Methodological evaluation of chemiluminescence microparticle immunoassay for determining HE4

Objective To evaluate the performance methodology of Chemiluminescence microparticle immunoassay(CMIA) for determining HE4 using Abbott Architect i2000SR Chemiluminescence analyzer.Methods According to a method by NCCLS recommended,we designed the evaluation program of quantitative detection methods.The within-run precision、between-run precision、linear range、carry-over and biological reference interval of HE4 were determined.Results The coefficient of variation(CV) of within-run precision of low and high value pooled serum were respectively 1.80% and 2.34%.The CV of between-run precision were respectively 2.03% and 2.70%.The linear range was from 19.8 pmol/L to 1 573.5 pmol/L.The 1carry-over was-0.02%.The biological reference interval was consistent with manufactures which is from 0.0 pmol/L to 140.0 pmol/L.Conclusion The within-run precision,between-run precision,linear range and carry-over of Abbott Architect i2000SR for determining HE4 meet the requirements of clinical use.The biological reference interval was consistent with that provided by the manufacturer.