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

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. 
Featured Work - Quality Assurance & Policy

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

Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid test and interpret their test result themselves at a time and place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting.

Read the full WHO interim guidance 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.

Featured Work - Quality Assurance & Policy Resource Centre - Policies

WHO policy brief: COVID-19 testing, 14 September 2022

Key points 

  • It remains critical for national programmes to continue to offer testing for COVID-19 in line with three main objectives: reduce morbidity and mortality through linkage to prompt care and treatment, reduce onward transmission and track the evolution of the epidemic and the virus itself.
  • Testing of suspected cases early in the disease course – especially among people at increased risk for hospitalization or severe COVID-19 – enables access to supportive care and COVID-19 therapeutics.
  • Confirming COVID-19 through testing for SARS-CoV-2 followed by isolation (and follow up of relevant contacts) can reduce transmission. At the population level, fluctuations in testing data can contribute to decisions on intensifying or relaxing public health and social measures.
  • WHO continues to recommend maintaining and strengthening COVID-19 surveillance, including use of sequencing, to monitor changes in epidemiological patterns, trends in morbidity and mortality, the burden of disease on health care capacity (health and care workers, hospitalizations and intensive care unit admissions) and the evolution and circulation of variants.

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