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Chronic kidney disease (CKD) is a progressive condition that affects more than 10% of the world's population. Monitoring urine albumin-to-creatinine ratio (uACR) has become the gold standard for nephropathy diagnosis and control. The objective of the present study was to develop a simple, accurate, sensitive, and rapid point-of-care test (PoCT) device, MyACR, for uACR measurement, intended for use in community healthcare to screen for the risk and monitor the progress of CKD. Albumin and creatinine concentrations in urine samples were determined using spectrophotometric dye (tetrabromophenol blue)-binding and colorimetric Jaffe assay, respectively. Urine samples were diluted with distilled water (1:80) and mixed separately with albumin and creatinine reaction mixture. The creatinine reaction was incubated at room temperature (25 °C) for 30 min before analysis. Optical density (OD) was measured at the wavelengths of 625 nm (albumin) and 515 nm (creatinine). All calibration curves (0–60 mg/L and 0–2 mg/dL for albumin and creatinine) yielded linear relationships with correlation coefficients (R2) of >0.997. Good accuracy (% deviation of mean value (DMV) ≤ 5.42%) and precision (% coefficients of variation (CV) ≤ 12.69%) were observed from both the intra- and inter-day assays for the determination of albumin and creatinine using MyACR. The limit of quantification (LOQ) of albumin and creatinine in urine samples determined using MyACR and a laboratory spectrophotometer were 5 mg/L and 0.25 mg/dL, respectively, using 37.5 μL urine spiked samples (n = 5). The device was well-applied with clinical samples from 20 CKD patients. The median (range) of %DMV of the central (hospital) laboratory method (immune-based assay) was 3.48 (−17.05 to 21.64)%, with a high correlation coefficient (R2 > 0.98). In conclusion, MyACR showed satisfactory test performance in terms of accuracy, reproducibility, and sensitivity. Cost-effectiveness and improvement in clinical decision making need to be proven in future multisite community and home studies. [ABSTRACT FROM AUTHOR]

Chronic kidney disease (CKD) poses a significant global health challenge with increasing prevalence and associated morbidity. Point-of-care testing (POCT) provides an opportunity to improve CKD management and outcomes through early detection and targeted interventions, particularly in underserved communities. This review evaluates the roles of POCT in CKD, focusing on utility (through screening programs, monitoring of kidney function, and assessing participants on renally excreted medications), accuracy, and acceptability. Screening programs employing POCT have demonstrated promising outcomes, with improved rates of CKD diagnosis in groups with disparate health outcomes, offering a vital avenue for early intervention in high-risk populations. These have been conducted in rural and urban community or pharmacy settings, highlighting convenience and accessibility as important facilitators for participants. In addition, POCT holds significant promise in the monitoring of CKD, particularly in groups requiring frequent testing, such as kidney transplant recipients and patients on renin-angiotensin-aldosterone inhibitors. The consideration of the variable analytical performance of different devices remains crucial in assessing the utility of a POCT intervention for CKD. While the convenience and improved accessibility of home self-testing versus healthcare professional management is important, it must be balanced with acceptable levels of accuracy and precision to maintain patient and clinical confidence. Despite challenges including variability in accuracy and the user-friendliness of devices, patient feedback has generally remained positive, with studies reporting increased patient satisfaction and engagement. However, challenges regarding wider uptake are limited by healthcare professional confidence (in test reliability), the potential for increased workload, and early prohibitive costs. In conclusion, POCT represents a growing and valuable tool in enhancing CKD care, particularly in resource-limited settings, but careful consideration of device selection and implementation strategies is essential to achieve desired outcomes. [ABSTRACT FROM AUTHOR]

