Charité - Universitätsmedizin Berlin, Corporate member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Institute of Tropical Medicine and International Health, Berlin, Germany.
Division of Clinical Tropical Medicine, Center of Infectious Diseases, Heidelberg University Hospital, Germany.
Infect Dis (Lond). 2021 Nov-Dec;53(12):947-952. doi: 10.1080/23744235.2021.1969426. Epub 2021 Aug 27.
Most SARS-CoV-2 antigen-detecting rapid diagnostic tests require nasopharyngeal sampling, which is frequently perceived as uncomfortable and requires healthcare professionals, thus limiting scale-up. Nasal sampling could enable self-sampling and increase acceptability. The term nasal sampling is often not used uniformly and sampling protocols differ.
This manufacturer-independent, prospective diagnostic accuracy study, compared professional anterior nasal and nasal mid-turbinate sampling for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test. The second group of participants collected a nasal mid-turbinate sample themselves and underwent a professional nasopharyngeal swab for comparison. The reference standard was real-time polymerase chain reaction (RT-PCR) using combined oro-/nasopharyngeal sampling. Individuals with high suspicion of SARS-CoV-2 infection were tested. Sensitivity, specificity, and percent agreement were calculated. Self-sampling was observed without intervention. Feasibility was evaluated by observer and participant questionnaires.
Among 132 symptomatic adults, both professional anterior nasal and nasal mid-turbinate sampling yielded a sensitivity of 86.1% (31/36 RT-PCR positives detected; 95%CI: 71.3-93.9) and a specificity of 100.0% (95%CI: 95.7-100). The positive percent agreement was 100% (95%CI: 89.0-100). Among 96 additional adults, self nasal mid-turbinate and professional nasopharyngeal sampling yielded an identical sensitivity of 91.2% (31/34; 95%CI 77.0-97.0). Specificity was 98.4% (95%CI: 91.4-99.9) with nasal mid-turbinate and 100.0% (95%CI: 94.2-100) with nasopharyngeal sampling. The positive percent agreement was 96.8% (95%CI: 83.8-99.8). Most participants (85.3%) considered self-sampling as easy to perform.
Professional anterior nasal and nasal mid-turbinate sampling are of equivalent accuracy for an antigen-detecting rapid diagnostic test in ambulatory symptomatic adults. Participants were able to reliably perform nasal mid-turbinate sampling themselves, following written and illustrated instructions. Nasal self-sampling will facilitate scaling of SARS-CoV-2 antigen testing.
大多数 SARS-CoV-2 抗原检测快速诊断测试需要进行鼻咽采样，这通常被认为是不舒服的，并且需要医疗保健专业人员，因此限制了其推广。鼻腔采样可以实现自我采样并提高可接受性。鼻腔采样这个术语的使用并不统一，采样方案也存在差异。
本研究为制造商独立的、前瞻性诊断准确性研究，比较了专业的前鼻和鼻腔中鼻甲采样，用于检测世界卫生组织列出的 SARS-CoV-2 抗原检测快速诊断测试。第二组参与者自行采集鼻腔中鼻甲样本，并进行专业的鼻咽拭子进行比较。参考标准是使用口咽/鼻咽联合采样的实时聚合酶链反应（RT-PCR）。对疑似 SARS-CoV-2 感染的个体进行了检测。计算了敏感性、特异性和阳性符合率。在没有干预的情况下观察自我采样。通过观察者和参与者的问卷评估可行性。
在 132 名有症状的成年人中，专业的前鼻和鼻腔中鼻甲采样均产生了 86.1%的敏感性（36 份 RT-PCR 阳性检测中检出 31 份；95%CI：71.3-93.9）和 100.0%的特异性（95%CI：95.7-100）。阳性符合率为 100%（95%CI：89.0-100）。在另外 96 名成年人中，自我鼻腔中鼻甲和专业鼻咽采样的敏感性相同，均为 91.2%（31/34；95%CI 77.0-97.0）。特异性为 98.4%（95%CI：91.4-99.9），鼻腔中鼻甲为 100.0%（95%CI：94.2-100），鼻咽为 100.0%（95%CI：94.2-100）。阳性符合率为 96.8%（95%CI：83.8-99.8）。大多数参与者（85.3%）认为自我采样很容易进行。
在有症状的门诊成年人中，专业的前鼻和鼻腔中鼻甲采样对于抗原检测快速诊断测试具有同等的准确性。参与者可以根据书面和插图说明，可靠地自行进行鼻腔中鼻甲采样。鼻腔自我采样将促进 SARS-CoV-2 抗原检测的扩展。
