Health
World Health Organization issues notice for in vitro diagnostics users – News-Medical.Net
Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2.
Product type: Nucleic acid testing (NAT) technologies that use real-time polymerase chain reaction (RT-PCR) for detection of SARS-CoV-2
Date: 7 December 2020
WHO-identifier: 2020/5, version 1
Purpose of this notice: To ensure users of certain nucleic acid testing (NAT) technologies are aware of certain aspects of the instructions for use (IFU) for all products.
Description of the problem: WHO has received user feedback on an elevated risk for false SARS-CoV-2 results when testing specimens using…
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