COVID-19 diagnostics

COVID-19 diagnostics

As the world is struggling to contain the novel coronavirus (COVID-19) outbreak, healthcare infrastructure and testing capacity have emerged as major issues.

On 11–12 February 2020, WHO organized a Forum to identify research gaps and priorities for COVID-19, in collaboration with the GloPID-R. One of the eight immediate research needs agreed upon as part of the Forum was to “mobilize research on rapid point of care diagnostics for use at the community level.” This was early recognition of the urgent need for access to accurate and standardized diagnostics for SARS-CoV-2 (the causative agent of COVID-19), which can be deployed in decentralized settings. An R&D Roadmap for COVID-19 was published in March 2020.

Current testing situation worldwide

Adequate testing capacity for SARS-CoV-2 is lacking worldwide, preventing people from accessing care. It also means the community is relying on models and estimates to get an accurate picture of the outbreak and its evolution, even though this information is critical to inform public health measures that could stop or slow disease transmission. Different countries have implemented different testing strategies, reflecting the availability of diagnostics and reagents, and the needs of their individual health systems. In many cases, political concerns have influenced the speed of response to the lack of tests.

We are working to build a picture of how many people in the world are being tested for COVID-19. Our interactive map tracks the number of SARS-CoV-2 tests that have been performed in each country, and compares it with the number that showed a positive result, at global and country levels.

We are also working closely with WHO and other partners to provide support on training, technical assistance and capacity building to ensure access to accurate and high-quality diagnostic testing for SARS-CoV-2, particularly in low- and middle-income countries.

COVID-19 diagnostics
backgrounder

What tests are available?

WHO is continually updating technical guidance for COVID-19, including recommendations on laboratory testing.

A wide range of diagnostic tests are commercially available for SARS-CoV-2, some of which have received authorizations for use by various national regulatory agencies. We are collating the pipeline, and also share information on diagnostic use cases.

We are also in the process of conducting an independent evaluation of both molecular tests and immunoassays, in collaboration with WHO, the Hôpitaux Universitaires de Genève and others. Products are being selected for evaluation through expressions of interest (EOI).

The first EOI for developers of in vitro diagnostics (IVDs) that detect SARS-CoV-2 nucleic acid (molecular assays) resulted in over 200 submissions and the evaluations are now underway.

More information on the SARS-CoV-2 molecular assay evaluation

A second call for test developers interested in having their immunoassays (manual ELISA, machine-based or lateral flow, rapid tests specific for SARS-CoV-2 antigen or antibodies) closed on 20 March 2020 with nearly 100 submissions.

More information on the SARS-CoV-2 IMMUNOassay evaluation

Data from these standardized evaluations will be made publicly available to assist in-country decision making.

More information

For more information on our COVID-19 activities, please contact our Emerging Threats team.