WP 9 Standardization


Newly developed diagnostic tests have to fulfil the requirements laid down in the “Manual of Standards for Diagnostic Tests and Vaccines” (OIE, 2008). Therefore, a first estimation of analytical and diagnostic sensitivity and specificity as well as repeatability will be done for each test by the partners during test development. For this purpose they will use a set of own samples. Once the tests have passed this first step of quality control their further evaluation will be done by a Proficiency Test (PT) organized by partner 9 in close cooperation with the partners of the FNG and WP3.

The partners in charge of the development of the assays will educate the members of the field net group how to use the tests.

The aim of this PT is to demonstrate the sensitivity and specificity as well as repeatability and robustness of the tests in other laboratories than the developing laboratory. Where necessary the results will be used to improve the tests. The PT will be organized according to the ISO 17043. The PT provider will put all the results of all participants in their central Laboratory Integrated Management System (LIMS). Also the participants are asked (via clear instructions: see subtask 9.2) to put their results and to report to the PT provider via their LIMS.

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