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Rapid Diagnostic Methods for Infectious Diseases

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A special issue of LabMed (ISSN 2813-9038).

Deadline for manuscript submissions: closed (30 April 2026) | Viewed by 17463

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Dr. Emmanouil Magiorkinis

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Department of Laboratory Haematology, General Oncology Hospital "Metaxas", Pireas, Greece
Interests: microbiology; haematology; virology; laboratory medicine
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Rapid diagnostic methods for infectious diseases are at the forefront of modern healthcare, driven by the urgent need to identify pathogens swiftly and accurately. Traditional culture-based tests, though highly specific, can be time-consuming—requiring days or even weeks to yield definitive results. In contrast, newer rapid diagnostic technologies leverage advances in molecular biology, immunology, and biosensor engineering to significantly reduce detection times often to mere hours or minutes. From polymerase chain reaction (PCR) and real-time nucleic acid amplification tests, to immunochromatographic assays and point-of-care biosensors, these methods perform the more rapid identification of pathogens and can even detect specific strains or resistance markers. Such prompt diagnoses are vital in preventing the spread of highly contagious diseases, enabling clinicians to initiate targeted therapies swiftly, and reducing inappropriate antibiotic use—one of the key factors contributing to antibiotic resistance.

Moreover, rapid tests benefit resource-limited settings in which immediate medical interventions can drastically alter patient outcomes. As infectious diseases continue to cause high rates of morbidity and mortality worldwide, ongoing research into rapid diagnostic methods remains essential. These innovative approaches not only advance clinical practice but also play a crucial role in public health, helping curb outbreaks and guiding evidence-based treatment decisions.

This Special Issue, entitled “Rapid Diagnostic Methods for Infectious Diseases”, seeks to showcase recent advances and innovations that enable the quicker, more accurate, and more accessible detection of pathogens in clinical and field settings. Rapid and reliable diagnostic tools are critical for initiating timely treatment, preventing the spread of disease, and improving patient outcomes. As infectious diseases evolve and novel pathogens emerge, the development of cutting-edge approaches that are able to diagnose these threats is more important than ever.

We welcome the submission of original research, review articles, and case studies that focus on the design, validation, and application of rapid diagnostic platforms for bacterial, viral, fungal, or parasitic infections. The scope of this Special Issue includes, but is not limited to, the following topics:

Point-of-Care Testing and Mobile Health: Innovative technologies that allow accurate diagnosis at or near the site of patient care, particularly in resource-limited regions.
Molecular and Genomic-Based Detection: Novel methods that employ nucleic acid amplification, next-generation sequencing, CRISPR-based diagnostics, and other molecular approaches.
Immunological and Serological Techniques: The development of immunoassays, biosensors, and other rapid antibody/antigen detection methodologies.
Biosensor Innovation and Biomarker Discovery: Emerging platforms, biomarkers, and nanotechnologies that enhance the sensitivity and specificity of infectious disease testing.
Data-Driven and AI-Assisted Diagnostics: Integration of artificial intelligence, machine learning, and big data analytics to support diagnostic accuracy and speed.
Translational and Clinical Studies: The implementation and performance evaluation of new diagnostic tools in diverse healthcare settings, including cost-effectiveness and policy implications.

By compiling multidisciplinary research and experiences, this Special Issue aims to foster collaboration among scientists, clinicians, engineers, epidemiologists, and policymakers. Through these contributions, we hope to accelerate the adoption of rapid diagnostic methods that reduce the global prevalence of infectious diseases, saving lives and improving healthcare outcomes for communities worldwide.

Dr. Emmanouil Magiorkinis
Guest Editor

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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-anonymized peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. LabMed is an international peer-reviewed open access quarterly 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 1000 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

rapid diagnostic methods
infectious diseases
point-of-care testing
molecular diagnostics
immunodiagnostics
antimicrobial resistance
biosensors
public health
clinical microbiology
emerging pathogens

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Published Papers (8 papers)

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Research

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8 pages, 1144 KB

Open AccessArticle

Pancreatic Stone Protein as an Early Biomarker of Sepsis in Critically Ill Non-Surgical Patients: A Retrospective Observational Study

