Abstract:

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.

Key words: Abbott architect i2000SR chemiluminescence analyzer；CMIA；HE4； Methodological evaluation