A Fully Automated Assay for Assessing Vascular Microcalcification Using Serum Biospecimens 🩸

Vascular calcification is an important pathological process associated with cardiovascular disease (CVD), coronary artery disease (CAD), chronic kidney disease (CKD), and other conditions. Human serum biospecimens are an important resource for investigating circulating biomarkers associated with these diseases and evaluating new approaches to cardiovascular risk assessment. While larger calcifications can be detected using established imaging techniques, microcalcifications are particularly important because they may contribute to plaque instability and increase the risk of acute cardiovascular events.

A recent study published in Biochemical and Biophysical Research Communications investigated a new blood-based approach to assessing vascular microcalcification. The research team developed a fully automated immunoassay to quantify tissue-nonspecific alkaline phosphatase (TNAP) activity on calcified extracellular vesicles (EVs) in human serum.

The study was conducted by Maria Kiriyama, Eiya Tamada, Mami Onishi, Masaya Muto, and Amane Harada of Sysmex Corporation and was published in Volume 793 in December 2025.

The researchers focused on calcified EVs because these vesicles may play an important role in vascular microcalcification and could provide a minimally invasive biomarker of active vascular calcification.

Human Serum Analysis Reveals Increased TNAP Activity in CAD and ESKD 📊

Imaging techniques such as 18F-sodium fluoride positron emission tomography (18F–NaF PET) can identify active microcalcifications, but their cost, accessibility, and radiation exposure can limit routine use. This highlights the potential value of simple blood-based biomarkers.

The researchers developed a fully automated calcified EV assay using the HISCL-5000 automated immunoassay system. The assay captures CD9-positive EVs and measures TNAP activity on their surface using chemiluminescence.

The method required only 25 μL of serum and provided results in approximately 17 minutes, while demonstrating high reproducibility, good dilution linearity, and minimal interference from common endogenous substances.

Clinical feasibility was evaluated using 50 commercially available human serum samples from non-disease individuals, patients with CAD, and patients with end-stage kidney disease (ESKD).

TNAP activity on calcified EVs was significantly higher in both disease groups compared with non-disease controls. Median activity was 58.8 μU/L in the CAD group versus 38.4 μU/L in controls, while the ESKD group showed a median of 65.9 μU/L. After adjustment for age and sex, TNAP activity remained independently associated with both CAD and ESKD.

Importantly, the human serum samples used for this clinical feasibility assessment were sourced from several biospecimen providers, including BIOMEDICA CRO. By supplying human serum biospecimens for this study, BIOMEDICA CRO contributed to research investigating a novel approach to cardiovascular risk assessment and biomarker development.

Access to well-characterized human biospecimens is an important component of translational research, helping researchers evaluate whether findings observed in experimental models can also be identified in clinically relevant human samples. Serum is widely used for biomarker discovery, assay development and validation, diagnostic research, and pharmaceutical development.

The findings support the potential of circulating calcified EVs as biomarkers of vascular microcalcification and cardiovascular and kidney disease risk, while further validation in larger, well-characterized cohorts is still needed.

The full publication is available here: A fully automated immunoassay for quantifying tissue-nonspecific alkaline phosphatase activity on calcified extracellular vesicles for cardiovascular risk assessment.

Looking to buy biosamples for your next study? Contact BIOMEDICA CRO to discuss your sample requirements and available sourcing options! 🧬

For researchers looking to buy serum for research, BIOMEDICA CRO provides access to human serum biospecimens from healthy and disease-specific donors.

Our biospecimen sourcing capabilities support a wide range of research applications, including:

biomarker discovery and validation;
immunoassay and diagnostic assay development;
cardiovascular and metabolic disease research;
translational research;
pharmaceutical and biotechnology studies;
analytical method development and validation.

Researchers can buy serum from our existing inventory or discuss prospective biospecimen collection when specific donor characteristics or clinical criteria are required.

Depending on the project, sample selection can be based on disease indication, donor characteristics, sample volume, clinical criteria, and available associated clinical information. Our team can also assess the feasibility of customized prospective collection programs when suitable samples are not available in the existing inventory.

The quality and relevance of biological samples can have a direct impact on the development and validation of new research methods. By providing access to human serum from defined donor populations, BIOMEDICA CRO helps researchers bridge the gap between experimental development and studies involving clinically relevant human specimens.

Our team works with pharmaceutical companies, biotechnology companies, diagnostic developers, academic researchers, and other organizations requiring human biospecimens for scientific research. Whether you need a small number of samples for assay feasibility testing or a larger cohort for biomarker validation, we can review your requirements and identify the most appropriate sourcing strategy.

🔍 Looking for specific biospecimens? Explore our inventory of 49,000+ banked biospecimens by clicking here. Use available filters to identify the most suitable samples and share your list with us so we can discuss tailored options for your study.

📩 Contact us: office@biomedica-cro.com.

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