CLIA-waived molecular influenza testing in the emergency department and outpatient settings
| Autor: | N. Esther Babady, James J Dunn, Roberta Madej |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Point-of-care testing 030106 microbiology Near point Ambulatory Care Facilities Article Food and drug administration 03 medical and health sciences 0302 clinical medicine Virology Health care Influenza Human Medicine Humans 030212 general & internal medicine Medical diagnosis Respiratory tract infections business.industry Diagnostic Tests Routine Clinical performance Emergency department Influenza B virus Infectious Diseases Molecular Diagnostic Techniques Influenza A virus Point-of-Care Testing Emergency medicine Reagent Kits Diagnostic business Emergency Service Hospital |
| Zdroj: | J Clin Virol |
| ISSN: | 1873-5967 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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