WHO Information Notice for IVD Users 2021/01

Product type: All in vitro diagnostic medical devices (IVDs) for detection of SARS-CoV-2

Date: 18 January 2021                                                                   

WHO-identifier: 2021/01, version 1  

Target audience: Laboratory professionals and users of IVDs.  

Purpose of this notice: To request that IVD users monitor mutations of SARS-CoV-2 and their impact on diagnosis. 

Description of the problem: 

Following the detection of SARS-CoV-2 variants containing mutations, including SARS-CoV-2 VOC 202012/01, and SARS-CoV-2 501Y.V2, WHO reminds users of IVDs to monitor detection rates for SARS-CoV-2 at their site.  

IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products. Certain mutations may increase the risk of delayed diagnosis (due to inconclusive or invalid results), and misdiagnosis. 

Manufacturers of IVDs listed by WHO (through Emergency Use Listing) must proactively scan literature and other sources for any documented mutations that might impact the safety, quality or performance of their product. This should be incorporated as part of their post-market surveillance plan and will be supplemented by feedback reported by IVD users in the form of unexpected results, as well as other product problems and adverse events. All gathered information must be reviewed in a timely fashion, using risk management principles to determine any necessary actions. 

Advice on action to be taken by IVD users:  

IVD users should notify the IVD manufacturer in the following circumstances: 

  1. Increased discrepancies in cycle threshold (Ct) values between different gene targets. 

  1. Failure to detect specific gene targets, including those containing gene sequences that coincide with documented mutations.  

  1. Misdiagnosis (for example, false negative).  

See WHO website for reporting form for IVD users to give feedback to manufacturers  

Contact person for further information: 

Anita SANDS, Regulation and Prequalification, World Health Organization,  
e-mail: rapidalert@who.int 

Reference: 

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.  

 

 

Product type: All in vitro diagnostic medical devices (IVDs) for detection of SARS-CoV-2

Date: 18 January 2021                                                                   

WHO-identifier: 2021/01, version 1  

Target audience: Laboratory professionals and users of IVDs.  

Purpose of this notice: To request that IVD users monitor mutations of SARS-CoV-2 and their impact on diagnosis. 

Description of the problem: 

Following the detection of SARS-CoV-2 variants containing mutations, including SARS-CoV-2 VOC 202012/01, and SARS-CoV-2 501Y.V2, WHO reminds users of IVDs to monitor detection rates for SARS-CoV-2 at their site.  

IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products. Certain mutations may increase the risk of delayed diagnosis (due to inconclusive or invalid results), and misdiagnosis. 

Manufacturers of IVDs listed by WHO (through Emergency Use Listing) must proactively scan literature and other sources for any documented mutations that might impact the safety, quality or performance of their product. This should be incorporated as part of their post-market surveillance plan and will be supplemented by feedback reported by IVD users in the form of unexpected results, as well as other product problems and adverse events. All gathered information must be reviewed in a timely fashion, using risk management principles to determine any necessary actions. 

Advice on action to be taken by IVD users:  

IVD users should notify the IVD manufacturer in the following circumstances: 

  1. Increased discrepancies in cycle threshold (Ct) values between different gene targets. 

  1. Failure to detect specific gene targets, including those containing gene sequences that coincide with documented mutations.  

  1. Misdiagnosis (for example, false negative).  

See WHO website for reporting form for IVD users to give feedback to manufacturers  

https://www.who.int/health-topics/substandard-and-falsified-medical-products/safety-info-medical-devices-in-vitro-diagnostics  

Contact person for further information: 

Anita SANDS, Regulation and Prequalification, World Health Organization,  
e-mail: rapidalert@who.int 

Reference: 

Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics. Geneva: World Health Organization; 2020. Licence: CC BY-NC-SA 3.0 IGO.  

 

 

Next Post

GACVS COVID-19 Vaccine Safety subcommittee meeting to review reports of deaths of very frail elderly individuals vaccinated with Pfizer BioNTech COVID-19 vaccine, BNT162b2

Ming Jan 24 , 2021
<p>The GACVS COVID-19 Vaccine Safety subcommittee met virtually on Tuesday, 19 January 2021, to review available information and data on deaths reported in frail, elderly individuals who had received the Pfizer BioNTech COVID-19 mRNA vaccine, BNT162b2 (hereafter, BNT162b2). Experts invited from the European Medicines Agency (EMA) and the Uppsala Monitoring Center (UMC) provided an overview of deaths reported in Europe and in the WHO global database (VigiBase) following vaccination with BNT162b2. </p><p> </p><p>Based on a careful scientific review of the information made available, the subcommittee came to the following conclusions:</p><p> </p><p>The current reports do not suggest any unexpected or untoward increase in fatalities in frail, elderly individuals or any unusual characteristics of adverse events following administration of BNT162b2. Reports are in line with the expected, all-cause mortality rates and causes of death in the sub-population of frail, elderly individuals, and the available information does not confirm a contributory role for the vaccine in the reported fatal events. In view of this, the committee considers that the benefit-risk balance of BNT162b2 remains favourable in the elderly, and does not suggest any revision, at present, to the recommendations around the safety of this vaccine. </p><p> </p><p>Countries should continue to monitor the safety of vaccines, and promote routine after-care following immunization, consistent with good immunization practices for any vaccine. The committee recommends that data on suspected adverse events should be collected and reviewed continuously - nationally, regionally, and globally - as the COVID-19 vaccines are rolled out, world-wide<a href="/Users/lamprianous/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/JP4M0NUW/GACVS%20subcommittee%20summary_20Jan_Final.docx#_ftn1" name="_ftnref1">[1]</a>. </p><p> </p><p>The GACVS subcommittee will continue to monitor the safety data from these vaccines and update any advice as necessary.</p><p> </p><div><br><div><p><a href="/Users/lamprianous/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/JP4M0NUW/GACVS%20subcommittee%20summary_20Jan_Final.docx#_ftnref1" name="_ftn1">[1]</a> The WHO COVID-19 vaccine safety surveillance manual provides guidance to countries on the safety monitoring and adverse events data sharing for the new COVID-19 vaccines, and can be accessed <a href="https://apps.who.int/iris/bitstream/handle/10665/338400/9789240018280-eng.pdf?sequence=1&isAllowed=y">here</a>.</p></div></div>