Dittadi Ruggero
Laboratory Medicine Unit, Ospedale dell'Angelo, and Regional Center for Biomarkers, Department of Clinical Pathology, Azienda ULSS 3 Serenissima, Mestre, 30122 Venice, Italy.
Diagnostics (Basel). 2022 Feb 14;12(2):483. doi: 10.3390/diagnostics12020483.
A WHO standard was prepared with the aim of harmonizing assays detecting antibodies against SARS-CoV-2, but the issue is currently being debated. We re-evaluated a previously studied set of cases (108 specimens of 48 patients and 60 specimens of 20 vaccinated subjects, collected after 14 days from the first dose and 14 days and 3 months after a second dose of the Comirnaty BNT162b2 vaccine), calculating the ratios between the results of two methods (SARS-CoV-2 IgG anti-RBD, SNIBE, and anti-SARS-CoV-2 QuantiVac ELISA IgG, Euroimmun). In the vaccinated subjects, the ratios of the results between methods according to the WHO standard were relatively dispersed, but the harmonization results were good. On the other hand, in patient samples, the variability between tests was very high, and the harmonization was unsatisfactory (median ratios between methods 2.23, 10th-90th percentile: 1.1-5.6). Interestingly, in patient samples, the harmonization depends on the time from the onset of symptoms and greatly improves after 6 months since the diagnosis. Forty patient specimens and thirty-one of the vaccinated subjects after the second dose were also evaluated with a third method (Access SARS-CoV-2 IgG (1st IS), Beckman Coulter), obtaining a similar trend. We can conclude that the actual effectiveness of harmonization between methods may vary depending on the scenario in which they will be used.
世界卫生组织制定了一项标准，旨在统一检测针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）抗体的检测方法，但目前该问题仍在讨论中。我们重新评估了一组先前研究的病例（48名患者的108份样本以及20名接种疫苗者的60份样本，这些样本在接种第一剂Comirnaty BNT162b2疫苗14天后、第二剂疫苗接种后14天和3个月采集），计算了两种方法（SARS-CoV-2 IgG抗受体结合域（RBD），SNIBE，以及抗SARS-CoV-2 QuantiVac ELISA IgG，Euroimmun）结果之间的比率。在接种疫苗者中，根据世界卫生组织标准，两种方法结果的比率相对分散，但一致性结果良好。另一方面，在患者样本中，检测之间的变异性非常高，一致性并不理想（两种方法之间的中位数比率为2.23，第10百分位数至第90百分位数：1.1 - 5.6）。有趣的是，在患者样本中，一致性取决于症状出现后的时间，自诊断后6个月后显著改善。还使用第三种方法（Access SARS-CoV-2 IgG（1st IS），Beckman Coulter）对40份患者样本和31名接种第二剂疫苗后的受试者进行了评估，得到了类似的趋势。我们可以得出结论，方法之间一致性的实际效果可能因使用场景而异。
