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Diagnostics
Special Issues
Advancing Blood-Based Diagnostics: Innovations, Challenges and Clinical Impact
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Advancing Blood-Based Diagnostics: Innovations, Challenges and Clinical Impact

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Clinical Laboratory Medicine".

Deadline for manuscript submissions: 30 September 2026 | Viewed by 2324

Special Issue Editor

Dr. Sapha Shibeeb

E-Mail Website
Guest Editor
School of Health and Biomedical Sciences, RMIT University, Melbourne, Australia
Interests: novel modulators of platelet function; role of platelets in cardiovascular diseases; advances in AI and diagnosis of hematological conditions
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues, 

Blood-based diagnostic testing remains one of the most widely utilized and clinically valuable tools in modern medicine, underpinning critical decisions across nearly every medical specialty. As healthcare shifts toward personalized, data-driven, and preventive models, blood tests are evolving rapidly, driven by advances in analytical techniques, biomarker discovery, and computational interpretation.

This Special Issue invites original research, reviews, and methodological papers that explore the development, evaluation, and clinical application of blood-based diagnostics.

By focusing on innovation, existing challenges, and clinical outcomes, this Special Issue aims to provide a comprehensive overview of how blood testing is advancing to meet the demands of modern clinical practice.

Dr. Sapha Shibeeb
Guest Editor

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All submissions that pass pre-check are peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 250 words) can be sent to the Editorial Office for assessment.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Diagnostics is an international peer-reviewed open access semimonthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 2600 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • diagnostic biomarkers
  • analytical performance
  • test interpretability
  • prognostic markers
  • translational diagnostics
  • artificial intelligence in diagnostics
  • precision medicine
  • clinical decision-making

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Further information on MDPI's Special Issue policies can be found here.

Published Papers (3 papers)

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Research

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15 pages, 1686 KB  
Article
Establishment and Temporal Validation of Next-Generation Reference Intervals for Routine Hematological Parameters Using Large-Scale Data
by Chaochao Ma, Lihua Guan, Qian Chen, Rongrong Cheng, Wei Wu and Ling Qiu
Diagnostics 2026, 16(6), 944; https://doi.org/10.3390/diagnostics16060944 - 23 Mar 2026
Viewed by 370
Abstract
Background: Conventional reference intervals (RIs) are typically expressed as fixed limits and may not adequately reflect continuous biological variation across age and sex. Next-generation reference intervals (NGRIs) allow dynamic modeling of laboratory parameters across the lifespan. This study aimed to establish age- [...] Read more.
Background: Conventional reference intervals (RIs) are typically expressed as fixed limits and may not adequately reflect continuous biological variation across age and sex. Next-generation reference intervals (NGRIs) allow dynamic modeling of laboratory parameters across the lifespan. This study aimed to establish age- and sex-specific NGRIs for routine hematological parameters using large-scale health examination data and to evaluate their temporal stability. Methods: Health examination records were linked with laboratory data, and a relatively healthy reference population was defined based on age (18–80 years), normal body mass index, normal blood pressure, and absence of documented disease history. NGRIs were constructed using generalized additive models for location, scale, and shape (GAMLSS) with the Box–Cox Cole and Green distribution. Age-dependent percentile curves (2.5th–97.5th) were generated using bootstrap resampling (100 iterations). Temporal external validation was conducted in five independent annual cohorts (2019–2023). Results: Age- and sex-dependent distributional patterns were observed across multiple hematological parameters, particularly RBC, HGB, and HCT. Continuous percentile curves demonstrated gradual age-related trends, with more pronounced changes in females after midlife. In temporal validation cohorts, the proportion of individuals classified outside the reference intervals remained consistently below 10% across years and sexes, indicating stable performance. Conclusions: Using large-scale real-world health examination data and a flexible distributional modeling framework, we established stable age-continuous next-generation reference intervals for routine hematological parameters. The proposed approach provides a reproducible strategy for modernizing laboratory reference interval construction and supports broader implementation in population-based laboratory medicine. Full article
(This article belongs to the Special Issue Advancing Blood-Based Diagnostics: Innovations, Challenges and Clinical Impact)
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15 pages, 3223 KB  
Article
First Clinical Description of Coagulation of Whole Blood with Resonant Acoustic Rheometry
by Connor M. Bunch, Weiping Li, Kiera Downey, Timothy L. Hall, Allen Chehimi, Samuel J. Thomas, Afsheen Mansoori, Miguel Velasco, Marie N. Karam, Jenny Chen, Jacob Tuttle, Matthew R. Walsh, Scott G. Thomas, Mark M. Walsh, Joseph B. Miller, Jan P. Stegemann and Cheri X. Deng
Diagnostics 2026, 16(1), 47; https://doi.org/10.3390/diagnostics16010047 - 23 Dec 2025
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Abstract
Background/Objectives: The timely evaluation of blood clot formation and breakdown is essential in the care of patients with severe bleeding or critical illness. Resonant acoustic rheometry is a novel, non-contact ultrasound method that measures changes in the viscoelastic properties of blood in [...] Read more.
Background/Objectives: The timely evaluation of blood clot formation and breakdown is essential in the care of patients with severe bleeding or critical illness. Resonant acoustic rheometry is a novel, non-contact ultrasound method that measures changes in the viscoelastic properties of blood in a standard microplate format. Here, we present the first clinical description of whole blood coagulation and fibrinolysis assessed with resonant acoustic rheometry, with paired thromboelastography measurements for comparison. Methods: In this retrospective analysis, whole blood samples from three critically ill patients were divided and tested under four different conditions that included a control mixture, kaolin activation, tissue factor activation, and a tissue factor mixture supplemented with tissue plasminogen activator. The resonant acoustic rheometry system obtained real time measurements of resonant surface waves and displacements from the samples. Heat maps and spectrograms of the resonant surface waves were analyzed to determine the onset of clotting, the rate of viscoelastic stiffening, the time to maximum rigidity, and the onset as well as magnitude of fibrinolysis. These measurements were compared with thromboelastography reaction time, clot strength, fibrinogen contribution, and lysis values. Results: Resonant acoustic rheometry detected reproducible transitions from liquid to clot and from clot to lysis in all samples. Activator-dependent changes in clot initiation and propagation matched the expected hierarchy observed in thromboelastography. Significantly, samples exposed to tissue plasminogen activator demonstrated a clear fall in resonant frequency and a corresponding rise in surface displacement that reflected fibrinolysis. The technique also reproduced clinically meaningful patterns of hemostasis that aligned with each patient’s underlying disease. Conclusions: Whole blood clotting can be measured with resonant acoustic rheometry in a manner that aligns with established clinical assays. These results suggest strong potential for future use of resonant acoustic rheometry as a cost-effective, complementary platform for rapid, scalable, and clinically informative hemostatic assessment. Full article
(This article belongs to the Special Issue Advancing Blood-Based Diagnostics: Innovations, Challenges and Clinical Impact)
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Review

