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Euro Surveill. 2015 Mar 26;20(12). pii: 21073.
Epidemiologisches Bulletin3 | 202121. Januar 2021 (online vorab)
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 ... more
This guideline is for: • health and care practitioners • health and care staff involved in planning and delivering services • commissioners. The recommendations bring together: • existing national and international guidance and policies • advice from specialists working in the NHS fr ... more
TARGET PRODUCT PROFILE
The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test i ... more
Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar ... more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar ... more
The development of this target product profile (TPP) was led by the WHO Department of Control of Ne- glected 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 ... more
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national mal ... more
Localized cutaneous leishmaniasis and its evolving forms (diffuse cutaneous leishmaniasis, mucosal leishmaniasis and cutaneous leishmaniasis recidivans), together with the sequela of visceral leishmaniasis (post-kala-azar dermal leishmaniasis), account for about one million cases of dermal leishmani ... more
BMJ Open 2021;11:e042279. doi:10.1136/bmjopen-2020-042279. Neglected tropical diseases tend to cluster in the same poor populations, and to make progress with their control, they will have to be dealt with in an integrated manner. Peptide microarrays may be a solution to tese problems, where diagnos ... more
TEchnical Note
Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV. Das BfArM bietet eine Liste von ... more
Die Liste wird kontinuierlich aktualisiert und beinhaltet die entsprechenden Tests zur professionellen Anwendung, die sich nach aktueller Kenntnis des BfArM in Deutschland in Verkehr befinden und laut den Herstellerangaben die jeweils aktuellen durch das Paul-Ehrlich-Institut (PEI) in Abstimmung mit ... more
TECHNICAL SPECIFICATIONS FOR TEST SELECTION ESSENTIAL IN VITRO DIAGNOSTIC TESTS FOR SARS-COV-2