Format

Send to

Choose Destination
J Clin Microbiol. 2018 Jun 25;56(7). pii: e00367-18. doi: 10.1128/JCM.00367-18. Print 2018 Jul.

Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests.

Author information

1
Department of Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, Connecticut, USA.
2
Department of Medicine, Section of Infectious Diseases, Yale University School of Medicine, New Haven, Connecticut, USA marie.landry@yale.edu.
3
Department of Laboratory Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.

Abstract

An accurate laboratory diagnosis of influenza, respiratory syncytial virus (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 respiratory syncytial virus (RSV) but have been faulted for low sensitivity. In 2015, the first POC NAAT for the 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. Consequently, many previously available RIDTs can no longer be purchased in the United States. In this review, recent developments in Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived testing for respiratory virus infections will be presented, with the focus on currently available FDA-cleared rapid antigen and molecular tests primarily for influenza A and B viruses and RSV.

KEYWORDS:

CLIA waived; NAAT; PCR; RIDT; influenza; point of care; rapid antigen test; respiratory syncytial virus; respiratory viruses; viral diagnosis

PMID:
29695519
PMCID:
PMC6018333
DOI:
10.1128/JCM.00367-18
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for HighWire Icon for PubMed Central
Loading ...
Support Center