Journal of the American Pharmacists Association
Volume 57, Issue 1, Pages 13–19
Renee R. Koski, Michael E. Klepser
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.
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.”
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.
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.
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%.
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.