A STUDY CONDUCTED TO EVALUATE THE PERFORMANCE OF THE SARS- COV-2 & INFLUENZA A/B ANTIGEN TEST
Study Type
Pivotal Study for potential CE/FDA EUA/WHO filing
Primary Objective
To evaluate the performance of a SARS-CoV-2 & Flu A/B Ag Test in detecting SARS-CoV-2 or Influenza A or B in nasal swabs collected from participants with signs and symptoms of COVID-19 or Influenza.
Study Population
Participants aged 2 or above, suspected of Influenza and/or COVID-19 on presentation.
Study Design
Participants are screened and eligibility determined using the study inclusion/exclusion criteria. Following completion of the informed consent process, the following study samples will be collected per participant:
- Two (2) Nasal Swab for use with study devices
- One (1) Nasal Swab for reference testing
Up to three swabs will be collected from each participant, with one swab processed for reference testing, and two sample processed with the study devices.
Sample Collection and On-Site Test Completion: For the performance evaluation of a SARS-CoV-2 & Flu A/B Test.
Sample Size
The total number of participants to be recruited will depend on prevalence. It is estimated that approximately 500 participants will be required to deliver the necessary number of positive samples. If prevalence of Influenza or SARS-CoV-2 is low, enrolment could be extended up to 1000 participants.
Duration of Participant Involvement
Participation in this study will consist of a single visit.
Following the informed consenting process, each participant’s involvement in the study will last approximately 45- 60 minutes. Once required samples and data are collected, participation is complete. No follow-up or subsequent participant involvement is required.
Study Duration
The study will be conducted during the 2024/2025 Influenza and predicted COVID- 19 season in South Africa.
If a sufficient number of samples are not collected during this Influenza/predicted COVID-19 season, the study may be continued into subsequent season(s).
Study Centre(s)
Single Centre
Sample Type(s)
- Nasal Swabs (NS)
Study Product
SARS-CoV-2 & Flu A/B Tests
- InteliSwab® COVID-19/Influenza A+B Rapid Test (Design A – Strip Design)
- InteliSwab® COVID-19/Influenza A+B Rapid Test (Design B – Device Design in Modified Developer Vial)
- InteliSwab® COVID-19/Influenza A+B Rapid Test (Design C – Direct Collect
Reference Device/Method
Xpert Xpress CoV-2/Flu/RSV Plus Assay and/or other FDA EUA approved method
Statistical Methodology
Will be outlined in Data Management and Analysis Plan (DMAP)
