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Diagnostics
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Point-of-Care Testing (POCT) for Infectious Diseases
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Point-of-Care Testing (POCT) for Infectious Diseases

A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Diagnostic Microbiology and Infectious Disease".

Deadline for manuscript submissions: 30 April 2026 | Viewed by 3347

Special Issue Editor

Prof. Dr. Rongzhang Hao

E-Mail Website
Guest Editor
1. Department of Toxicology and Sanitary Chemistry, School of Public Health, Capital Medical University, Beijing, China
2. Beijing Key Laboratory of Environment and Aging, Beijing, China
Interests: microfluidic chip; biosensor; nanomaterial; point-of-care test; pathogen; infectious disease; respiratory disease; drug resistance; organ/organoid on a chip; lab on a chip

Special Issue Information

Dear Colleagues,

This Special Issue highlights cutting-edge advances in point-of-care testing (POCT) for infectious diseases, presenting the latest global research and practical cases. With millions dying annually from infectious diseases worldwide, POCT—featuring portability, simplicity, rapidity, and cost-effectiveness—greatly boosts treatment efficiency and resource utilization, becoming vital for primary care and outbreak response.

It explores the on-site early detection and clinical value of technologies (molecular diagnostics, immunochromatography, microfluidic chips, nanomaterials, and biosensors) in respiratory, gastrointestinal, and bloodstream infections, among others. Contributions integrating artificial intelligence (AI), wearable real-time monitoring, automated data transmission, and cloud analysis are encouraged. This Special Issue provides technical support for public health emergencies, hierarchical healthcare, and home diagnostics, aiding a faster, more accessible infectious disease control system.

Prof. Dr. Rongzhang Hao
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

  • point-of-care testing (POCT)
  • microfluidic chip and biosensor
  • ultrafast detection techniques
  • AI-integrated testing systems
  • infectious disease
  • pathogen

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Published Papers (4 papers)

