Molecular point-of-care (POC) tests offer high sensitivity, rapid turnaround times, relative ease of use, and the convenience of laboratory-grade testing in the absence of formal laboratory spaces and equipment, making them appealing options for infectious disease diagnosis in resource-limited settings. In this review, we discuss the role and potential of molecular POC tests in resource-limited settings and their associated logistical challenges. We discuss U.S. Food and Drug Administration approval, Clinical Laboratory Improvement Amendments complexity levels, and the REASSURED criteria as a starting point for assessing options currently available inside and outside of the United States. We then present POC tests currently in research and development phases that have potential for commercialization and implementation in limited-resource settings. Finally, we review published studies that have assessed the clinical impact of molecular POC testing in limited- and moderate-resource settings.

Objective: To test the validity and clinical utility of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) severity specifiers for binge-eating disorder (BED) in predicting treatment outcomes. Method: Participants (N=521) were patients in randomized controlled trials (RCTs) at one medical center testing treatments for BED; data were aggregated from RCTs testing cognitive-behavioral therapy (CBT), behavioral weight loss (BWL), and/or multi-modal (i.e., CBT or BWL plus pharmacotherapy) treatment. Participants were categorized according to DSM-5 severity specifiers for BED: “mild” (n=273; 52.5%), “moderate” (n=182; 34.9%), and “severe/extreme” (n=58; 11.1%). Participants had weight and height measured and were assessed using established interviews and self-report measures at baseline, throughout treatment, and post-treatment. Results: Mixed models revealed that severity category did not significantly predict treatment response. However, there were main effects of BED severity category: “severe/extreme” BED had greater binge-eating frequency and had greater global eating-disorder psychopathology than “mild” BED across all time points. “Severe/extreme” BED was less likely to have remission from binge eating than “mild” BED. Weight loss and depression scores did not significantly differ by severity category. Conclusion: In a large series of treatment-seeking individuals with BED aggregated across RCTs at one medical center testing psychological and pharmacological treatments for BED, DSM-5 severity specifiers for BED had limited validity and utility predicting response to treatments. Future research is needed to identify more robust severity indicators with clinical utility to inform future DSM revisions and clinical practice.

Abstract Background Point-of-care (POC) diagnostic devices deliver rapid, near-patient results that drive timely clinical decisions across diverse settings (from emergency departments to home care). Their decentralized deployment mandates a rigorous, multi-phase validation strategy to ensure analytical accuracy, clinical reliability, and real-world utility before both regulatory clearance and reimbursement. Content We propose an expanded, integrated framework comprising 4 pillars: Analytical validity: Quantification of sensitivity, specificity, predictive values adjusted for prevalence, limits of detection, bias/imprecision, and reproducibility using Receiver Operating Characteristic (ROC) curve analysis, Bland–Altman comparison, Passing–Bablok/Deming regression, and nonparametric techniques for semiquantitative outputs. Clinical validity: Demonstration of substantial equivalence via FDA 510(k) (Class II), de novo (novel low/moderate risk), or premarket approval (PMA; Class III with Investigational Device Exemption (IDE)-supported pivotal trials) pathways, supported by prospective, multicenter clinical studies, and human-factors usability assessments in intended use environments. Clinical utility: Evidence of improved patient care from outcome-based trials (e.g., time-to-treatment and readmission rates), health-economic analyses (cost per quality-adjusted life year and budget-impact models), and patient-reported outcome measures capturing usability, satisfaction, and adherence. Regulatory alignment: Harmonization of FDA and Health Canada requirements, including ISO 14971 risk management, post-market surveillance (21 CFR 820; Medical Device Licence [MDL] vigilance), to streamline market access and payer coverage decisions. Summary This comprehensive, staged validation pathway, from analytical benchmarks through clinical performance and utility to regulatory and reimbursement strategies, provides a practical roadmap for innovators, clinicians, and regulators. Embedding real-world evidence and coordinating US and Canadian frameworks accelerates the adoption of safe, effective, and value-based POC diagnostics, fostering better patient outcomes, and supporting modern precision medicine.

No laboratory test performed to date provides an absolute guarantee for detecting infectious agents. Nucleic acid amplification techniques/tests (NAT) associated with serological tests can increase safety and provide greater diagnostic accuracy for patients. We investigated the added safety of NAT technology combined with serological tests for screening blood donors for Hepatitis C virus (HCV), human immunodeficiency virus (HIV) and hepatitis B virus (HBV). Data were obtained from a systematic search conducted up until march 30, 2024 in five electronic databases: PubMed, Web of Science, Scopus, Embase, and the Cochrane library. Twenty-nine studies, published between 1998 and 2023, were included in the review. Notably, HBV infection was predominant among donors with positive NAT results, with 425 cases, including 373 with positive serology and 52 with negative serology. Data from the diagnostic window period (WP) indicated the highest number of HBV infection cases, with 154 reported. Of the 29 included studies, 10 reported cases of occult HBV infection and diagnostic WP infection. Thirteen studies identified donors during the occult HBV infection period, and 17 identified WP cases. Meta-analyses of positive NAT results following negative serological screening for HBV, HCV, and HIV revealed a significantly pooled frequency (p < 0.001). Positive NAT results retrieved from donors with negative serological HBV and HCV showed a significantly combined frequency (p < 0.001), while for HIV occurs the opposite (p = 0.085). For HBV, HBC and HIV serological tests and NAT-positive results, the pooled frequency was significantly (p < 0.001). The findings demonstrate the positive relationship and safety of molecular technology in screening blood donors for HBV, HCV, and HIV using serological tests. Molecular testing remains a valuable tool for detecting and elucidating bloodborne infections.

