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Review
. 2019 Jul:116:44-48.
doi: 10.1016/j.jcv.2019.05.002. Epub 2019 May 10.

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

N Esther Babady  1 , James J Dunn  2 , Roberta Madej  3
Affiliations
Review

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

N Esther Babady et al. J Clin Virol. 2019 Jul.

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.

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References

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