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La Rivista Italiana della Medicina di Laboratorio 2022 Aug 31

DOI: 10.23736/S1825-859X.22.00153-0

Copyright © 2022 EDIZIONI MINERVA MEDICA

language: Italian

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

Simonetta MILIA , Daniele ALTEA, Silvia DORATIOTTO, Paola RAGATZU, Tiziana A. SALIS, Mariella DEMONTIS, Alessandra MURA, Alessandra FARINA, Daniela MASIA, Giovanna A. PORCU, Manuela ATZORI, Angela Stefania CONGIU, Roberto IRDE

Laboratorio di Patologia Clinica, Ospedale S. Martino, ASL n 5, Oristano, Italia


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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 emergency department (E.D.).
METHODS: 1576 UTM nasopharyngeal swabs, collected in E.D., have been tested for SARS Cov2 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).
RESULTS: 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%.
CONCLUSIONS: ICGENE RNA RT-LAMP kit efficiently exclude the presence of infection and reliably detects infectious patients (with Ct<30). RNA RT-LAMP could replace rRTPCR where there is need to rapidly identify potentially contagious individuals, but its low PPV suggests that positive results should be confirmed by a reference method.


KEY WORDS: RT Lamp; POCT; COVID19

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