Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.
Cochrane Netherlands, University Medical Center Utrecht, Utrecht University, Universiteitsweg 100, 3584 CG, Utrecht, The Netherlands.
BMC Med. 2022 Oct 24;20(1):406. doi: 10.1186/s12916-022-02603-x.
The diagnostic accuracy of unsupervised self-testing with rapid antigen diagnostic tests (Ag-RDTs) is mostly unknown. We studied the diagnostic accuracy of a self-performed SARS-CoV-2 saliva and nasal Ag-RDT in the general population.
This large cross-sectional study consecutively included unselected individuals aged ≥ 16 years presenting for SARS-CoV-2 testing at three public health service test sites. Participants underwent molecular test sampling and received two self-tests (the Hangzhou AllTest Biotech saliva self-test and the SD Biosensor nasal self-test by Roche Diagnostics) to perform themselves at home. Diagnostic accuracy of both self-tests was assessed with molecular testing as reference.
Out of 2819 participants, 6.5% had a positive molecular test. Overall sensitivities were 46.7% (39.3-54.2%) for the saliva Ag-RDT and 68.9% (61.6-75.6%) for the nasal Ag-RDT. With a viral load cut-off (≥ 5.2 log10 SARS-CoV-2 E-gene copies/mL) as a proxy of infectiousness, these sensitivities increased to 54.9% (46.4-63.3%) and 83.9% (76.9-89.5%), respectively. For the nasal Ag-RDT, sensitivities were 78.5% (71.1-84.8%) and 22.6% (9.6-41.1%) in those symptomatic and asymptomatic at the time of sampling, which increased to 90.4% (83.8-94.9%) and 38.9% (17.3-64.3%) after applying the viral load cut-off. In those with and without prior SARS-CoV-2 infection, sensitivities were 36.8% (16.3-61.6%) and 72.7% (65.1-79.4%). Specificities were > 99% and > 99%, positive predictive values > 70% and > 90%, and negative predictive values > 95% and > 95%, for the saliva and nasal Ag-RDT, respectively, in most analyses. Most participants considered the self-performing and result interpretation (very) easy for both self-tests.
The Hangzhou AllTest Biotech saliva self Ag-RDT is not reliable for SARS-CoV-2 detection, overall, and in all studied subgroups. The SD Biosensor nasal self Ag-RDT had high sensitivity in individuals with symptoms and in those without prior SARS-CoV-2 infection but low sensitivity in asymptomatic individuals and those with a prior SARS-CoV-2 infection which warrants further investigation.
自我使用抗原快速检测（Ag-RDT）进行无监督检测的诊断准确性大多未知。我们研究了一般人群中自我进行的 SARS-CoV-2 唾液和鼻腔 Ag-RDT 的诊断准确性。
这项大型横断面研究连续纳入了在三个公共卫生服务检测点进行 SARS-CoV-2 检测的年龄≥16 岁的未选择个体。参与者接受了分子检测采样，并接受了两种自我检测（杭州艾康生物技术有限公司的唾液自我检测和罗氏诊断公司的 SD Biosensor 鼻腔自我检测），在家中自行进行检测。以分子检测为参考，评估了两种自我检测的诊断准确性。
在 2819 名参与者中，有 6.5%的人分子检测呈阳性。总体敏感性分别为唾液 Ag-RDT 的 46.7%（39.3-54.2%）和鼻腔 Ag-RDT 的 68.9%（61.6-75.6%）。以（≥5.2 log10 SARS-CoV-2 E 基因拷贝/mL）作为传染性的病毒载量切点，这些敏感性分别增加到 54.9%（46.4-63.3%）和 83.9%（76.9-89.5%）。对于鼻腔 Ag-RDT，在采样时有症状和无症状的个体中，敏感性分别为 78.5%（71.1-84.8%）和 22.6%（9.6-41.1%），应用病毒载量切点后，敏感性分别增加至 90.4%（83.8-94.9%）和 38.9%（17.3-64.3%）。在有和没有先前 SARS-CoV-2 感染的个体中，敏感性分别为 36.8%（16.3-61.6%）和 72.7%（65.1-79.4%）。唾液和鼻腔 Ag-RDT 的特异性分别为>99%和>99%，阳性预测值分别为>70%和>90%，阴性预测值分别为>95%和>95%，在大多数分析中。大多数参与者认为两种自我检测的自我操作和结果解释（非常）简单。
杭州艾康生物技术有限公司的唾液自我 Ag-RDT 总体上和在所有研究亚组中均不可靠，无法用于 SARS-CoV-2 的检测。SD Biosensor 鼻腔自我 Ag-RDT 在有症状的个体和没有先前 SARS-CoV-2 感染的个体中具有高敏感性，但在无症状个体和有先前 SARS-CoV-2 感染的个体中敏感性较低，这需要进一步研究。
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