与严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）抗原检测结果、实时逆转录聚合酶链反应（rRT-PCR）循环阈值、亚基因组 RNA 和病毒培养结果相关的流行病学特征，来自大学检测。
Epidemiologic Characteristics Associated With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen-Based Test Results, Real-Time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) Cycle Threshold Values, Subgenomic RNA, and Viral Culture Results From University Testing.
机构信息
COVID-19 Response Team, Centers for Disease Control and Prevention (CDC), Atlanta, Georgia, USA.
Epidemic Intelligence Service, CDC, Atlanta, Georgia, USA.
出版信息
Clin Infect Dis. 2021 Sep 15;73(6):e1348-e1355. doi: 10.1093/cid/ciab303.
BACKGROUND
Real-time reverse transcription polymerase chain reaction (rRT-PCR) and antigen tests are important diagnostics for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Sensitivity of antigen tests has been shown to be lower than that of rRT-PCR; however, data to evaluate epidemiologic characteristics that affect test performance are limited.
METHODS
Paired mid-turbinate nasal swabs were collected from university students and staff and tested for SARS-CoV-2 using both Quidel Sofia SARS Antigen Fluorescent Immunoassay (FIA) and rRT-PCR assay. Specimens positive by either rRT-PCR or antigen FIA were placed in viral culture and tested for subgenomic RNA (sgRNA). Logistic regression models were used to evaluate characteristics associated with antigen results, rRT-PCR cycle threshold (Ct) values, sgRNA, and viral culture.
RESULTS
Antigen FIA sensitivity was 78.9% and 43.8% among symptomatic and asymptomatic participants, respectively. Among rRT-PCR positive participants, negative antigen results were more likely among asymptomatic participants (odds ratio [OR] 4.6, 95% confidence interval [CI]: 1.3-15.4) and less likely among participants reporting nasal congestion (OR 0.1, 95% CI: .03-.8). rRT-PCR-positive specimens with higher Ct values (OR 0.5, 95% CI: .4-.8) were less likely, and specimens positive for sgRNA (OR 10.2, 95% CI: 1.6-65.0) more likely, to yield positive virus isolation. Antigen testing was >90% positive in specimens with Ct values < 29. Positive predictive value of antigen test for positive viral culture (57.7%) was similar to that of rRT-PCR (59.3%).
CONCLUSIONS
SARS-CoV-2 antigen test advantages include low cost, wide availability and rapid turnaround time, making them important screening tests. The performance of antigen tests may vary with patient characteristics, so performance characteristics should be accounted for when designing testing strategies and interpreting results.
背景
实时逆转录聚合酶链反应（rRT-PCR）和抗原检测是严重急性呼吸综合征冠状病毒 2（SARS-CoV-2）的重要诊断方法。抗原检测的敏感性已被证明低于 rRT-PCR；然而，评估影响检测性能的流行病学特征的数据有限。
方法
从大学生和教职工的中鼻甲鼻拭子中采集配对样本，使用 Quidel Sofia SARS 抗原荧光免疫分析（FIA）和 rRT-PCR 检测试剂盒同时检测 SARS-CoV-2。通过 rRT-PCR 或抗原 FIA 任一检测呈阳性的标本均放入病毒培养物中，并检测亚基因组 RNA（sgRNA）。使用逻辑回归模型评估与抗原结果、rRT-PCR 循环阈值（Ct）值、sgRNA 和病毒培养相关的特征。
结果
抗原 FIA 的敏感性在有症状和无症状参与者中分别为 78.9%和 43.8%。在 rRT-PCR 阳性参与者中，无症状参与者的抗原结果更有可能为阴性（比值比[OR] 4.6，95%置信区间[CI]：1.3-15.4），而报告鼻塞的参与者则不太可能为阴性（OR 0.1，95%CI：0.03-0.8）。Ct 值较高（OR 0.5，95%CI：0.4-0.8）的 rRT-PCR 阳性标本更不可能产生阳性病毒分离物，而 sgRNA 阳性（OR 10.2，95%CI：1.6-65.0）的标本更有可能产生阳性病毒分离物。Ct 值<29 的标本抗原检测阳性率>90%。抗原检测对阳性病毒培养的阳性预测值（57.7%）与 rRT-PCR 相似（59.3%）。
结论
SARS-CoV-2 抗原检测具有成本低、广泛可用性和快速周转时间等优势，使其成为重要的筛查检测方法。抗原检测的性能可能因患者特征而异，因此在设计检测策略和解释结果时应考虑性能特征。
Zotero 插件