Background: high-sensitive cardiac TroponinI (hs-cTnI) is widely used for diagnosis of acute coronary syndromes. The latest recommendation for hs-cTnI determination is the protocol 0–1 h finalized to improve the rule out accuracy of the test. A Point of Care Testing able to guarantee these performances could be very useful due to reducing the turnaround time and ruling out patients suspected of ACS, especially by using biological matrices that are not required for centrifuge. The aim of our work is to compare the results for hs-cTnI obtained using different biological matrices and anticoagulants, obtained between Atellica® VTLi hs-cTnI POCT and Access AccuTnI+3 DxI800 performances, in order to establish a possible bias derived directly from these pre-analytical conditions. Methods: Li-heparinized pool samples were primary employ for hs-cTnI with Atellica® VTLi as whole blood, then centrifuged and tested on Atellica® VTLi and DxI800. K3EDTA pool samples were centrifuged and measured on DxI800 too. A comparison of methods was performed according to CLSI_EP-09A2 protocol. Constant and proportional errors were investigated with Deming regression. Bias between methods was evaluated with the Bland Altman test. Results: comparing whole blood lithium heparin results obtained with Atellica versus lithium heparin and K3EDTA plasma tested on DxI 800, the Deming regression revealed a proportional error, whereas in both cases Bland Altman highlighted a minimal underestimation. A similar performance was revealed when considering plasma lithium heparin tested on Atellica versus lithium heparin and K3EDTA plasma obtained with DxI800, confirming the same underestimation. Considering values close to the cut off, no significant differences were found. Conclusions: in the laboratory, the estimation of the bias of two different analyzers is pivotal. Once more this is crucial when different biological matrices and anticoagulants are employed for the analysis. Our study demonstrates that no significant differences among the two matrices are present when comparing Atellica and DxI800 performances. [ABSTRACT FROM AUTHOR]

In April 2020, the Aboriginal and Torres Strait Islander COVID-19 Point-of-Care (POC) Testing Program was initiated to improve access to rapid molecular-based SARS-CoV-2 detection in First Nations communities. At capacity, the program reached 105 health services across Australia. An external review estimated the program contributed to averting between 23,000 and 122,000 COVID-19 infections within 40 days of the first infection in a remote community, equating to cost savings of between AU$337 million and AU$1.8 billion. Essential to the quality management of this program, a customised External Quality Assessment (EQA) program was developed with the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP). From July 2020 to May 2022, SARS-CoV-2 EQA participation ranged from 93 to 100%. Overall concordance of valid EQA results was high (98%), with improved performance following the first survey. These results are consistent with those reported by 12 Australian and 4 New Zealand laboratories for three SARS-CoV-2 RNA EQA surveys in March 2020, demonstrating that SARS-CoV-2 RNA POC testing in primary care settings can be performed to an equivalent laboratory analytical standard. More broadly, this study highlights the value of quality management practices in real-world testing environments and the benefits of ongoing EQA program participation. [ABSTRACT FROM AUTHOR]

Background: Peritoneal dialysis-related peritonitis (PDRP) is the most common complication of peritoneal dialysis (PD), which can lead to poor outcomes if not diagnosed and treated early. We aimed to investigate the diagnostic accuracy of MMP-8 and IL-6-based point-of-care tests (POCTs) in diagnosing PDRP in PD patients. Methods: This retrospective chart review study was conducted at a comprehensive kidney center in Qatar. It involved all adult PD patients who underwent PDRP from July 2018 to October 2019 and for whom MMP-8 and IL-6-based POCTs were used to diagnose presumptive peritonitis. Measures of diagnostic accuracy were computed. Peritoneal fluid effluent analysis was the reference standard. Results: We included 120 patients (68 [56.7%] females, ages 55.6 ± 15.6 years, treatment duration 39.5 ± 30.4 months [range: 5–142 months]). In this population, MMP-8 and IL-6-based POCTs yielded 100% in all dimensions of diagnostic accuracy (sensitivity, specificity, positive and negative predictive values). Conclusions: MMP-8 and IL-6-based POCTs might be helpful in the early detection of PDRP. This monocentric observation requires further confirmation in a prospective multicentric setting. [ABSTRACT FROM AUTHOR]

