Verification of the Abbott Alinity m Resp-4-Plex assay for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus

Annie Cheng; Stefan Riedel; Ramy Arnaout; James E Kirby

doi:10.1016/j.diagmicrobio.2021.115575

Verification of the Abbott Alinity m Resp-4-Plex assay for detection of SARS-CoV-2, influenza A/B, and respiratory syncytial virus

Diagn Microbiol Infect Dis. 2022 Feb;102(2):115575. doi: 10.1016/j.diagmicrobio.2021.115575. Epub 2021 Oct 22.

Authors

Annie Cheng¹, Stefan Riedel², Ramy Arnaout³, James E Kirby⁴

Affiliations

¹ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA.
² Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
³ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Clinical Informatics, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA.
⁴ Department of Pathology, Beth Israel Deaconess Medical Center, Boston, MA, USA; Harvard Medical School, Boston, MA, USA. Electronic address: jekirby@bidmc.harvard.edu.

Abstract

COVID-19 symptomology may overlap with other circulating respiratory viruses that may also cause severe disease and for which there are specific and potentially life-saving treatments. The Abbott Alinity m Resp-4-Plex assay is a multiplex PCR assay that simultaneously detects and differentiates infection with SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV). We characterized its accuracy, precision, and analytical sensitivity. All were found to be robust for measures examined. In the context of sample-to-answer, near random access automation on the Alinity m platform, we believe that the Resp-4-Plex assay offers significant utility in addressing the current needs of the SARS-CoV-2 pandemic and future needs during anticipated endemic circulation of SARS-CoV-2 with other respiratory viruses.

Keywords: Influenza; Molecular diagnostics; Multiplex; Nucleic acid amplification technology; Respiratory syncytial virus; SARS-CoV-2.

MeSH terms

COVID-19 / diagnosis*
Female
Humans
Influenza A virus / genetics
Influenza B virus / genetics
Influenza, Human / diagnosis*
Limit of Detection
Male
Middle Aged
Molecular Diagnostic Techniques*
Multiplex Polymerase Chain Reaction
Nucleic Acid Amplification Techniques
Respiratory Syncytial Virus Infections / diagnosis*
Respiratory Syncytial Virus, Human / genetics
SARS-CoV-2 / genetics
Sensitivity and Specificity