Open AccessMeasurement of HE 4 and CA 125 and establishment of reference intervals for the ROMA index in the sera of pregnant women
Author(s) -
Lu Jie,
Zheng Zhipeng,
Zhang Qi,
Li Guoli,
Li Fengying,
Le Zhian,
Huang Jun,
Xie Xinyou,
Zhang Jun
Publication year - 2018
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.22368
Subject(s) - medicine , cancer antigen , pregnancy , index (typography) , immunoassay , gynecology , tumor marker , obstetrics , andrology , cancer , immunology , antibody , biology , genetics , world wide web , computer science
Introduction Cancer antigen 125 ( CA 125) and human epididymis protein 4 ( HE 4) are biomarkers for ovarian cancer. Their specificity and sensitivity are often limited during pregnancy as a result of great fluctuations. The risk of ovarian malignancy algorithm ( ROMA ) score, which combines CA 125, HE 4, and menopausal status, may improve diagnostic performance. There are no reports regarding the ROMA index in pregnant women. Therefore, the aim of our study was to establish appropriate reference intervals ( RI s) for the ROMA index in pregnant Chinese women and compare them with those of CA 125 and HE 4 during pregnancy. Methods Serum concentrations of CA 125 and HE 4 were simultaneously measured in healthy pregnant women via electrochemiluminescence immunoassay ( ECLIA ). The ROMA index was calculated using premenopausal algorithms. Results The RI s for the ROMA index calculated by premenopausal algorithms were substantially closer to the normal range in the first 2 trimesters. For pregnant women, the great misclassifications identified in CA 125 may be reversed by the use of ROMA index. Conclusions We established the RI s for HE 4 and CA 125, as well as the ROMA index, in pregnant women at different gestational periods. The ROMA index is suggested to be a more promising tumor marker for pregnant women diagnosed with malignance.