COVID-19 RESPONSE: SEROLOGY TEST VALIDATION

Working with the UK testing task force and other trusted partners, ARC Regulatory are evaluating and validating safe and effective rapid serology tests for detection of neutralising antibodies to the SARS-CoV-2 virus.

There is currently no effective rapid immunoassay that is recommended by the WHO for deployment in clinical practice. Leveraging ARC Regulatory's significant expertise in designing, initiating and managing In vitro diagnostic clinical performance studies, we are partnering with hospital and academic collaborators to expedite the availability of high quality rapid serology tests.

High quality immunoassays have been identified as a key piece of the pandemic response framework that can be deployed in multiple settings and have potential utility in diagnostic testing to replace or supplement PCR testing, in key worker screening for absence of infection and return to work and in population screening for exposure to COVID-19 (contact tracing and epidemiological surveillance).

Ensuring effective performance of rapid tests (lateral flow assays) that can be used at the point of care by healthcare professionals or at home in the lay use setting, is of critical importance and requires a high negative predictive value and positive predictive values with the caveat that we do not yet know the level of protection from re-infection afforded by development of antibodies to SARS-CoV-2. 

There are currently over 100 CE-IVD immunoassay tests for the detection of antibodies to SARS-CoV-2. These tests have reported clinical performance (diagnostic sensitivity and specificity) that supports their CE-mark, however the ECDC has indicated that clinical trials are needed for the clinical validation of COVID-19 immunoassays before they can be safely and reliably used for medical or public health decision-making. While it is too early for sound scientific evidence on the long-term protective immunity against SARS-CoV-2, the ECDC has advised the EU that immunoassays detecting specific antibodies against SARS-CoV-2 will play an important role in the future for epidemiological surveillance, evaluation of immunity and the outcome of vaccination studies.