MEDBOX | Toolbox Diagnostics & Laboratory Guidance

Methods for the detection and characterisation of SARS-CoV-2 variants: second update, 21 June 2022

World Health Organization WHO, Regional Office of Europe (2022) C_WHO

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, 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

Tags: SARS-CoV-2, détection, laboratory, laboratory management, laboratory work,

Source: https://apps.who.int/iris/bitstream/hand

Detecção e diagnóstico de SARS-CoV-2 no contexto da circulação da variante de preocupação Ômicron

Pan American Health Organization PAHO, World Health Organization WHO (2022) C_WHO

Tags: Coronavirus, COVID-19, SARS-CoV-2, diagnóstico, laboratórios, omicron,

Source: https://www.paho.org/pt/file/101812/down

World Health Organization WHO (2022) C_WHO

Весь персонал, проводящий экспресс-диагностику антигена SARS-CoV-2 (Ag-RDT), должен понимать, как безопасно проводить тестирование, обеспечивать качество тестирования и интерпретировать результаты. Этот курс был разработан ВОЗ и FIND, Глобальным альянсом по диагностике, для предоставления теоретических знаний по тестированию SARS-CoV-2 Ag-RDT. Учебный пакет состоит из 10 модулей, включающих видео и презентаци�

Tags: COVID-19, SARS-CoV-2, RDT, rapid antigen test, Online Courses,

Source: https://openwho.org/courses/SARS-CoV-2-A

Implementation of simultaneous diagnostic testing for COVID-19 and TB in high TB burden countries

Stop TB Partnership; WHO (2022) C_WHO

Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19

Tags: TB, COVID-19, Policy, Testing, diagnostic,

Source: https://www.stoptb.org/file/9883/downloa

Antigen-Tests auf SARS-CoV-2 zur professionellen Anwendung

Paul-Ehrlich-Institu PEI (2022) CC

25 März 2022

Tags: SARS-CoV-2, Rapid Diagnostic Tests, Schnelltest, COVID-19, Antigen testing,

Source: https://antigentest.bfarm.de/ords/antige

Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing

World Health Organization WHO (2022) C_WHO

9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid test and interpret their test result themselves at a time and place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting

Tags: COVID-19, self-testing, RDT, antigen, rapid antigen test,

Source: https://www.who.int/publications/i/item/

Interim guidance on COVID-19 Rapid Antigen self-testing to African Union Member States

African Union; Africa CDC Centres for Disease Control and Prevention (2022) C1

This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssu

Tags: rapid antigen test, COVID-19, self-testing, Africa, Surveillance, Outbreak Control, household, Ethical Issues,

Source: https://africacdc.org/download/interim-g

Vergleichende Evaluierung der Sensitivität von SARS-CoV-2-Antigenschnelltests

Paul-Ehrlich-Institu PEI (2022) CC

Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV. Das BfArM bietet eine Liste von Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen

Tags: rapid antigen test, evaluierung, Schnelltest, COVID-19,

Source: https://www.pei.de/DE/newsroom/dossier/c

Manual de Biossegurança Laboratorial. Quarta Edição

Organización Mundial de la Salud OMS PAHO (2021) C_WHO

Esta quarta edição do manual se baseia no esquema de avaliação de risco apresentado na terceira edição. Uma avaliação completa, baseada em evidências e transparente dos riscos permite que as medidas de segurança sejam equilibradas com o risco real de trabalhar com agentes biológicos, caso a caso. Isso permitirá que os países implementem políticas e práticas de biossegurança e biosseguridade laboratoriais economicamente viáveis e sustentáveis que sejam relevantes para suas circunstâncias e prioridades individuais.A necessidade de atualizar as diretrizes de biossegurança de laboratórios internacionais faz parte de uma iniciativa mais ampla para globalizar a biossegurança e enfatizar os princípios e as abordagens que são acessíveis a países que tenham ampla gama de recursos financeiros, técnicos e regulatórios. A OMS revisou o Regulamento Sanitário Internacional em 2005 “para ajudar a comunidade internacional a prevenir e a responder aos riscos agudos de saúde pública que tenham o potencial de cruzar fronteiras e ameaçar pessoas em todo o mundo”. Esses regulamentos exigem que todos os 196 estados-membros da OMS estejam bem preparados para surtos em potencial e novas doenças; isso inclui o diagnóstico precoce e a confirmação laboratorial para facilitar a prevenção e o controle de infecções

