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COVID-19 outbreak: diagnostic update

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Current situation

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 recognition underscores 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.

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

FIND released one expression of interest (EOI), which is now closed, for test developers of in vitro diagnostics (IVDs) that detect SARS-CoV-2 nucleic acid. A total of 220 submissions for this evaluation have been received. These are now being assessed against the inclusion criteria and manufacturers will be informed of next steps by 16 March 2020. For questions relating to the evaluation of molecular tests, please contact our Emerging Threats team.

FIND has now launched a second EOI process for test developers interested in having their immunoassays (machine-based or lateral flow, rapid tests specific for SARS-CoV-2 antigen or antibodies) evaluated using a standardized, independent protocol. The information submitted through the EOI will be used to inform selection of assays to be included the evaluation studies. Results from these studies will be shared with the global health community so that countries have objective and independent evidence on the performance of available SARS-CoV-2 immunoassays.

The deadline to respond to the EOI for evaluation of a SARS-CoV-2 immunoassay is 23:59 CET, 20 March 2020.

EOI: evaluation of a SARS-CoV-2 immunoassay

Please note: if you have previously submitted an EOI to FIND for a SARS-CoV-2 immunoassay evaluation, you DO NOT need to resubmit, unless you have updated information on performance or regulatory status.

 

COVID-19 diagnostic pipeline

We are collating an overview of all SARS-CoV-2 tests in development for the diagnosis of COVID-19. While every effort is being made, we cannot guarantee that this is a fully comprehensive list. The below is information directly submitted by test suppliers or obtained from publicly available sources, and is not independently verified. If you have queries or updates, please contact us.

SUBMISSION FORM TO ADD A TEST TO THIS tracker

MOLECULAR ASSAYS
Commercialized
Manual NAT


Automated lab-based, near-POC NAT or POC NAT
In development
Manual NAT


Automated lab-based, near-POC or POC NAT
IMMUNOASSAYS
Commercialized
Manual or automated immunoassays


Rapid diagnostic tests
In development
Manual or automated immunoassays


Rapid diagnostic tests
DIGITAL SOLUTIONS
SAMPLE COLLECTION / INACTIVATION
OTHER DIAGNOSTICS

EUA – Emergency Use Authorization
HSA – Health and Safety Authority/Health and Sciences Authority
MFDS – Ministry of Food and Drug Safety
NRA – National Regulatory Authority
RUO – Research Use Only

More information

For more information please contact us.

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