2015-10-24-世界卫生组织-WHO_BS_2015.2256_WHO_International_Collaborative_Study_of_the_Proposed_1st_IS_for_human_C-peptide_76页_1mb

WHO International Collaborative Study for Proposed 1st International Standard for Human C-Peptide

The World Health Organisation (WHO) Expert Committee on Biological Standardisation (ECBS) identified the need for a replacement for the existing International Reference Reagent (IRR) for human C-peptide (code 84/510), as stocks were exhausted. An international collaborative study was conducted from October 2014 to September 2015, involving 24 laboratories in 10 countries, to characterize and assign a value to a candidate standard (13/146).

The study had three phases:

• Phase I: Assigned a primary calibrant (PC01) value of 209 µg C-peptide per ampoule using amino acid analysis.
• Phase II: Calibrated the candidate standard 13/146 via HPLC, yielding a content of 8.64 µg/ampoule with expanded uncertainty 8.21-9.07 (95% confidence; k=2.45). Stability testing showed minimal degradation.
• Phase III: Confirmed immunological activity and commutability with serum and urine samples using immunoassay, indicating suitability for calibration.

The candidate standard was established as the 1st WHO International Standard for human C-peptide. Comments on this proposal were requested by 28 September 2015.