Optimizing Available Tools for Achieving Result Standardization: Value Added by Joint Committee on Traceability in Laboratory Medicine (JCTLM)

Abstract

Background The JCTLM created a Task Force on Reference Measurement System Implementation (TF-RMSI) to provide guidance on metrological traceability implementation for the in vitro diagnostics (IVD) community. Content TF-RMSI investigated the reference measurement systems (RMS) for 13 common measurands by applying the following procedural steps: (a) extracting data from the JCTLM database of available certified reference materials (CRMs) and reference measurement procedures (RMPs); (b) describing the RMS to which each recruited CRM or RMP belongs; (c) identifying the intended use of the CRMs, and, if used as a common calibrator for IVD measuring systems and/or trueness assessment of field methods was included, checking the CRM’s certificate for information about commutability with clinical samples; and (d) checking if the CRM or RMP measurement uncertainty (MU) has the potential to be small enough to avoid significantly affecting the analytical performance specifications (APS) for MU of clinical sample results when the MU from the IVD calibrator and from the end-user measuring system were combined. Summary We produced a synopsis of JCTLM-listed higher-order CRMs and RMPs for the selected measurands, including their main characteristics for implementing traceability and fulfilling (or not) the APS for suitable MU. Results showed that traceability to higher-order references can be established by IVD manufacturers within the defined APS for most of the 13 selected measurands. However, some measurands do not yet have suitable CRMs for use as common calibrators. For these measurands, splitting clinical samples with a laboratory performing the RMP may provide a practical alternative for establishing a calibration hierarchy.

Overview of metrological traceability of total PSA diagnostic kits inbrazilian clinical laboratories

“…A utilização de materiais comutáveis e a participação em programas externos de avaliação da qualidade também são importantes para a avaliação do desempenho do IVD-MD 44 . O JCTLM tem sido fundamental no fornecimento de orientações sobre a implementação da rastreabilidade para fabricantes de IVD, com foco em sistemas de medição de referência (RMS) e seu impacto nas medições clínicas 45 .…”

Evaluation of Coefficients of Variation for Clinical Chemistry Tests Based on Internal Quality Control Data Across 5,425 Laboratories in China From 2013 to 2022

“…Even the minimum goal will be difficult to achieve for all three analytes. Recently, a performance specification for Na was suggested, with a desirable CV of 0.3% and minimum CV of 0.4%, levels that at present cannot be achieved with any routine method [13,14]. The specification for Na measurement should not be based on BV as the present analytical quality seems to meet the present medical need [15].…”

Definition and application of performance specifications for measurement uncertainty of 23 common laboratory tests: linking theory to daily practice

“…where u cal =√(u ref 2 + u value assignment 2 + u bias 2 ), if not negligible, and u Rw is defined by ISO/TS 20914:2019 as "uncertainty component under conditions of within-laboratory precision" [3]. Because more than one metrological traceability option may be available for the transfer trueness process and MU of IVD-MD may be influenced by the selected traceability chain [33], u cal should be always provided as combined with uncertainties introduced by higher levels of the selected calibration hierarchy. In practice, however, few, if none, manufacturers provide u cal estimated as described above.…”

“…In previous papers, we discussed in detail the issue of MU of serum albumin and how MU of the currently available reference material (i.e., ERM-DA470k/IFCC) is probably not small enough to guarantee the performance needed in terms of MU for the clinical usefulness of the test [4,37,38]. We previously recommended that no more than one third of APS for MU should be consumed by the u ref , letting the remaining allowable uncertainty available for other MU sources in the lower parts of calibration hierachy, i.e., u value assignment and u Rw [33,39]. Serum albumin is therefore representative of a measurand for which it should be a priority to significantly reduce the uncertainty associated to the upper levels of metrological chain.…”