CLIA-waived molecular influenza testing in the emergency department and outpatient settings.
CLIA-waived molecular influenza testing in the emergency department and outpatient settings.
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DOI:
10.1016/j.jcv.2019.05.002
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发表时间:
2019-07
期刊:
影响因子:
--
通讯作者:
Madej R
中科院分区:
文献类型:
--
作者:
Babady NE;Dunn JJ;Madej R
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.
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