by Francesco Perrotta and Andrea Sparascio

LabMed 2026, 3(3), 17; https://doi.org/10.3390/labmed3030017 - 7 Jul 2026

Viewed by 392

Abstract

Background: Timely identification of sepsis in critically ill patients remains challenging. Commonly used biomarkers, including C-reactive protein (CRP) and procalcitonin (PCT), show suboptimal diagnostic performance. Pancreatic stone protein (PSP) has recently been proposed as an early indicator of infection and sepsis. Methods: We performed a retrospective observational study involving 90 adult ICU patients, including septic and non-septic patients selected during the study period. Sepsis was defined according to Sepsis-3 criteria. Diagnostic accuracy was evaluated using receiver operating characteristic curves, and sensitivity, specificity, and predictive values were calculated. The association between PSP levels and in-hospital mortality was examined using multivariable logistic regression analysis. Results: Of the 90 patients included, 45 (50%) were diagnosed with sepsis. PSP levels were significantly higher in septic patients compared to non-septic patients (210 (175–265) vs. 105 (80–135) ng/mL; p < 0.001). PSP demonstrated the best diagnostic performance among the evaluated biomarkers (AUC 0.88, 95% CI 0.81–0.94), compared with PCT (0.82) and CRP (0.74). At a threshold of 150 ng/mL, PSP showed a sensitivity of 84% and a specificity of 80%. Higher PSP values were independently associated with increased in-hospital mortality and longer ICU stay. Conclusions: PSP appears to be a useful biomarker for early identification of sepsis in critically ill non-surgical patients, with better diagnostic performance than CRP and PCT. Its incorporation into clinical assessment may support earlier recognition and improved risk stratification. Further multicenter studies are needed to confirm these findings and to better define its role in clinical decision-making. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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10 pages, 564 KB

Open AccessArticle

Pitfalls of UBT, SAT, and Nested PCR Reliability for Diagnosing Helicobacter pylori

by Janka Klingová, Bianka Prokopová, Barbora Šipková, Vanesa Bujková and Pavol Sulo

LabMed 2026, 3(2), 13; https://doi.org/10.3390/labmed3020013 - 30 Apr 2026

Viewed by 964

Abstract

Helicobacter pylori is the leading cause of chronic gastrointestinal tract diseases, with a worldwide prevalence of around 50%. For identification in medical practice, non-invasive methods such as the immunochromatographic test for antigen in stool (SAT) and the urease breath test (UBT) are widely used. Recently, we developed a highly sensitive and specific nested PCR (NPCR) that involves two amplification reactions and uses primers designed to target the variable regions of the 16S rRNA gene to amplify a short 148 bp amplicon. The aim of this study was to compare two classical methods, SAT and UBT, with the 148 bp amplicon NPCR. We examined samples from 137 volunteers, and found 46 positives with NPCR using stool samples, 34 with UBT, and only 24 with SAT. H. pylori origin of the 148 bp amplicons was confirmed by sequencing. NPCR had the highest detection rate in this cohort, suggesting that a portion of the population may be misdiagnosed, particularly by SAT. Due to the cost and simple performance in practice, SAT is a method of choice for initial screening. However, in cases of negative results and persistent digestive problems, we recommend the more sensitive UBT. NPCR may be a useful complementary method, especially in discordant or clinically suspicious cases. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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14 pages, 752 KB

Open AccessArticle

Predictors and Trends of Hepatitis B Virus Transmissions in Selected Regions of Kenya

by Missiani Ochwoto, Raphael O. Ondondo, Lydia Moraa Matoke, Gladys Tuitoek, Elizabeth Ogwora, Samuel W. Omari, Haron Mong’are, Francis Otieno Onoka, Esther Sigilai, James Hungo Kimotho, Robert Rono, Amos Otedo, Vincent Were and Damaris Matoke-Muhia

LabMed 2026, 3(1), 5; https://doi.org/10.3390/labmed3010005 - 2 Feb 2026

Cited by 1 | Viewed by 1746

Abstract

Hepatitis B virus (HBV) infection is a silent epidemic; many infected people are asymptomatic and not aware of the infection. In 2022, it was reported that approximately 254 million people were living with chronic HBV infection globally, majority being in sub-Saharan Africa and Asia. In Kenya, the national HBV prevalence is estimated to be 3.5%. Our study was aimed at identifying key predictors and transmission trends that could inform the development of sustainable prevention models needed to address existing gaps in the national framework towards HBV elimination. We targeted participants seeking health services in Baringo and Kisumu county health facilities and conducted community mass testing in the two counties. Participants were interviewed using a study questionnaire and were tested for hepatitis B surface antigen (HBsAg) using an HBsAg rapid test. Venous blood was collected from participants who tested HBsAg+ for further infection confirmation and linkage to care. Logistic regression was performed to assess factors correlated with HBV infection. Out of 3034 participants, 192 tested positive for HBsAg and the prevalence of HBV infection was 6.3% (95% CI = 0.055–0.072). Intrafamilial infections in Baringo were 15.0%. HBV infection prevalence exceeded 10% among those aged 25–49 years, peaking at 13.1% in the 45–49-year age group and lowest at 1.8% in the 16–19-year age group. Overall, males had a higher prevalence in younger ages, while females above 60 years old were more affected. In multivariable logistic regression, individuals residing in Baringo (aPR = 8.1; 95% CI = 2.2–29.4), users of other injectable drugs (aPR = 6.7; 95% CI = 1.3–204.0), those traditionally circumcised (aPR 1.02; 95% CI = 0.56, 1.88), and staying >5 km from a health care facility (aPR = 10.4; 95% CI = 2.2–49.4) had significantly higher prevalence ratios of being infected with HBV. These different infection predictors underscore the need for different care and prevention approach models. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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17 pages, 1562 KB

