Low cost quality control human serum: method of preparation, validation of values and its comparison with the commercial control serum.

ABSTRACT

OBJECTIVE: To prepare low-cost quality controls (QC) human serum and scientifically evaluate its advantages/disadvantages when compared with commercially available sera. METHODS: The home made QC serum was prepared as per WHO recommended protocol from four healthy volunteers. It was screened for HIV, HCV and HBV, pooled together and stabilized with ethylene glycol. The initial 40 values were used for calculation of means, SDs and CVs for seventeen routinely measured analytes and results were compared with those of commercially available lyophilized human sera. RESULTS: The average concentrations of seventeen commonly analyzed constituents were found to be near the middle of the physiological range of healthy subjects and the home made serum could be a good substitute for the commercial serum of normal range. The narrower CVs of the analytes imply a lesser vial to vial variation in the home made sera. Additional advantages include easy preparation, no need for reconstitution and lower cost. CONCLUSION: Home made serum is a good substitute for the commercial serum of the normal range especially in developing countries like Pakistan.