Diagnostic performance of different sampling approaches for SARS-CoV-2 RT-PCR testing: a systematic review and meta-analysis.
Diagnostic performance of different sampling approaches for SARS-CoV-2 RT-PCR testing: a systematic review and meta-analysis.
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DOI：
10.1016/s1473-3099(21)00146-8
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发表时间：
2021-09
期刊：
影响因子：
--
通讯作者：
Ip DKM
中科院分区：
文献类型：
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作者：
Tsang NNY;So HC;Ng KY;Cowling BJ;Leung GM;Ip DKM
不同临床采样方法在疑似感染人群中通过RT-PCR诊断SARS-CoV-2感染的比较性能尚不清楚。本荟萃分析旨在系统地比较不同临床标本采集方法的诊断性能。在本系统性综述和荟萃分析中，我们系统检索了PubMed、Embase、MEDLINE、Web of Science、medRxiv、bioRxiv、SSRN和Research Square，检索时间为2000年1月1日至2020年11月16日。我们纳入了最初的临床研究，这些研究检查了鼻咽拭子和任何其他呼吸道标本在门诊患者中诊断SARS-CoV-2感染的性能。没有配对样本数据的研究，或仅检查来自确诊SARS-CoV-2病例的不同样本的研究，对于检查检测的诊断性能没有用处，因此被排除在外。诊断性能，包括敏感性，特异性，阳性预测值，阴性预测值，采用随机效应模型和双反正弦变换进行了检查。在我们检索的5577项研究中，纳入了23项研究，包括7973名参与者和16762份呼吸道样本。这些研究中检查的呼吸道标本包括7973份鼻咽拭子、1622份鼻拭子、6110份唾液样本、338份咽拭子和719份合并鼻和咽拭子。使用鼻咽拭子作为金标准，合并鼻拭子和咽拭子的灵敏度最高，为97%（95% CI 93-100），而唾液（85%，75-93）和鼻拭子（86%，77-93）的灵敏度较低，咽拭子的灵敏度低得多（68%，35-94）。合并鼻和咽喉（97%，90-100）和鼻拭子（96%，87-100）获得了极高的阳性预测值，唾液（93%，88-97）获得了略低的阳性预测值。咽拭子的阳性预测值最低，为75%（95% CI 45-96）。在不同的临床标本中观察到相当高的特异性（范围97-99%）和阴性预测值（范围95-99%）。比较医护人员采集和自我采集的混合鼻和咽喉拭子和鼻拭子，显示诊断性能相当。在合并鼻拭子和咽拭子以及咽拭子的分析中未观察到显著异质性，而在唾液和鼻拭子研究中观察到中度至显著异质性（I2 ≥30%）。我们的综述表明，与鼻咽拭子的金标准相比，混合鼻和咽拭子提供了最好的诊断性能的替代采样方法，用于诊断SARS-CoV-2感染的门诊护理。唾液和鼻拭子的诊断性能相当且非常好，是临床上可接受的替代标本采集方法。咽拭子的敏感性和阳性预测值低得多，不应推荐。混合鼻和咽拭子以及鼻拭子的自我采集与诊断准确性的任何显著损害无关。我们的研究结果还提供了一个有用的参考框架，正确解释SARS-CoV-2检测结果使用不同的临床标本。香港研究赠款理事会。
The comparative performance of different clinical sampling methods for diagnosis of SARS-CoV-2 infection by RT-PCR among populations with suspected infection remains unclear. This meta-analysis aims to systematically compare the diagnostic performance of different clinical specimen collection methods. In this systematic review and meta-analysis, we systematically searched PubMed, Embase, MEDLINE, Web of Science, medRxiv, bioRxiv, SSRN, and Research Square from Jan 1, 2000, to Nov 16, 2020. We included original clinical studies that examined the performance of nasopharyngeal swabs and any additional respiratory specimens for the diagnosis of SARS-CoV-2 infection among individuals presenting in ambulatory care. Studies without data on paired samples, or those that only examined different samples from confirmed SARS-CoV-2 cases were not useful for examining diagnostic performance of a test and were excluded. Diagnostic performance, including sensitivity, specificity, positive predictive value, and negative predictive value, was examined using random effects models and double arcsine transformation. Of the 5577 studies identified in our search, 23 studies including 7973 participants with 16 762 respiratory samples were included. Respiratory specimens examined in these studies included 7973 nasopharyngeal swabs, 1622 nasal swabs, 6110 saliva samples, 338 throat swabs, and 719 pooled nasal and throat swabs. Using nasopharyngeal swabs as the gold standard, pooled nasal and throat swabs gave the highest sensitivity of 97% (95% CI 93–100), whereas lower sensitivities were achieved by saliva (85%, 75–93) and nasal swabs (86%, 77–93) and a much lower sensitivity by throat swabs (68%, 35–94). A comparably high positive predictive value was obtained by pooled nasal and throat (97%, 90–100) and nasal swabs (96%, 87–100) and a slightly lower positive predictive value by saliva (93%, 88–97). Throat swabs have the lowest positive predictive value of 75% (95% CI 45–96). Comparably high specificities (range 97–99%) and negative predictive value (range 95–99%) were observed among different clinical specimens. Comparison between health-care-worker collection and self-collection for pooled nasal and throat swabs and nasal swabs showed comparable diagnostic performance. No significant heterogeneity was observed in the analysis of pooled nasal and throat swabs and throat swabs, whereas moderate to substantial heterogeneity (I2 ≥30%) was observed in studies on saliva and nasal swabs. Our review suggests that, compared with the gold standard of nasopharyngeal swabs, pooled nasal and throat swabs offered the best diagnostic performance of the alternative sampling approaches for diagnosis of SARS-CoV-2 infection in ambulatory care. Saliva and nasal swabs gave comparable and very good diagnostic performance and are clinically acceptable alternative specimen collection methods. Throat swabs gave a much lower sensitivity and positive predictive value and should not be recommended. Self-collection for pooled nasal and throat swabs and nasal swabs was not associated with any significant impairment of diagnostic accuracy. Our results also provide a useful reference framework for the proper interpretation of SARS-CoV-2 testing results using different clinical specimens. Hong Kong Research Grants Council.