This concept note describes the methods used to assess the prevalence of any HIVDR and HIVDR by PMTCT exposure among children less than 18 months of age using remnant dried blood spot specimens from early infant diagnosis over a 12-month period
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 ...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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Antimicrobial Resistance Surveillance and Research Network | This manual describes well accepted methods to carry out drug susceptibility testing on important gram positive and gram negative clinically relevant bacteria. Methods of specimen collection, transport, culture, anti-microbial drug suscept...ibility testing (common, special phenotypic and
molecular techniques) as well as quality control and quality assurance have been described in a concise manner.
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2nd edition .
This Framework applies to the sharing of H5N1 and other influenza viruses with human pandemic potential and the sharing of benefits. This Framework does not apply to seasonal influenza viruses or other non-influenza pathogens or biological substances that may be contained in clinical ...specimens shared under this Framework
This second edition of the Pandemic Influenza Preparedness (PIP) Framework reflects an amendment to Annex 2, Standard Material Transfer Agreement 2, Footnote 1, that was adopted by the Seventy-second World Health Assembly in May 2019.The amendment clarifies that, under certain circumstances, the indirect use of PIP Biological Materials will require the conclusion of an SMTA2. The amendment is in effect from the closure of the Seventy-second World Health Assembly (28 May 2019).
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The Virtual Microscope is a full-fledged simulation that allows users to select and position slides, adjust lighting, magnification and focus, and measure specimens. A narrated demonstration is available to guide students through the steps required to bring a specimen into focus. There is also a che...cklist that indicates which steps have been completed successfully
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Accessed 2017
Please Download all Documents directly from the website: https://www.finddx.org/tb-laboratory-standard-operating-procedures-sops/
Laboratory Quality (TB01), General Procedures (TB02), Specimen Handling (TB03), Microscopy Procedures (TB04), Culture and drugs susceptibility testing (T...B05), Molecular methods (TB06), Equipment use and maintenance (TB07).
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This job aid provides information for laboratorians about how to receive, process, and store dried blood spot specimens collected for early infant diagnosis, viral load, or drug resistance testing.
A technical guide for sputum smear microscopy, initiated by the International Union against Tuberculosis, is designed to be an easy to use reference standard for the collection, storage and transport of sputum specimens and for the examination of sputum smears by direct microscopy. This edition incl...udes updates addressing bio-safety and quality assurance aspects of sputum smear microscopy.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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In this document, recommendations are provided on designing and implementing
a cross-sectional serosurvey using school-based sampling to estimate age-specific
DENV seroprevalence to inform a country’s national dengue vaccination program.
The document includes recommendations for methods for ...planning and conducting
serosurveys, including survey design, specimen collection, laboratory testing, data
analysis, and the interpretation and reporting of results.
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This document aims to provide guidance to healthcare facilities and healthcare providers in the European Union/European Economic Area (EU/EEA) and the United Kingdom (UK) on preparedness and infection prevention and control (IPC) measures for the management of possible and confirmed cases of COVID-1...9 in healthcare settings, including long-term care facilities (LTCFs). In addition, this document addresses the management of clinical diagnostic specimens at laboratories in the EU/EEA. This is the sixth update of the ECDC guidance on ‘Infection prevention and control and preparedness for COVID-19 in healthcare settings’, and replaces the document dated 6 October 2020.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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The latest update (28 January 2021) includes the following addition and revision:
biosafety aspects for working with antigen-detecting rapid diagnostic test;
handling new variants of SARS-CoV-2 in the laboratory;
updated assay decontamination before disposal;
personal protectiv...e equipment (PPE) for specimen collection;
addressing chemical hazards and their safe disposal; and
the fourth edition of the WHO Laboratory Biosafety Manual (LBM4) is now available and the terminology in this guidance was aligned with the LBM4.
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28 January 2021. The purpose of this document is to provide interim guidance on laboratory biosafety related to the testing of clinical specimens of patients.
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 a...nd 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.
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Any individual that meets the suspected case definition of monkeypox should be offered testing in appropriately equipped laboratories by staff trained in the relevant technical and safety procedures. Confirmation of monkeypox virus infection is based on nucleic acid amplification testing (NAAT), usi...ng real-time or conventional polymerase chain reaction (PCR), for detection of unique sequences of viral DNA. PCR can be used alone, or in combination with sequencing. The recommended specimen type for laboratory confirmation of monkeypox is skin lesion material, including swabs of lesion surface and/or exudate, roofs from more than one lesion, or lesion crusts.
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The meeting was held from 26 to 27 March 2018 to review and discuss the following topics:
Advances and challenges in the use of fTLC, and new approaches to detecting mycolactone using monoclonal antibodies (mAbs).
The status of development of rapid diagnostic tests (RDTs) targeting the M...UL_3720 protein.
The role of PCR as a reference test, and hurdles in providing a confirmatory diagnosis and in establishing a quality assurance programme.
New molecular tools with potential for implementation at a level lower than in the national or regional reference laboratory, such as loop-mediated isothermal amplification (LAMP) and recombinase polymerase amplification (RPA).
The need to harmonize and standardize methods for collection and preparation of specimens, so samples can be referred for diagnosis and stored for evaluation of new diagnostic tests in optimal conditions.
Barriers to accessing early diagnosis and treatment, including coordination at the programme level, and lack of adequate diagnostic tools.
Defining target product profiles (TPPs) to guide the development of new diagnostic tools that can be applied at different levels of the health system. Participants agreed that two TPPs would be developed to address the current gaps: (i) a rapid test for BU diagnosis at the primary health-care level; and (ii) a test for diagnosis of BU that can also assist in treatment monitoring and differential diagnosis at the district hospital or reference centre.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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This updated manual provides a basic understanding of the principles of laboratory and point-of-care (POC) testing in the context of screening and diagnostic approaches, as well as antimicrobial susceptibility testing, as components of sexually transmitted infections (STIs) control. As with previous... editions, this manual covers each disease in a separate chapter which provides detailed information on specimen collection, transport and laboratory testing. Two useful annexes covering media, reagents, diagnostic tests and stains (recipes) and laboratory supplies are included at the end of the manual.
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Anaemia is a serious global public health problem that particularly affects young children, menstruating adolescent girls and women, and pregnant and postpartum women. It is a condition in which the number of red blood cells or the haemoglobin concentration within them is lower than normal, affectin...g the blood’s ability to carry oxygen to the body’s tissues.
To reliably monitor the prevalence of anaemia at a population level, it is vital to measure the haemoglobin concentration in an accurate and precise way. In large-scale surveys, however, haemoglobin is most commonly measured using single-drop capillary blood specimens in point-of-care devices. Emerging evidence suggests that the use of single-drop capillary blood can introduce random and/or systematic errors, which may lead to inaccurate estimates, complicating effective anaemia programming.
This technical brief describes the current best practices for haemoglobin measurement, providing guidance to help plan or implement field surveys to assess anaemia at a population level. Continuing work to review emerging evidence is led by members of the WHO-UNICEF Technical Expert Advisory group on nutrition Monitoring (TEAM).
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