A candidate reference method for determination of total protein in serum. II. Test for transferability

Area of Science:

• Clinical Chemistry
• Biotechnology
• Analytical Chemistry

Background:

• Accurate measurement of total serum protein is crucial for clinical diagnostics.
• Standardization of analytical methods is essential for reliable laboratory results.
• The candidate Reference Method for total serum protein required validation for inter-laboratory transferability.

Purpose of the Study:

• To assess the transferability of a candidate Reference Method for total serum protein.
• To evaluate the method's performance in multiple independent laboratories.
• To establish the reliability of the method for routine clinical use.

Main Methods:

• The study involved eight laboratories in the United States and Europe.
• National Bureau of Standards SRM 927 (bovine serum albumin) was used as the calibration standard.
• Four serum pools were analyzed over 15 days to assess variation.

Main Results:

• The mean absorptivity value for the calibration standard was 0.2983 L g-1 cm-1.
• Within-run coefficients of variation (CV) ranged from 0.1% to 2.5%.
• Day-to-day (total) variation was between 0.4% and 1% in most laboratories.

Conclusions:

• The candidate Reference Method for total serum protein is transferable across different laboratories.
• The method exhibits acceptable precision for reliable protein quantification.
• This validation supports the adoption of the method for standardized clinical laboratory testing.