Performance verification of lactate dehydrogenase in Johnson Vitros 5 .1 FS biochemical analyzer / 国际检验医学杂志

ABSTRACT

Objective To study the performance verification of lactate dehydrogenase(LDH) in the Johnson Vitros 5 .1 FS bio‐chemical analyzer .Methods According to CLSI instrumentation evaluation standard and referring to the validation scheme provided by the Johnson company ,the precision ,accuracy ,linear range of LDH ,maximum dilution degree ,biological reference range were verified .Results The LDH intra‐batch and inter‐batch precision experiments were≤3 .30% ;the accuracy experiment≤4 .00% ;the determination coefficient of the linear experiment was 0 .997 2 ;the LDH maximum dilution degree was 8 times with saline solution dilution;the biological reference range experiment verified that the reference range 313-618 U/L provided by the VITROS Meth‐odology Manual could be quote .Conclusion The performance verification of LDH detected by the Johnson Vitros 5 .1 FS biochemi‐cal analyzer basically conforms to the requirements of the quality objectives and manufacturer′s instructions ,and meets the needs of clinical test .