Testing and diagnosis of hepatitis B (HBV) and C (HCV) infection is the gateway for access to both prevention and treatment services, and is a crucial component of an effective response to the hepatitis epidemic. Early identification of persons with chronic HBV or HCV infection enables them to recei...ve the necessary care and treatment to prevent or delay progression of liver disease. Testing also provides an opportunity to link people to interventions to reduce transmission, through counselling on risk behaviours and provision of prevention commodities (such as sterile needles and syringes) and hepatitis B vaccination.
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The overall objective of this implementation plan is to define the strategy for implementation of the Xpert MTB/RIF test for rapid detection of TB and rifampicin (RIF) resistance in Tanzania, within the context of the National Tuberculosis and Leprosy Programme (NTLP) strategic plan and other nation...al health guidelines. It is intended to serve as the main guiding document for national, regional and local programme managers, clinicians, coordinators, laboratory staff and other health workers; national and regional reference laboratories; local and international implementing partners; and donors involved in TB control.
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Following review of the latest evidence, WHO recommends that TB-LAMP can be used as a replacement for microscopy for the diagnosis of pulmonary TB in adults with signs and symptoms of TB. It can also be considered as a follow-on test to microscopy in adults with signs and symptoms of pulmonary TB, e...specially when further testing of sputum smear-negative specimens is necessary.
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4th edition
The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors globally, serving as a de facto global standard that presents best practices and sets trends in biosafety.
LBM encouraged countries t...o accept and implement basic concepts in biological safety and to develop national codes of practice for the safe handling of biological agents in laboratories within their geographical borders.
This fourth edition of the manual builds on the risk assessment framework introduced in the third edition. A thorough, evidence-based and transparent assessment of the risks allows safety measures to be balanced with the actual risk of working with biological agents on a case-by-case basis.
This novel evidence- and risk-based approach will allow optimised resource use and sustainable laboratory biosafety and biosecurity policies and practices that are relevant to their individual circumstances and priorities, enabling equitable access to clinical and public health laboratory tests and biomedical research opportunities without compromising safety.
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The updated List of Essential Diagnostics contains 46 general tests that can be used for routine patient care as well as for the detection and diagnosis of a wide array of disease conditions, and 69 tests intended for the detection, diagnosis and monitoring of specific diseases.
The List is divid...ed into two sections depending on the user and setting: one for community settings, which includes self-testing; and a second one for clinical laboratories, which can be general and specialized facilities.
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This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional considerations in the procurement of rapid tests.
The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. These guidelines include laboratory design considerat...ions, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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Due to the anticipated significant rise in VL testing occasioned by Ghana’s adaptation of 2016 ART guidelines, it has become necessary to develop this VL scale-up and operational plan to assure complete client access to laboratory monitoring towards the achievement of the third 90 of the HIV care ...cascade. The plan will enhance VL testing, monitoring whilst improving the clinical and laboratory interface for improved client care.
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User GuideThe toolkit is composed of three sections: Hospital and Health System Resources - includes a readiness assessment tool, the starting point in developing or enhancing a successful Antimicrobial Stewardship Program (ASP). The tool, a checklist developed by the CDC, should be shared with se...nior management, a senior leader for quality, purchasing directors, clinic managers, nurse managers, key physician leaders, risk managers, pharmacy leaders, infection preventionists and hospital epidemiologists, laboratory staff and information technology staff. For ease of use, it is divided into two sections, one for those just beginning a program, the other for those who wish to enhance an existing program. Clinician Resources - includes webinars, clinical evidence supporting appropriate use of antibiotics, implementation guides and related articles.Patient Resources - includes frequently asked questions, pamphlets and handouts on how patients can best engage in their care and resources on appropriate use of antibiotics.
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6 July 2021. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included.
The latest operational handbook includes the new classes recommended by WHO. It aims at facilitating the implementation of the WHO recommendations by the Member States, technical partners, and ot...hers involved in managing patients with TB and DR-TB. The operational handbook provides practical information on existing and new tests recommended by WHO, step-by-step advice on implementing and scale-up testing to achieve local and national impact and lastly, model diagnostic algorithms, which are updated to incorporate the latest recommendations. An overview of budgetary considerations and information sheets on each of the newly recommended tests is provided.