Open AccessArticle

Adapting the Illumina COVIDSeq for Whole Genome Sequencing of Other Respiratory Viruses in Multiple Workflows and a Single Rapid Workflow

by Nqobile Mthembu, Sureshnee Pillay, Hastings Twalie Musopole, Shirelle Janine Naidoo, Nokukhanya Msomi, Bertha Cinthia Baye, Derek Tshiabuila, Nokulunga Zamagambu Memela, Thembelihle Tombo, Tulio de Oliveira and Jennifer Giandhari

LabMed 2025, 2(4), 19; https://doi.org/10.3390/labmed2040019 - 4 Oct 2025

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Abstract

Acute respiratory infections (ARIs) continue to pose a major global health threat, particularly among vulnerable populations. These infections often present with similar clinical symptoms, complicating accurate diagnosis and facilitating unmonitored transmissions. Genomic surveillance has emerged as an invaluable tool for pathogen identification and monitoring of such infectious pathogens; however, its implementation is frequently limited by high costs. The widespread use of high-throughput sequencing during the COVID-19 pandemic has created an opportunity to repurpose existing genomic platforms for broader respiratory virus surveillance. In this study, we evaluated the feasibility of adapting the Illumina COVIDSeq assay—initially designed for SARS-CoV-2 whole-genome sequencing—for use with Influenza A/B, Respiratory Syncytial Virus (RSV), and Rhinovirus. Positive control samples were processed using two approaches for library preparation: four virus-specific multiple workflows and a combined rapid workflow. Both workflows incorporated pathogen-specific primers for amplification and followed the Illumina COVIDSeq protocol for library preparation and sequencing. Sequencing quality metrics were analysed, including Phred scores, read length distribution, and coverage depth. The study did not identify significant differences in genome coverage and genetic diversity metrics between workflows. Genome Detective consistently identified the correct species across both methods. The findings of this study demonstrate that the COVIDSeq assay can be effectively adapted for multi-pathogen genomic surveillance and that the combined rapid workflow can offer a cost- and labour-efficient alternative with minimal compromise to data quality. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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18 pages, 1136 KB

Open AccessArticle

Advancing Drug Resistance Detection: Comparative Analysis Using Short-Read and Long-Read Next-Generation Sequencing Technologies

by Julie Martinez, Rezak Drali, Amira Doudou, Chalom Sayada, Ronan Boulmé, Dimitri Gonzalez, Laurent Deblir, Matthieu Barralon, Jérome Wautrin, Jonathan Porzio, Arnaud Reffay, Mohamed Errafyqy, Jonathan Kolsch, Jonathan Léonard, Giuseppina Zuco, Aitor Modol and Sofiane Mohamed

LabMed 2025, 2(3), 14; https://doi.org/10.3390/labmed2030014 - 20 Aug 2025

Viewed by 3500

Abstract

In recent years, antiviral therapy has proved crucial in the treatment of infectious diseases, particularly infections by highly variable viruses such as human immunodeficiency virus, hepatitis B, hepatitis C, SARS-CoV-2 or bacteria such as Mycobacterium tuberculosis. Under the effect of selection pressure, this variability induces mutations that lead to resistance to antiviral and antibacterial drugs, and thus to escape from treatment. The use of Advanced Biological Laboratories (ABL) assays technology combined with next-generation sequencing (NGS) and automatized software to detect majority and minority variants involved in treatment resistance has become a mainstay for establishing therapeutic strategies. The present study demonstrated high concordance between majority and minority subtypes and mutations identified in 15 samples across four NGS platforms: ISeq100 (Illumina (San Diego, CA, USA)), MiSeq (Illumina), DNBSEQ-G400 (MGI (Santa Clara, CA, USA)) and Mk1C MinION (Oxford Nanopore (Oxford Science Park, UK)). However, nanopore technology showed a higher number of minority mutations (<20%). The analysis also validated the pooling of microbiological samples as a method for detecting mutations and genotypes in viral and bacterial organisms, using the easy-to-use DeepChek^® bioinformatics software, compatible with all four sequencing platforms. This study underlines the constant evolution of microbiological diagnostic research and the need to adapt rapidly to improve patient care. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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11 pages, 454 KB

