Performance verification of chemiluminesent micropaticle immunoassay for 6-indicator sex hormones / 国际检验医学杂志

ABSTRACT

Objective To verify and evaluate the methodological performance of chemiluminesent micropaticle immunoassay(CMIA) in the ARCHITECT i2000SR analyzer for detecting estradiol(E2),progesterone(Prog),luteinizing hormone(LH),follicle stimulating hormone(FSH),prolactin(PRL) and testosterone(Tes).Methods The precision,accuracy,linearity range,reference interval and low detection limit in the 6-indicator sex hormones detection were verified according to the CLSI related documents.The results were compared with the performance indicators or acceptable quality target claimed by the manufacturer.Results The within-run imprecision of 6-indicator sex hormones was ≤2.62%,the total imprecision was ≤3.17%.Accuracy was within ±9.41%.The slope(a) within linearity was 1.00 ±0.05,and the correlation coefficient(r2) was >0.995.The coincidence rate of reference interval was ≥90%.The low detection limits were less than the indicator claimed by the manufacturer.Conclusion The methodological performance of 6-indicator sex hormones detected by the ARCHITECT i2000SR analyzer is satisfactory,reliable in detection results and suitable for clinical needs.