WHO Information Notice for IVD Users
Date: 7 December 2020
https://www.who.int/news/item/14-12-2020-who-information-notice-for-ivd-users
Therefore, healthcare providers are encouraged to take into consideration testing results along with clinical signs and symptoms, confirmed status of any contacts, etc.
Users of RT-PCR reagents should read the IFU carefully to determine if manual adjustment of the PCR positivity threshold is necessary to account for any background noise which may lead to a specimen with a high cycle threshold (Ct) value result being interpreted as a positive result.
the IFU will state that the cut-off should be manually adjusted to ensure that specimens with high Ct values are not incorrectly assigned SARS-CoV-2 detected due to background noise.
Advice on action to be taken by users:
Healthy people pretending to be sick for almost one year.
Date: 7 December 2020
https://www.who.int/news/item/14-12-2020-who-information-notice-for-ivd-users
Therefore, healthcare providers are encouraged to take into consideration testing results along with clinical signs and symptoms, confirmed status of any contacts, etc.
Users of RT-PCR reagents should read the IFU carefully to determine if manual adjustment of the PCR positivity threshold is necessary to account for any background noise which may lead to a specimen with a high cycle threshold (Ct) value result being interpreted as a positive result.
the IFU will state that the cut-off should be manually adjusted to ensure that specimens with high Ct values are not incorrectly assigned SARS-CoV-2 detected due to background noise.
Advice on action to be taken by users:
- Please read carefully the IFU in its entirety.
- Contact your local representative if there is any aspect of the IFU that is unclear to you.
- Check the IFU for each incoming consignment to detect any changes to the IFU.
- Consider any positive result (SARS-CoV-2 detected) or negative results (SARS-CoV-2 not detected) in combination with specimen type, clinical observations, patient history, and epidemiological information.
- Provide the Ct value in the report to the requesting healthcare provider.
Healthy people pretending to be sick for almost one year.