WHO has listed the first two diagnostic tests for emergency use during the Covid-19 pandemic. The move should help increase access to quality-assured, accurate tests for the disease. It also means that the tests can now be supplied by the United Nations and other procurement agencies supporting the COVID-19 response.
Both in vitro diagnostics, the tests are genesig Real-Time PCR Coronavirus (COVID-19) and cobas SARS-CoV-2 Qualitative assay for use on the cobas® 6800/8800 Systems.
“The emergency use listing of these products will enable countries to increase testing with quality assured diagnostics,” says Dr Mariângela Simão, WHO Assistant-Director General for Medicines and Health Products. “Facilitating access to accurate tests is essential for countries to address the pandemic with the best tools possible.”
The Emergency Use Listing procedure (EUL) was established to expedite the availability of diagnostics needed in public health emergency situations. It is intended to help procurement agencies and countries navigate the large presence of different devices on the market and, by assessing them, provides assurance of the products’ quality and performance.
The genesig Real-Time PCR Coronavirus (COVID-19) (Primerdesign, United Kingdom) is an open system more suitable for laboratories with moderate sample testing capacity, while the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems (Roche, United States of America) is a closed system assay for larger laboratories.
EUL listed products:
https://www.who.int/diagnostics_laboratory/200407_eul_sars_cov2_product_list.pdf?ua=1
Roche test:
https://www.who.int/diagnostics_laboratory/eul_0504-046-00_cobas_sars_cov2_qualitative_assay_ifu.pdf?ua=1
Primerdesign test:
https://www.who.int/diagnostics_laboratory/eul_0489_185_00_path_covid19_ce_ivd_ifu_issue_2.0.pdf?ua=1
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