Microvida Laboratory for Medical Microbiology, Amphia Hospital, Breda, The Netherlands.
GGD West-Brabant, Breda, The Netherlands.
PLoS One. 2021 May 13;16(5):e0250886. doi: 10.1371/journal.pone.0250886. eCollection 2021.
SARS-CoV-2 real-time reverse transcriptase polymerase chain reaction (qRT-PCR) is well suited for the diagnosis of clinically ill patients requiring treatment. Application for community testing of symptomatic individuals for disease control purposes however raises challenges. SARS-CoV-2 rapid antigen tests might offer an alternative, but quality evidence on their performance is limited.
We conducted an evaluation of the test accuracy of the 'BD Veritor System for Rapid Detection of SARS-CoV-2' (VRD) compared to qRT-PCR on combined nose/throat swabs obtained from symptomatic individuals at Municipal Health Service (MHS) COVID-19 test centers in the Netherlands. In part one of the study, with the primary objective to evaluate test sensitivity and specificity, all adults presenting at one MHS test center were eligible for inclusion. In part two, with the objective to evaluate test sensitivity stratified by Ct (cycle threshold)-value and time since symptom onset, adults who had a positive qRT-PCR obtained at a MHS test center were eligible.
In part one (n = 352) SARS-CoV-2 prevalence was 4.8%, overall specificity 100% (95%CI: 98·9%-100%) and sensitivity 94·1% (95%CI: 71·1%-100%). In part two (n = 123) the sensitivity was 78·9% (95%CI: 70·6%-85·7%) overall, 89·4% (95% CI: 79·4%-95·6%) for specimen obtained within seven days after symptom onset and 93% (95% CI: 86%-97.1%) for specimen with a Ct-value below 30.
The VRD is a promising diagnostic for COVID-19 testing of symptomatic community-dwelling individuals within seven days after symptom onset in context of disease control. Further research on practical applicability and the optimal position within the testing landscape is needed.
SARS-CoV-2 实时逆转录聚合酶链反应（qRT-PCR）非常适合需要治疗的临床疾病患者的诊断。然而，为了控制疾病的目的，对有症状的个体进行社区检测，这在应用上带来了挑战。SARS-CoV-2 快速抗原检测可能是一种替代方法，但关于其性能的高质量证据有限。
我们评估了“BD Veritor 系统快速检测 SARS-CoV-2”（VRD）与荷兰市立卫生服务（MHS）COVID-19 检测中心从有症状个体的鼻/咽拭子中获得的 qRT-PCR 相比的检测准确性。在研究的第一部分，主要目的是评估检测的敏感性和特异性，所有在一个 MHS 检测中心就诊的成年人都符合纳入条件。在第二部分，目的是评估按 Ct（循环阈值）值和症状出现后时间分层的检测敏感性，符合条件的是在 MHS 检测中心获得阳性 qRT-PCR 的成年人。
在第一部分（n=352）中，SARS-CoV-2 的流行率为 4.8%，总体特异性为 100%（95%CI：98.9%-100%），敏感性为 94.1%（95%CI：71.1%-100%）。在第二部分（n=123）中，总体敏感性为 78.9%（95%CI：70.6%-85.7%），症状出现后 7 天内采集的标本敏感性为 89.4%（95%CI：79.4%-95.6%），Ct 值低于 30 的标本敏感性为 93%（95%CI：86%-97.1%）。
VRD 是一种很有前途的诊断方法，可用于控制疾病的目的，对症状出现后 7 天内的社区居住的有症状个体进行 COVID-19 检测。需要进一步研究其实用性和在检测中的最佳位置。
