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- Title
Comparative Diagnostic Performance of a Novel Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) Kit for the Rapid Detection of SARS-CoV-2.
- Authors
Domnich, Alexander; Orsi, Andrea; Panatto, Donatella; De Pace, Vanessa; Ricucci, Valentina; Caligiuri, Patrizia; Guarona, Giulia; Chessa, Valerio; Ferone, Diego; Boccotti, Simona; Bruzzone, Bianca; Icardi, Giancarlo
- Abstract
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.
- Subjects
SARS-CoV-2; DIAGNOSTIC reagents &; test kits; TURNAROUND time; CLINICAL pathology; MOLECULAR diagnosis; ELECTROCHEMILUMINESCENCE
- Publication
Pathogens, 2021, Vol 10, Issue 12, p1629
- ISSN
2076-0817
- Publication type
Article
- DOI
10.3390/pathogens10121629