Novel Rapid Influenza Diagnostic Test Demonstrates Good Sensitivity, Specificity

This article is part of Pulmonology Advisor’s coverage of the American Thoracic Society Virtual 2020 meeting.

The Theraflu Home FluTest, a novel rapid influenza diagnostic test, demonstrated good sensitivity and specificity for both influenza A and B viruses, according to study results presented virtually at the American Thoracic Society 2020 Virtual meeting, held August 5 to 10, 2020.

Rapid influenza diagnostic tests are important for early treatment and control measures, but their use is limited to point of care (POC) settings. However, an influenza test is currently in development for consumer use. Therefore, researchers conducted a prospective study across 25 sites in the United States to evaluate the performance of the Theraflu Home FluTest for the detection of influenza A and B viruses. They enrolled 1012 participants between December 2018 and April 2019 who self-administered nasal swabs or performed by caregivers if participants were aged ≥2 years with influenza-like symptoms.

Key performance values were based on comparison with 3 reference methods: nucleic acid amplification testing, shell viral culture, and a real-time polymerase chain reaction consensus comparator. In addition, participants completed a questionnaire regarding the ease of use of the Theraflu Home FluTest using a 5-point Likert scale (1=strongly disagree to 5=strongly agree).

In terms of influenza A, the Theraflu Home FluTest compared with the consensus result demonstrated a positive agreement of 87.7% (95% confidence limit [CL], 83.6%-90.9%) and a negative agreement of 98.0% (95% CL, 96.6%-98.9%). Meanwhile, for influenza B, the Theraflu Home FluTest compared with the consensus result demonstrated a specificity of 97.9% (95% CL, 98.6%-98.7%).

Because of the small sample size of participants with influenza B (n=12), the researchers conducted a further analysis using 89 archived samples. This analysis demonstrated a sensitivity vs consensus result of 86.3% (95% CL, 74.3%-93.2%). In the safety data set, 5 participants experienced an adverse event related to nasal swabbing, but none were determined to be serious. Furthermore, ≥95% of participants agreed or strongly agreed that the test was easy to use and that they would feel confident using it at home, according to the usability questionnaire. In addition, 88% agreed or strongly agreed that the nose swab was easy to complete.

“The [Theraflu Home FluTest] should expand opportunities as an aid to rapid influenza detection and management beyond POC settings,” the researchers concluded.

Reference

Mallefet P, Maret S, Fry S. A prospective, multicenter study to evaluate the performance of a novel home diagnostic kit for detection of influenza A and B. Presented at: American Thoracic Society 2020 Virtual; August 5-10, 2020. Abstract #324.

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