We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
LGC Clinical Diagnostics

FUJIREBIO

Fujirebio is a global leader in the field of IVD testing with more than 50 years’ experience in the conception, devel... read more Featured Products: More products

Download Mobile App




Immunoassays Compared for Serum HE4 Estimation for Ovarian Cancer

By LabMedica International staff writers
Posted on 26 Jul 2021
Print article
Image: The HE4 EIA is an enzyme immunometric assay for the quantitative determination of human epididymis protein 4 (HE4) in human serum. HE4 is consistently expressed in patients with ovarian cancer, and it has demonstrated increased sensitivity and specificity over that of CA125 alone (Photo courtesy of Fujirebio)
Image: The HE4 EIA is an enzyme immunometric assay for the quantitative determination of human epididymis protein 4 (HE4) in human serum. HE4 is consistently expressed in patients with ovarian cancer, and it has demonstrated increased sensitivity and specificity over that of CA125 alone (Photo courtesy of Fujirebio)
Ovarian cancer is the sixth most common cancer in women and the leading cause of death from gynecological malignancy in the UK. Cancer antigen 125 (CA125) is the most widely used diagnostic biomarker for ovarian cancer; however it lacks the diagnostic accuracy to reliably detect ovarian cancer at an early stage.

There has been growing interest in human epididymis protein 4 (HE4), a protein found on cells that line the lungs and reproductive organs, such as the ovaries, as an additional serum biomarker for ovarian cancer. With clinical use of HE4 expanding, a high throughput automated assay that allows multiple samples to be analyzed rapidly is needed.

Medical Scientists at the Manchester Academic Health Science Centre (Manchester UK) and their colleagues compared two immunoassay methods for the measurement of serum HE4. The study population included all primary care requested serum CA125 samples received by the Manchester University NHS Foundation Trust (MFT) Clinical Biochemistry laboratory between April 2018 and April 2019.

The team analyzed 1,348 serum samples for serum HE4 using both the conventional manual enzyme immunometric-assay (EIA), and an automated chemiluminescent immunoassay (CLEIA) methods. Samples were analyzed using the HE4 EIA (Fujirebio, Gent, Belgium) and the Lumipulse G600II analyzer also from Fujirebio. The EIA is a solid phase non-competitive immunoassay using mouse monoclonal antibodies (MAb) 2H5 and 3D8 directed against different HE4 epitopes. The maximum detection limit is 900 pmol/L. The CLEIA uses a two-step sandwich immunoassay technique. The immunoreaction cartridges contain two monoclonal antibodies, MAb 2H5 and alkaline phosphatase (ALP)-labeled MAb 12A2. The maximum detection limit is 1,500 pmol/L.

The investigators demonstrated in their study a significant difference in serum HE4 values measured using CLEIA and conventional EIA. There was moderate agreement between the two methods, but CLEIA significantly overestimated HE4 values when compared to EIA, with a mean percentage bias of 16.25%. Identified biases of 7.2 pmol/L and 10 pmol/L, at the thresholds of 70 pmol/L and 140 pmol/L respectively, are likely to significantly impact clinical interpretation and decision making when using values measured by the CLEIA, highlighting the importance of assay-specific cut-offs for clinical application.

The authors concluded that the CLEIA significantly overestimates HE4 values compared to the EIA, suggesting that a common clinical decision limit may not be appropriate. The study was published in the August, 2021 issue of the journal Practical Laboratory Medicine.

Related Links:
Manchester Academic Health Science Centre
Fujirebio


Gold Member
Fully Automated Cell Density/Viability Analyzer
BioProfile FAST CDV
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Silver Member
Verification Panels for Assay Development & QC
Seroconversion Panels
New
Respiratory QC Panel
Assayed Respiratory Control Panel

Print article

Channels

Molecular Diagnostics

view channel
Image: Researcher Kanta Horie places a sample in a mass spectrometer that measures protein levels in blood plasma and other fluids (Photo courtesy of WashU Medicine)

Highly Accurate Blood Test Diagnoses Alzheimer’s and Measures Dementia Progression

Several blood tests are currently available to assist doctors in diagnosing Alzheimer's disease in individuals experiencing cognitive symptoms. However, these tests do not provide insights into the clinical... Read more

Microbiology

view channel
Image: Schematic representation illustrating the key findings of the study (Photo courtesy of UNIST)

Breakthrough Diagnostic Technology Identifies Bacterial Infections with Almost 100% Accuracy within Three Hours

Rapid and precise identification of pathogenic microbes in patient samples is essential for the effective treatment of acute infectious diseases, such as sepsis. The fluorescence in situ hybridization... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.