In vitro diagnostics for COVID-19
Laboratory testing guidance
Country & Technical Guidance - Coronavirus disease (COVID-19)
And information on PCR tests for Emergency Use only, can be found at:
WHO Emergency Use Listing (EUL) for in vitro diagnostics
Patient tested in the COVID-19 Health Centre at the Central de Abasto, main wholesale and retail market for consumer products in the Metropolitan Area. Mexico 2020
- Assays for the detection of SARS-CoV-2 nucleic acid (multiplex assays, detecting more than one viral target)
- Rapid diagnostic tests (RDT) for the detection of SARS-CoV-2 antigens; other platforms to detect SARS-CoV-2 antigen will be considered on a case-by-case basis
The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations.
It is intended to assist interested procurement agencies and Member States on the suitability for use of a specific IVD, based
on a minimum set of available quality, safety, and performance data.
Publications on In vitro diagnostics for COVID-19
Technical specifications for selection of essential in vitro diagnostics for SARS-CoV-2
NOTE: This publication is under review and a new version will be published during the third quarter of 2022. Technical specifications for in vitro diagnostics...
ACT Accelerator on in vitro diagnostics for COVID
The diagnostics pillar is co-led by FIND and the Global Fund. The investment case is available here.
"The Access to COVID-19 Tools ACT-Accelerator, is a new, groundbreaking global collaboration to accelerate the development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines. It was set up in response to a call from G20 leaders in March and launched by the WHO, EC, France and The Bill & Melinda Gates Foundation in April 2020."
What is the ACT-Accelerator?
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