The diagnostic accuracy of nucleic acid point-of-care tests for human coronavirus: A systematic review and meta-analysis

Subsoontorn, P.; Lohitnavy, M.; Kongkaew, C.

Many recent studies reported coronavirus point of care tests (POCTs) based on isothermal amplification. However, the performances of these tests have not been systematically evaluated. We searched databases for studies that provide data to calculate sensitivity, specificity and diagnostic odds ratio (DOR). We included 43 studies on 5204 specimens. Most studies had high risk of patient selection and index test bias but low risk in other domains. Most studies (n = 21) used reverse-transcribed loop-mediated isothermal amplification (RT-LAMP) to diagnose Coronavirus disease 2019 (COVID-19). Summary estimated ln(DOR) for RT-LAMP of RNA purified COVID-19 samples is 6.50 (95%CI 5.25-7.76), similar to the previously reported value for RT-LAMP of other RNA virus. RT-LAMP from crude samples has significantly lower ln(DOR) at 4.46 (95%CI 3.53-5.38). SAMBA-II has the highest ln(DOR) at 8.00 (95%CI 6.14-9.87). Abbott ID Now performance is similar to RT-LAMP of crude sample. The performances of CRISPR diagnosis and RT-LAMP are not significantly different. Types of coronaviruses and publication status have no significant effect on diagnosis performance. Existing nucleic acid POCTs, particularly RT-LAMP, CRISPR diagnosis and SAMBA-II, have good diagnostic performance. Future work should focus on improving a study design to minimize the risk of biases.