Division of Infectious Diseases, Department of Pediatrics, Boston Children's Hospital, Boston, Massachusetts, USA.
Division of Infectious Diseases, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts, USA.
J Clin Microbiol. 2021 Apr 20;59(5). doi: 10.1128/JCM.02881-20.
Nasopharyngeal (NP) swabs are considered the highest-yield sample for diagnostic testing for respiratory viruses, including SARS-CoV-2. The need to increase capacity for SARS-CoV-2 testing in a variety of settings, combined with shortages of sample collection supplies, have motivated a search for alternative sample types with high sensitivity. We systematically reviewed the literature to understand the performance of alternative sample types compared to NP swabs. We systematically searched PubMed, Google Scholar, medRxiv, and bioRxiv (last retrieval 1 October 2020) for comparative studies of alternative specimen types (saliva, oropharyngeal [OP], and nasal [NS] swabs) versus NP swabs for SARS-CoV-2 diagnosis using nucleic acid amplification testing (NAAT). A logistic-normal random-effects meta-analysis was performed to calculate % positive alternative-specimen, % positive NP, and % dual positives overall and in subgroups. The QUADAS 2 tool was used to assess bias. From 1,253 unique citations, we identified 25 saliva, 11 NS, 6 OP, and 4 OP/NS studies meeting inclusion criteria. Three specimen types captured lower % positives (NS [82%, 95% CI: 73 to 90%], OP [84%, 95% CI: 57 to 100%], and saliva [88%, 95% CI: 81 to 93%]) than NP swabs, while combined OP/NS matched NP performance (97%, 95% CI: 90 to 100%). Absence of RNA extraction (saliva) and utilization of a more sensitive NAAT (NS) substantially decreased alternative-specimen yield of positive samples. NP swabs remain the gold standard for diagnosis of SARS-CoV-2, although alternative specimens are promising. Much remains unknown about the impact of variations in specimen collection, processing protocols, and population (pediatric versus adult, late versus early in disease course), such that head-to head studies of sampling strategies are urgently needed.
鼻咽(NP)拭子被认为是用于诊断呼吸道病毒(包括 SARS-CoV-2)的最高产样本。在各种环境中增加 SARS-CoV-2 检测能力的需求,加上样本采集用品的短缺,促使人们寻找具有高灵敏度的替代样本类型。我们系统地回顾了文献,以了解替代样本类型与 NP 拭子相比的性能。我们系统地搜索了 PubMed、Google Scholar、medRxiv 和 bioRxiv(最后检索日期为 2020 年 10 月 1 日),以获取关于替代标本类型(唾液、口咽[OP]和鼻[NS]拭子)与 NP 拭子相比用于 SARS-CoV-2 诊断的核酸扩增检测(NAAT)的比较研究。使用逻辑正态随机效应荟萃分析计算替代标本的阳性率、NP 的阳性率和总体及亚组的双重阳性率。使用 QUADAS 2 工具评估偏倚。从 1253 个独特的引文,我们确定了 25 个唾液、11 个 NS、6 个 OP 和 4 个 OP/NS 研究符合纳入标准。三种标本类型捕获的阳性率较低(NS [82%,95%CI:73 至 90%]、OP [84%,95%CI:57 至 100%]和唾液 [88%,95%CI:81 至 93%])比 NP 拭子,而组合的 OP/NS 与 NP 表现相匹配(97%,95%CI:90 至 100%)。缺乏 RNA 提取(唾液)和使用更敏感的 NAAT(NS)显著降低了阳性样本的替代标本产量。NP 拭子仍然是 SARS-CoV-2 诊断的金标准,尽管替代标本很有前途。关于标本采集、处理方案和人群(儿科与成人、疾病早期与晚期)的变化的影响仍有许多未知之处,因此迫切需要对头对头的采样策略研究。