Tags: COVID-19, laboratory biosafety, Manual, Infection Prevention and Control (IPC), Brazil, biosecurity,

Source: https://iris.paho.org/handle/10665.2/545

World Health Organization WHO (2021) C_WHO

Interim guidance, 6 October 2021 Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage

Tags: diagnostic, Testing, Laboratory diagnostics, COVID-19, SARS-CoV-2, antigen, Rapid Diagnostic Tests, rapid antigen test,

Source: https://apps.who.int/iris/rest/bitstream

	Methods for the detection and characterisation of SARS-CoV-2 variants: second update, 21 June 2022 World Health Organization WHO, Regional Office of Europe (2022) C_WHO View PDF(0) Download (0) Add to my MEDBOX 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, 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 Tags: SARS-CoV-2, détection, laboratory, laboratory management, laboratory work, Source: https://apps.who.int/iris/bitstream/hand
	Detecção e diagnóstico de SARS-CoV-2 no contexto da circulação da variante de preocupação Ômicron Pan American Health Organization PAHO, World Health Organization WHO (2022) C_WHO View PDF(11) Download (13) Add to my MEDBOX Tags: Coronavirus, COVID-19, SARS-CoV-2, diagnóstico, laboratórios, omicron, Source: https://www.paho.org/pt/file/101812/down
	Диагностический экспресс-тест на антигены SARS-CoV-2 World Health Organization WHO (2022) C_WHO Open external link (82) Add to my MEDBOX Весь персонал, проводящий экспресс-диагностику антигена SARS-CoV-2 (Ag-RDT), должен понимать, как безопасно проводить тестирование, обеспечивать качество тестирования и интерпретировать результаты. Этот курс был разработан ВОЗ и FIND, Глобальным альянсом по диагностике, для предоставления теоретических знаний по тестированию SARS-CoV-2 Ag-RDT. Учебный пакет состоит из 10 модулей, включающих видео и презентаци� Tags: COVID-19, SARS-CoV-2, RDT, rapid antigen test, Online Courses, Source: https://openwho.org/courses/SARS-CoV-2-A
	Implementation of simultaneous diagnostic testing for COVID-19 and TB in high TB burden countries Stop TB Partnership; WHO (2022) C_WHO View PDF(16) Download (37) Add to my MEDBOX Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infections, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19 Tags: TB, COVID-19, Policy, Testing, diagnostic, Source: https://www.stoptb.org/file/9883/downloa
	Antigen-Tests auf SARS-CoV-2 zur professionellen Anwendung Paul-Ehrlich-Institu PEI (2022) CC Open external link (71) Add to my MEDBOX 25 März 2022 Tags: SARS-CoV-2, Rapid Diagnostic Tests, Schnelltest, COVID-19, Antigen testing, Source: https://antigentest.bfarm.de/ords/antige
	Use of SARS-CoV-2 antigen-detection rapid diagnostic tests for COVID-19 self-testing World Health Organization WHO (2022) C_WHO View PDF(10) Download (17) Add to my MEDBOX 9 March 2022, Timely and accurate diagnostic testing for SARS-CoV-2 is an essential part of a comprehensive COVID-19 response strategy. Ag-RDTs can be performed by individuals in which they collect their own specimen, perform a simple rapid test and interpret their test result themselves at a time and place of their choosing, termed COVID-19 self-testing. This interim guidance provides a new recommendation that COVID-19 self-testing, using SARS-CoV-2 Ag-RDTs, should be offered as part of SARS-CoV-2 testing services. It also includes implementation considerations that can guide decisions on whether, and how, to adopt self-testing in different contexts, including the populations being prioritized; the disease prevalence in that population; and the impact on accessibility of testing, health care services and result reporting Tags: COVID-19, self-testing, RDT, antigen, rapid antigen test, Source: https://www.who.int/publications/i/item/
