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21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition

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A special issue of Diagnostics (ISSN 2075-4418). This special issue belongs to the section "Point-of-Care Diagnostics and Devices".

Deadline for manuscript submissions: 30 June 2026 | Viewed by 5555

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Special Issue Editor

Dr. Gerald J. Kost

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Pathology and Laboratory Medicine, School of Medicine, University of California, Davis, CA 95616, USA
Interests: point-of-care testing; critical limits/values; global warming; pre-hospital diagnostics; crisis response
Special Issues, Collections and Topics in MDPI journals

Special Issue Information

Dear Colleagues,

Point-of-care testing is medical testing at or near the site of patient care. COVID-19 brought about the worldwide acceptance of point-of-care strategies to manage a major infectious threat. This Special Issue builds on that progress. We welcome papers focused on point-of-care themes addressing (a) rapid pathogen detection; (b) discovery, mitigation, and management of outbreaks; (c) antimicrobial resistance; (d) home and self-testing; (e) mobile identification of community contagion; (f) rapid diagnostics for disasters, emergencies, and public health crises; (g) instrument robustness in harsh environments; (h) multiplex pathogen detection for targeted therapeutics; (i) results in interpretation in different prevalence settings; (j) smartphone-enabled tests; (k) land, sea, and air ambulance prehospital technologies; (l) cost-effectiveness for limited resource users; and general point-of-care inventions and innovations for the diagnosis of infectious diseases with the goals of enhanced decision making, standards of care, and public health resilience at points of critical need.

Dr. Gerald J. Kost
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
infectious diseases
early detection
emergency management
disaster readiness
prehospital diagnosis
health promotion
public health resilience

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Published Papers (6 papers)

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18 pages, 2521 KB

Open AccessArticle

Critical Decision Thresholds for Urgent Physician Notification of Point-of-Care Testing Results

by Kami Osher and Gerald J. Kost

Diagnostics 2026, 16(8), 1139; https://doi.org/10.3390/diagnostics16081139 - 10 Apr 2026

Viewed by 540

Abstract

Background/Objectives: Critical limits define quantitative thresholds for life-threatening diagnostic test results that require immediate clinician notification and may prompt urgent intervention to prevent adverse outcomes. This study aims to (1) characterize point-of-care (POC) critical limits for adults and newborns using a comprehensive U.S. national database, (2) identify POC instruments associated with these limits, and (3) support harmonization of point-of-care testing (POCT) practices. Methods: We gathered critical limit notification lists from 417 hospitals across all 50 states and Washington D.C., comprising university hospitals, trauma and heart centers, centers of excellence, community hospitals, and network hospitals. We extracted POC and central laboratory critical limits (at hospitals with POC), adult international normalized ratio (INR) data, and instrument usage. Results: Low and high glucose critical limits were the most frequently listed POC thresholds, with median values of 50 and 450 mg/dL, respectively, reported by 73 hospitals (17.5%). Troponin was listed by ten hospitals, specified as troponin (n = 4), troponin I (n = 5), or “troponin TnI” (n = 1). A few hospitals assigned instrument-specific critical limits for the same analyte, and 55 hospitals did not specify instrument usage for any measurand. Median differences in matched pairs of laboratory versus POC critical limits differed significantly (Wilcoxon signed-rank, p < 0.05) for low and high ionized calcium (n = 21), low hemoglobin (n = 23) and high INR critical limits for adults (n = 27) and newborns (n = 10). In some cases, matched pair analytes demonstrated identical critical limits. Conclusions: Harmonizing critical limit notification thresholds across point-of-care testing and different devices may improve consistency in clinical decision-making and patient outcomes. Despite the potential of POCT to shorten time to urgent intervention, relatively few hospitals currently include POCT critical limits on notification lists. Establishing standards, annual updating, and enforcing risk mitigation could enhance adoption and reliability. Broader inclusion and transparent sharing of POCT critical values could harmonize practices across institutions, facilitate inter-institutional collaboration, and promote more timely and reliable responses to life-threatening diagnostic results. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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15 pages, 1119 KB

