2020年2月10日 · In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means ‘in glass’, meaning these tests are typically conducted in test tubes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.

2023年10月19日 · Updated biennially, the Essential Diagnostics List is intended to support national in vitro diagnostics policy development and to improve access to IVD testing and clinical laboratory services. As well as informing national EDLs, it provides advice on prioritization of IVDs at different levels of the healthcare system.

2021年1月18日 · IVD users should routinely review test results to detect unexpected increases or decreases in test results, including positivity rate, target detection rate, invalid or unreturnable result rate, etc. These variations may be early indicators of impact on the safety, quality or performance of the IVD products.

2024年6月13日 · The Week of Quality for IVDs 2024 with the theme Optimising IVD product development: principles of design, quality and compliance is specifically designed to equip manufacturers and regulatory authorities in low- and middle-income countries (LMICs) with the essential knowledge and guidance needed to promote strategies for product design ...

2023年10月18日 · Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the methodologist that assessed the supportive ...

2019年8月6日 · This page provides answers to frequently asked questions relating to EUL assessment of in vitro diagnostics (IVD) to detect SARS-CoV-2 or anti-SARS-CoV-2 antibodies. These questions and answers provide additional clarity on the procedure and instructions documents published on our website and do not intended to introduce any new requirements or to modify any existing processes in place.

Technical specifications for in vitro diagnostics (IVDs) constitute a set of predefined criteria and baseline requirements to ensure good quality, safety, performance and efficacy. The specifications are companions to the WHO Model List of Essential In Vitro Diagnostics (EDL) and are provided to help Member States, donor agencies and nongovernmental organizations (NGOs) select specific ...

2021年1月29日 · 该清单中的建议建立在确凿证据之上，并考虑到了国家适用性。清单制定过程在体外诊断战略咨询专家组（sage ivd）的监督下进行，该小组由世界各地在体外诊断及其实施、使用、监管和评估领域具有长期经验的专家组成。

2022年11月18日 · The 4th SAGE IVD meeting was held on 14–18 November 2022 in a virtual format. On the first day of the meeting, the WHO EDL Secretariat organized an open webinar session with the participation of worldwide laboratory medicine professionals and nongovernmental organizations (NGOs), and representatives of WHO regional offices, country offices, and headquarters.In the subsequent days, the 2021 ...