Hallo,

Darauf kan man nicht genug verweisen!!!

20 January 2021 Medical product alert Geneva Reading time: 1 min (370 words)

Product type: Nucleic acid testing (NAT) technologies that use polymerase chain reaction (PCR) for detection of SARS-CoV-2

Date: 13 January 2021

WHO-identifier: 2020/5, version 2

Target audience: laboratory professionals and users of IVDs.

Purpose of this notice: clarify information previously provided by WHO. This notice supersedes WHO Information Notice for In Vitro Diagnostic Medical Device (IVD) Users 2020/05 version 1, issued 14 December 2020.

Description of the problem: WHO requests users to follow the instructions for use (IFU) when interpreting results for specimens tested using PCR methodology.

Users of IVDs must read and follow the IFU carefully to determine if manual adjustment of the PCR positivity threshold is recommended by the manufacturer.
...
Siehe weiter Quelle: https://www.who.int/news/item/20-01-2021-who-information-notice-for-ivd-users-2020-05

MfG. Reffke

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Die Lüge ist wahrer als die Wahrheit, weil die Wahrheit so verlogen ist. André Heller
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