Department of Pathology and Immunology, Baylor College of Medicine, Houston, TX.
Section of Clinical Chemistry, Division of Laboratory Medicine, Department of Pathology, Texas Children's Hospital, Houston.
Am J Clin Pathol. 2020 Nov 4;154(6):742-747. doi: 10.1093/ajcp/aqaa157.
Evaluation of serostatus against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has emerged as an important tool in identification of exposure to coronavirus disease 2019 (COVID-19). We report on the validation of the Vitros Anti-SARS-CoV-2 Total (CoV2T) assay for qualitative serologic testing of SARS-CoV-2 antibodies.
We performed validation studies according to Commission of Office Laboratories Accreditation guidelines, using samples previously tested for SARS-CoV-2 by reverse transcription-polymerase chain reaction (RT-PCR). We evaluated precision, analytical interferences, and cross-reactivity with other viral infections; evaluated concordance with molecular and other serologic testing; and evaluated seroconversion.
The Vitros CoV2T assay exhibited acceptable precision and did not exhibit cross-reactivity with other acute respiratory virus infections. The CoV2T assay exhibited 100% negative predictive agreement (56/56) and 71% positive predictive agreement (56/79) with RT-PCR across all patient samples and was concordant with other serologic assays. Concordance with RT-PCR was 97% more than 7 days after symptom onset. The CoV2T assay was robust to icterus and lipemia but had interference from significant hemolysis.
The Vitros CoV2T assay was successfully validated in our laboratory. We anticipate it will be a useful tool in screening for exposure to SARS-CoV-2; however, the use of the CoV2T and other serologic assays in the clinical management of patients with COVID-19 is unknown and must be evaluated in future studies.
血清学状态评估严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）已成为识别 2019 年冠状病毒病（COVID-19）暴露的重要工具。我们报告 Vitros 抗 SARS-CoV-2 总抗体（CoV2T）检测试剂用于 SARS-CoV-2 抗体的定性血清学检测的验证结果。
我们根据美国病理学家协会临床实验室改进修正案认证委员会的指导原则进行了验证研究，使用先前通过逆转录聚合酶链反应（RT-PCR）检测 SARS-CoV-2 的样本。我们评估了精密度、分析干扰和与其他病毒感染的交叉反应；评估与分子和其他血清学检测的一致性；并评估血清转化。
Vitros CoV2T 检测试剂的精密度可接受，与其他急性呼吸道病毒感染无交叉反应。在所有患者样本中，CoV2T 检测试剂与 RT-PCR 的阴性预测一致性为 100%（56/56），阳性预测一致性为 71%（56/79），与其他血清学检测试剂一致。症状出现后 7 天以上与 RT-PCR 的一致性为 97%。CoV2T 检测试剂对黄疸和脂血具有稳定性，但存在严重溶血的干扰。
Vitros CoV2T 检测试剂在我们实验室中得到了成功验证。我们预计它将成为筛查 SARS-CoV-2 暴露的有用工具；然而，CoV2T 检测试剂和其他血清学检测试剂在 COVID-19 患者的临床管理中的应用尚不清楚，必须在未来的研究中进行评估。
