NDLI: Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

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Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2

Content Provider	MDPI
Author	Domnich, Alexander Orsi, Andrea Panatto, Donatella Pace, Vanessa De Ricucci, Valentina Caligiuri, Patrizia Guarona, Giulia Chessa, Valerio Ferone, Diego Boccotti, Simona Bruzzone, Bianca Icardi, Giancarlo
Copyright Year	2021
Description	Although the reverse transcription-polymerase chain reaction (RT-PCR) is considered a standard-of-care assay for the laboratory diagnosis of SARS-CoV-2, several limitations of this method have been described. Reverse transcription loop-mediated isothermal amplification (RT-LAMP) is an alternative molecular assay and is potentially able to overcome some intrinsic shortcomings of RT-PCR. In this study, we evaluated the diagnostic performance of the novel HG COVID-19 RT-LAMP assay. In this retrospective analysis, a total of 400 routinely collected leftover nasopharyngeal samples with a known RT-PCR result were tested by means of the HG COVID-19 RT-LAMP assay. The overall sensitivity and specificity values of HG COVID-19 RT-LAMP versus RT-PCR were 97.0% (95% CI: 93.6–98.9%) and 98.5% (95% CI: 95.7–99.7%), respectively. Inter-assay agreement was almost perfect (κ = 0.96). Concordance was perfect in samples with high viral loads (cycle threshold < 30). The average time to a positive result on RT-LAMP was 17 min. HG COVID-19 RT-LAMP is a reliable molecular diagnostic kit for detecting SARS-CoV-2, and its performance is comparable to that of RT-PCR. Shorter turnaround times and the possibility of performing molecular diagnostics in the point-of-care setting make it a valuable option for facilities without sophisticated laboratory equipment.
Starting Page	1629
e-ISSN	20760817
DOI	10.3390/pathogens10121629
Journal	Pathogens
Issue Number	12
Volume Number	10
Language	English
Publisher	MDPI
Publisher Date	2021-12-15
Access Restriction	Open
Subject Keyword	Pathogens Microbiology Covid-19 Sars-cov-2 Rt-lamp Rt-pcr Diagnostic Accuracy
Content Type	Text
Resource Type	Article

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