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Research

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12 pages, 561 KB  
Article
Development and Evaluation of a Lyophilized Plasma-Based Internal Quality Control for Human Immunodeficiency Virus Rapid Diagnostic Tests
by Siriphailin Jomjunyoung, Wanvisa Treebuphachatsakul, Supaporn Suparak, Nam K. Tran, Gerald J. Kost and Napaporn Apiratmateekul
Diagnostics 2026, 16(4), 608; https://doi.org/10.3390/diagnostics16040608 - 19 Feb 2026
Viewed by 250
Abstract
Background/Objectives: Rapid diagnostic tests (RDTs) for human immunodeficiency virus (HIV) are widely used, but most kits lack standardized internal quality control (IQC) materials. In this study, we aimed to develop and evaluate a plasma-based IQC compatible with five HIV RDT brands and with [...] Read more.
Background/Objectives: Rapid diagnostic tests (RDTs) for human immunodeficiency virus (HIV) are widely used, but most kits lack standardized internal quality control (IQC) materials. In this study, we aimed to develop and evaluate a plasma-based IQC compatible with five HIV RDT brands and with proven long-term stability. Methods: Control samples at three reactivity levels were tested with five HIV RDT kits in lyophilized and liquid forms. Lyophilized samples were produced with and without trehalose, whereas liquid samples were prepared with and without StabilZyme™ SELECT Stabilizer (Stabilizer). Accelerated stability testing was performed at 37 °C and 45 °C for 28 days, and the most stable formulation was selected for long-term storage at 4 ± 2 °C and 25 ± 5 °C. Stability was assessed based on test-line visibility and signal intensity. Signal-intensity trends were analyzed using simple linear regression with a t-test on the slope; samples were considered stable when no significant trend was detected (p > 0.05). Results: Reactivity measured using the Elecsys HIV combi PT assay yielded cutoff index (COI) values of 772.65 (1:8) for the strong-positive control and 269.95 (1:25) for the weak-positive control. Trehalose-containing lyophilized samples maintained reactivity under accelerated testing at 37 and 45 °C and for 6 months at 4 ± 2 °C and 25 ± 5 °C, with no significant change in signal intensity (p > 0.05). Conclusions: The plasma-based IQC materials were compatible with all five HIV RDTs, and trehalose-stabilized lyophilized plasma showed high stability, supporting transport and storage without strict cold-chain requirements. Full article
(This article belongs to the Special Issue Point-of-Care Testing (POCT) for Infectious Diseases)
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13 pages, 3453 KB  
Article
Rapid and Sensitive Fluorescent RT-RAA Assay for the Detection of a Panel of Six Respiratory Viruses
by Xudong Guo, Dongli Gao, Yi Yang, Wanying Liu, Hongbo Liu, Rongtao Zhao and Hongbin Song
Diagnostics 2026, 16(1), 9; https://doi.org/10.3390/diagnostics16010009 - 19 Dec 2025
Viewed by 952
Abstract
Background: Rapid pathogen detection is crucial for the timely containment of outbreaks, particularly for respiratory infectious diseases which are highly transmissible and possess high epidemic potential. Methods: We developed a sensitive reverse transcription recombinase-aided amplification (RT-RAA) assay for the rapid detection [...] Read more.
Background: Rapid pathogen detection is crucial for the timely containment of outbreaks, particularly for respiratory infectious diseases which are highly transmissible and possess high epidemic potential. Methods: We developed a sensitive reverse transcription recombinase-aided amplification (RT-RAA) assay for the rapid detection of six common respiratory viruses: respiratory syncytial virus type A (RSV A), influenza A virus (Flu A), influenza B virus (Flu B), human parainfluenza virus (HPIV), SARS-CoV-2 and adenovirus (ADV). The assay employs a single, standardized protocol for the on-demand detection of any one of the six targets. Its performance was validated using nucleic acid standards and clinical pharyngeal swab specimens. Results: The assay enables rapid detection within 20 min at 39 °C using a portable, self-powered device. It demonstrated high sensitivity, with detection limits below 103 copies/mL for all targets and as low as 101 copies/mL for ADV. Cross-reactivity testing with 21 other pathogens confirmed excellent specificity. Validation with 85 clinical samples showed 100% concordance with RT-PCR, while offering significantly faster results and enhanced portability compared to RT-PCR. Conclusions: This sensitive, specific, and user-friendly RT-RAA assay provides a robust tool for rapid detection of respiratory viruses, particularly suitable for deployment in resource-limited settings and point-of-care testing during outbreaks. Full article
(This article belongs to the Special Issue Point-of-Care Testing (POCT) for Infectious Diseases)
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13 pages, 1754 KB  
Article
An ERA-CRISPR/Cas12a Method for Highly Sensitive Detection of Human Adenovirus Type 55
by Letian Zhang, Zhenghan Luo, Taiwu Wang, Yifang Han, Fuqiang Ye, Chunhui Wang, Yue Chen and Jinhai Zhang
Diagnostics 2025, 15(21), 2725; https://doi.org/10.3390/diagnostics15212725 - 27 Oct 2025
Viewed by 1004
Abstract
Background/Objectives: Human adenovirus 55 (HAdV55) is a notable pathogen causing community-acquired pneumonia; outbreaks occur frequently in military camps, hospitals, and schools, thereby posing a threat to public health security. This study aimed to develop a method for detecting HAdV55 nucleic acid by targeting [...] Read more.
Background/Objectives: Human adenovirus 55 (HAdV55) is a notable pathogen causing community-acquired pneumonia; outbreaks occur frequently in military camps, hospitals, and schools, thereby posing a threat to public health security. This study aimed to develop a method for detecting HAdV55 nucleic acid by targeting the conserved region of the Hexon gene. The sequence was amplified using enzymatic recombination isothermal amplification (ERA) technology, in conjunction with CRISPR-Cas12a technology, to enhance the amplification signal. Methods: Optimized primer and crRNA sequences were selected through ERA isothermal amplification testing. The ERA-CRISPR/Cas12a detection method was completed within 30 min at a constant temperature of 42 °C. Results: Sensitivity was assessed by detecting standard plasmids and live strains at various dilution concentrations. The detection limits were determined to be 9 copies/reaction for standard plasmids and 2.5 copies/reaction for cultured HAdV55 strains. Specificity tests were conducted on positive samples for five common respiratory pathogens and five other adenovirus subtypes, all of which showed no cross-reactivity. Conclusions: A rapid ERA-CRISPR/Cas12a nucleic acid detection method for HAdV55 has been successfully developed, demonstrating high sensitivity and specificity without the need for expensive or complex instruments. This method holds promise for on-site pathogen screening and detection. Full article
(This article belongs to the Special Issue Point-of-Care Testing (POCT) for Infectious Diseases)
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Review

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32 pages, 946 KB  
Review
Paper-Based Microfluidic Chips for At-Home Point-of-Care Nucleic Acid Testing: Applications and Challenges
by Hao Liu, Yuhan Jia, Yitong Jiang, You Nie and Rongzhang Hao
Diagnostics 2026, 16(2), 251; https://doi.org/10.3390/diagnostics16020251 - 13 Jan 2026
Viewed by 665
Abstract
Along with the growing demands for personalized medicine and public health surveillance, diagnostic technologies capable of rapid and accurate pathogen nucleic acid testing in home settings are becoming increasingly crucial. Paper-based microfluidic chips (μPADs) have emerged as a potential core platform for enabling [...] Read more.
Along with the growing demands for personalized medicine and public health surveillance, diagnostic technologies capable of rapid and accurate pathogen nucleic acid testing in home settings are becoming increasingly crucial. Paper-based microfluidic chips (μPADs) have emerged as a potential core platform for enabling molecular testing at home, owing to their advantages of low cost, portability, and independence from complex instrumentation. However, significant challenges remain in the current μPADs systems regarding nucleic acid extraction efficiency, isothermal amplification stability, and signal readout standardization, which hinder their practical and large-scale application. This review systematically summarizes recent research progress in μPADs for home-based nucleic acid testing from four key aspects: extraction–amplification–detection system integration, with a particular focus on the synergistic effects and development trends of critical technologies such as material engineering, fluid control, signal transduction, and intelligent readout. We further analyze typical application cases of this technology in the rapid screening of infectious disease. Promising optimization pathways are proposed, focusing on standardized manufacturing, cold-chain-independent storage, and AI-assisted result interpretation, aiming to provide a feasible framework and forward-looking perspectives for constructing home-based molecular diagnostic systems. Full article
(This article belongs to the Special Issue Point-of-Care Testing (POCT) for Infectious Diseases)
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