Accurate clinical diagnosis of patients presenting to primary care settings with acute sore throat remains challenging, often resulting in the over-prescribing of antibiotics. Using point-of-care tests (POCTs) to differentiate between respiratory infections is well-accepted, yet evidence on the application within primary care is sparse. We assessed the application of testing patients (n = 160) from three family practices with suspected Streptococcal infections using rapid molecular tests (ID NOW Strep A2, Abbott). In addition to comparing clinical evaluation and prescription rates with either usual care or testing, patients and staff completed a questionnaire about their experience of molecular POCT in primary care. The immediate availability of the result was important to patients (100%), and staff (≈90%) stated that molecular testing improved the quality of care. Interestingly, only 22.73% of patients with a Centor score > 2 tested positive for Strep A and, overall, less than 50% of Centor scores 3 and 4 tested positive for Strep A with the ID NOW testing platform. The addition of rapid molecular POCTs to clinical assessment resulted in a 55–65% reduction in immediate and deferred antibiotic prescriptions. The intervention was popular with patients and medical staff but was associated with increased cost and a longer appointment length. [ABSTRACT FROM AUTHOR]

The integration of artificial intelligence (AI) into point-of-care (POC) biosensing has the potential to revolutionize diagnostic methodologies by offering rapid, accurate, and accessible health assessment directly at the patient level. This review paper explores the transformative impact of AI technologies on POC biosensing, emphasizing recent computational advancements, ongoing challenges, and future prospects in the field. We provide an overview of core biosensing technologies and their use at the POC, highlighting ongoing issues and challenges that may be solved with AI. We follow with an overview of AI methodologies that can be applied to biosensing, including machine learning algorithms, neural networks, and data processing frameworks that facilitate real-time analytical decision-making. We explore the applications of AI at each stage of the biosensor development process, highlighting the diverse opportunities beyond simple data analysis procedures. We include a thorough analysis of outstanding challenges in the field of AI-assisted biosensing, focusing on the technical and ethical challenges regarding the widespread adoption of these technologies, such as data security, algorithmic bias, and regulatory compliance. Through this review, we aim to emphasize the role of AI in advancing POC biosensing and inform researchers, clinicians, and policymakers about the potential of these technologies in reshaping global healthcare landscapes. [ABSTRACT FROM AUTHOR]

The study compared two plasma procalcitonin (PCT) assays, the point of care (POC) Finecare™ Procalcitonin Rapid Quantitative Test and the Elecsys® BRAHMS PCT immunoassay, in sepsis ICU patients. Forty-one plasma samples were analyzed, showing a strong correlation (r = 0.98) and no significant difference in PCT values. The mean POC PCT value was 4.46 ng/mL (SD 8.68), and for laboratory BRAHMS PCT, it was 4.67 ng/mL (SD 10.03). The study found a strong linear relationship between plasma POC PCT and laboratory BRAHMS PCT (r = 0.98). Different regression methods showed varying intercepts and slopes: Ordinary Least Squares had an intercept of 0.49 and a slope of 0.85; Deming regression showed an intercept of 0.43 and a slope of 0.86; Passing–Bablok regression showed an intercept of 0.02 and a slope of 1.08. Precision results for cut-offs of 0.5 ng/mL were a coefficient of variation (CV) of 5%, and for 2.5 ng/mL, the CV was 2.5%. The Pearson correlation coefficient (r) for linearity was ≥0.99. The study revealed no significant difference between the POC Finecare™ PCT and Elecsys® BRAHMS PCT immunoassay in sepsis samples from ICU patients, supported by strong correlation, minimal bias, a consistent CV, and linearity. [ABSTRACT FROM AUTHOR]

