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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.
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Drinking-water quality regulations and standards developed or revised in accordance with this guidance will reflect the best practices identified in the WHO Guidelines for Drinking-water Quality to most effectively protect public health. Moreover, t
...
he regulations and standards will consider local needs, priorities and capacities to ensure that they are realistic and appropriate. Topics covered include:
- Guiding principles
- Getting started
- Selecting parameters and parameter limits
- Setting out compliance monitoring requirements more
- Guiding principles
- Getting started
- Selecting parameters and parameter limits
- Setting out compliance monitoring requirements more
The country profiles incorporate facts indicating the national status of medical devices in areas such as: medical device policies, regulations, incorporation, lists, inventories, nomenclature, health technology assessment, management, and biomedi
...
cal engineering resources. This publication is intended for use as a reference by decision-makers in Ministries of Health, nongovernmental organizations and academic institutions involved in health technology at the district, national, regional, or global levels.
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"Achieving, maintaining and improving accuracy, timeliness and reliability are major challenges for health laboratories. Countries worldwide committed themselves to build national capacities for the detection of, and response to, public
...
health events of international concern when they decided to engage in the International Health Regulations implementation process. Only sound management of quality in health laboratories will enable countries to produce test results that the international community will trust in cases of international emergency. This handbook is intended to provide a comprehensive reference on Laboratory Quality Management System for all stakeholders in health laboratory processes, from management, to administration, to bench-work laboratorians. This handbook covers topics that are essential for quality management of a public health or clinical laboratory. They are based on both ISO 15189 and CLSI GP26-A3 documents"--Page 7.
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