Afzal Nayab, Tariq Naila, Raza Saba, Shakeel Danish
Clinical Chemistry, National Medical Center, Karachi, PAK.
Chemical Pathology, National Medical Center, Karachi, PAK.
Cureus. 2021 Jan 9;13(1):e12588. doi: 10.7759/cureus.12588.
To determine the diagnostic accuracy of fully automated electro-chemiluminescence immunoassay (ECLIA) anti-SARS-CoV-2 serological test for detection of past SARS-CoV-2 infection and to be used in seroprevalence surveys.
A total of 426 patients who had tested for anti-SARS-CoV-2 from August 1 to 31, 2020 were selected for the study. Informed consent was obtained and a questionnaire including the patient's age, gender, symptoms, and past polymerase chain reaction (PCR) status was filled by the patient. Samples were analyzed for anti-SARS-CoV-2 antibodies on Roche Cobas e601.
The mean age of the patients was 42.43±16.67 years. One hundred and five (24.6%) were PCR positive, while 321 (75.4%) were PCR negative. Most patients were males 241 (56.6%) while 185(43.3%) were females. Over 185(43.3%) patients presented with symptoms, and the rest of the patients 241 (56.6%) were asymptomatic. Anti-SARS-CoV-2 had sensitivity 89.5%, specificity 99.06%, positive predictive value (PPV) 96.90%, negative predictive value (NPV) 96.6%, and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of anti-SARS-CoV-2 was 96.7% based on receiver-operating characteristic (ROC) curve analysis.
Anti-SARS-CoV-2 is very useful for the detection of past COVID-19 infection; it can be proved helpful in the identification of post-COVID complications and actual disease burden in a population.
确定全自动电化学发光免疫分析（ECLIA）抗SARS-CoV-2血清学检测对既往SARS-CoV-2感染检测的诊断准确性，并用于血清流行率调查。
选取2020年8月1日至31日期间进行抗SARS-CoV-2检测的426例患者进行研究。获得患者知情同意，患者填写包括年龄、性别、症状及既往聚合酶链反应（PCR）结果的问卷。采用罗氏Cobas e601分析仪检测抗SARS-CoV-2抗体。
患者的平均年龄为42.43±16.67岁。105例（24.6%）PCR检测呈阳性，321例（75.4%）PCR检测呈阴性。大多数患者为男性，共241例（56.6%），女性185例（43.3%）。超过185例（43.3%）患者出现症状，其余241例（56.6%）患者无症状。抗SARS-CoV-2检测的敏感性为89.5%，特异性为99.06%，阳性预测值（PPV）为96.90%，阴性预测值（NPV）为96.6%，阳性似然比为4.26，阴性似然比为0.1。根据受试者工作特征（ROC）曲线分析，抗SARS-CoV-2的诊断准确性为96.7%。
抗SARS-CoV-2检测对于既往COVID-19感染的检测非常有用；可有助于识别COVID-19后的并发症及人群中的实际疾病负担。