Salmonella species are prominent foodborne microbial pathogens transmitted through contaminated food or water and pose a significant threat to human health. Accurate and rapid point-of-care (POC) diagnosis is gaining attention in effectively preventing outbreaks of foodborne disease. However, the presence of dead bacteria can interfere with an accurate diagnosis, necessitating the development of methods for the rapid, simple, and efficient detection of viable bacteria only. Herein, we used an improved propidium monoazide (PMAxx) to develop a nucleic acid lateral flow (NALF) assay based on recombinase polymerase amplification (RPA) to differentiate viable Salmonella Typhimurium. We selected an RPA primer set targeting the invA gene and designed a probe for NALF. RPA-based NALF was optimized for temperature (30–43 °C), time (1–25 min), and endonuclease IV concentration (0.025–0.15 unit/µL). PMAxx successfully eliminated false-positive results from dead S. Typhimurium, enabling the accurate detection of viable S. Typhimurium with a detection limit of 1.11 × 102 CFU/mL in pure culture. The developed method was evaluated with spiked raw chicken breast and milk with analysis completed within 25 min at 39 °C. This study has potential as a tool for the POC diagnostics of viable foodborne pathogens with high specificity, sensitivity, rapidity, and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Introduction: Point-of-care ultrasound has become a universal practice, employed by physicians across various disciplines, contributing to diagnostic processes and decision-making. Aim: To assess the association of reduced (<50%) left-ventricular ejection fraction (LVEF) based on prospective point-of-care ultrasound operated by medical students using an artificial intelligence (AI) tool and 1-year primary composite outcome, including mortality and readmission for cardiovascular-related causes. Methods: Eight trained medical students used a hand-held ultrasound device (HUD) equipped with an AI-based tool for automatic evaluation of the LVEF of non-selected patients hospitalized in a cardiology department from March 2019 through March 2020. Results: The study included 82 patients (72 males aged 58.5 ± 16.8 years), of whom 34 (41.5%) were diagnosed with AI-based reduced LVEF. The rates of the composite outcome were higher among patients with reduced systolic function compared to those with preserved LVEF (41.2% vs. 16.7%, p = 0.014). Adjusting for pertinent variables, reduced LVEF independently predicted the composite outcome (HR 2.717, 95% CI 1.083–6.817, p = 0.033). As compared to those with LVEF ≥ 50%, patients with reduced LVEF had a longer length of stay and higher rates of the secondary composite outcome, including in-hospital death, advanced ventilatory support, shock, and acute decompensated heart failure. Conclusions: AI-based assessment of reduced systolic function in the hands of medical students, independently predicted 1-year mortality and cardiovascular-related readmission and was associated with unfavorable in-hospital outcomes. AI utilization by novice users may be an important tool for risk stratification for hospitalized patients. [ABSTRACT FROM AUTHOR]

The current standard of care for coronary artery disease (CAD) requires an intake of radioactive or contrast enhancement dyes, radiation exposure, and stress and may take days to weeks for referral to gold-standard cardiac catheterization. The CAD diagnostic pathway would greatly benefit from a test to assess for CAD that enables the physician to rule it out at the point of care, thereby enabling the exploration of other diagnoses more rapidly. We sought to develop a test using machine learning to assess for CAD with a rule-out profile, using an easy-to-acquire signal (without stress/radiation) at the point of care. Given the historic disparate outcomes between sexes and urban/rural geographies in cardiology, we targeted equal performance across sexes in a geographically accessible test. Noninvasive photoplethysmogram and orthogonal voltage gradient signals were simultaneously acquired in a representative clinical population of subjects before invasive catheterization for those with CAD (gold-standard for the confirmation of CAD) and coronary computed tomographic angiography for those without CAD (excellent negative predictive value). Features were measured from the signal and used in machine learning to predict CAD status. The machine-learned algorithm achieved a sensitivity of 90% and specificity of 59%. The rule-out profile was maintained across both sexes, as well as all other relevant subgroups. A test to assess for CAD using machine learning on a noninvasive signal has been successfully developed, showing high performance and rule-out ability. Confirmation of the performance on a large clinical, blinded, enrollment-gated dataset is required before implementation of the test in clinical practice. [ABSTRACT FROM AUTHOR]

