Validation and clinical evaluation of a SARS-CoV-2 surrogate virus neutralisation test (sVNT).
Validation and clinical evaluation of a SARS-CoV-2 surrogate virus neutralisation test (sVNT).
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DOI：
10.1080/22221751.2020.1835448
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发表时间：
2020-12
影响因子：
13.2
通讯作者：
Reusken C
中科院分区：
文献类型：
--
作者：
Meyer B;Reimerink J;Torriani G;Brouwer F;Godeke GJ;Yerly S;Hoogerwerf M;Vuilleumier N;Kaiser L;Eckerle I;Reusken C
为了了解SARS-CoV-2在自然感染或接种疫苗后的免疫情况，需要进行功能分析，如病毒中和试验。到目前为止，检测SARS-CoV-2中和抗体的方法依赖于基于细胞培养的感染分析，要么使用野生型SARS-CoV-2，要么使用假型病毒。这种化验是劳动密集型的，需要适当的生物安全设施，而且很难标准化。最近，一种新的替代病毒中和试验(SVNT)被描述，它利用ELISA法的原理来测量针对受体结合域的抗SARS-CoV-2抗体的中和能力。在这里，我们对2020年之前收集的269例聚合酶链式反应确诊的新冠肺炎病例和259例不匹配的样本的广泛血清进行了稳健性、特异性和敏感性的独立评估，并将其与基于细胞的中和分析进行了比较。我们发现SNNT的特异性为99.2(95%CI：96.9-99.9)，总体敏感性为80.3(95%CI：74.9-84.8)。早期(症状出现或诊断后14天，DPOS/DPD)和晚期(>；14 DPOS/DPD)之间的临床敏感性从75.0(64.7-83.2)增加到83.1(76.5-88.1)。此外，严重程度越高，临床敏感性也越高。通过与基于细胞的中和分析比较，我们确定了滴度≥10对40和≥40对160的分析灵敏度分别为74.3%(56.4%-86.9%)和98.2%(89.4%-99.9%)。只有滴度为≥160的样本在SNNT中始终为阳性。综上所述，SVNT可作为一种额外的检测方法来确定接种疫苗的个体中新冠肺炎感染者的免疫状态，但其价值需要根据每种具体情况进行评估。
To understand SARS-CoV-2 immunity after natural infection or vaccination, functional assays such as virus neutralising assays are needed. So far, assays to detect SARS-CoV-2 neutralising antibodies rely on cell-culture based infection assays either using wild type SARS-CoV-2 or pseudotyped viruses. Such assays are labour-intensive, require appropriate biosafety facilities and are difficult to standardize. Recently, a new surrogate virus neutralisation test (sVNT) was described that uses the principle of an ELISA to measure the neutralisation capacity of anti-SARS-CoV-2 antibodies directed against the receptor binding domain. Here, we performed an independent evaluation of the robustness, specificity and sensitivity on an extensive panel of sera from 269 PCR-confirmed COVID-19 cases and 259 unmatched samples collected before 2020 and compared it to cell-based neutralisation assays. We found a high specificity of 99.2 (95%CI: 96.9–99.9) and overall sensitivity of 80.3 (95%CI: 74.9–84.8) for the sVNT. Clinical sensitivity increased between early (<14 days post symptom onset or post diagnosis, dpos/dpd) and late sera (>14 dpos/dpd) from 75.0 (64.7–83.2) to 83.1 (76.5–88.1). Also, higher severity was associated with an increase in clinical sensitivity. Upon comparison with cell-based neutralisation assays we determined an analytical sensitivity of 74.3 (56.4–86.9) and 98.2 (89.4–99.9) for titres ≥10 to <40 and ≥40 to <160, respectively. Only samples with a titre ≥160 were always positive in the sVNT. In conclusion, the sVNT can be used as an additional assay to determine the immune status of COVID-19 infected of vaccinated individuals but its value needs to be assessed for each specific context.
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