Theory
The most reliable and accurate method of converting laboratory data is based upon the analysis of reference samples of human serum. The data harmonisation process involves the analysis of a quality reference material, of known parameter values, being analysed by each participating local laboratory. The analyses are conducted on a specified number of occasions and over a set period of time. The resulting data is then used to calculate a conversion factor for each parameter involved and applied to all subsequent data from each specific laboratory throughout the trial.
When identical reference standards are assayed by each laboratory, the resulting values can be linked to the defined reference standard values:
Sample | Lab 1 | Lab 2 | Ref Value |
---|---|---|---|
Level 1 reference material | 65 | 28 | 52 |
Level 2 reference material | 140 | 61 | 120 |
Reference Rang | 40-125 |
Analyses of identical reference standards at two levels by both laboratories