Author(s)

Alan Ninad

Affiliation(s)

The Park Centre for Mental Health, Wacol, Queensland, Australia.

Corresponding Author

Alan Ninad

ABSTRACT

The construction of laboratory medicine reference measurement system is an important guarantee for the traceability of medical laboratory test results, and is also an important basis for achieving standardization and mutual recognition of results. Over the past half century, a laboratory medicine reference measurement system structured around reference measurement procedures, reference materials and reference measurement laboratories has been basically formed and gradually improved. In the past 10 years, the development of China's medical reference measurement laboratories has made significant progress, but the research on reference measurement procedures and reference materials lags behind. The six papers published in the special topic "Research and Application of Reference Measurement Systems in Laboratory Medicine" respectively deal with standardization of clinical chemistry, establishment of reference measurement procedures and uncertainty assessment, development of reference materials and evaluation of matrix effects, and the application of reference measurement systems in in vitro diagnosis. Products (IVD) and applications in laboratory quality evaluation are introduced, hoping to provide reference for further promoting the research and application of Chinese medical reference measurement systems.

KEYWORDS

Measurement system; Measurement procedure; Material; Measurement laboratory

CITE THIS PAPER

Alan Ninad. Research and application of laboratory medicine reference measurement system. World Journal of Clinical Sciences. 2024, 2(1): 12-15. DOI: 10.61784/wjcs240156.

REFERENCES

[1] International Organization for Standardization. In vitro diagnostic medical devices-requirements for establishing metrological traceability of values assig ned to calibrators, truthness control materials and human samples. ISO 17511, ISO, 2020.

[2] International Organization for Standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirements for content and presentation of reference measurement procedures. ISO 15193, ISO, 2009.

[3] International Organization for Standardization. In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-requirements for certified reference materials and the content of supporting documentation. ISO 15194, ISO, 2009.

[4] International Organization for Standardization. General requirements for the competence of testing and calibration laboratories. ISO/IEC 17025, ISO, 2017.

[5] International Organization for Standardization. Laboratory medicine-requirements for the competence of calibration laboratories using reference measurement procedures. ISO 15195, ISO, 2018.

[6] Zhou Weiyan, Liu Qingxiang, Liu Jenny. Metrological traceability and clinical testing reference system. Journal of Clinical Laboratory, 2020, 38(10): 721-728.

[7] Clinical and Laboratory Standards Institute. Characterization and qualification of commutable reference materials for laboratory medicine; approved guideline. EP30-A, CLSI, ISO, 2010.

[8] Clinical and Laboratory Standards Institute. Evaluation of commutability of processed samples; approved guideline—third edition. EPl4-A3, CLSI, ISO, 2014.

[9] MILLER WG, SCHIMMEL H, REJ R. IFCC working group recommendations for assessing commutability part 1: general experimental design. Clin Chem, 2018, 64(3): 447-454.

[10] NILSSON G, BUDD J R, GREENBERG N. IFCC working group recommendations for assessing commutability part 2: using the difference in bias between a reference material and clinical samples. Clin Chem, 2018, 64 (3): 455-464.

[11] International Organization for Standardization. Uncertainty of measurement-part 3: guide to the expression of uncertainty in measurement (GUM: 1995). ISO/IEC Guide 98-3, ISO, 2008.

[12] ELLISON S L R, ROSSEIN M, WILLIAMS A. EURACHEM/CITAC guide : quantifying uncertainty in analytical measurement. EURACHEM/CITAC, 1995.

[13] International Organization for Standardization. Propagation of distributions using a Monte Carlo method. ISO/IEC Guide 98-3/Supplement 1, ISO, 2008.

[14] International Organization for Standardization. In vitro diagnostic medical devices-requirements for international harmonization protocols establishing metrological traceability of values assigned to calibrators and human samples. ISO 21151, ISO, 2020.

[15] International Organization for Standardization. Conformity assessment-general requirements for pro?ciency testing. ISO/IEC 17043, ISO, 2010.