The growing understanding of how sequence information can contribute to improved public health is driving global investments in sequencing facilities and programmes. The falling cost and complexity of generating GSD provides opportunities for expand
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ing sequencing capacity; however, challenges to widespread implementation remain. This document provides policy-makers and stakeholders with guidance on how to maximize the public health benefit of SARS-CoV-2 genomic sequencing activities in the short and long term as the pandemic continues to unfold. Practical considerations for the implementation of a virus genomic sequencing programme and an overview of the public health objectives of genomic sequencing are covered. This guidance focuses on SARS-CoV-2 but is applicable to other pathogens of public health concern.
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8 January 2021
Sequencing enabled the world to rapidly identify SARS-CoV-2 and develop diagnostic tests and other tools for outbreak management. Continued genome sequencing supports the monitoring
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of the disease’s spread and evolution of the virus. Accelerated integration of genome sequencing into the practices of the global health community is required if we want to be better prepared for the future threats. This document provides guidance for laboratories on maximizing the impact of SARS-CoV-2 sequencing now and other emerging pathogens in the future.
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Whole-genome sequencing (WGS) provides a vast amount of information and the highest possible resolution for pathogen subtyping. The application of WGS for global surveillance can provide information on the early emergence and spread of AMR and furth
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er inform timely policy development on AMR control. Sequencing data emanating from AMR surveillance may provide key information to guide the development of rapid diagnostic tools for better and more rapid characterization of AMR, and thus complement phenotypic methods. This document addresses the applications of WGS for AMR surveillance, including the benefits and limitations of current WGS technologies
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This technical guidance aims to provide guidelines to laboratories and relevant stakeholders in the European Union (EU), European Economic Area (EEA) and other countries in the WHO European region in making decisions on establishing sequencing capac
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ities and capabilities, in making decisions on which technologies to use and/or in deciding on the role of sequencing for SARS-CoV-2 diagnostics, research, outbreak investigations and surveillance. It addresses the most used sequencing technologies and their applications and proposes a central standardisation process to analyse and report the findings of SARS-CoV-2 genetic characterisations.
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This document aims to provide interim guidance for microbiology and virology experts, other laboratory professionals, laboratory managers, infectious disease programme managers, public health professionals and other stakeholders that provide primary, confirmatory or advanced testing for SARS-CoV-2,
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including genomic sequencing, or are involved in making decisions on establishing or scaling up capability and capacity to detect and characterize circulating SARS-CoV-2 variants.
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This document aims to describe a minimum set of surveillance activities recommended at the national level to detect and monitor the relative prevalence of SARS-CoV-2 variants and outline a set of activities for the characterization and assessment of risk posed by these variants. A set of indicators
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is also provided to standardize monitoring and public reporting of variant circulation.
The document is primarily intended for national and sub-national public health authorities and partners who support implementation of surveillance for SARS-CoV-2 variants
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The growing understanding of how sequence information can contribute to improved public health is driving global investments in sequencing facilities and programmes. The falling cost and complexity of generating GSD provides opportunities for expand
...
ing sequencing capacity; however, challenges to widespread implementation remain. This document provides policy-makers and stakeholders with guidance on how to maximize the public health benefit of SARS-CoV-2 genomic sequencing activities in the short and long term as the pandemic continues to unfold. Practical considerations for the implementation of a virus genomic sequencing programme and an overview of the public health objectives of genomic sequencing are covered. This guidance focuses on SARS-CoV-2 but is applicable to other pathogens of public health concern.
more
This document provides practical guidance on planning and implementing next-generation sequencing (NGS) technology for characterization of Mycobacterium tuberculosis complex (MTBC) bacteria. The aim is to detect mutations associated with drug resist
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ance in the context of a surveillance system for tuberculosis (TB).
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Pathogen genomic surveillance has become a priority for public health systems in recent years. Genomic sequencing is increasingly being used to characterize pathogens and monitor important public health priorities (e.g. poliovirus, influenza virus,
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Mycobacterium tuberculosis and Vibrio cholerae, antimicrobial resistance (AMR)). The decrease in cost and time of sequencing and the exponential development of bioinformatic pipelines have played a critical role in integrating pathogen genomics into routine public health surveillance. The coronavirus disease 2019 (COVID-19) pandemic has highlighted the role that sequencing plays in the surveillance of infectious diseases. Sequencing facilitates earlier detection, more accurate investigation of outbreaks, closer real-time monitoring of pathogen evolution and tailored development and evaluation of interventions to inform local to global public health decision-making and action. However, there remains a need to coordinate efforts, leverage and link existing surveillance and laboratory networks and capabilities, and systematically integrate genetic sequence data (GSD) with clinical and epidemiological data to strengthen its utility.
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The aim of the operational framework is to ensure 1) accurate collection, handling, shipment and storage of specimens collected in countries implementing HIV drug resistance surveillance; and 2) the availability of quality-assured HIV genotyping laboratory services producing comparable and reliable
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results at the national, regional and global levels.