	Interim guidance on COVID-19 Rapid Antigen self-testing to African Union Member States African Union; Africa CDC Centres for Disease Control and Prevention (2022) C1 View PDF(9) Download (15) Add to my MEDBOX This guidance addresses rationale, risk-based scenarios, practical considerations prior to adoption of the self-testing products, quality assurance, safety and ethical considerations, and data management considerations for COVID-19 self-testing. The Africa CDC recommends the use of rapid antigen self-testing within two key scenarios. The first includes testing for case identification within scenarios with a high risk of infection, including symptomatic cases and contacts of a confirmed case. The second scenario involves general screening within scenarios of low or unknown risk exposure allowing for self-care such as before gatherings with at-risk individuals and prior to participation in events involving members of different households. Within these scenarios, a positive test result indicates likelihood of current infection, while a negative test result indicates a lower risk of active infection, though it does not rule out infection altogether. All positive cases should be managed following the national COVID-19 management protocol of Member States.ssu Tags: rapid antigen test, COVID-19, self-testing, Africa, Surveillance, Outbreak Control, household, Ethical Issues, Source: https://africacdc.org/download/interim-g
	Vergleichende Evaluierung der Sensitivität von SARS-CoV-2-Antigenschnelltests Paul-Ehrlich-Institu PEI (2022) CC Open external link (387) Add to my MEDBOX Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV. Das BfArM bietet eine Liste von Antigen-Tests zum direkten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen Tags: rapid antigen test, evaluierung, Schnelltest, COVID-19, Source: https://www.pei.de/DE/newsroom/dossier/c
	Manual de Biossegurança Laboratorial. Quarta Edição Organización Mundial de la Salud OMS PAHO (2021) C_WHO View PDF(5) Download (10) Add to my MEDBOX Esta quarta edição do manual se baseia no esquema de avaliação de risco apresentado na terceira edição. Uma avaliação completa, baseada em evidências e transparente dos riscos permite que as medidas de segurança sejam equilibradas com o risco real de trabalhar com agentes biológicos, caso a caso. Isso permitirá que os países implementem políticas e práticas de biossegurança e biosseguridade laboratoriais economicamente viáveis e sustentáveis que sejam relevantes para suas circunstâncias e prioridades individuais.A necessidade de atualizar as diretrizes de biossegurança de laboratórios internacionais faz parte de uma iniciativa mais ampla para globalizar a biossegurança e enfatizar os princípios e as abordagens que são acessíveis a países que tenham ampla gama de recursos financeiros, técnicos e regulatórios. A OMS revisou o Regulamento Sanitário Internacional em 2005 “para ajudar a comunidade internacional a prevenir e a responder aos riscos agudos de saúde pública que tenham o potencial de cruzar fronteiras e ameaçar pessoas em todo o mundo”. Esses regulamentos exigem que todos os 196 estados-membros da OMS estejam bem preparados para surtos em potencial e novas doenças; isso inclui o diagnóstico precoce e a confirmação laboratorial para facilitar a prevenção e o controle de infecções Tags: COVID-19, laboratory biosafety, Manual, Infection Prevention and Control (IPC), Brazil, biosecurity, Source: https://iris.paho.org/handle/10665.2/545
	Antigen-detection in the diagnosis of SARS-CoV-2 infection World Health Organization WHO (2021) C_WHO View PDF(29) Download (21) Add to my MEDBOX Interim guidance, 6 October 2021 Direct detection of SARS-CoV-2 viral proteins (antigens) in nasal swabs and other respiratory secretions using lateral flow immunoassays (also known as rapid diagnostic tests, RDTs) offers a faster and less expensive method to test for SARS-CoV-2 than the reference method, nucleic acid amplification tests (NAATs). This interim guidance offers recommendations on the priority uses of antigen-detecting rapid diagnostic tests (Ag-RDTs) in specific populations and settings, including (i) for primary case detection in symptomatic individuals suspected to be infected and asymptomatic individuals at high risk of COVID-19, (ii) for contact tracing, (iii) during outbreak investigations and (iv) to monitor trends of disease incidence in communities. Ag-RDTs meeting minimum performance requirements can be used outside of clinical and laboratory settings, including in communities, by trained operators in accordance with instructions. The guidance additionally provides recommendations on implementation, product selection and storage Tags: diagnostic, Testing, Laboratory diagnostics, COVID-19, SARS-CoV-2, antigen, Rapid Diagnostic Tests, rapid antigen test, Source: https://apps.who.int/iris/rest/bitstream

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