The screening value of RT-LAMP and RT-PCR in the diagnosis of COVID-19: systematic review and meta-analysis

•RT-PCR and RT-LAMP are widely used; however false negative rate (FNR) are 6% ∼ 12 %.•Sensitivity and FNR of index test were significantly affected by the reference method.•PCR is not the perfect gold standard for comparison of diagnostic accuracy with COVID-19.•Performance of RT-LAMP may be exagger...

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Vydáno v:Journal of virological methods Ročník 300; s. 114392
Hlavní autoři: Pu, Ruiyang, Liu, Sha, Ren, Xiaoyu, Shi, Dian, Ba, Yupei, Huo, Yanbei, Zhang, Wenling, Ma, Lingling, Liu, Yanyan, Yang, Yan, Cheng, Ning
Médium: Journal Article
Jazyk:angličtina
Vydáno: Netherlands Elsevier B.V 01.02.2022
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ISSN:0166-0934, 1879-0984, 1879-0984
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Shrnutí:•RT-PCR and RT-LAMP are widely used; however false negative rate (FNR) are 6% ∼ 12 %.•Sensitivity and FNR of index test were significantly affected by the reference method.•PCR is not the perfect gold standard for comparison of diagnostic accuracy with COVID-19.•Performance of RT-LAMP may be exaggerated when RT-PCR is used as reference. The purpose of this systematic review is to evaluate the test accuracy of reverse-transcription loop-mediated isothermal amplification (RT-LAMP) and reverse transcription-PCR (RT-PCR) for the diagnosis of coronavirus disease 2019 (COVID-19). We comprehensively searched PUBMED, Web of Science, the Cochrane Library, the Chinese National Knowledge Infrastructure, and the Chinese Biomedical Literature Service System until September 1, 2021. We included clinical studies assessing the sensitivity and specificity of RT-PCR and RT-LAMP using respiratory samples. Thirty-three studies were included with 9360 suspected cases of SARS-CoV-2 infection. The RT-PCR or other comprehensive diagnostic method was defined as the reference method. The results showed that the overall pooled sensitivity of RT-PCR and RT-LAMP was 0.96 (95 % CI, 0.93−0.98) and 0.92 (95 % CI, 0.85−0.96), respectively. RT-PCR and RT-LAMP had a 0.06 (95 % CI, 0.04−0.08) and 0.12 (95 % CI, 0.06−0.16) false-negative rates (FNR), respectively. Moreover, subgroup analysis showed mixed sampling and multiple target gene diagnosis methods had better diagnostic value than single-site sampling and a single target gene. The sensitivity and FNR were also significantly affected by the reference method. Comparing RT-LAMP with established suboptimal RT-PCR may exaggerate the performance of RT-LAMP. RT-PCR and RT-LAMP showed high values in the diagnosis of COVID-19, but there was still a FNR of about 6%–12%.
Bibliografie:ObjectType-Article-1
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ISSN:0166-0934
1879-0984
1879-0984
DOI:10.1016/j.jviromet.2021.114392