Molecular point-of-care tests: efficiency of RT-LAMP in the rapid diagnosis of COVID-19 to assess hospital access.

ABSTRACT

Background: Safe hospital access needs rapid testing for SARS-CoV-2 to enable rationale use of limited resources. The current standard method for Coronavirus detection is the RT-qPCR. This study aimed to determine the diagnostic performance of the new rapid RT-LAMP test, compared to RT-qPCR, and his efficiency for rapid hospital access through the Emergency Department (E.D.). Method(s) 1576 UTM nasopharyngeal swabs, collected in E.D., have been tested for SARS-CoV-2 infection, using a kit RTLAMP. The same samples were also analyzed with a traditional RT-qPCR assay and the results have been compared in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV). Result(s) The assay has demonstrated a sensitivity of 73.3% (95%CI 62.4/82.0) and specificity of 87.1% (95%CI 85.3/88.7), PPV 22.1%, NPV 98.5%. Conclusion(s) ICGENE RNA RT-LAMP kit (ICGENEHEALTH;Enbiotech, Angri, Salerno, Italy) efficiently exclude the presence of infection and reliably detects infectious patients (with Ct<30). RNA RT-LAMP could replace rRTPCR where there is the need to rapidly identify potentially contagious individuals, but its low PPV suggests that positive results should be confirmed by a reference method.Copyright © 2022 EDIZIONI MINERVA MEDICA.