Rapid differential diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial viruses: Validation of a novel RT-PCR assay

• Published in: Journal of clinical virology Vol. 161; p. 105402
• Main Authors: Domnich, Alexander, Bruzzone, Bianca, Trombetta, Carlo-Simone, De Pace, Vanessa, Ricucci, Valentina, Varesano, Serena, Garzillo, Giada, Ogliastro, Matilde, Orsi, Andrea, Icardi, Giancarlo
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.04.2023
• Subjects: Coinfection - diagnosis; COVID-19 - diagnosis; Diagnosis, Differential; Diagnostic accuracy; Humans; Influenza; Influenza A virus - genetics; Influenza B virus - genetics; Influenza, Human - diagnosis; Molecular Diagnostic Techniques - methods; point-of-care testing; rapid RT-PCR; Real-Time Polymerase Chain Reaction - methods; Respiratory Syncytial Virus Infections - diagnosis; Respiratory Syncytial Virus, Human - genetics; Respiratory Syncytial Viruses; Retrospective Studies; Reverse Transcriptase Polymerase Chain Reaction; RSV; SARS-CoV-2; SARS-CoV-2 - genetics; Sensitivity and Specificity; point-of-care testing; SARS-CoV-2; RSV; Influenza; Diagnostic accuracy; rapid RT-PCR
• ISSN: 1386-6532; 1873-5967
• DOI: 10.1016/j.jcv.2023.105402

•STANDARD M10 Flu/RSV/SARS-CoV-2 PoC RT-PCR assay was compared with Allplex RT-PCR.•STANDARD M10 Flu/RSV/SARS-CoV-2 showed high diagnostic performance for all viruses.•PoC RT-PCR assays are useful for differential diagnosis of the common respiratory viruses. Influenza and respiratory syncytial (RSV) viruses are expected to co-circulate with SARS-CoV-2 in the upcoming seasons and clinical differential diagnosis between them is difficult. Laboratory-based RT-PCR is a gold standard diagnostic method for influenza, RSV and SARS-CoV-2. The objective of this study was to estimate the diagnostic performance of a novel point-of-care RT-PCR assay STANDARD M10 Flu/RSV/SARS-CoV-2 (SD Biosensor) in a large number of clinical specimens with diversified (co)-infection patterns and viral loads. This was a retrospective study, in which all samples were tested in both STANDARD M10 Flu/RSV/SARS-CoV-2 index and Allplex SARS-CoV-2/Respiratory Panel 1 (Seegene) reference kits. Samples with discordant results were further processed in a third resolver test (Resp-4-Plex, Abbott). A total of 1,019 naso-/oropharyngeal samples (50.3% positive for at least one virus) were processed in both STANDARD M10 Flu/RSV/SARS-CoV-2 and Allplex assays and the overall between-assay agreement was as high as 94.6%. Positive percent agreement of the STANDARD M10 Flu/RSV/SARS-CoV-2 was 100%, 96.6%, 97.3% and 99.4% for influenza A, B, RSV and SARS-CoV-2, respectively. The corresponding negative percent agreement was 99.7%. 100%, 100% and 98.4%, respectively. The expected positive and negative predictive values for all viruses were constantly above 96% in a reasonable range of disease prevalence. STANDARD M10 Flu/RSV/SARS-CoV-2 is a reliable RT-PCR assay able to detect influenza A, influenza B, RSV and SARS-CoV-2 in one hour or less, fostering a rapid differential diagnosis of common respiratory viruses.