(1) Background: Standard semen analysis methods may exhibit variability between observers and/or human error; therefore, additional methods are needed to overcome these handicaps. We aimed to present a new smartphone-applied semen analyzer, Sperm Cell™, investigate its diagnostic efficacy by comparing it with the standard analysis method, and determine its user-friendly nature. (2) Methods: A cross-sectional study was conducted on a large sample cohort, including 102 men. Three semen analyses were performed for each semen sample. The first employed the standard manual method, whereas the others were smartphone-based analyses performed by technicians and patients. We compared major semen parameters between the three semen analyses. The user-friendly nature of the analyzer was also evaluated with a mini-questionnaire completed by the participants. (3) Results: The determined median sperm count, motile sperm count, and percentage of motile sperms, on standard manual semen analysis, were 50.00 × 106/mL (0–160 × 106/mL), 23.94 × 106/mL (0–108 × 106/mL) and 50.00% (0–73.00%), respectively. Median sperm count and motile sperm count were 50.52 × 106/mL (<1–150 × 106/mL) vs. 55.77 × 106/mL (<1–160 × 106/mL) and 23.34 × 106/mL (0–105 × 106/mL) vs. 23.53 × 106/mL (0–104 × 106/mL) for SpermCell™-based semen analysis performed by a technician and patients themselves, respectively. The percentages of motile sperms were 47.40% (0–67.00%) vs. 47.61% (0–80.20%), respectively. All the parameters were statistically similar between the three semen analysis methods (p > 0.05 for each). The SpermCell™ analysis results were correlated with the standard manual method with up to 0.85 correlation coefficients. Moreover, substantial diagnostic accuracy, sensitivity and specificity were obtained in determining the oligospermia and asthenozoospermia via the device-based analyses performed by technician and patients. The mini-questionnaire results revealed that the analyzer is useful. (4) Conclusions: The novel smartphone-applied semen analyzer is a helpful tool with acceptable diagnostic accuracy in determining the major semen parameters. It can be used as an efficient at-home point-of-care testing method in the initial assessment of couples with infertility concerns. [ABSTRACT FROM AUTHOR]

This review describes the appearance of extrapulmonary tuberculosis manifestations in comprehensive and multiparametric ultrasound imaging. The aim is to increase awareness of typical ultrasound findings regarding extrapulmonary tuberculosis, correlate those with pathological features, and facilitate differential diagnosis. Point of care ultrasound protocols can be used as a screening method in high-risk populations, although the negative findings do not exclude tuberculosis. Conversely, the diagnosis of extrapulmonary tuberculosis can never be made using ultrasound alone, as many ultrasound findings in extrapulmonary tuberculosis are non-specific. However, ultrasound-based sampling techniques can significantly facilitate the collection of samples for microbiological or molecular proof of tuberculosis, as well as facilitating the establishment of alternative diagnoses. [ABSTRACT FROM AUTHOR]

This review aims to explore the role of professional diagnostic rapid testing of acute respiratory infections (ARIs), especially COVID-19 and influenza, ensuring proper disease management and treatment in Europe, and particularly in Czech Republic, Poland, and Romania. The paper was constructed based on a review of scientific evidence and national and international policies and recommendations, as well as a process of validation by four experts. The development of new testing technologies, treatment options, and increased awareness of the negative multidimensional impact of ARI profiles transformed differential diagnosis into a tangible and desirable reality. This review covers the following topics: (1) the multidimensional impact of ARIs, (2) ARI rapid diagnostic testing platforms and their value, (3) the policy landscape, (4) challenges and barriers to implementation, and (5) a set of recommendations illustrating a path forward. The findings indicate that rapid diagnostic testing, including at the point of care (POC), can have a positive impact on case management, antimicrobial and antibiotic stewardship, epidemiological surveillance, and decision making. Integrating this strategy will require the commitment of governments and the international and academic communities, especially as we identified room for improvement in the access and expansion of POC rapid testing in the focus countries and the inclusion of rapid testing in relevant policies. [ABSTRACT FROM AUTHOR]