Open AccessArticle

Evaluation of Flu A/B, SARS-CoV-2, and RSV Antigen Combo Rapid Test in Hospitalized Children Under Two Years of Age

by Birhan Mulugeta, Dessalegn Fentahun, Dawit Hailu, Asmare Moges, Abiy Ayele Angelo, Getu Girmay, Abaysew Ayele and Tesfaye Gelanew

Diagnostics 2026, 16(6), 830; https://doi.org/10.3390/diagnostics16060830 - 11 Mar 2026

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Abstract

Background/Objectives: Next to malaria, respiratory viruses, particularly respiratory syncytial virus (RSV), are responsible for the hospitalization and death of thousands of young children each year in sub-Saharan Africa. During peak seasons, conducting separate tests is time-consuming and distressing. This underscores the need for efficient, rapid multiplexed diagnostic tools. This study aimed to evaluate the clinical performance of a lateral flow assay (LFA) based antigen combo rapid diagnostic test (ML Ag Combo RDT, manufactured by MobiLab) that detects RSV, influenza viruses A and B (Flu A/B), and SARS-CoV-2. Methods: The Allplex panel 1 rRT-qPCR assay was used as a reference assay to evaluate the clinical performance of the LFA Ag Combo RDT in pediatric hospital settings. It was performed using 470 nasopharyngeal swab (NPS) specimens from hospitalized children under two years of age with respiratory symptoms. Results: Based on the comparative analysis of the testing results for 470 NPS, the ML Ag Combo RDT demonstrated high sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 90.06%, 98.38%, 93.67, and 97.39% for RSV, and 30%, 100%, 100%, and 95.43 for Flu A/B, respectively. Agreement with the Allplex panle1 1 rRT-qPCR was strong (κ = 0.90 for RSV) and moderate (κ = 0.45 for Flu A/B), with overall accuracies of 96.63% for RSV and 95.5 for Flu A/B. This was further supported by ROC analysis for aggregated data (RSV and, Flu A/B) with an AUC value of 0.925. As expected, in samples with high viral loads (Ct < 20), the Ag Combo RDT achieved 100% sensitivity for RSV and Flu A/B. Sensitivity declined slightly at lower viral loads (Ct > 35). Conclusions: The ML Ag Combo RDT demonstrates high specificity and diagnostic accuracy for the detection of RSV and Flu A/B in pediatric hospital settings where timely diagnosis is critical. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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11 pages, 1701 KB

Open AccessArticle

Morphological Analysis and Short-Term Evolution in Pulmonary Infarction Ultrasound Imaging: A Pilot Study

by Chiara Cappiello, Elisabetta Casto, Alessandro Celi, Camilla Tinelli, Francesco Pistelli, Laura Carrozzi and Roberta Pancani

Diagnostics 2026, 16(3), 383; https://doi.org/10.3390/diagnostics16030383 - 24 Jan 2026

