Tag: Regulatory

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Featured Work - Quality Assurance & Policy

WHO: In vitro diagnostics for COVID-19

Safe and effective in vitro diagnostics (IVDs) are a critical component of an overall strategy to control the COVID-19 pandemic.

WHO prequalification of in vitro diagnostics (IVDs) provides a valuable service to manufacturers and regulators in both quality assurance and product selection.

It has developed an Emergency Use Listing (EUL) procedure to hasten the availability of IVDs in public health emergencies such as COVID-19.

WHO reviews all documentation submitted for EUL and checks the evidence on a product’s safety, quality and performance. This procedure helps agencies and Member States decide on which IVD is suitable for their use. 

The IVD part of the WHO prequalification website also provides key prequalification outputs as well as detailed information about submission of IVDs.

·       Read more here

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WHO interim guidance: antigen-detection in the diagnosis of SARS-CoV-2 infection

This is an interim guidance published by the World Health Organization on how to select rapid antigen tests and when and where to use them.

Rapid antigen tests for SARS-CoV-2 are less expensive and faster. They should be used for primary case detection in symptomatic individuals and asymptomatic individuals who are at high risk of COVID-19, such as health workers. 

The tests should also be used for contact tracing, conducting outbreak investigations, and to monitor trends of disease incidence in communities. 

There are some variations in test performance, but these tests are very much suitable in track, trace, and isolate programmes aimed at interrupting community transmission.

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WHO interim guidance: Recommendations for national SARS-CoV-2 testing strategies and diagnostic capacities

In June 2021, the World Health Organization issued recommendations for SARS-CoV-2 national testing strategies.

At the time, the deadly Delta variant was the dominant variant globally.

WHO recommendations highlight the importance of diagnostic testing for SARS-CoV-2 as a critical component for both preventing the spread of the virus and controlling outbreaks. 

It advised that countries should have testing strategies in place that are context specific and that testing must be connected to other public health strategies like tracking, tracing, and treatment.

WHO’s list of who should be tested

  • Everyone with symptoms meeting the case definition for COVID-19, regardless of vaccination status or prior infection. 
  • Symptomatic individuals must be tested first and if there are not enough tests, those who are at high risk of severe disease must be tested first. 
  • Others for whom testing must be prioritized include health workers, hospitalized patients, and those who first showed symptoms in congregate settings.

Asymptomatic individuals should be tested if they were in close contact with  patients with a confirmed SARS-CoV-2 infection, health workers or long-term care workers.

What tests must be used?

PCR tests remain the gold standard. 

High-quality antigen tests can be used to scale up testing programmes fast.

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Featured Work - Quality Assurance & Policy

WHO interim guidance: Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing 

In March 2022, the World Health Organization published its first guide to self-testing for COVID-19 using rapid antigen tests.

“The goal is to contribute to the effective management of COVID-19 as a public health problem,” their guidelines read.

The document emphasizes  that this option must be offered in addition to professionally administered testing.

WHO further explains that there is evidence showing users can use self-tests in a reliable and accurate manner, and that it is both acceptable and feasible to use the tests.

An explanation of when self-testing will be appropriate must be provided, as must complete instructions tailored for country specific contexts.

Clear messaging is also needed on what to do with the results of a test and what individual responsibilities will be.

Other recommendations include:

  • COVID-19 self-test kits should meet the existing World Health Organization (WHO) standards.
  • Self-tests should be accepted for screening and diagnostic purposes.
  • If positive, a self-test should, if appropriate in a country-specific context, be sufficient to link a positive-tested patient with clinical care and therapeutics. 
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SARS-CoV-2 antigen-detecting rapid diagnostic tests: An implementation guide

This guide, produced by FIND and the World Health Organization, provides information on implementing diagnostic programs using rapid antigen tests. 

It shows how rapid antigen testing can be implemented to support individual case management, contact tracing, surveillance and outbreak investigations.

The guide stresses the use of strict testing protocols and clear communication, and the need to protect healthcare workers against transmission. 

It outlines the different types of available testing  and where rapid antigen testing fits in. Rapid antigen tests are used to find a protein the body produces in response to an infection with the SARS-CoV-2 virus.

It produces fast results and is easy to use in low-resource settings where laboratories are unavailable. 

The guide provides step-by-step instructions on the use of these tests and how best to communicate and follow up on patients after a test result is obtained. 

It also explains the best practice of testing within 5 to 7 days of the onset of symptoms. 

While rapid tests are easy to use in most instances, the guide lists where they should not be used. 

This includes testing patients without symptoms unless they are a close contact of a confirmed case; where there are no appropriate infection control measures in place; where test results will not influence the treatment of the patients and for screening at points of entry.

The use of rapid antigen tests is also not advised  prior to elective surgery or blood donation.

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R&D blueprint expands for COVID-19 epidemic and beyond

The R&D Blueprint is a global strategy and preparedness plan that allows the rapid activation of research and development activities during epidemics. 

It aims to fast-track the availability of effective tests, vaccines and medicines that can be used to save lives and avert large scale crises. 

With WHO as convener, WHO Member States welcomed the development of the Blueprint at the World Health Assembly in May 2016.

As part of WHO’s response to the coronavirus pandemic in 2020, the R&D Blueprint was activated during COVID-19 to accelerate diagnostics, vaccines and therapeutics for the novel virus. 

This aims to improve coordination between scientists and global health professionals, accelerate the research and development process, and develop new norms and standards to inform the global response.

Building on the response to recent outbreaks of Ebola virus disease, SARS-CoV and MERS-CoV, the R&D Blueprint has facilitated a coordinated and accelerated response to COVID-19.

In 202, WHO published the final version of Target Product Profiles (TPP) for priority COVID-19 diagnostics. These TPPs describe the desirable and minimally acceptable profiles for four tests.

  • Read more on the R&D Blueprint here
  • Read more on COVID-19 Blueprint  here
  • Read more on TPP here
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WHO product, policy and standards related to COVID-19

WHO’s health products policy and standards team supports countries to formulate evidence-based policies, and to ensure good practice and good governance throughout the supply chain.

Its work includes the Essential Diagnostic List (EDL), which aims to provide evidence-based guidance. The EDL is a reference for the development or update of national lists of essential in vitro diagnostic tests.

There are infographics and video clips available to explain the use of the EDL and the importance of diagnostics.

The health products policy and standards team also supports countries on access to health products for COVID-19. 

It works with the (ACT) Accelerator to enhance the development, manufacture, procurement and distribution of COVID-19 treatments for populations in low- and middle-income countries. This include medicines, vaccines, medical devices, and in vitro diagnostics. 

The WHO’s Disease Commodity Packages (DCPs) are a series of disease specific datasheets that list the critical commodities and the technical specifications for each commodity per disease. This overview includes links to DCPs for various diseases, including COVID-19, which may be downloaded.