背景:分子和抗原即时检测(POCT)增强了我们快速识别和管理SARS-CoV-2感染的能力。然而,他们的临床表现在各个研究中有所不同。
目的:对基于分子和抗原的POCT的性能进行评估,怀疑,或可能的COVID-19病例与现实生活中基于实验室的RT-PCR相比。
方法:MEDLINE/PubMed,Scopus,Embase,WebofScience,科克伦图书馆,CochraneCOVID-19研究登记册,和来自伯尔尼大学的COVID-19生活证据数据库。
方法:同行评审或预印观察性研究或随机对照试验,评估了SARS-CoV-2的任何类型的市售抗原和/或分子POCT,包括多重PCR小组,由美国食品和药物管理局批准,具有紧急使用授权,和/或标有欧洲委员会/欧洲联盟的“符合欧洲标准”。
方法:密切接触者和/或有症状和/或无症状的患者,怀疑,或任何年龄的可能的COVID-19感染。
未经授权:基于分子和/或抗原的SARS-CoV-2POCT。
未经鉴定:基于实验室的SARS-CoV-2RT-PCR。
UNASSIGNED:使用诊断准确性研究2工具对符合条件的研究进行质量控制和偏倚风险评估。
UNASSIGNED:使用双变量模型估计了其95%CI的总体敏感性和特异性。当至少三项研究告知结果时,进行亚组分析。
结果:共有123篇合格出版物(评估基于抗原和分子POCT的97项和26项研究,分别)从4674条初始记录中检索。13种基于分子的POCT的合并敏感性和特异性分别为92.8%(95%CI,88.9-95.4%)和97.6%(95%CI,96.6-98.3%),分别。来自138个单独评估的基于抗原的POCT的敏感性大大低于分子POCT;合并的敏感性和特异性分别为70.6%(95%CI,67.2-73.8%)和98.9%(95%CI,98.5-99.2%)。分别。
结论:需要进一步的研究来评估基于分子和抗原的POCT在代表性不足的患者亚组和不同呼吸道样本中的表现。
BACKGROUND: Molecular and antigen point-of-care tests (POCTs) have augmented our ability to rapidly identify and manage SARS-CoV-2 infection. However, their clinical performance varies among individual studies.
OBJECTIVE: The evaluation of the performance of molecular and antigen-based POCTs in confirmed, suspected, or probable COVID-19 cases compared with that of laboratory-based RT-PCR in real-life settings.
METHODS: MEDLINE/PubMed, Scopus, Embase, Web of Science, Cochrane Library, Cochrane COVID-19 study register, and COVID-19 Living Evidence Database from the University of Bern.
METHODS: Peer-reviewed or preprint observational studies or randomized controlled trials that evaluated any type of commercially available antigen and/or molecular POCTs for SARS-CoV-2, including multiplex PCR panels, approved by the United States Food and Drug Administration, with Emergency Use Authorization, and/or marked with Conformitè Europëenne from European Commission/European Union.
METHODS: Close contacts and/or patients with symptomatic and/or asymptomatic confirmed, suspected, or probable COVID-19 infection of any age.
UNASSIGNED: Molecular and/or antigen-based SARS-CoV-2 POCTs.
UNASSIGNED: Laboratory-based SARS-CoV-2 RT-PCR.
UNASSIGNED: Eligible studies were subjected to quality-control and risk-of-bias assessment using the Quality Assessment of Diagnostic Accuracy Studies 2 tool.
UNASSIGNED: Summary sensitivities and specificities with their 95% CIs were estimated using a bivariate model. Subgroup analysis was performed when at least three studies informed the outcome.
RESULTS: A total of 123 eligible publications (97 and 26 studies assessing antigen-based and molecular POCTs, respectively) were retrieved from 4674 initial records. The pooled sensitivity and specificity for 13 molecular-based POCTs were 92.8% (95% CI, 88.9-95.4%) and 97.6% (95% CI, 96.6-98.3%), respectively. The sensitivity of antigen-based POCTs pooled from 138 individual evaluations was considerably lower than that of molecular POCTs; the pooled sensitivity and specificity rates were 70.6% (95% CI, 67.2-73.8%) and 98.9% (95% CI, 98.5-99.2%), respectively.
CONCLUSIONS: Further studies are needed to evaluate the performance of molecular and antigen-based POCTs in underrepresented patient subgroups and different respiratory samples.