Supporting prioritization efforts of higher-order reference providers using evidence from the Joint Committee for Traceability in Laboratory Medicine database.

Abstract

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) database represents a valuable resource for implementing metrological traceability in laboratory medicine. Three main database users can be identified: (a) in vitro diagnostic (IVD) manufacturers, using the database information for meeting ISO 17511:2020 requirements, (b) laboratory professionals, for defining the quality of their test results, and (c) providers of higher-order certified reference materials (CRM) and reference measurement procedures (RMP), to be helped in improving the suitability of their products, if needed, and assistance with prioritizing their future efforts. In this report, we focus on the utility of the information provided (or still not provided) by the JCTLM database on this last category of users. Two types of information are discussed: (a) the use of listed CRMs as common calibrators intended to transfer trueness from the top of the calibration hierarchy to commercial IVD calibrators, and (b) the measurement uncertainty (MU) of CRM certified values and the reproducibility characteristics of RMP measurements, considering their impact on the MU of clinical samples, when compared to maximum allowable MU (MAU). The discussion output is a recommendation for suppliers to respond urgently to the need to provide higher-order references (CRMs and/or RMPs) for a number of key analytes that are currently lacking or do not yet fully meet quality criteria related to: (a) commutability assessment, (b) contribution to MAU fulfilment, and (c) demonstration of the extent of equivalence to an already listed higher-order reference.