Open AccessArticle

Direct PCR for Rapid and Safe Pathogen Detection: Laboratory Evaluation Supporting Field Use in Infectious Disease Outbreak

by Ivan Brukner and Matthew Oughton

LabMed 2025, 2(3), 12; https://doi.org/10.3390/labmed2030012 - 11 Jul 2025

Cited by 4 | Viewed by 3447

Abstract

Rapid, safe, and field-deployable molecular diagnostics are crucial for the effective management of infectious disease outbreaks, particularly those involving highly infectious pathogens, which can produce clinical symptoms similar to less infectious pathogens, thus raising potential biosafety concerns. In this study, we evaluated DNA/RNA Defend Pro (DRDP) buffer, a novel viral-inactivating transport medium designed to stabilize nucleic acids and allow direct PCR without nucleic acid extraction. To ensure critical qPCR parameters were not compromised by using DRDP, we conducted serial dilution tests using herpes simplex viruses 1 and 2 (HSV-1, HSV-2) and varicella-zoster virus (VZV), comparing DRDP to standard universal transport medium (UTM). Detection sensitivity, determined by cycle quantification (Cq) values, favored DRDP, as UTM samples required a 2–3-fold dilution to mitigate PCR inhibition. DRDP maintained reliable PCR compatibility at reaction volumes containing up to 25% buffer. At higher DRDP concentrations (30–35%), PCR inhibition occurred due to EDTA content but was fully reversible by adding supplemental magnesium. Furthermore, DRDP samples did not require an initial 95 °C thermal lysis step, thus simplifying the procedure without reducing PCR sensitivity or efficiency. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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Review

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16 pages, 437 KB

Open AccessReview

Sample Adequacy Control for Negative Molecular Results: An Integrated Specimen-Process Framework to Strengthen Result Interpretation

by Ivan Brukner, Shaun Eintracht and Matthew T. Oughton

LabMed 2026, 3(3), 16; https://doi.org/10.3390/labmed3030016 - 30 Jun 2026

Viewed by 456

Abstract

Sample adequacy control (SAC) is a validated specimen-specific marker or metric, threshold, and reporting rule used to decide whether a negative molecular result is supported by the submitted specimen. SAC is not simply a cell-count or biomass check. Depending on specimen type and target, an unsupported negative result may reflect insufficient or nonrepresentative material, adequacy-marker degradation, inefficient transfer or extraction, matrix-associated inhibition, or mismatch between marker and anatomical compartment. SAC is therefore best understood as an integrated specimen-process adequacy control for negative-result interpretation. Its result should be reported as valid, borderline, or invalid for the intended negative interpretation, not as detected/not detected like the disease-specific biomarker. This perspective synthesizes quantitative polymerase chain reaction (qPCR) control guidance, preanalytical-quality literature, respiratory and enteric sampling studies, human papillomavirus (HPV) evidence, cartridge-assay precedents, and decentralized workflows. Direct prospective evidence that SAC improves patient or epidemiologic outcomes remains limited; available evidence is outcome-adjacent or operational, including HPV cellularity-control associations, Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) and Ebola cartridge precedents, respiratory workflows showing lower pathogen positivity at higher SAC quantification cycle (Cq) strata, and reporting rules that change validity or recollection decisions. We propose a risk-based framework for selecting, validating, reporting, and monitoring SAC, with particular value in direct-amplification, point-of-care, and self-collection workflows where preanalytical failures affect negative-result interpretation. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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20 pages, 455 KB

Open AccessReview

Monocyte Distribution Width as a Biomarker of Sepsis

by Ioanna Kotsiri, Dimitrios Theodoridis, Angeliki Tsifi and Emmanouil Magiorkinis

LabMed 2026, 3(2), 9; https://doi.org/10.3390/labmed3020009 - 24 Mar 2026

Cited by 1 | Viewed by 1686

Abstract

Sepsis is a life-threatening syndrome caused by dysregulated host response to infection and remains a major global health challenge with high healthcare burden. Early recognition is critical for improving outcomes, yet current diagnostic tools and conventional biomarkers such as C-reactive protein and procalcitonin have important limitations related to kinetics, specificity, and cost. This review examines Monocyte Distribution Width (MDW), a novel hematologic parameter derived from routine complete blood count analysis, as an emerging biomarker for early sepsis detection and prognostic assessment. MDW reflects monocyte morphological heterogeneity associated with innate immune activation and rises early in the inflammatory cascade, often at the time of initial clinical presentation. Evidence from emergency department and intensive care unit studies demonstrates that MDW provides high sensitivity and negative predictive value for early sepsis screening and performs comparably to or better than established biomarkers, particularly when integrated with clinical scoring systems and other laboratory indices. Beyond diagnosis, elevated MDW correlates with disease severity, organ dysfunction, and adverse outcomes, suggesting prognostic utility. Although promising, current evidence is limited by heterogeneity and the need for standardized cut-off values and multicenter validation. Overall, MDW represents a rapid, cost-effective adjunct that may enhance multimodal sepsis assessment and clinical decision-making. Full article

(This article belongs to the Special Issue Rapid Diagnostic Methods for Infectious Diseases)

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