Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, Mayo Clinicgrid.66875.3a, Rochester, Minnesota, USA.
Division of Clinical Biochemistry, Department of Laboratory Medicine and Pathology, Mayo Clinicgrid.66875.3a, Rochester, Minnesota, USA.
J Clin Microbiol. 2021 Aug 18;59(9):e0084821. doi: 10.1128/JCM.00848-21.
Rapid and accurate diagnostic testing is essential to bring the ongoing COVID-19 pandemic to an end. As the demand for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing continues to increase amid supply shortages, many laboratories have investigated the use of sources other than nasopharyngeal (NP) swabs. Saliva and midturbinate (MT) nasal swabs are attractive alternatives, as they allow for self-collection and are well accepted by patients. Saliva also requires limited consumables. We compared the performance of health care provider-collected NP swabs, patient-collected MT swabs, and patient-collected saliva specimens for SARS-CoV-2 detection using a laboratory-developed PCR assay that had received Emergency Use Authorization by the FDA. Of 281 total evaluable samples, 33 (11.7%) NP swabs, 33 (11.7%) MT swabs, and 32 (11.4%) saliva specimens were positive for SARS-CoV-2 following resolution of discordant results. Compared to NP swabs, saliva exhibited a sensitivity of 90.9% (30/33) and specificity of 99.2% (246/248), while patient-collected MT swabs exhibited a sensitivity of 93.9% (31/33) and specificity of 99.2% (246/248). When comparing to the consensus standard, the sensitivity was found to be 100% (31/31) for both NP and MT swabs and 96.8% (30/31) for saliva specimens, while specificity was the same in both NP swabs and saliva specimens (98.8% [247/250]) and 99.2% (248/250) for MT swabs. Pretreatment of saliva with proteinase K and heating for 15 min prior to extraction reduced the invalid rate from 26.7% (52/195) to 0% (0/195). These data show that midturbinate nasal swabs and saliva are suitable sources for self-collection in individuals who require routine monitoring for SARS-CoV-2 infection.
快速准确的诊断检测对于结束当前的 COVID-19 大流行至关重要。由于在供应短缺的情况下,对严重急性呼吸综合征冠状病毒 2(SARS-CoV-2)检测的需求持续增加,许多实验室已经研究了使用鼻咽(NP)拭子以外的其他来源。唾液和中鼻甲(MT)鼻拭子是很有吸引力的替代品,因为它们允许自我采集,并且患者易于接受。唾液还需要有限的消耗品。我们使用经过 FDA 紧急使用授权的实验室开发的 PCR 检测方法,比较了医疗保健提供者采集的 NP 拭子、患者采集的 MT 拭子和唾液样本对 SARS-CoV-2 的检测性能。在 281 个总可评估样本中,33 个(11.7%)NP 拭子、33 个(11.7%)MT 拭子和 32 个(11.4%)唾液样本在解决不一致的结果后呈 SARS-CoV-2 阳性。与 NP 拭子相比,唾液的敏感性为 90.9%(30/33),特异性为 99.2%(246/248),而患者采集的 MT 拭子的敏感性为 93.9%(31/33),特异性为 99.2%(246/248)。与共识标准相比,NP 和 MT 拭子的敏感性均为 100%(31/31),唾液样本的敏感性为 96.8%(30/31),而 NP 拭子和唾液样本的特异性相同(98.8% [247/250])和 MT 拭子(99.2% [248/250])。在提取前用蛋白酶 K 预处理唾液并加热 15 分钟,将无效率从 26.7%(52/195)降低至 0%(0/195)。这些数据表明,中鼻甲鼻拭子和唾液是需要常规监测 SARS-CoV-2 感染的个体进行自我采集的合适来源。