Working Group on Diagnostic Tests


In 2020, the Royal Statistical Society convened a Working Group on Diagnostic Tests, chaired by former RSS president, Professor Deborah Ashby, and by Professor Jon Deeks, to provide for statistical evidence on in vitro diagnostic tests (IVDs) that are used for analysis or control of infectious diseases.

The RSS was concerned that, during the Covid-19 outbreak, many new diagnostic tests for SARS-CoV-2 antigen or antibodies have come to market for use both in clinical practice and for surveillance without adequate provision for statistical evaluation of their clinical and analytical performance. 

The working group's key aim was to review the statistical evidence needed to assure the performance of new tests, for patients, decision-makers and regulators, with particular reference to IVDs for infectious diseases.

In June 2021, the group produced a 90-page report with recommendations around study design, regulation and transparency matters.

Membership

Deborah Ashby (chair)
Sheila Bird
Jon Deeks (chair)
Stephen Evans
Rafael Perera
Yemisi Takwoingi
Olivia Varley-Winter (RSS staff)

Download the Diagnostic Tests Working Group report
Download the report.

Considerations

  • Statistical issues specific to the diagnosis and surveillance of infectious diseases, including new emerging infectious diseases
  • Key characteristics to be evaluated when assuring the performance of an IVD test for an infectious disease 
  • Design aspects of studies that are necessary to provide estimates of these key characteristics 
  • Statistical principles to be followed by decision makers (including regulators) when assessing the adequacy of the performance of a test for its intended role in the protection of public health 
  • Information that needs to be in the public domain to provide confidence in the performance of tests. 

To contact the working group, email o.varley-winter@rss.org.uk