How well does a rapid multiplex diagnostic assay for SARS-CoV-2 and Influenza A/B perform in symptomatic patients in the community?

Problem

Point-of-care tests (POCTs) for viral respiratory pathogens have potential to inform immediate clinical decision making, including guiding test and treat strategies in community settings. Whilst there has been unprecedented development of POCTs for respiratory viruses during the pandemic, performance data from clinical settings has often been lacking.

Approach

As part of the Rapid community point-of-care testing for COVID-19 (RAPTOR-C19) platform study, we performed a diagnostic accuracy evaluation of a SARS-CoV-2 & Flu A/B multiplex POCT in patients presenting with suspected SARS-CoV-2 in UK primary care. POCT procedures were carried out according to the manufacturer’s instructions by clinical staff on site and not by specialist laboratory personnel. Samples were also collected for the reference standard multi-pathogen panel real-time RT-PCR assay.

Findings

Adulst and children (n=892) were recruited from May – Dec 2022, until 147 SARS-CoV-2 positive cases had been recruited, in line with sample size calculations. We estimated the performance of the index test for SARS-CoV-2 and Influenza and compared the SARS-CoV-2 estimate to the UK Medicines and Healthcare Products Regulatory Agency SARS-CoV-2 POCT Target Product Profile performance criteria. Data analysis is ongoing and full details of outcomes will be presented.

Consequences

Test performance will be discussed in the context of clinical utility, specifically of the capacity of this test to rule in/out SARS-CoV-2 or Flu infection in symptomatic patients in community healthcare settings and the implications for test utilisation to inform patient management, transmission control and for high-stakes applications, such as enabling access of individuals to vulnerable populations.