With peptide and amino acid standards, the traceability to SI unit of protein quantitation was re...

Start Date

End Date

Staff

Related Programs and Projects

Contact Us

General Information:

Address: No.18,Bei San Huan
Dong Lu,Chaoyang
Dist,Beijing,P.R.China, 100013

ws@nim.ac.cn
Tel:+86-10-64525678

Research on Key Technology of Protein Quantitation and CRM Development for Medical Devices and IVD Reagents

 

With the development of biological science and industry, more and more protein biomarkers are discovered and applied for clinical laboratory tests. At the same time, the corresponded in-vitro diagnostic devices and IVDs are developed. However, poor comparable results and incomplete traceability chain become a serious problem due to the lack of metrological standards including higher order CRMs.

 

To solve the problems, traceability chain of protein quantitation was investigated and established. With peptide and amino acid standards, the traceability to SI unit of protein quantitation was realized by means of isotope dilution mass spectrometry technology. Compared with previous reports, several systematic errors were eliminated, such as protein impurities, degradation of amino acids, incomplete proteolysis and so on. Therefore, a lower uncertainty was achieved for protein quantitation. The revised IDMS technology was applied for development of protein CRMs. Solid bovine serum albumin, bovine serum albumin solution, HbA1c and C-peptide CRMs were developed by IDMS technology. Based on these higher order protein CRMs, calibration regulations of immune-analyzer, glycated hemoglobin analyzer, and serum protein analyzer were drafted. Both CRMs and regulations have been applied for calibration of in-vitro diagnostic systems in several hospitals, which benefit improving the comparability of clinical laboratory results.