We evaluated the diagnostic performance of the STANDARD i-Q COVID-19 Ag Test, which was developed to detect viral antigens, using nasal and oral swabs. Sixty positive and 100 negative samples were analyzed. We determined the distribution of the Ct values according to the day of sample collection after symptom onset, the diagnostic performance of the total samples and subgroups separated by Ct value or time of sample collection, and the Ct value at which maximal accuracy was expected. No differences were observed in Ct values, except for the samples obtained on the day of symptom onset. The diagnostic sensitivity and specificity of the oral swabs were 75.0 and 100.0%, respectively, whereas those of the nasal swabs were 85.0 and 98.0%, respectively. The sensitivity was higher in samples with a high viral load collected earlier than those collected later, although the difference was not significant. False-negative results were confirmed in all samples with a Ct value ≥ 30.0. These results indicate that tests using oral and nasal swabs are helpful for diagnosing acute symptomatic cases with suspected high viral loads. Our tests exhibited relatively low sensitivity but high specificity rates, indicating the need to assess negative antigen test results. [ABSTRACT FROM AUTHOR]

Transient elastography (TE), recommended by the WHO, is an established method for characterizing liver fibrosis via liver stiffness measurement (LSM). However, technical barriers remain towards point-of-care application, as conventional TE requires wired connections, possesses a bulky size, and lacks adequate imaging guidance for precise liver localization. In this work, we report the design, phantom validation, and clinical evaluation of a palm-sized TE system that enables simultaneous B-mode imaging and LSM. The performance of this system was validated experimentally using tissue-equivalent reference phantoms (1.45–75 kPa). Comparative studies against other liver elastography techniques, including conventional TE and two-dimensional shear wave elastography (2D-SWE), were performed to evaluate its reliability and validity in adults with various chronic liver diseases. Intra- and inter-operator reliability of LSM were established by an elastography expert and a novice. A good agreement was observed between the Young's modulus reported by the phantom manufacturer and this system (bias: 1.1–8.6%). Among 121 patients, liver stiffness measured by this system and conventional TE were highly correlated (r = 0.975) and strongly agreed with each other (mean difference: −0.77 kPa). Inter-correlation of this system with conventional TE and 2D-SWE was observed. Excellent-to-good operator reliability was demonstrated in 60 patients (ICCs: 0.824–0.913). We demonstrated the feasibility of employing a fully integrated phased array probe for reliable and valid LSM, guided by real-time B-mode imaging of liver anatomy. This system represents the first technical advancement toward point-of-care liver fibrosis assessment. Its small footprint, along with B-mode guidance capability, improves examination efficiency and scales up screening for liver fibrosis. [ABSTRACT FROM AUTHOR]

Critically ill patients with rapidly deteriorating clinical status secondary to respiratory and cardio-vascular compromise are at risk for immediate collapse if the underlying pathology is not recognized and treated. Rapid diagnosis is of utmost importance regardless of the setting. Although there are data to support the use of point-of-care ultrasound in critical patients, there is no consensus about the best educational strategy to implement. We designed a curriculum based on the ABC (Airway, Breathing, Circulation) protocol that covers essential airway, lung, and cardiac ultrasound skills needed for fast diagnosis in critical patients and applied it in high-fidelity simulation-based medical education sessions for anesthesia and intensive care residents year one and two. After theoretical and practical assessments, our results show statistical differences in the theoretical knowledge and above-average results in practical assessment. Our proposed curriculum based on a simple ABC POCUS protocol, with an Airway, Breathing, and Circulation approach, is useful in teaching ultrasound basics regarding airway, lung, and cardiac examination using high-fidelity simulation training to anesthesia and intensive care residents, but further research is needed to establish the utility of Simulation-Based Medical Education in Point of Care Ultrasound in the critical patient. [ABSTRACT FROM AUTHOR]

Background: Childhood dyslipidemia is a common condition that can lead to atherosclerotic cardiovascular disease in adulthood. It is usually multifactorial. Screening for cholesterol disorders in children varies based on risk factors, with some guidelines recommending cascade screening for children with a clear family history of familial hypercholesterolemia, targeted screening for those with specific risk factors, and universal screening. Point-of-care testing (POCT) cholesterol tests offer potential advantages, including ease of use, portability, increased patient access, low cost, fewer medical or laboratory visits, and instant results. This study aimed to evaluate the effect of POCT cholesterol screening on the diagnosis of hypercholesterolemia in children in a family practice setting. Methods: We used a POCT cholesterol analyzer to perform two different (universal and targeted) screening approaches for dyslipidemia in children. We used the NCEP guidelines for the classification of the results. Results: We screened 183 children, 105 in the universal screening group and 78 in the targeted screening group. Eight patients in the targeted screening group had elevated cholesterol levels (p = 0.02). Conclusions: All participants received instant feedback and recommendations. Using a targeted screening approach, POCT could be a practical and effective tool for identifying at-risk children with hypercholesterolemia. [ABSTRACT FROM AUTHOR]

