Clinical Evaluation of the Panbio™ COVID-19/Flu A&B Rapid Panel Professional Use Device and the Panbio™ COVID-19/Flu A&B Rapid Panel Self-Test Device

Overview

This study is designed as an international prospective, multicentric, clinical study to investigate the performance and usability of the Panbio™ COVID-19/Flu A\&B Rapid Panel Professional Use and Self- Test devices for the qualitative detection of COVID-19 antigen, Influenza A antigen and Influenza B antigen in human nasopharyngeal (NP) and mid-turbinate nasal swabs, respectively. This study is part of the performance evaluation to support the CE conformity assessment procedures.

In total, a minimum of 1531 male and female subjects will be prospectively enrolled at multiple clinical sites. A minimum of 100 lay users will also be asked to interpret randomly assigned mock devices. After obtaining written informed consent, a study-specific subject identification number (ID) will be assigned to the subject. All eligible subjects will be assigned to both Professional Use arm and the Self-Test arm of the study. Subject demographics and a brief medical history will be collected. Lay users (self-tester or caregiver) will first collect one mid-turbinate nasal swab from both nostrils, and perform and interpret the Panbio™ Rapid Panel ST device, under the observation of a trained observer. All procedures for testing and result interpretation, including sample collection and extraction, will be conducted following the IFU provided in the kit. Each Panbio™ Rapid Panel ST result will be interpreted firstly by the lay user and followed immediately by the observer who will also photograph the test at the time of interpretation. Each lay user will fill out a user evaluation questionnaire, and a study staff member will complete an observer questionnaire for each lay user. A minimum of 100 lay users will also read mock device tests presented by a study staff member. Mock devices (simulated to represent testing results) will be used for usability testing (result interpretation). A study staff member will then collect two NP swabs (one swab from each nostril) from all subjects. The first NP swab sample will be used to conduct a Panbio™ Rapid Panel PU test, following the IFU. The test result will be photographed at the time of result interpretation. Each study staff member who performs a Panbio™ Rapid Panel PU test will fill out a user evaluation questionnaire once, to assess the usability of the device. The second NP swab sample will be eluted in Universal Transport Medium (UTM) provided by Abbott/the Core Laboratory, labelled and stored, according to the laboratory manual. UTM samples will be shipped to the Core Laboratory for testing with RT-PCR protocols for Flu A, Flu B and SARS-CoV-2, according to the laboratory manual. Each subject's demographic information, education, symptomology data, test results and questionnaires, where relevant, will be recorded on source documentation and transferred to an Electronic Data Capture system.