![]() ![]() The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for: The three different types of COVID-19 diagnostic tests UNICEF distributes globally are explained below.MaThe FDA has finalized two guidances: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19). In addition, extraction kits and sample collection kits were offered. In addition, thousands of other items, including extraction kits, calibration plates, transport media and swabs were distributed to improve and assist COVID-19 testing.īy the end of 2020 the UNICEF Supply Catalogue featured a variety of COVID-19 tests available for global procurement, including 11 molecular (PCR) tests for manual use, four molecular (PCR) tests for automated use, and two antigen-detecting rapid tests. In partnership with the Nigeria Central Disease Control, UNICEF procured eight different types of COVID-19 tests that were delivered to 50 diagnostics laboratories across the country. While most countries relied on two to four select products, in Nigeria, an approach for diversification of the supplier base was taken, which helped prevent critical dependencies, allowing for a competitive market and ability to adapt to different needs per location. In 2020, over 3.7 million COVID-19 tests were distributed to 63 countries, with the largest proportions sent to Nigeria, India, Uganda, Iran and Zimbabwe. In parallel, with a new quality assurance policy developed for procuring COVID-19 diagnostics, UNICEF launched a dynamic tender process designed to capture all types of new tests (including rapid diagnostic tests), thereby enabling for immediate access to the market.ĬOVID-19 diagnostics delivered to 63 countries in 2020 ![]() ![]() At the onset of the pandemic, UNICEF urgently initiated the preparatory work by leveraging existing long-term agreements with major diagnostics suppliers. UNICEF’s groundwork enabled a rapid responseĪs a global leader in procuring, distributing and programming for disease diagnostics – including for the Ebola, Zika virus, malaria and HIV diseases – UNICEF already had a solid system in place. Therefore, the World Health Organization (WHO) launched their Emergency Use Listing (EUL) – a risk-based procedure for assessing and listing essential emergency health products – to expedite the availability of COVID-19 diagnostics.Īt the same time, countries began urgently looking to UNICEF for support, as the demand for tests quickly began to rise. However, the quality and acceptability of the tests were uncertain. With no vaccine available at that time and many uncertainties in the air, reliable tests were essential to help contain the spread of the disease.ĭiagnostics manufactures quickly responded to the emergency needs, and by early 2020, several new COVID-19 tests were already on the market. With the declaration of the COVID-19 pandemic in March 2020, diagnostic testing became a crucial part of the global response. ![]()
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