Report of a trial with lyophilised QC sera in the CMCH/ACBI EQAS programmes in India

Abstract

2000 vials of lyophilized QC of two different levels (low and high) were donated by Roche Diagnostics GmbH, through the IFCC and received by CMCH in June 2001. A total of 240 la boratories were enrolled for this 6 month pilot study. In addition to the 12 analytes in the liquid QC programme, six additional analytes, LDH, triglyceride, urate, total bilirubin, phosphate and amylase were included. It was also possible to measure sodium and potassium by ion selective electrode (ISE) methods in the QC for the first time.The performance of the laboratories for the existing 12 analytes using liquid stabilized QC was compared to the performance using lyophilized QC. Using a statistical comparison of the methodwise mean variance index score (MVIS) values, five assays viz glucose, albumin, cholesterol, and SGOT and SGPT performance was the same in liquid QC and lyophilized QC. Three assays viz urea, calcium and creatinine were significantly better, and 4 assays total protein, sodium, potassium and ALP were significantly worse. However the overall VIS (OMVIS) for the laboratories was the same and the ranking pattern of this 6 month OMVIS was also unaltered.The lyophilized QC scheme highlighted a negative bias between flame and ISE methods for sodium and potassium, and a definite standardization problem in reporting LDH and amylase results, but triglyceride, urate and total bilirubin assays were performing well.It was concluded that the introduction of lyophilized QCs will not cause any deterioration of performance to participating laboratories. Stability of the material seems to be good and the laboratories are generally using a good reconstitution technique.