Study of Reference Materials and Establishment of the Metrological Traceability System for in Vitro Diagnostics

Hongmei LI, Key Laboratory of Chemical Metrology and Applications for State Market Regulation, National Metrology Institute, Beijing, China P. R. (lihm@nim.ac.cn)
Peng XIAO , Key Laboratory Of Chemical Metrology And Applications For State Market Regulation, National Metrology Institute, Beijing, China P. R.
Huan YAO, Key Laboratory Of Chemical Metrology And Applications For State Market Regulation, National Metrology Institute, Beijing, China P. R.

ISO 17511 defined different calibration hierarchies for practitioners to observe equivalent clinical testing results. Reference materials (RMs) and reference measurement procedures (RMPs) are the essentials among these calibration hierarchies. However, whilst the required metrological tools, such as higher order RMPs, pure substance and matrix certified RMs, are established for small well defined molecules, difficulties still remain in the provision of such standards in the area of diseases-related larger biomolecules notably peptides and proteins.

In recent years, my team has made some technological progress focusing on the high order measurement standards for large molecular biomarkers. The quantification approaches for matrix RMs were carefully researched and developed. A representative study is the SI-traceable certified reference material (CRM) of serum CRP. The RMPs targeted on serum cTnI, serum BNP, NT-proBNP and cerebrospinal fluid aβ40/42, are being carried out as planned.

Ensuring the equivalence of testing results from different laboratories and procedures is essential via metrological traceability of measurement standards for in-vitro diagnostics reagent (IVD). Until now, most SI-traceable CRMs developed by NIM have been adopted by Chinese IVD manufacturers (JCTLM stakeholders) as the calibrator for their reagents. We believe that the growing number of matrix CRMs would be applied to ensure the patients’ test results can be traced to SI or a uniform standard, further promoting the high-quality development of in vitro diagnostics.

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Short Biography of Presenting Author

Prof. Li is a committee member of CIPM/CCQM, member of ISO reference material committee, Chairperson of APMP Food Safety Focus Group (FSFG), etc. She also serves as an editor in Chief of Accreditation and Quality Assurance.

Her team has made breakthrough in: 1) the key technologies for separation and detection of pesticides, veterinary drugs and illicit drugs, supporting mutual recognition on Calibration and Measurement Capabilities(CMCs) for pure substances from China; 2) the measurement standards for biomarkers of major diseases including cardiovascular, cerebrovascular diseases, tumors etc., and for drugs of monoclonal antibodies and heparin in China.

She has won 2 second prize of National Prize for Progress in Science and Technology. She took part in the development of more than 300 national certified reference materials and issued 210 papers and 4 monographs.