Immunoassays Compared for Serum HE4 Estimation for Ovarian Cancer
|
By LabMedica International staff writers Posted on 26 Jul 2021 |
|
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
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
Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
ADAMTS-13 Protease Activity Test
ATS-13 Activity Assay
Latest Immunology News
- AI Predicts Tumor-Killing Cells with High Accuracy
- Diagnostic Blood Test for Cellular Rejection after Organ Transplant Could Replace Surgical Biopsies
- AI Tool Precisely Matches Cancer Drugs to Patients Using Information from Each Tumor Cell
- Genetic Testing Combined With Personalized Drug Screening On Tumor Samples to Revolutionize Cancer Treatment
- Testing Method Could Help More Patients Receive Right Cancer Treatment
- Groundbreaking Test Monitors Radiation Therapy Toxicity in Cancer Patients
- State-Of-The Art Techniques to Investigate Immune Response in Deadly Strep A Infections
- Novel Immunoassays Enable Early Diagnosis of Antiphospholipid Syndrome
- New Test Could Predict Immunotherapy Success for Broader Range Of Cancers
- Simple Blood Protein Tests Predict CAR T Outcomes for Lymphoma Patients
- Cell Sorter Chip Technology to Pave Way for Immune Profiling at POC
- Chip Monitors Cancer Cells in Blood Samples to Assess Treatment Effectiveness
- Automated Immunohematology Approaches Can Resolve Transplant Incompatibility
- AI Leverages Tumor Genetics to Predict Patient Response to Chemotherapy
- World’s First Portable, Non-Invasive WBC Monitoring Device to Eliminate Need for Blood Draw
- Predictive T-Cell Test Detects Immune Response to Viruses Even Before Antibodies Form
Channels
Clinical Chemistry
view channel
3D Printed Point-Of-Care Mass Spectrometer Outperforms State-Of-The-Art Models
Mass spectrometry is a precise technique for identifying the chemical components of a sample and has significant potential for monitoring chronic illness health states, such as measuring hormone levels... Read more.jpg "Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)")
POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection
Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more
Highly Reliable Cell-Based Assay Enables Accurate Diagnosis of Endocrine Diseases
The conventional methods for measuring free cortisol, the body's stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting... Read more
Molecular Diagnostics
view channel
Blood Proteins Could Warn of Cancer Seven Years before Diagnosis
Two studies have identified proteins in the blood that could potentially alert individuals to the presence of cancer more than seven years before the disease is clinically diagnosed. Researchers found... Read more (1)_1.jpg "Image: Ultrasound image of micro-histotripsy liberation of biomarkers in a tumor (Photo courtesy of Joy Wang and Pradyumna Kedarisetti)"){kind=small}
Ultrasound-Aided Blood Testing Detects Cancer Biomarkers from Cells
Ultrasound imaging serves as a noninvasive method to locate and monitor cancerous tumors effectively. However, crucial details about the cancer, such as the specific types of cells and genetic mutations... Read more_1.jpg "Image: The innovative method to customize and strengthen DNA origami structure promises breakthroughs in medicine (Photo courtesy of Shutterstock)")
.jpg "Image: The QIAstat-Dx Respiratory Panel Plus has received U.S. FDA clearance (Photo courtesy of QIAGEN)")
Hematology
view channel
Next Generation Instrument Screens for Hemoglobin Disorders in Newborns
Hemoglobinopathies, the most widespread inherited conditions globally, affect about 7% of the population as carriers, with 2.7% of newborns being born with these conditions. The spectrum of clinical manifestations... Read more
First 4-in-1 Nucleic Acid Test for Arbovirus Screening to Reduce Risk of Transfusion-Transmitted Infections
Arboviruses represent an emerging global health threat, exacerbated by climate change and increased international travel that is facilitating their spread across new regions. Chikungunya, dengue, West... Read more
POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy
Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more
First Affordable and Rapid Test for Beta Thalassemia Demonstrates 99% Diagnostic Accuracy