The use of handheld point-of-care ultrasound (HH-POCUS) platforms is rapidly increasing, but the diagnostic performance of HH-POCUS in the emergency department (ED) has not been well-studied. For a period of one year, only a HH-POCUS system that uses a non-piezoelectric array (Butterfly iQ+™) was available for clinical POCUS examinations in our ED. We performed a retrospective observational study of patients who underwent cardiac, thoracic, renal, biliary, or lower extremity venous (DVT) examinations from November 2021–November 2022 and calculated performance characteristics of HH-POCUS relative to radiology imaging. A total of 381 HH-POCUS studies were evaluated. Cardiac image quality was significantly lower than lung (p = 0.002). Over half of the studies (213/381) had imaging available for comparison, and HH-POCUS identified 86.5% (32/37, (95%CI) 70.4–94.9) of prespecified emergent diagnoses, including acute cholecystitis, severely reduced left ventricular ejection fraction, pericardial effusion or tamponade, moderate or larger pleural effusion, pneumothorax, moderate or larger hydronephrosis, and DVT. For less emergent diagnoses, 84.3% (43/51, (95%CI) 70.9–92.5) were identified. Overall, HH-POCUS using a non-piezoelectric array showed modest real-world performance in the ED for cardiac, thoracic, renal, biliary, and DVT examinations. HH-POCUS may be inadequate to rule out some common ED diagnoses, but had good specificity for certain conditions such as pericardial effusion. [ABSTRACT FROM AUTHOR]

Antimicrobial resistance is a major global health threat, which is increased by the irrational use of antibiotics, for example, in the treatment of respiratory tract infections in community care. By using rapid point-of-care diagnostics, overuse can be avoided. However, the diagnostic tests are rarely used in most European countries. We mapped potential barriers and facilitators in health technology assessment (HTA), pricing, and funding policies related to the use of rapid diagnostics in patients with community-acquired acute respiratory tract infections. Expert interviews were conducted with representatives of public authorities from five European case study countries: Austria, Estonia, France, Poland, and Sweden. Barriers to the HTA process include the lack of evidence and limited transferability of methods established for medicines to diagnostics. There was no price regulation for the studied diagnostics in the case study countries, but prices were usually indirectly determined via procurement. The lack of price regulation and weak purchasing power due to regional procurement processes were mentioned as pricing-related barriers. Regarding funding, coverage (reimbursement) of the diagnostic tests and the optimized remuneration of physicians in their use were mentioned as facilitators. There is potential to strengthen peri-launch policies, as optimized policies may promote the uptake of POCT. [ABSTRACT FROM AUTHOR]

Faced with the pandemic viral circulation of SARS-CoV-2, healthcare establishments have had to maintain an effective screening strategy in order to prevent nosocomial clusters. Automated antigenic tests appear to be a reliable and complementary alternative to RT-PCR (reverse transcriptase polymerase chain reaction) in order to optimize patient care in the emergency department. We report our experience of the deployment of the LumiraDx antigen tests on the LumiraDx platform, as well as the comparison of these tests' results with the RT-PCR results on a population of patients sampled in the emergency department. [ABSTRACT FROM AUTHOR]