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This publication is based on the list of clinical interventions selected from clinical guidelines on prevention, screening, diagnosis, treatment, palliative care, monitoring and end of life care. This publication addresses medical devices for six types of cancer: breast, cervical, colorectal, leukem...ia, lung and prostate. The first section defines the global increase in cancer cases, the global goals to manage NCDs and the WHO activities related to these goals. The second section presents the methodology used for the selection of medical devices that support clinical interventions required to screen, diagnose, treat and monitor cancer stages, as well as the provision of palliative care, based on evidence-based information. The third section lists the priority medical devices required to manage cancer in seven different units of health care services: 1. Vaccination, clinical assessment and endoscopy, 2. Medical imaging and nuclear medicine, 3. Surgery, 4. Laboratory and pathology, 5. Radiotherapy, 6. Systemic therapy and 7. Palliative and end of life care
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6 July 2021. The “WHO consolidated guidelines on tuberculosis. Module 3: Diagnosis - Rapid diagnostics for tuberculosis detection 2021 update” is the latest document replacing the one issued in 2020. Three new nucleic acid amplification test (NAAT) classes are endorsed by WHO and included in the... latest consolidated guideline
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The Committee discussed the implications for preparedness for smallpox-like events reflected by the ongoing COVID-19 pandemic. The Committee noted how quickly diagnostics and vaccines could be developed and deployed when resources and political will were abundant. This rapidity was also due to the f...act that the genetic sequence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) had been shared worldwide. It was noted that in one country SARS-CoV-2 had been reconstructed in a laboratory from the viral genome sequence before the first case of COVID-19 had been reported, highlighting the benefits of synthetic biology technologies for accelerated development of diagnostics as well as the oft-described potential risks. Lessons learned about clinical care during the COVID-19 pandemic were also discussed.
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The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was form...ed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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Most neglected tropical diseases (NTDs) occur in remote areas of low- and middle-income countries, where health systems are often poorly developed. Therefore, these neglected patients generally lack access to quality preventive, diagnostic, and therapeutic care [1]. The difficulty to access NTD-ende...mic areas, challenging logistics, and the lack of skilled human resources in these areas are also major obstacles to conduct clinical research. We had to face these when conducting a good clinical practice/good clinical laboratory practice (GCP/GCLP)-compliant clinical study in eastern Sudan, a well-known endemic area for visceral leishmaniasis and other NTDs. We share here the challenges related to study preparation and implementation of this GCP/GCLP study that investigated the causes of persistent fever in a rural hospital located in Gedaref State in eastern Sudan. We think this type of paper may be of interest for researchers planning to conduct a clinical trial in a resource-limited setting as well as for funders of such research.
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Despite the development of point-of-care diagnostic tests for syphilis, chlamydia, gonorrhoea, and trichomoniasis, none comply with all WHO criteria. This analysis overviews landscape analyses of point-of-care diagnostic technologies for Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vagi...nalis and syphilis, available and in the pipeline. The target audience for the target product profiles is broad and includes clinicians, researchers working on diagnostics, laboratory experts, including, microbiologists and virologists, public health experts, epidemiologists, developers, and representatives for manufactures, including biotech engineers, policy-and decision-makers as well as representatives from regulatory bodies and agencies, donor agencies and international organizations.
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This brief update on tuberculosis (TB) in the African region covers the state of TB in the WHO African region, strategic priorities and targets and the impact of COVID-19 on essential services. This is followed by key figures for the region, the role of WHO in country support and, recognizing the im...portance of diagnosis and drug susceptibility testing, a focus onstrengthening laboratory networks and the regional laboratory and diagnostic objectives. A brief update of the state of the science and how this is funded across the African region is provided, before closing with challenges and opportunities,strategic directions and a brief discussion of funding concerns. Discussions around the drivers of the disease, and issues of the poverty, inequality and stigma that continue to plague those living with TB are fully recognized, but are outside the scope of this report.
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