Validation of a new cellulose acetate membrane named “SELECA-VSP” for electrophoretic fractionation of serum protein: Collaborative study to evaluate lot-to-lot variation and inter-laboratory comparison

Abstract

In order to substitute SELECA-VSP for SEPARAX-SP, we investigated membrane performance difference among SELECA-VSP lots and among laboratories. We examined three lots of SELECA-VSP, namely T10, T12 and T14. Automated electrophoresis system for protein fraction test used are Olympus AES series in two laboratories and JOKOH CTE series in other two laboratories. The 4 laboratories assayed common serum samples as usual procedure of each laboratory.
Among different membrane lots, good correlation between each two lot was observed in the five serum protein fractions. There was statistically significant difference among the membrane lots, however, it might be only due to good reproducibility and statistics. The bias was below clinical permission limit.
Among laboratories, good correlation between each two laboratory was observed in the five serum protein fractions. The bias between laboratories is below permission limit, compared with bias detected from external quality assessment program for SEPARAX-SP.
In conclusion, because the bias in membrane lots and laboratories can be ignored for laboratory diagnosis of serum protein fraction test, SELECA-VSP will come onto the market to make up for SEPARAX-SP.