ABSTRACT
Objective To explore the methods of preparing whole blood control of seven trace elements (magnesium,manganese,iron,copper,zinc,lead,calcium) in laboratory and evaluate its performance.Methods Heparin sodium anticoagulant calf whole blood was used as substrateMetal salt or standard solution with target concentration of each element was added.And whole blood control product was made after process of anticorrosion,mixing and sub-packaging.Antibacterial effect was observed,uniformity and stabilitywasevaluatedaccording to CNAS-GL03 and matrix effects was evaluatedaccording to CLSI EP14.SDI (standard deviation index) and detection coefficient of variation (CV)were calculated to evaluateapplication effectiveness.Results Laboratory preparation of whole blood control reached target concentration,sterility tests was qualified,results of uniformity and stability indicated that the substrate was even and stable at least for one year.Besides,matrix effects of other six elements can be ignored except lead.Historical and inter-laboratory comparisons had shown that laboratory preparation of whole blood control has no obvious difference with commercial ones in performance.Conclusion The formulation and evaluation scheme of whole blood control of seven trace elements (magnesium,manganese,iron,copper,zinc,lead,calcium) was feasible and can be used as commercial ones for elementary tests in medical laboratory.