ArticlePractical laboratory medicine2021
Comparison of two immunoassays for the measurement of serum HE4 for ovarian cancer.
Article in Practical laboratory medicine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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Who cites it
9 citing papers in PubMed, 14 citations in OpenAlex.
- Evaluation of the Comparability of Wantai Wan200+ Instrument with Routine Laboratory Assays for 21 Different Analytes.Journal of clinical medicine · 2024Article
- Comparison of the ADNEX and ROMA risk prediction models for the diagnosis of ovarian cancer: a multicentre external validation in patients who underwent surgery.British journal of cancer · 2024Article
- Article
- Protein Glycosylation as Biomarkers in Gynecologic Cancers.Diagnostics (Basel, Switzerland) · 2022Review
- Serum CA125 and HE4 as Biomarkers for the Detection of Endometrial Cancer and Associated High-Risk Features.Diagnostics (Basel, Switzerland) · 2022Article
- Urine CA125 and HE4 for the Triage of Symptomatic Women with Suspected Endometrial Cancer.Cancers · 2022Article
- Article
- New Analytical Approach for the Alignment of Different HE4 Automated Immunometric Systems: An Italian Multicentric Study.Journal of clinical medicine · 2022Article
- HE4 as a Biomarker for Endometrial Cancer.Cancers · 2021Review
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Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe use of Human Epididymis Protein 4 (HE4) as a biomarker for ovarian cancer is gaining traction, providing the impetus for development of a high throughput automated HE4 assay that is comparable to the conventional manual enzyme immunometric-assay (EIA). The aim of this study was to compare two immunoassay methods for the measurement of serum HE4. MATERIALS AND
methods1348 serum samples were analysed for serum HE4 using both the EIA and the automated chemiluminescent immunoassay (CLEIA) methods. HE4 values were compared using a Passing-Bablok regression and agreement assessed using Lin's concordance correlation coefficient (CCC). The absolute and percentage bias of the CLEIA compared to EIA was determined.
resultsThere was moderate agreement between the two methods (CCC 0.929, 95%CI 0.923-0.936). Passing-Bablok regression demonstrated an overestimation of the CLEIA [constant 4.44 (95%CI 2.96-5.68), slope 1.04 (95%CI 1.02-1.07)]. The CLEIA method had a mean percentage bias of 16.25% compared to the EIA method.
conclusionThe CLEIA significantly overestimated serum HE4 values compared to the EIA, which could impact clinical interpretation and patient management. Further studies are required to develop an appropriate cut-off depending on the population being investigated and the analytic method being used.
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