OBJECTIVES: Rapid influenza diagnostic tests (RIDTs) have a potential role in community pharmacy to optimize influenza infection management. The U.S. Food and Drug Administration (FDA) proposed changes to the classification of RIDTs may affect their use in community pharmacy. We reviewed the performance and features of RIDTs likely to meet FDA-proposed reclassification requirements. DATA SOURCES: PubMed and Medline database searches were performed using the terms "Sofia Influenza A and B Fluorescent Immunoassay," "BD Veritor System for Rapid Detection of Flu A and B", and "Alere i Influenza A and B." STUDY SELECTION: All studies involving the use of the BD Veritor System for Rapid Detection of Flu A+B (BD Veritor, Sparks, MD), the Sofia Influenza A+B Fluorescent Immunoassay (Sofia FIA, San Diego, CA), and Alere i Influenza A&B (Alere i, Scarborough, ME) containing sensitivities and specificities with confidence intervals were considered for inclusion. DATA EXTRACTION: Patient demographics, specimen type collected, setting, sensitivities, specificities, true positives, true negatives, false positives, false negatives, positive predictive values, and negative predictive values were extracted. RESULTS: Of the 22 studies identified, 14 contained sufficient data to incorporate into this review. One study contained comparative data for BD Veritor and Sofia FIA, 1 study compared Alere i and Sofia FIA, 2 studies specifically included BD Veritor, 5 studies specifically included Sofia FIA, and 5 studies specifically included Alere i. Performance characteristics among the RIDTs varied; however, all 3 RIDTs consistently provided sensitivities and specificities >70%. CONCLUSION: BD Veritor, Sofia FIA, and Alere i RIDTs performed well compared with reverse transcriptase-polymerase chain reaction or viral culture. These RIDTs are likely to satisfy the proposed reclassification requirements. Pharmacists are considered the most accessible health care providers, and implementing RIDT services in community pharmacy may benefit health systems.
OBJECTIVES: Rapid influenza diagnostic tests (RIDTs) have a potential role in community pharmacy to optimize influenza infection management. The U.S. Food and Drug Administration (FDA) proposed changes to the classification of RIDTs may affect their use in community pharmacy. We reviewed the performance and features of RIDTs likely to meet FDA-proposed reclassification requirements. DATA SOURCES: PubMed and Medline database searches were performed using the terms "Sofia Influenza A and B Fluorescent Immunoassay," "BD Veritor System for Rapid Detection of Flu A and B", and "Alere i Influenza A and B." STUDY SELECTION: All studies involving the use of the BD Veritor System for Rapid Detection of Flu A+B (BD Veritor, Sparks, MD), the Sofia Influenza A+B Fluorescent Immunoassay (Sofia FIA, San Diego, CA), and Alere i Influenza A&B (Alere i, Scarborough, ME) containing sensitivities and specificities with confidence intervals were considered for inclusion. DATA EXTRACTION: Patient demographics, specimen type collected, setting, sensitivities, specificities, true positives, true negatives, false positives, false negatives, positive predictive values, and negative predictive values were extracted. RESULTS: Of the 22 studies identified, 14 contained sufficient data to incorporate into this review. One study contained comparative data for BD Veritor and Sofia FIA, 1 study compared Alere i and Sofia FIA, 2 studies specifically included BD Veritor, 5 studies specifically included Sofia FIA, and 5 studies specifically included Alere i. Performance characteristics among the RIDTs varied; however, all 3 RIDTs consistently provided sensitivities and specificities >70%. CONCLUSION: BD Veritor, Sofia FIA, and Alere i RIDTs performed well compared with reverse transcriptase-polymerase chain reaction or viral culture. These RIDTs are likely to satisfy the proposed reclassification requirements. Pharmacists are considered the most accessible health care providers, and implementing RIDT services in community pharmacy may benefit health systems.
Authors: Cristalyne Bell; Maureen Goss; Jennifer Birstler; Emily Temte; Guanhua Chen; Peter Shult; Erik Reisdorf; Thomas Haupt; Shari Barlow; Jonathan Temte Journal: PLoS One Date: 2022-05-10 Impact factor: 3.752
Authors: Daniel Olson; Diva M Calvimontes; Molly M Lamb; Gerber Guzman; Edgar Barrios; Andrea Chacon; Neudy Rojop; Kareen Arias; Melissa Gomez; Guillermo Antonio Bolanos; Jose Monzon; Anna N Chard; Chelsea Iwamoto; Lindsey M Duca; Nga Vuong; Melissa Fineman; Kelsey Lesteberg; David Beckham; Mario L Santiago; Kendra Quicke; Gregory Ebel; Emily Zielinski Gutierrez; Eduardo Azziz-Baumgartner; Frederick G Hayden; Hani Mansour; Kathryn Edwards; Lee S Newman; Edwin J Asturias Journal: medRxiv Date: 2022-02-08
Authors: Sarah Pope; Hunter Hill; Lindsey Cardosi; Lindsey Henson; Mike Wasson; Sara Stallworth; Kim Ward; Shane P Desselle; Kenneth C Hohmeier Journal: Explor Res Clin Soc Pharm Date: 2021-06-10
Authors: Joseph Jonathan Lee; Jan Y Verbakel; Clare Rosemary Goyder; Thanusha Ananthakumar; Pui San Tan; Phillip James Turner; Gail Hayward; Ann Van den Bruel Journal: Clin Infect Dis Date: 2019-06-18 Impact factor: 9.079