLV) assay for detection of neutralizing antibodies. We assessed the correlation of cPass with an ELISA detecting anti-RBD immunoglobulin (Ig)G, IgM, and IgA antibodies at a single timepoint and across intervals from onset of symptoms of SARS-CoV-2 infection.
Compared with PRNT-50, cPass sensitivity ranged from 77% to 100% and specificity was 95% to 100%. Sensitivity was also high compared with the pseudotyped lentiviral neutralization assay (93%; 95% confidence interval [CI], 85-97), but specificity was lower (58%; 95% CI, 48-67). Highest agreement between cPass and ELISA was for anti-RBD IgG ( = 0.823). Against the pseudotyped lentiviral neutralization assay, anti-RBD IgG sensitivity (99%; 95% CI, 94-100) was very similar to that of cPass, but overall specificity was lower (37%; 95% CI, 28-47). Against PRNT-50, results of cPass and anti-RBD IgG were nearly identical.
The added value of cPass compared with an IgG anti-RBD ELISA was modest.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）替代中和试验无需病毒培养，在通量和成本方面具有显著优势。cPass SARS-CoV-2中和抗体检测试剂盒（金斯瑞）是首个可商购的此类试验，用于检测阻断受体结合域（RBD）/血管紧张素转换酶（ACE）-2相互作用的抗体。我们旨在评估cPass，为其使用提供参考，并评估其与抗RBD酶联免疫吸附测定（ELISA）相比的附加价值。
使用包含205个样本的血清参考面板，将cPass与空斑减少中和试验（PRNT）和假型慢病毒中和（PLV）试验进行比较，以检测中和抗体。我们在单个时间点以及从SARS-CoV-2感染症状出现开始的不同时间段，评估了cPass与检测抗RBD免疫球蛋白（Ig）G、IgM和IgA抗体的ELISA之间的相关性。
与PRNT-50相比，cPass的敏感性范围为77%至100%，特异性为95%至100%。与假型慢病毒中和试验相比，敏感性也较高（93%；95%置信区间[CI]，85-97），但特异性较低（58%；95%CI，48-67）。cPass与ELISA之间一致性最高的是抗RBD IgG（=0.823）。与假型慢病毒中和试验相比，抗RBD IgG的敏感性（99%；95%CI，94-100）与cPass非常相似，但总体特异性较低（37%；95%CI，28-47）。与PRNT-50相比，cPass和抗RBD IgG的结果几乎相同。
与IgG抗RBD ELISA相比，cPass的附加价值不大。
