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Diagnostics
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Advances in the Laboratory Diagnosis
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Advances in the Laboratory Diagnosis

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

Deadline for manuscript submissions: 28 February 2025 | Viewed by 3463

Special Issue Editors

Prof. Dr. Giuseppe Lippi

grade E-Mail Website
Guest Editor
Laboratory Medicine, Clinical Biochemistry, Coagulation, Haematology, Sports Medicine, University of Verona, Verona, Italy
Interests: pre-analytical variability; analytical and clinical validation of biomarkers; proteomics; diagnostics of the acute coronary syndrome; metabolism of lipoproteins and relevant assay methods; frailty; diagnosis and management of disorders of hemostasis
Dr. Camilla Mattiuzzi

E-Mail Website
Guest Editor
Medical Direction, Rovereto Hospital, Provincial Agency for Social and Sanitary Services (APSS), 38068 Rovereto, Italy
Interests: public health; health technology assessment; evaluation of diagnostic techniques; hospital infections; prevention; hygiene

Special Issue Information

Dear Colleagues,

We have the pleasure of guest-editing a Special Issue entitled "Advances in the Laboratory Diagnosis" in collaboration with Diagnostics, an open access journal published by MDPI, Switzerland.

Laboratory medicine is an essential medical discipline, whose contribution to screening, diagnosis, prognosis, and therapeutic management in modern clinical medicine is undeniable. Advances in laboratory diagnostics have recently revolutionized several areas of medicine by enabling more accurate, efficiency, and cost-effective testing. These innovations span several domains, including traditional phenotypic testing, molecular diagnostics, point-of-care testing, digitization, and artificial intelligence (AI)-driven analytics.

This Special Issue welcomes submissions that cover technological and translational aspects of laboratory medicine, which have provided significant advancements in patient care. Submissions can include articles from current original research, experimental methodologies, reviews, perspectives, and letters. We look forward to receiving insightful contributions.

Prof. Dr. Giuseppe Lippi
Dr. Camilla Mattiuzzi
Guest Editors

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 100 words) can be sent to the Editorial Office for announcement on this website.

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

  • laboratory diagnosis
  • biomarkers
  • clinical chemistry
  • laboratory analysis
  • artificial intelligence

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

Published Papers (5 papers)