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Abstract

Background: Pulmonary infarction (PI) is the result of the occlusion of distal pulmonary arteries resulting in damage to downstream lung areas that become ischemic, hemorrhagic, or necrotic, and it is often a complication of an underlying condition such as pulmonary embolism (PE). Since in most of cases it is located peripherally, lung ultrasound (LUS) can be a good evaluation tool. The typical radiological features of PI are well-known; however, there are limited data on its sonographic characteristics and its evolution. Methods: The aim of this study is to evaluate, using LUS, a convenience sample of patients with acute PE with computed tomography (CT) consolidation findings consistent with PI. Patients’ clinical characteristics were collected and LUS findings at baseline and their short-term progression was assessed. LUS was performed within 72 h of PE diagnosis (T0) and repeated after one (T1) and four weeks (T2). Each procedure started with a focused examination of the areas of lesions based on CT findings, followed by an exploration of the other posterior and lateral lung fields. The convex probe was used for initial evaluation integrating LUS evaluation with the linear one was employed for smaller and more superficial lesions and when appropriate. Color Doppler mode was added to study vascularization. Results: From June to October 2023, 14 consecutive patients were enrolled at the Respiratory Unit of the University Hospital of Pisa. The main population characteristics included the absence of respiratory failure and prognostic high-risk PE (100%), the absence of significant comorbidities (79%), and the presence of typical symptoms, such as chest pain (57%) and dyspnea (50%). The average number of consolidations per patient was 1.4 ± 0.6. Follow-up LUS showed the disappearance of some consolidations and some morphological changes in the remaining lesions: the presence of hypoechoic consolidation with a central hyperechoic area (“bubbly consolidation”) was more typical at T1 while the presence of a small pleural effusion often persisted both at T1 and T2. A decrease in wedge/triangular-shaped consolidations was observed (82% at T0, 67% at T1, 24% at T2), as was an increase in elongated shapes, representing a residual pleural thickening over time (9% at T0, 13% at T1, 44% at T2). A reduction in size was also observed by comparing the mean diameter, long axis, and short axis measurements of each consolidation at the three different studied time points: the average of the short axes and the median of the mean diameters showed a statistically significant reduction after four weeks. Additionally, a correlation between lesion size and pleuritic pain was described, although it did not achieve statistical significance. Conclusions: Patients’ clinical characteristics and ultrasound features are consistent with previous studies studying PI at PE diagnosis. Most consolidations detected by LUS change over time regarding size and form, but a minority of them do not differ. LUS is a safe and non-invasive exam that could help to improve patients’ clinical approach in emergency rooms as well as medical and pulmonology settings, clinically contextualized for cases of chest pain and dyspnea. Future studies could expand the morphological study of PI. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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12 pages, 2555 KB

Open AccessArticle

Genogroup-Specific Multiplex Reverse Transcriptase Loop-Mediated Isothermal Amplification Assay for Point-of-Care Detection of Norovirus

by Wahedul Karim Ansari, Mi-Ran Seo and Yeun-Jun Chung

Diagnostics 2025, 15(15), 1868; https://doi.org/10.3390/diagnostics15151868 - 25 Jul 2025

Cited by 2 | Viewed by 1169

Abstract

Background/Objectives: Norovirus is a major cause of acute gastroenteritis worldwide. Considering its highly infectious and transmissible nature, rapid and accurate diagnostic tools are of utmost importance for the effective control of outbreaks in the context of point-of-care testing (POCT). In this study, we developed a genogroup-specific multiplex reverse transcriptase loop-mediated isothermal amplification assay to detect the human norovirus genogroups I and II (GI and GII, respectively). Methods: For the comprehensive detection of clinically relevant genotypes, two sets of primers were incorporated into the assays targeting the RdRp-VP1 junction: one against GI.1 and GI.3, and the other for GII.2 and GII.4. Following optimization of the reaction variables, we standardized the reaction conditions at 65 °C with 6 mM MgSO₄, 1.4 mM dNTPs, 7.5 U WarmStart RTx Reverse Transcriptase, and Bst DNA polymerase at 8 U and 10 U for GI and GII, respectively. Amplification was monitored in real-time using a thermocycler platform to ensure precise quantification and detection. Finally, the assay was evaluated through portable isothermal detection device to test its feasibility in on-site settings. Results: Both assays detected the template down to 10²–10³ copies per reaction and showed high target selectivity, yielding no non-specific amplification across 39 enteric pathogens. These assays enabled prompt detection of GI within 10–12 min and of GII within 12–17 min after the reaction was initiated. Onsite validation reveals all template detection below 15 min, demonstrating its potential feasibility in point-of-care applications. Including the sample preparation time, test results were obtained in less than 1 h. Conclusions: This method is a rapid, reliable, and scalable solution for detecting human norovirus in POCT settings for both clinical diagnosis and public health surveillance. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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16 pages, 2526 KB

Open AccessSystematic Review

Meta-Analytic Modeling to Define Decision Thresholds for Cerebrospinal Fluid Heparin-Binding Protein in Healthcare-Associated Ventriculitis and Meningitis

by Hsiang-Yi Hung, Po-An Su, Pei-Chun Lai and Yen-Ta Huang

Diagnostics 2026, 16(7), 1110; https://doi.org/10.3390/diagnostics16071110 - 7 Apr 2026