Abstract Introduction Insufficient physical activity is a significant contributor to non-communicable disease amongst the global population. Insufficient physical activity is directly linked with reduced cardiorespiratory fitness (CRF). CRF is as strong a predictor of mortality as well-established risk-factors such as smoking, hypertension, dyslipidaemia, and type 2 diabetes mellitus, however, it remains the only major risk factor not routinely assessed in primary health care settings. The aim of this review was to assess the validity and reliability of existing submaximal tests of CRF which can be employed in a standard medical consultation for the estimation of CRF and physical function in adults. Methods A systematic review of the scientific literature was undertaken to find all studies reporting the reliability and/or validity of submaximal tests of CRF and physical function. Studies published up to 12 January 2023 were included in the search of the Medline, Embase, Cinahl, SPORTdiscus, Cochrane library, Informit Health and Web of Science databases. Risk of bias was assessed using the JBI critical appraisal checklist for analytical cross-sectional studies. Data including reliability of the submaximal protocols as measured by test-retest Pearson’s r (r) or Intraclass co-efficient (ICC); and validity as measured by the correlation between the submaximal protocol results and the graded exercise test results (r) was extracted. Meta-analyses were performed to determine the overall mean r of the correlation coefficients. Results In total 1754 studies were identified. Following screening, 143 studies including 15,760 participants were included. All clinical tests included in meta-analysis demonstrated strong reliability. The Siconolfi step test (r=0.81), Incremental shuttle walk test (r=0.768) and 1- minute sit-to-stand test (r=0.65) demonstrated strongest validity following meta-analysis. Conclusion Based on the validity of the tests outlined, these can be used as an acceptable method of estimating VO2peak in a broad population, without the cost and access issues of formal GXT.

The intestinal microbiome is composed of myriad microbial species with impacts on host health that are mediated by the production of metabolites. While loss of bacterial species and beneficial metabolites from the fecal microbiome is associated with development of a range of diseases and medical complications, there are currently no clinical diagnostic tests that rapidly identify individuals with microbiome deficiencies. This method aims to rapidly quantify fecal concentrations of butyrate and deoxycholic acid, as depletion of these two metabolites are associated with adverse clinical outcomes

Physiology, and Clinical Application". Ames: Iowa State University Press. Meeker, M (2005). "Pupil examination: validity and clinical utility of an automated Pupillometry, the measurement of pupil size and reactivity, is a key part of the clinical neurological exam for patients with a wide variety of neurological injuries. It is also used in psychology. Automated pupillometry removes subjectivity from the pupillary evaluation, providing more accurate and trendable pupil data, and allowing earlier detection…

The purpose of this study was to develop and verify a quantifiable symmetry score for infantile postural and movement asymmetries.Three studies were conducted. For reliability, 6 test items examining postural and movement asymmetries, which came under consideration, were investigated in 24 infants with postural abnormality (range: 14-24 weeks). The inter-rater reliability was chosen as the primary endpoint. Furthermore, intrarater reliability and test-retest reliability were determined. Analysis and weighting of the items were performed by calculating the intraclass correlation coefficient. The validity was reviewed by expert opinion and by using a study with 26 infants (range: 12-28 weeks) of a cross-section population. The pilot study involved 38 infants, aged 14 to 24 weeks, who were examined using video. Their autonomic symptoms were recorded, and subsequently, they were treated once by means of manual medicine. The parents were instructed to a daily home program that focused on "tummy time."The reliability tests led to a 4-item symmetry score with a point value between 4 points (very symmetrical) and 17 points (very asymmetrical). The chosen items achieved an intraclass correlation coefficient >0.8 and Cohen's κ >0.6, respectively. The experts' opinions matched mainly to a majority agreement (>50%). Furthermore, a comparison between the outcome of clinical testing and the symmetry score applied to 26 children without diagnosed abnormalities displayed an agreement of 84.6

detected bubbles and decompression sickness. The utility of Doppler-detected bubbles in the pulmonary arteries for reliably predicting clinical DCS is low. The physiology of decompression is the aspect of physiology which is affected by exposure to large changes in ambient pressure. It involves a complex interaction of gas solubility, partial pressures and concentration gradients, diffusion, bulk transport by perfusion, and bubble mechanics in living tissues. Gas is inhaled at ambient pressure, and some of this gas dissolves into the blood through th Gr…