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Research

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11 pages, 2637 KiB  
Article
Modified FIB-4 Index in Type 2 Diabetes Mellitus with Steatosis: A Non-Linear Predictive Model for Advanced Hepatic Fibrosis
by Jonghyun Kim, Takanori Ito, Taeang Arai, Masanori Atsukawa, Miwa Kawanaka, Hidenori Toyoda, Takashi Honda, Ming-Lung Yu, Eileen L. Yoon, Dae Won Jun, Kyungjoon Cha and Mindie H. Nguyen
Diagnostics 2024, 14(22), 2500; https://doi.org/10.3390/diagnostics14222500 - 8 Nov 2024
Viewed by 123
Abstract
Background: The Fibrosis-4 (FIB-4) index is widely recommended as a first-tier method for screening advanced hepatic fibrosis; however, its diagnostic performance is known to be suboptimal in patients with Type 2 diabetes mellitus (T2DM). We aim to propose a modified FIB-4, using the [...] Read more.
Background: The Fibrosis-4 (FIB-4) index is widely recommended as a first-tier method for screening advanced hepatic fibrosis; however, its diagnostic performance is known to be suboptimal in patients with Type 2 diabetes mellitus (T2DM). We aim to propose a modified FIB-4, using the parameters of the existing FIB-4, tailored specifically for diabetic patients with metabolic dysfunction-associated steatotic liver disease (MASLD). Methods: A total of 1503 patients who underwent liver biopsy were divided into T2DM (n = 517) and non-T2DM (n = 986) groups. The model was developed using multiple regression analysis in the derivation cohort and validated in the validation cohort. Diagnostic accuracy was evaluated using the area under the receiver operating characteristic (AUC) curves. Results: Among the 1503 individuals, those with T2DM were older, more likely to be male, and had a higher prevalence of advanced hepatic fibrosis (≥F3) compared to non-T2DM individuals. Independent risk factors for advanced fibrosis in T2DM included age, AST, AST/ALT ratio, albumin, triglycerides, and platelet count. The optimized FIB-4 model for T2DM with MASLD (Diabetes Fibrosis Index) demonstrated superior diagnostic accuracy (AUC 0.771) compared to the FIB-4 (AUC 0.735, p = 0.012). The model showed a higher negative predictive value than the original FIB-4 across all age groups in the diabetic group. Conclusions: The newly optimized FIB-4 model for T2DM with MASLD (Diabetes Fibrosis Index), incorporating a non-linear predictive model, improves diagnostic performance (AUC) and the negative predictive value in MASLD with T2DM. Full article
(This article belongs to the Special Issue Advances in the Laboratory Diagnosis)
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12 pages, 1843 KiB  
Article
Evaluation of C-C Motif Chemokine Receptor 5 (CCR5) as a Sample Adequacy Control in HPV Molecular Diagnostics
by Ruth C. Njoku, Marianna Martinelli, Chiara Giubbi, Sofia De Marco, Barbara Torsello, Morena d’Avenia, Manuela Sironi, Cristina Bianchi and Clementina E. Cocuzza
Diagnostics 2024, 14(19), 2194; https://doi.org/10.3390/diagnostics14192194 - 30 Sep 2024
Viewed by 515
Abstract
Background: Reliable Human Papillomavirus (HPV) testing and genotyping are essential for quality assurance in HPV-based primary screening, disease management and for monitoring the impact of HPV vaccination. The clinical validation of HPV molecular diagnostic assays has significantly contributed to these objectives; however, little [...] Read more.
Background: Reliable Human Papillomavirus (HPV) testing and genotyping are essential for quality assurance in HPV-based primary screening, disease management and for monitoring the impact of HPV vaccination. The clinical validation of HPV molecular diagnostic assays has significantly contributed to these objectives; however, little emphasis has been placed on assuring sample quality. This study aimed to evaluate the accuracy of sample cellularity assessment using the C-C Motif Chemokine Receptor 5 (CCR5) gene target as a marker of sample adequacy in molecular diagnostics. Methods: Jurkat cell line samples were counted using both a Thoma cell-counting chamber and Fluorescence-Activated Cell Sorting (FACS). Jurkat cell line samples at three different concentrations were subsequently evaluated using the OncoPredict HPV Quality Control (QC) real-time PCR assay, employing CCR5 for molecular cellularity quantification. Results: The cellularity values obtained were comparable across the three different methods for all dilutions of the cell line tested. Conclusions: The results obtained from this study show that CCR5 represents a promising molecular marker for the accurate quantification of sample cellularity, confirming its use as a reliable sample adequacy control, thus reducing the risk of “false-negative” results. Full article
(This article belongs to the Special Issue Advances in the Laboratory Diagnosis)
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14 pages, 1637 KiB  
Article
The Role of the Basophil Activation Test in the Diagnosis of Drug-Induced Anaphylaxis
by Maria Czarnobilska, Małgorzata Bulanda, Ewa Czarnobilska, Wojciech Dyga and Marcel Mazur
Diagnostics 2024, 14(18), 2036; https://doi.org/10.3390/diagnostics14182036 - 13 Sep 2024
Viewed by 674
Abstract
The diagnosis of drug-induced anaphylaxis (DIA) is a serious health problem. The Basophil activation test (BAT) is considered a specific in vitro provocation, and compared to in vivo provocation, it is more convenient, cheaper, and safer for the patient. This study aimed to [...] Read more.
The diagnosis of drug-induced anaphylaxis (DIA) is a serious health problem. The Basophil activation test (BAT) is considered a specific in vitro provocation, and compared to in vivo provocation, it is more convenient, cheaper, and safer for the patient. This study aimed to evaluate the usefulness of the BAT in the diagnosis of DIA. This study included 150 patients referred to a reference allergy clinic with suspected drug allergies. All patients underwent a detailed clinical evaluation supplemented with the BAT. Positive BAT results were obtained in two out of 21 patients who were to receive the COVID-19 vaccine. The sensitivity and specificity of the BAT were 40% and 75% for the COVID-19 vaccine, 67% and 58% for DMG PEG 2000, and 100% and 75% for PEG 4000, respectively. Nine out of 34 patients with suspected antibiotic allergies had positive BAT results with 14 different antibiotics. Positive BAT results were also obtained with NSAIDs in two patients and with local anesthetics in three patients. The confirmation of allergy by the BAT improves the safety profile of the diagnostic work-up as it may defer the need for drug provocation, preventing potential anaphylactic reactions. Full article
(This article belongs to the Special Issue Advances in the Laboratory Diagnosis)
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Review