Viewed by 467

Abstract

Background/Objectives: Healthcare-associated ventriculitis and meningitis (HAVM) is a life-threatening complication of neurosurgical procedures. Conventional cerebrospinal fluid (CSF) indices cannot reliably distinguish bacterial infection from sterile postoperative inflammation, and cultures are frequently delayed or negative. We conducted the first systematic review and meta-analysis to determine the pooled diagnostic accuracy of CSF heparin-binding protein (HBP) for HAVM and to establish clinically actionable decision thresholds. Methods: PubMed, Embase, the Cochrane Library, and China National Knowledge Infrastructure were searched from inception to 15 February 2026. Risk of bias was assessed using QUADAS-3. Sensitivity and specificity were pooled with a bivariate random-effects model, and heterogeneity was explored through subgroup analyses and metaregression. Thresholds were derived using likelihood ratio (LR)-based and diagmeta cutoff modeling. Results: Twelve studies (n = 1761) were included. Pooled sensitivity was 0.861 (95% confidence interval [CI]: 0.777–0.917) and specificity was 0.848 (95% CI: 0.781–0.897), with a positive LR (LR+) of 5.65 and a negative LR (LR−) of 0.164. At a 50% pretest probability, post-test probability was increased to 85% by a positive result and reduced to 14% by a negative result. Intracerebral hemorrhage cohorts showed lower accuracy (sensitivity: 0.675, specificity: 0.755), whereas brain tumor-predominant cohorts demonstrated the highest performance (sensitivity: 0.935, specificity: 0.922; p = 0.017). Thresholds of ≥41.3 (rule-in; LR+ ≥10) and ≤30.1 ng/mL (rule-out; LR− ≤0.1) defined clinically actionable decision zones. Conclusions: CSF HBP provides quantitatively defined rule-in and rule-out thresholds that meaningfully shift the post-test probability and may support antimicrobial decision-making in suspected HAVM. Prospective multicenter validation is warranted. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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19 pages, 3665 KB

Open AccessSystematic Review

Diagnostic Accuracy of Lung Ultrasound for Pneumonia in Acutely and Critically Ill Neonates, Children, and Young Adults: A Systematic Review and Meta-Analysis

by Carmina Guitart, Judit Becerra, Sara Bobillo-Perez, Josep L. Carrasco, Gonzalo Peon, Monica Balaguer and Iolanda Jordan

Diagnostics 2025, 15(24), 3122; https://doi.org/10.3390/diagnostics15243122 - 8 Dec 2025

Viewed by 1326

Abstract

Background: Pneumonia remains a major cause of morbidity and mortality among critically ill children. Lung ultrasound has emerged as a promising bedside diagnostic tool. Methods: A systematic review and meta-analysis across PubMed, Embase, The Cochrane Library, Scopus, World Health Organization Libraries, Epistemonikos, and MedRxiv was conducted to evaluate the diagnostic accuracy of lung ultrasound for pneumonia in paediatric patients. Publication bias was evaluated using the generalised Egger’s test. Diagnostic performance metrics, including sensitivity, specificity, and the area under the receiver operating characteristic curve were pooled using a bivariate random-effects model. Results: Thirty studies comprising a total of 4356 children were included. The studies were of high methodological quality, with minimal heterogeneity. Lung ultrasound pooled sensitivity was 91% (95% CI: 87–94%), and specificity was 90% (95% CI: 83–94%). The ROC curve was 0.95 (95% CI: 0.90–0.95), indicating excellent diagnostic performance. Conclusions: LUS is a reliable and accurate imaging modality for diagnosing pneumonia in critically ill children. The findings support its use as a first-line diagnostic tool in emergency and intensive care settings. PROSPERO Research registration number: CRD42021223679. Full article

(This article belongs to the Special Issue 21st Century Point-of-Care, Near-Patient and Critical Care Testing—2nd Edition)

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