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

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%.

Automated summary

This systematic review evaluates the test accuracy of RT-LAMP and RT-PCR for diagnosing COVID-19. The overall sensitivity of RT-PCR and RT-LAMP was found to be 0.96 and 0.92, respectively, with false-negative rates of 0.06 and 0.12. Subgroup analysis suggests that mixed sampling and multiple target gene diagnosis methods have better diagnostic value. The study shows that RT-PCR and RT-LAMP have high value in diagnosing COVID-19, but there is still a false-negative rate of about 6%-12%.