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11 pages, 404 KiB  
Review
Emerging Role of Natriuretic Peptides in Diabetes Care: A Brief Review of Pertinent Recent Literature
by Dipti Tiwari and Tar Choon Aw
Diagnostics 2024, 14(19), 2251; https://doi.org/10.3390/diagnostics14192251 - 9 Oct 2024
Viewed by 641
Abstract
Diabetes markedly increases susceptibility to adverse cardiovascular events, including heart failure (HF), leading to heightened morbidity and mortality rates. Elevated levels of natriuretic peptides (NPs), notably B-type natriuretic peptide (BNP) and N-terminal-proBNP (NT-proBNP), correlate with cardiac structural and functional abnormalities, aiding in risk [...] Read more.
Diabetes markedly increases susceptibility to adverse cardiovascular events, including heart failure (HF), leading to heightened morbidity and mortality rates. Elevated levels of natriuretic peptides (NPs), notably B-type natriuretic peptide (BNP) and N-terminal-proBNP (NT-proBNP), correlate with cardiac structural and functional abnormalities, aiding in risk stratification and treatment strategies in individuals with diabetes. This article reviews the intricate relationship between diabetes and HF, emphasizing the role of NPs in risk assessment and guiding therapeutic strategies, particularly in individuals with type 2 diabetes mellitus (T2DM). We also explore the analytical and clinical considerations in the use of natriuretic peptide testing and the challenges and prospects of natriuretic-peptide-guided therapy in managing cardiovascular risk in patients with diabetes. We conclude with some reflections on future prospects for NPs. Full article
(This article belongs to the Special Issue Advances in the Laboratory Diagnosis)
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Other

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12 pages, 442 KiB  
Perspective
Update on Patient Self-Testing with Portable and Wearable Devices: Advantages and Limitations
by Giuseppe Lippi, Laura Pighi and Camilla Mattiuzzi
Diagnostics 2024, 14(18), 2037; https://doi.org/10.3390/diagnostics14182037 - 13 Sep 2024
Viewed by 1008
Abstract
Laboratory medicine has undergone a deep and multifaceted revolution in the course of human history, in both organizational and technical terms. Over the past century, there has been a growing recognition of the need to centralize numerous diagnostic activities, often similar or identical [...] Read more.
Laboratory medicine has undergone a deep and multifaceted revolution in the course of human history, in both organizational and technical terms. Over the past century, there has been a growing recognition of the need to centralize numerous diagnostic activities, often similar or identical but located in different clinical departments, into a common environment (i.e., the medical laboratory service), followed by a progressive centralization of tests from smaller laboratories into larger diagnostic facilities. Nevertheless, the numerous technological advances that emerged at the beginning of the new millennium have helped to create a new testing culture characterized by a countervailing trend of decentralization of some tests closer to patients and caregivers. The forces that have driven this (centripetal) counter-revolution essentially include a few key concepts, namely “home testing”, “portable or even wearable devices” and “remote patient monitoring”. By their very nature, laboratory medical services and remote patient testing/monitoring are not contradictory, but may well coexist, with the choice of one or the other depending on the demographic and clinical characteristics of the patient, the type of analytical procedure and the logistics and local organization of the care system. Therefore, this article aims to provide a general overview of patient self-testing, with a particular focus on portable and wearable (including implantable) devices. Full article
(This article belongs to the Special Issue Advances in the Laboratory Diagnosis)
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