Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis.
Performance of Rapid Antigen Tests for COVID-19 Diagnosis: A Systematic Review and Meta-Analysis.
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DOI：
10.3390/diagnostics12010110
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发表时间：
2022-01-04
期刊：
影响因子：
--
通讯作者：
Aziah I
中科院分区：
文献类型：
--
作者：
Khalid MF;Selvam K;Jeffry AJN;Salmi MF;Najib MA;Norhayati MN;Aziah I
利用逆转录定量聚合酶链反应（RT-qPCR）鉴定病毒RNA是鉴定SARS-CoV-2引起的感染的金标准。RT-qPCR的局限性，如需要昂贵的仪器、训练有素的工作人员和实验室设施，导致了快速抗原检测（rat）的发展。rat的性能已被广泛评估，并发现在不同的设置是不同的。本系统综述旨在评价市售rat的敏感性和特异性。本综述已在PROSPERO注册（注册号：CRD42021278105）。通过PubMed、Embase和Cochrane COVID-19 Study Register进行文献检索，检索截至2021年8月26日发表的研究。计算大鼠和亚组分析的总体敏感性和特异性。使用诊断准确性研究质量评估2 （QUADAS-2）来评估每项研究的偏倚风险。总的综合敏感性和特异性分别为70% （95% CI: 69-71）和98% （95% CI: 98-98）。在亚组分析中，鼻拭子的灵敏度最高，为83% (95% CI: 80-86)，其次是鼻咽拭子71% (95% CI: 70-72)，咽拭子69% （95% CI: 63-75）和唾液68% （95% CI: 59-77）。有症状患者样本的敏感性为82% (95% CI: 82-82)，而无症状患者的敏感性为68% (95% CI: 65-71)，而周期阈值(Ct)≤25的敏感性为96% (95% CI: 95-97)，高于较高的Ct值。虽然需要提高rat的敏感性，但在缺乏实验室设施的地方，它可能仍然是一个可行的选择，以便在疾病的早期阶段进行诊断。
The identification of viral RNA using reverse transcription quantitative polymerase chain reaction (RT-qPCR) is the gold standard for identifying an infection caused by SARS-CoV-2. The limitations of RT-qPCR such as requirement of expensive instruments, trained staff and laboratory facilities led to development of rapid antigen tests (RATs). The performance of RATs has been widely evaluated and found to be varied in different settings. The present systematic review aims to evaluate the pooled sensitivity and specificity of the commercially available RATs. This review was registered on PROSPERO (registration number: CRD42021278105). Literature search was performed through PubMed, Embase and Cochrane COVID-19 Study Register to search studies published up to 26 August 2021. The overall pooled sensitivity and specificity of RATs and subgroup analyses were calculated. Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) was used to assess the risk of bias in each study. The overall pooled sensitivity and specificity of RATs were 70% (95% CI: 69–71) and 98% (95% CI: 98–98), respectively. In subgroup analyses, nasal swabs showed the highest sensitivity of 83% (95% CI: 80–86) followed by nasopharyngeal swabs 71% (95% CI: 70–72), throat swabs 69% (95% CI: 63–75) and saliva 68% (95% CI: 59–77). Samples from symptomatic patients showed a higher sensitivity of 82% (95% CI: 82–82) as compared to asymptomatic patients at 68% (95% CI: 65–71), while a cycle threshold (Ct) value ≤25 showed a higher sensitivity of 96% (95% CI: 95–97) as compared to higher Ct value. Although the sensitivity of RATs needs to be enhanced, it may still be a viable option in places where laboratory facilities are lacking for diagnostic purposes in the early phase of disease.
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期刊：
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影响因子：
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影响因子：
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期刊：
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影响因子：
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