CLIA-waived molecular influenza testing in the emergency department and outpatient settings

J Clin Virol. 2019 Jul;116:44-48. doi: 10.1016/j.jcv.2019.05.002. Epub 2019 May 10.

Abstract

Respiratory tract infections are a common cause of visits to emergency departments and outpatient settings. Infections with influenza viruses A and B in particular, are responsible for significant morbidity and mortality in both pediatric and adult populations worldwide. A significant number of influenza diagnoses occur in the emergency departments with many being performed using rapid influenza diagnostic tests (RIDT) which have sensitivities as low as 30% depending on the specific RIDT and patient population. More recently, rapid molecular tests for the detection of influenza viruses A and B have become commercially available as point-of-care platforms. In the United States, several of these new tests are approved by the Food and Drug Administration as CLIA-waived tests. In this report, we review the data on the analytical and clinical performance of RIDTs and CLIA-waived molecular tests, present and discuss potential key challenges and opportunities for implementation of CLIA-waived molecular tests at or near point of care in the emergency departments and outpatient settings.

Keywords: Antigen tests; CLIA-waived testing; Emergency department; Influenza testing; Molecular tests; Point-Of-Care testing.

Publication types

  • Research Support, N.I.H., Extramural
  • Review

MeSH terms

  • Ambulatory Care Facilities
  • Diagnostic Tests, Routine / classification
  • Diagnostic Tests, Routine / standards*
  • Emergency Service, Hospital
  • Humans
  • Influenza A virus / isolation & purification
  • Influenza B virus / isolation & purification
  • Influenza, Human / diagnosis*
  • Molecular Diagnostic Techniques* / standards
  • Point-of-Care Testing / organization & administration
  • Point-of-Care Testing / standards*
  • Reagent Kits, Diagnostic / classification
  • Reagent Kits, Diagnostic / standards

Substances

  • Reagent Kits, Diagnostic