Hagbom Marie, Carmona-Vicente Noelia, Sharma Sumit, Olsson Henrik, Jämtberg Mikael, Nilsdotter-Augustinsson Åsa, Sjöwall Johanna, Nordgren Johan
Division of Molecular Medicine and Virology, Department of Biomedical and Clinical Sciences, Linköping University, 581 85, Linköping, Sweden.
Noviral Sweden AB, Västmannagatan 3, 111 24, Stockholm, Sweden.
Heliyon. 2022 Feb 22;8(2):e08998. doi: 10.1016/j.heliyon.2022.e08998. eCollection 2022 Feb.
Using saliva samples would facilitate sample collection, diagnostic feasibility, and mass screening of SARS-CoV-2. We tested two rapid antigen (RAD) immunochromatographic tests designed for detection of SARS-CoV-2 in saliva: Rapid Response™ COVID-19 Antigen Rapid Test Cassette for oral fluids and DIAGNOS™ COVID-19 Antigen Saliva Test. Evaluation of detection limit was performed with purified SARS-CoV-2 nucleocapsid protein and live SARS-CoV-2 virus. Sensitivity and specificity were further evaluated with reverse transcription quantitative PCR (RT-qPCR) positive and negative saliva samples from hospitalized individuals with COVID-19 (n = 39) and healthcare workers (n = 20). DIAGNOS showed higher sensitivity than Rapid Response for both nucleocapsid protein and live virus. The limit of detection of the saliva test from DIAGNOS was further comparable with the Abbott Panbio™ COVID-19 Ag Rapid Test designed for nasopharyngeal samples. DIAGNOS and Rapid Response detected nine (50.0%) and seven (38.9%), respectively, of the 18 RT-qPCR positive saliva samples. All RT-qPCR negative saliva (n = 41) were negative with both tests. Only one of the RT-qPCR positive saliva samples contained infectious virus as determined by cell culture and was also positive using the saliva RADs. The results show that the DIAGNOS may be an important and easy-to-use saliva RAD complement to detect SARS-CoV-2 positive individuals, but validation with a larger sample set is warranted.
使用唾液样本将有助于严重急性呼吸综合征冠状病毒2(SARS-CoV-2)的样本采集、诊断可行性及大规模筛查。我们测试了两种专为检测唾液中SARS-CoV-2设计的快速抗原(RAD)免疫层析检测:用于口腔液体的快速反应™新冠病毒抗原快速检测试剂盒和诊断™新冠病毒抗原唾液检测。使用纯化的SARS-CoV-2核衣壳蛋白和活的SARS-CoV-2病毒进行检测限评估。用来自新冠肺炎住院患者(n = 39)和医护人员(n = 20)的逆转录定量聚合酶链反应(RT-qPCR)阳性和阴性唾液样本进一步评估敏感性和特异性。对于核衣壳蛋白和活病毒,诊断™显示出比快速反应™更高的敏感性。诊断™唾液检测的检测限与为鼻咽样本设计的雅培Panbio™新冠病毒抗原快速检测相当。在18份RT-qPCR阳性唾液样本中,诊断™和快速反应™分别检测出9份(50.0%)和7份(38.9%)。所有RT-qPCR阴性唾液样本(n = 41)在两种检测中均为阴性。通过细胞培养确定,RT-qPCR阳性唾液样本中只有一份含有传染性病毒,并且使用唾液RAD检测也呈阳性。结果表明,诊断™可能是检测SARS-CoV-2阳性个体的一种重要且易于使用的唾液RAD补充检测方法,但需要用更大的样本集进行验证。
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