Department of Pathology, University of Pittsburgh Medical Center, Pittsburgh, PA, USA.
Department of Pediatrics, Division of Infectious Diseases, UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA, USA.
Am J Clin Pathol. 2021 May 18;155(6):773-775. doi: 10.1093/ajcp/aqab033.
Serologic assay performance studies for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in pediatric populations are lacking, and few seroprevalence studies have routinely incorporated orthogonal testing to improve accuracy.
Remnant serum samples for routine bloodwork from 2,338 pediatric patients at UPMC Children's Hospital of Pittsburgh were assessed using the EUROIMMUN Anti-SARS-CoV-2 ELISA IgG (EuroIGG) assay. Reactive cases with sufficient volume were also tested using 3 additional commercial assays.
Eighty-five specimens were reactive according to the EuroIGG, yielding 3.64% (95% confidence interval [CI], 2.91%-4.48%) seropositivity, of which 73 specimens had sufficient remaining volume for confirmation by orthogonal testing. Overall, 19.18% (95% CI, 10.18%-28.18%) of samples were positive on a second and/or third orthogonal assay. This 80.82% false positivity rate is disproportionate to the expected false positivity rate of 50% given our pediatric population prevalence and assay performance.
In pediatric populations, false-positive SARS-CoV-2 serology may be more common than assay and prevalence parameters would predict, and further studies are needed to establish the performance of SARS-CoV-2 serology in children.
针对儿童人群的严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）血清学检测性能研究较为缺乏，且很少有血清流行率研究常规纳入正交检测以提高准确性。
评估匹兹堡大学医学中心儿童医院 2338 例儿科患者的常规血液检查剩余血清样本，使用 EUROIMMUN Anti-SARS-CoV-2 ELISA IgG（EuroIGG）检测试剂盒。对于具有足够量的反应性病例，还使用另外 3 种商业检测试剂盒进行检测。
根据 EuroIGG，85 份标本呈阳性，血清阳性率为 3.64%（95%置信区间[CI]，2.91%-4.48%），其中 73 份标本有足够的剩余量用于正交检测确认。总体而言，19.18%（95%CI，10.18%-28.18%）的样本在第二和/或第三种正交检测中呈阳性。鉴于我们的儿科人群流行率和检测性能，这种 80.82%的假阳性率与预期的 50%假阳性率不成比例。
在儿科人群中，SARS-CoV-2 血清学的假阳性可能比检测和流行率参数预测的更为常见，需要进一步研究来确定 SARS-CoV-2 血清学在儿童中的性能。