This publication updates the WHO HIVResNet HIV drug resistance laboratory operational framework published in 2017 and reflects technical and strategic developments over the past three years.
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Mpox is an emerging zoonotic disease caused by the mpox virus, a member of the Orthopoxvirus genus closely related to the variola virus that causes smallpox. Mpox was first discovered in 1958 when outbreaks of a pox-like disease occurred in monkeys kept for research. The first human case was recorde
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d in 1970 in the Democratic Republic of the Congo (DRC) during a period of intensified effort to eliminate smallpox and since then the infection has been reported in a number of African countries. Mpox can spread in humans through close contact, usually skin-to-skin contact, including sexual contact, with an infected person or animal, as well as with materials contaminated with the virus such as clothing, beddings and towels, and respiratory droplets in prolonged face to face contact. People remain infectious from the onset of symptoms until all the lesions have scabbed and healed. The virus may spread from infected animals through handling infected meat or through bites or scratches. Diagnosis is confirmed by polymerase chain reaction (PCR) testing of material from a lesion for the virus’s DNA. Two separate clades of the mpox virus are currently circulating in Africa: Clade I, which includes subclades Ia and Ib, and Clade II, comprising subclades IIa and IIb. Clade Ia and Clade Ib have been associated with ongoing human-to-human transmission and are presently responsible for outbreaks in the Democratic Republic of the Congo (DRC), while Clade Ib is also contributing to outbreaks in Burundi and other countries.
In 2022‒2023 mpox caused a global outbreak in over 110 countries, most of which had no previous history of the disease, primarily driven by human-to-human transmission of clade II through sexual contact. In just over a year, over 90,000 cases and 150 deaths were reported to the WHO. For the second time since 2022, mpox has been declared a global health emergency as the virus spreads rapidly across the African continent. On 13 Aug 2024, Africa CDC declared the ongoing mpox outbreak a Public Health Emergency of Continental Security (PHECS), marking the first such declaration by the agency since its inception in 2017.7 This declaration empowered the Africa CDC to lead and coordinate responses to the mpox outbreak across affected African countries. On August 14, 2024, the WHO declared the resurgence of mpox a Public Health Emergency of International Concern (PHEIC) emphasizing the need for coordinated international response.
As of August 2024, Mpox has expanded beyond its traditional endemic regions, with new cases reported in countries including Sweden, Thailand, the Philippines, and Pakistan. Sweden has confirmed its first case of Clade 1 variant, which has been rapidly spreading in Africa, particularly in DRC. The emergence of this new variant raises concerns about its potential for higher lethality and transmission rates outside Africa.
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The Strategy provides a high-level unifying framework to leverage existing capacities, address barriers and strengthen the use of genomic surveillance in the detection, monitoring and response to public health threats. Genomic surveillance is part of the broader surveillance and laboratory system, a
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nd its implementation should reinforce end-to-end capacities including sample collection, diagnostics, data sharing and analysis. The strategy aims to facilitate the connectivity between different disease control programs and surveillance networks. This interoperability will strengthen the cross-cutting essential public health laboratory functions underpinning genomics holistically. The strategy articulates the overarching goal, objectives and strategic actions needed. These are dependent on commitments from countries, partners and WHO for their implementation.
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Sequencing SARS-CoV-2 in the Americas
The COVID-19 Genomic Surveillance Regional Network was created in 2020 not only to strengthen the sequencing capacity in the participating laboratories, but a
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lso for them to establish a routine SARS-CoV-2 genomic sequencing, as a strategy to increase the amount of genetic sequence data available to the global community, which is critical to support the development of diagnostic protocols, the information for vaccine development and to better understand the evolution and molecular epidemiology of the SARS-CoV-2.
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WHO-2019-nCoV-genomic_sequencing
Representative, quality, timely and continuous genetic surveillance of SARS-CoV-2 is critical to the COVID-19 outbreak response. This document provides practical guidance to Global Influenza Surveillance and Response System (GISRS) laboratories and other relevant national laboratories to move beyond
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virus detection to genomic sequencing of SARS-CoV-2 PCR positive materials obtained from sentinel surveillance of influenza-like illness (ILI), acute respiratory infection (ARI) and severe acute respiratory infection (SARI). It contains considerations on sample selection for sequencing, numbers of viruses to be sequenced, metadata and timeliness for sharing genetic sequence data (GSD) and opportunities for technical support.
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his guidance provides interim guidance for the integration of SARS-CoV-2 and influenza virologic and genomic surveillance, from sentinel site case enrolment and sampling to the eventual sharing of the virus sequence data, a process known as end-to-end surveillance. This guidance builds on experience
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s and lessons learned as countries adapted their influenza surveillance systems in the context of the COVID-19 pandemic and reviews new evidence to provide guidance on end-to-end surveillance. The guidance includes new algorithms and strategies to adapt sentinel systems to make them resilient and agile for addressing global and national surveillance needs for influenza and COVID-19.covid-
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