Influenza home diagnostic kit demonstrates good sensitivity, specificity

A novel rapid influenza diagnostic test demonstrated beneficial sensitivity and specificity for the detection of influenza A and B with positive user experience and no safety concerns, according to a study.

“An easy home flu test has the potential to improve antiviral prescribing and reduce transmission of flu in the community by providing individuals with a means to identify the condition, enable them to seek early intervention and keeping them at home to reduce the possible risk of infection to others as well as minimize the risk of additional infection,” Pascal Mallefet, global medical affairs director at GlaxoSmithKline Consumer Healthcare, Switzerland, said during his prerecorded presentation.

Researchers conducted a prospective, multicenter study across 25 U.S. sites to evaluate Theraflu Home FluTest performance on 996 enrolled participants with influenza-like symptoms from December 2018 to April 2019.

The participant or the participant’s caregiver self-collected nasal swabs in a simulated home setting and an additional swab was collected by the investigator as a control to be analyzed by the Theraflu Home FluTest. Due to the low prevalence of influenza B virus during the 2018-2019 flu season, researchers acquired stock clinical samples from previous flu seasons to include in the analysis.

Participants completed a user questionnaire to assess the ease of use of the home diagnostic test.

Compared with the consensus result, the Theraflu Home FluTest showed a positive agreement of 87.7% (95% CI, 83.6-90.9) and a negative agreement of 98% (95% CI, 96.6-98.9) for detection of influenza A.

Compared with the consensus result, the Theraflu Home FluTest showed a specificity of 97.9% (95% CI, 96.8-98.7), and the analysis involving the archived samples showed that the home diagnosis test provided a sensitivity result of 86.3% (95% CI, 74.3-93.2) for detection of influenza B.

For safety, five participants reported adverse events mild in severity with no serious adverse events recorded.

Most participants (95% or more) agreed or strongly agreed that the Theraflu Home FluTest was easy to use and they would be confident using the test at home, with 88% agreeing that the nose swab was easy to accomplish.

“In summary, the home flu test demonstrated good positive and negative agreement for influenza A and B viruses, there were no safety concerns and the test was well received by subjects,” Mallefet said. “Importantly, the home flu test demonstrates that it met or exceeded the minimum requirements specified by the FDA call of regulation for the influenza antigen detection system.”

Reference:

Mallefet P, et al. Am J Respir Crit Care Med. 2020;201:A2952.