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J Clin Microbiol. 2018 Apr 25. pii: JCM.00367-18. doi: 10.1128/JCM.00367-18. [Epub ahead of print]
Detection of influenza A and B viruses and respiratory syncytial virus using CLIA-waived point-of-care assays: A paradigm shift to molecular tests.
Azar MM1, Landry ML2.
Author information
Abstract
An accurate laboratory diagnosis of influenza, RSV and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC).Simple, rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and RSV, but have been faulted for low sensitivity. In 2015, the first POC NAAT for detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from Class I to Class II devices with new minimum performance standards, and a requirement for annual reactivity testing. In January 2018, the FDA began enforcing these standards and consequently, many previously available RIDTs can no longer be purchased in the U.S. In this review, current concepts and recent developments in CLIA-waived testing, primarily for influenza A and B viruses and RSV, will be presented with the focus on currently available FDA-cleared rapid antigen and molecular tests.
PMID: 29695519 DOI: 10.1128/JCM.00367-18
Detection of influenza A and B viruses and respiratory syncytial virus using CLIA-waived point-of-care assays: A paradigm shift to molecular tests.
Azar MM1, Landry ML2.
Author information
Abstract
An accurate laboratory diagnosis of influenza, RSV and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC).Simple, rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and RSV, but have been faulted for low sensitivity. In 2015, the first POC NAAT for detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from Class I to Class II devices with new minimum performance standards, and a requirement for annual reactivity testing. In January 2018, the FDA began enforcing these standards and consequently, many previously available RIDTs can no longer be purchased in the U.S. In this review, current concepts and recent developments in CLIA-waived testing, primarily for influenza A and B viruses and RSV, will be presented with the focus on currently available FDA-cleared rapid antigen and molecular tests.
PMID: 29695519 DOI: 10.1128/JCM.00367-18