COVID-19 is a potentially lethal mainly respiratory disease, caused by the SARS-CoV-2 virus. COVID-19 was initially reported in Wuhan (Hubei province, China) where it caused a large scale, yet localized epidemic near the end of 2019. SARS-CoV-2 testing for clinical diagnostics and surveillance
Several tests (nucleic acids [NAT], antigen tests [detecting viral proteins]) and serological methods have been developed or are in the pipeline (https://www.finddx.org/covid-19/pipeline/). WHO, other international and national health authorities worldwide have underlined the urgent need to increase testing capacity, availability of assays and reagents, in particular of rapid tests with point-of-care applicability. Several health agencies have set up frameworks for rapid test validation and provisional authorization. Given the abundance of new assay arriving on the market, health authorities need lists of well validated assays.
Testing for SARS-CoV-2 is vital not only for the diagnosis and treatment of COVID-19 patients but is crucial in the efforts of public health systems around the world to contain and mitigate the COVID-19 pandemic by identifying infected individuals to prevent further person-to-person transmission of COVID-19. Due to the rapid spread of the virus and the urgency for large scale testing, many regulatory bodies issued provisional authorisation of assays with non-comparative analytical performance and without claims for target benchmarks. The VALidation of SARS-CORona Virus-2 assays or VALCOR is a protocol designed to establish an independent, reliable decision support platform on the clinical diagnostic performance of SARS-CoV-2 diagnostic assays. The VALCOR protocol is inspired on VALGENT (VALidation of HPVGENotyping Tests) which is a successful forum for comparison and validation of human papillomavirus tests usable for cervical cancer screening. It aims to contribute in setting up a framework for test validation. The result will be the publication of well-validated assays that can be used safely for diagnosis of patients, screening of risk groups or tracing of suspicious contacts. The outcomes of VALCOR will be the:
- development of principles of robust SARS-COV-2 test validation
- generation of an international network for SARS-COV-2 test comparison
- publication of a list of assays that can be used safely in the field of COVID-19 control.