Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation.

Performance of SARS-CoV-2 antigen testing in symptomatic and asymptomatic adults: a single-center evaluation.
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DOI:
10.1186/s12879-021-06716-1
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发表时间:
2021-10-18
影响因子:
3.7
通讯作者:
Wells A
Wells A
中科院分区:
医学3区
文献类型:
--
作者:
Mitchell SL;Orris S;Freeman T;Freeman MC;Adam M;Axe M;Gribschaw J;Suyama J;Hoberman A;Wells A

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抗原检测为SARS-CoV-2提供了快速和廉价的检测,但对性能,特别是敏感性的担忧仍然存在。在无症状患者中使用抗原检测的数据有限;因此,抗原检测的性能和可靠性仍不清楚。包括148名有症状的成人和144名无症状的成人。采集鼻拭子,由Quidel索菲亚SARS IFA(索菲亚)作为护理点进行检测。还采集了鼻咽拭子,并运送至实验室进行Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV RT-PCR(Cepheid)检测。总体而言,索菲亚在成人中与Cepheid具有良好的一致性(> 95%),但敏感性较低。索菲亚对有症状和无症状患者的敏感性分别为87.8%和33.3%。在有症状的患者中,症状发作后> 5天检测的敏感性(82%)低于症状发作后5天内检测的敏感性(90%)。在无症状队列中的4名索菲亚假阴性结果中,50%在检测后5天内继续发展为COVID-19疾病。有症状和无症状队列的特异性均为100%。当症状发作< 5天后进行测试时,索菲亚在有症状的成人中具有可接受的性能。当检测症状≥ 5天的患者时应谨慎。低患病率和敏感性降低的组合导致在无症状患者中的相对较差的性能。当抗原检测不可靠时,应考虑基于NAAT的诊断检测,特别是在症状发作> 5天的有症状患者和无症状患者中。
Antigen testing offers rapid and inexpensive testing for SARS-CoV-2 but concerns regarding performance, especially sensitivity, remain. Limited data exists for use of antigen testing in asymptomatic patients; thus, performance and reliability of antigen testing remains unclear. 148 symptomatic and 144 asymptomatic adults were included. A nasal swab was collected for testing by Quidel Sofia SARS IFA (Sofia) as point of care. A nasopharyngeal swab was also collected and transported to the laboratory for testing by Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV RT-PCR (Cepheid). Overall, Sofia had good agreement with Cepheid (> 95%) in adults, however was less sensitive. Sofia had a sensitivity of 87.8% and 33.3% for symptomatic and asymptomatic patients, respectively. Among symptomatic patients, testing > 5 days post symptom onset resulted in lower sensitivity (82%) when compared with testing within 5 days of symptom onset (90%). Of the four Sofia false-negative results in the asymptomatic cohort, 50% went on to develop COVID-19 disease within 5 days of testing. Specificity in both symptomatic and asymptomatic cohorts was 100%. Sofia has acceptable performance in symptomatic adults when tested < 5 days of symptom onset. Caution should be taken when testing patients with ≥ 5 days of symptoms. The combination of low prevalence and reduced sensitivity results in relatively poor performance of in asymptomatic patients. NAAT-based diagnostic assays should be considered in when antigen testing is unreliable, particularly in symptomatic patients with > 5 days of symptom onset and asymptomatic patients.
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