Comparison and bias evaluation of two methods for detection of pepsinogen / 国际检验医学杂志

ABSTRACT

Objective To explore the consistency of chemiluminescence microparticle immunoassay(CMIA)reagent and particle‐enhanced turbidimetric immunoassay(PETIA) reagent for detecting pepsinogen(PG) ,so as to provide laboratory references for en‐suring the reliability of PETIA reagent in detecting PG .Methods According to the requirement of EP9‐A2 file made by the Nation‐al Committee for Clinical Laboratory Standards(NCCLS) ,taking PETIA as evaluating method and CMIA as reference method ,a to‐tal of 92 specimens collected from patients with various degrees of gastric atrophy were selected ,PETIA and CMIA reagents were utilized for bidirectional detection of PG .Then recorded test results of pepsinogenⅠ(PGⅠ) ,and PGⅠ /pepsinogenⅡ(PG Ⅱ) rati‐o ,and carried out method comparison and bias evaluation for the two kinds of reagents .Results The expected relative bias of detec‐tion results of PGⅠ and PGⅠ /PG Ⅱ ratio by using PETIA and CMIA reagents were acceptable within linear range of methods . Conclusion The results of PGⅠ and PG Ⅱ detected by using PETIA reagent could be accepted .