Introduction. Lateral flow test (LFTs) have been used as an alternative to reverse transcription quantitative PCR (RT-qPCR) in point-of-care testing. Despite their benefits, the sensitivity of LFTs may be low and is affected by several factors. We have previously reported the feasibility of using direct lysis of individual or pools of saliva samples from symptomatic and asymptomatic patients as a source of viral genomes for detection by RT-qPCR.Hypothesis. Direct lysed saliva is more sensitive than antigen tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in samples from children.Aim. Our goals here were to valuate the specificity and sensitivity of the PanBio COVID-19 antigen rapid test device (Ag-RTD) compared with RT-qPCR of direct lysed saliva.Methodology. We evaluated the performance of the PanBio COVID-19 Ag-RTD in comparison to RT-qPCR direct lysed saliva from paired samples of 256 symptomatic and 242 asymptomatic paediatric patients.Results. Overall, although there were no differences in the specificity (96.6%), we found a lower sensitivity (64.3%) of the PanBio Ag-test RTD compared to saliva in both symptomatic and asymptomatic patients. In addition, the sensitivity of PanBio was not correlated with the viral load present in the samples.Conclusion. Our data highlight the benefits of using RT-qPCR and saliva samples for SARS-CoV-2 detection, particularly in paediatric patients.

中文翻译：

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唾液采样及其直接裂解是儿科患者 SARS-CoV-2 诊断的绝佳选择：与有症状和无症状儿童的 PanBio COVID-19 抗原快速检测进行比较


介绍。在即时检测中，侧向层析检测 (LFT) 已被用作逆转录定量 PCR (RT-qPCR) 的替代方法。尽管有很多好处，但 LFT 的敏感性可能较低，并且受到多种因素的影响。我们之前曾报道过直接裂解有症状和无症状患者的个体或唾液样本池作为病毒基因组来源以进行 RT-qPCR 检测的可行性。假设。直接裂解唾液比抗原测试更灵敏地检测儿童样本中的严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2)。我们的目标是评估 PanBio COVID-19 抗原快速检测装置 (Ag-RTD) 与直接裂解唾液的 RT-qPCR 相比的特异性和敏感性。方法学。我们通过比较来自 256 名有症状和 242 名无症状儿科患者的配对样本的 RT-qPCR 直接裂解唾液，评估了 PanBio COVID-19 Ag-RTD 的性能。结果。总体而言，尽管特异性 (96.6%) 没有差异，但我们发现在有症状和无症状患者中，与唾液相比，PanBio Ag 测试 RTD 的敏感性较低 (64.3%)。此外，PanBio 的敏感性与样本中存在的病毒载量不相关。结论。我们的数据强调了使用 RT-qPCR 和唾液样本检测 SARS-CoV-2 的好处，特别是对于儿科患者。