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17 pages, 468 KB  
Review
Harmonising ctDNA Measurement in Haematological Malignancies: Traceability, Commutability and Reporting
by Sapha Shibeeb
Diagnostics 2026, 16(7), 1056; https://doi.org/10.3390/diagnostics16071056 - 1 Apr 2026
Viewed by 522
Abstract
Circulating tumour DNA (ctDNA) assays are increasingly applied in haematological malignancies for non-invasive genotyping, quantitative response assessment, measurable residual disease (MRD) detection, and relapse surveillance, often complementing bone marrow-based testing and, in selected scenarios, potentially reducing its frequency. Yet, translating ctDNA results into [...] Read more.
Circulating tumour DNA (ctDNA) assays are increasingly applied in haematological malignancies for non-invasive genotyping, quantitative response assessment, measurable residual disease (MRD) detection, and relapse surveillance, often complementing bone marrow-based testing and, in selected scenarios, potentially reducing its frequency. Yet, translating ctDNA results into comparable clinical decisions across laboratories, platforms, and time remains challenging because ctDNA measurements are influenced by the definition of the measurand (for example, variant allele fraction versus mutant molecules per mL), pre-analytical variables, end-to-end workflow losses, and lineage-specific confounders such as clonal haematopoiesis of indeterminate potential (CHIP), therapy-related clonal haematopoiesis, and compartmental disease (marrow, plasma, cerebrospinal fluid, extramedullary sites). This review proposes a harmonisation framework for haematological ctDNA based on three linked concepts—metrological traceability, which connects reported values to reference systems with stated uncertainty, commutability, which ensures that reference materials behave like patient specimens across diverse workflows and fit-for-purpose reference materials that support calibration, and quality control, external quality assessment, and cut-off setting for intended uses such as early molecular response in large B-cell lymphoma, molecular MRD in acute myeloid leukaemia, and deep response monitoring in multiple myeloma. This framework is accompanied by harmonised CHIP-aware reporting rules for settings without matched cellular DNA and practical change-control/bridging strategies to preserve clinical decision thresholds when platforms or bioinformatic pipelines evolve. Full article
(This article belongs to the Special Issue Advancing Blood-Based Diagnostics: Innovations, Challenges and Clinical Impact)
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