Hemoglobin disorders rank as some of the most prevalent monogenic diseases globally. Among various hemoglobin disorders, beta thalassemia, a hereditary blood disorder, affects about 1.5% of the world's... Read moreMicrobiology
view channel
Integrated Solution Ushers New Era of Automated Tuberculosis Testing
Tuberculosis (TB) is responsible for 1.3 million deaths every year, positioning it as one of the top killers globally due to a single infectious agent. In 2022, around 10.6 million people were diagnosed... Read more
Automated Sepsis Test System Enables Rapid Diagnosis for Patients with Severe Bloodstream Infections
Sepsis affects up to 50 million people globally each year, with bacteraemia, formerly known as blood poisoning, being a major cause. In the United States alone, approximately two million individuals are... Read more
Enhanced Rapid Syndromic Molecular Diagnostic Solution Detects Broad Range of Infectious Diseases
GenMark Diagnostics (Carlsbad, CA, USA), a member of the Roche Group (Basel, Switzerland), has rebranded its ePlex® system as the cobas eplex system. This rebranding under the globally renowned cobas name... Read more
Clinical Decision Support Software a Game-Changer in Antimicrobial Resistance Battle
Antimicrobial resistance (AMR) is a serious global public health concern that claims millions of lives every year. It primarily results from the inappropriate and excessive use of antibiotics, which reduces... Read morePathology
view channel
AI Integrated With Optical Imaging Technology Enables Rapid Intraoperative Diagnosis
Rapid and accurate intraoperative diagnosis is essential for tumor surgery as it guides surgical decisions with precision. Traditional intraoperative assessments, such as frozen sections based on H&E... Read more
HPV Self-Collection Solution Improves Access to Cervical Cancer Testing
Annually, over 604,000 women across the world are diagnosed with cervical cancer, and about 342,000 die from this disease, which is preventable and primarily caused by the Human Papillomavirus (HPV).... Read more
Hyperspectral Dark-Field Microscopy Enables Rapid and Accurate Identification of Cancerous Tissues
Breast cancer remains a major cause of cancer-related mortality among women. Breast-conserving surgery (BCS), also known as lumpectomy, is the removal of the cancerous lump and a small margin of surrounding tissue.... Read more
Technology
view channel
New Diagnostic System Achieves PCR Testing Accuracy
While PCR tests are the gold standard of accuracy for virology testing, they come with limitations such as complexity, the need for skilled lab operators, and longer result times. They also require complex... Read more
DNA Biosensor Enables Early Diagnosis of Cervical Cancer
Molybdenum disulfide (MoS2), recognized for its potential to form two-dimensional nanosheets like graphene, is a material that's increasingly catching the eye of the scientific community.... Read more
Self-Heating Microfluidic Devices Can Detect Diseases in Tiny Blood or Fluid Samples
Microfluidics, which are miniature devices that control the flow of liquids and facilitate chemical reactions, play a key role in disease detection from small samples of blood or other fluids.... Read more
Breakthrough in Diagnostic Technology Could Make On-The-Spot Testing Widely Accessible
Home testing gained significant importance during the COVID-19 pandemic, yet the availability of rapid tests is limited, and most of them can only drive one liquid across the strip, leading to continued... Read moreIndustry
view channel
Danaher and Johns Hopkins University Collaborate to Improve Neurological Diagnosis
Unlike severe traumatic brain injury (TBI), mild TBI often does not show clear correlations with abnormalities detected through head computed tomography (CT) scans. Consequently, there is a pressing need... Read more
Beckman Coulter and MeMed Expand Host Immune Response Diagnostics Partnership
Beckman Coulter Diagnostics (Brea, CA, USA) and MeMed BV (Haifa, Israel) have expanded their host immune response diagnostics partnership. Beckman Coulter is now an authorized distributor of the MeMed... Read more_1.jpg "Image: Thermo Fisher will distribute Bio-Techne products across Europe (Photo courtesy of 123RF)")
