Tornberg Emma C, Tomlinson Alexander, Oshiro Nicholas T T, Derfalie Esraa, Ali Rabeka A, Curlin Marcel E
Department of Medicine, Division of Infectious Diseases, Oregon Health and Sciences University, Portland, OR 97239, USA.
Diagnostics (Basel). 2024 May 8;14(10):986. doi: 10.3390/diagnostics14100986.
The COVID-19 pandemic presents unique requirements for accessible, reliable testing, and many testing platforms and sampling techniques have been developed over the course of the pandemic. Not all test methods have been systematically compared to each other or a common gold standard, and the performance of tests developed in the early epidemic have not been consistently re-evaluated in the context of new variants. We conducted a repeated measures study with adult healthcare workers presenting for SARS-CoV-2 testing. Participants were tested using seven testing modalities. Test sensitivity was compared using any positive PCR test as the gold standard. A total of 325 individuals participated in the study. PCR tests were the most sensitive (saliva PCR 0.957 ± 0.048, nasopharyngeal PCR 0.877 ± 0.075, oropharyngeal PCR 0.849 ± 0.082). Standard nasal rapid antigen tests were less sensitive but roughly equivalent (BinaxNOW 0.613 ± 0.110, iHealth 0.627 ± 0.109). Oropharyngeal rapid antigen tests were the least sensitive (BinaxNOW 0.400 ± 0.111, iHealth brands 0.311 ± 0.105). PCR remains the most sensitive testing modality for the diagnosis of COVID-19 and saliva PCR is significantly more sensitive than oropharyngeal PCR and equivalent to nasopharyngeal PCR. Nasal AgRDTs are less sensitive than PCR but have benefits in convenience and accessibility. Saliva-based PCR testing is a viable alternative to traditional swab-based PCR testing for the diagnosis of COVID-19.
新冠疫情对可及、可靠的检测提出了独特要求，在疫情期间已开发出许多检测平台和采样技术。并非所有检测方法都经过相互间的系统比较或与通用金标准进行比较，而且在早期疫情中开发的检测方法的性能在新变种背景下也未得到持续重新评估。我们对前来进行新冠病毒检测的成年医护人员开展了一项重复测量研究。参与者使用七种检测方式进行检测。以任何阳性PCR检测作为金标准来比较检测敏感性。共有325人参与了该研究。PCR检测最为灵敏（唾液PCR为0.957±0.048，鼻咽PCR为0.877±0.075，口咽PCR为0.849±0.082）。标准鼻拭子快速抗原检测敏感性较低但大致相当（BinaxNOW为0.613±0.110，艾康为0.627±0.109）。口咽快速抗原检测敏感性最低（BinaxNOW为0.400±0.111，艾康品牌为0.311±0.105）。PCR仍然是诊断新冠病毒最灵敏的检测方式，唾液PCR比口咽PCR明显更灵敏，与鼻咽PCR相当。鼻拭子抗原快速检测（AgRDT）比PCR敏感性低，但在便利性和可及性方面有优势。基于唾液的PCR检测是诊断新冠病毒的传统拭子PCR检测的可行替代方法。
