Flu@home Trial Tests At-Home Influenza RDTs With App-Based Symptom Triggers
This innovative study prepositioned influenza rapid diagnostic test kits with 5,229 participants who used a mobile app to trigger self-testing at symptom onset. While the concept of app-supported home testing proved feasible, the QuickVue RDT showed only 28% sensitivity for influenza A and 32% for influenza B despite 99% specificity, far too low for clinical use. The study validates the at-home testing model but highlights the need for more sensitive assays to make home-based respiratory virus diagnosis practical.
The original study
Flu@home: the Comparative Accuracy of an At-Home Influenza Rapid Diagnostic Test Using a Prepositioned Test Kit, Mobile App, Mail-in Reference Sample, and Symptom-Based Testing Trigger.
- Authors
- Kotnik JH, Cooper S, Smedinghoff S, Gade P, Scherer K, Maier M, et al.
- Journal
- Journal of clinical microbiology
- Type
- Journal Article, Research Support, Non-U.S. Gov't, Research Support, U.S. Gov't, P.H.S., Review
- PMID
- 35107302
Original abstract
At-home testing with rapid diagnostic tests (RDTs) for respiratory viruses could facilitate early diagnosis, guide patient care, and prevent transmission. Such RDTs are best used near the onset of illness when viral load is highest and clinical action will be most impactful, which may be achieved by at-home testing. We evaluated the diagnostic accuracy of the QuickVue Influenza A+B RDT in an at-home setting. A convenience sample of 5,229 individuals who were engaged with an on-line health research platform were prospectively recruited throughout the United States. "Flu@home" test kits containing a QuickVue RDT and reference sample collection and shipping materials were prepositioned with participants at the beginning of the study. Participants responded to daily symptom surveys. If they reported experiencing cough along with aches, fever, chills, and/or sweats, they used their flu@home kit following instructions on a mobile app and indicated what lines they saw on the RDT. Of the 976 participants who met criteria to use their self-collection kit and completed study procedures, 202 (20.7%) were positive for influenza by qPCR. The RDT had a sensitivity of 28% (95% CI = 21 to 36) and specificity of 99% (98 to 99) for influenza A, and 32% (95% CI = 20 to 46) and 99% (95% CI = 98 to 99), for influenza B. Our results support the concept of app-supported, prepositioned at-home RDT kits using symptom-based triggers, although it cannot be recommended with the RDT used in this study. Further research is needed to determine ways to improve the accuracy and utility of home-based testing for influenza.