Int. J. Mol. Sci. 2017, 18, 341, 1 - 10
This report, published in conjunction with a summary overview of results of rounds 1–8, is the eighth and final report in a series of laboratory-based evaluations of rapid diagnostic tests (RDTs) for malaria. It provides a comparative measure of their performance in a standardized way to distingu...ish between well and poorly performing tests.
These results constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs and inform the current WHO procurement recommendations. In round 8, 35 RDTs from 17 manufacturers were assessed. For the first time the evaluation included an assessment of product performance against a panel of P. falciparum parasites with pfhrp2/3 gene deletions and therefore not expressing HRP2.
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The Lancet Global Health 2016 Published Online August 30, 2016
http://dx.doi.org/10.1016/S2214-109X(16)30175-9
Tokar et al. Health Research Policy and Systems (2019) 17:23 https://doi.org/10.1186/s12961-019-0415-4
These National Operational Guidelines for Viral Load Testing detail how routine viral load testing will be implemented at the facility level in India. They include frequency and interpretation of monitoring, sample collections, storage and transportation, receipt of results, adherence counseling, an...d reporting requirements. Roles and responsibilities are outlined as well as turnaround time requirements.
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This document provides a systematic approach in developing a coordinated, standardized, reliable, efficient, cost-effective, and sustainable specimen transport and referral system to support IVHD and VL testing networks. This document provides technical and programmatic recommendations on the approp...riate specimen storage and transportation of specimens for HIV VL and IVHD testing. Along with the national guidelines for specimen storage and transport, these standards should provide guidance on the creation or improvement of specimen referral networks and specimen transport systems. In addition, standard operating procedures (SOPs) targeting drivers and persons responsible for packing of specimens and results return are included in this document.
No publication year indicated in the document.
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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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Aлгоритм лабораторной диагностики и мониторинга лечения туберкулеза легких и туберкулеза с лекарственной устойчивостью на основе применения современных быстрых... молекулярных методов.
Экспертное заключение членов основной группы Европейской лабораторной инициативы, подготовленное для Европейского региона ВОЗ.
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Expert opinion of the European Tuberculosis Laboratory Initiative core group members for the WHO European Region.
This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
Interium guidance, 25 June 2021Timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. This document describes recommendations for national testing strategies and the use of PCR and rapid antigen tests in different transmission scenarios of t...he COVID-19 outbreak, including how testing might be rationalized in low resource settings. All testing should be followed by a strong public health response including isolating those who test positive and providing them care, contact tracing and quarantine of contacts.
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HIV-1 drug resistance (HIVDR) genotyping is an essential component of the WHO global HIVDR surveillance strategy. Plasma “gold standard” specimen type for HIVDR genotyping, but its use may not be feasible in rural, remote areas in low- and middle-income countries, since preparing and storing it ...require personnel and laboratory infrastructure that are often lacking. An alternative specimen type is dried blood spots (DBS), which can be made without special laboratory processing. DBS are more easily transported than plasma because they can be shipped at ambient temperature as non-hazardous materials using regular mail or courier services.
3rd edition
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ASLM in collaboration with the Africa Centres for Disease Control and Prevention, and in partnership with the Clinton Health Access Initiative, Amref and Last Mile Health present the Quality Assurance Framework for SARS-CoV-2 Antigen Rapid Testing for Diagnosis of COVID-19. This framework aims to pr...ovide general technical guidance to African Union Members States on the rollout, establishment, implementation, monitoring, and evaluation of SARS-CoV-2 Ag RDT interventions so as to effectively and efficiently detect, control and minimise errors in the performance of COVID-19 laboratory testing processes. It describes the core components for quality assurance, resources mobilisation and advocacy for scale up, monitoring, evaluation, learning and accountability for SARS-CoV-2 implementation.
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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 sel...f-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.ssur
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