SARS-CoV-2, influenza A/B virus (IAV/IBV), and respiratory syncytial virus (RSV) are among the common viruses causing acute respiratory infections. Clinical diagnosis to differentiate these viruses is challenging due to similar clinical presentations; thus, laboratory-based real-time RT PCR is the gold standard for diagnosis. This retrospective study aimed to evaluate the diagnostic performance of STANDARD M10 Flu/RSV/SARS-CoV-2 (SD Biosensor Inc., Seoul, Korea) using archived positive and negative respiratory samples for SARS-CoV-2, IAV, IBV, and RSV. A total of 322 respiratory samples were tested, comprising 215 positive samples (49 SARS-CoV-2, 48 IAV, 53 IBV, 65 RSV) and 107 negative samples. All samples were tested with both STANDARD M10 and compared to either Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV (Cepheid, Sunnyvale, CA, USA). The sensitivity, specificity, positive predictive value, and negative predictive value rates of STANDARD M10 were very similar to Xpert Xpress SARS-CoV-2 or Xpert Xpress Flu/RSV ranges for each virus (98–100%). The duration of testing and workflows were similar. The overall agreement was 99.4%, including 99.1% agreement for positive samples and 100% agreement for negative samples. In conclusion, the STANDARD M10 point-of-care test is suitable for rapid simultaneous detection of SARS-CoV-2, IAV, IBV, and RSV. [ABSTRACT FROM AUTHOR]

In this study, we assessed the correlations between hemoglobin A1c (HbA1c) measurements obtained using three different diagnostic methods, namely reversed-phase cation-exchange chromatography, high-performance liquid chromatography, and lateral flow immunoassay (LIFA) with an AnyLab F instrument. HbA1c levels measured with the AnyLab F instrument and those measured with the HA8190V, HA8180, and D100 instruments were strongly correlated. High R-square values and low p-values indicated significant and reliable correlations, supporting the clinical interchangeability of these methods. Notably, demographic and clinical analyses revealed uniform HbA1c levels across age groups, suggesting minimal age-related variations in HbA1c levels in the cohort. This finding has implications for diabetes management strategies across different age groups, emphasizing the versatility of the AnyLab F instrument. Overall an average HbA1c level of 7.857% among diabetes mellitus-diagnosed participants suggests moderately elevated HbA1c levels, underscoring the need for improved diabetes management. Younger individuals exhibited lower HbA1c levels, potentially owing to heightened awareness and treatment plan adherence. Conversely, older adults had higher HbA1c levels, likely influenced by age-related changes and comorbidities. Larger sample sizes and a comprehensive evaluation of various measurement principles are needed to strengthen the findings herein. Additionally, exploring additional biomarkers and assessing LIFA performance in larger sample sets will advance the clinical utility of HbA1c measurements. [ABSTRACT FROM AUTHOR]

Background: Normal-anion-gap metabolic acidosis (AGMA) and high-anion-gap metabolic acidosis (HAGMA) are two forms of metabolic acidosis, which is a common complication in patients with chronic kidney disease (CKD). The aim of this study is to identify the prevalence of various acid–base disorders in patients with advanced CKD using point-of-care testing (POCT) and to determine the relationship between POCT parameters. Methods: In a group of 116 patients with CKD in stages G4 and G5, with a mean age of 62.5 ± 17 years, a sample of arterial blood was taken during the arteriovenous fistula procedure for POCT, which enables an assessment of the most important parameters of acid–base balance, including: pH, base excess (BE), bicarbonate (HCO3−), chloride(Cl−), anion gap (AG), creatinine and urea concentration. Based on this test, patients were categorized according to the type of acidosis-base disorder. Results: Decompensate acidosis with a pH < 7.35 was found in 68 (59%) patients. Metabolic acidosis (MA), defined as the concentration of HCO3− ≤ 22 mmol/L, was found in 92 (79%) patients. In this group, significantly lower pH, BE, HCO3− and Cl− concentrations were found. In group of MA patients, AGMA and HAGMA was observed in 48 (52%) and 44 (48%) of patients, respectively. The mean creatinine was significantly lower in the AGMA group compared to the HAGMA group (4.91 vs. 5.87 mg/dL, p < 0.05). The AG correlated positively with creatinine (r = 0.44, p < 0.01) and urea (r = 0.53, p < 0.01), but there was no correlation between HCO3− and both creatinine (r = −0.015, p > 0.05) and urea (r = −0.07, p > 0.05). The Cl− concentrations correlated negatively with HCO3− (r = −0.8, p < 0.01). Conclusions: The most common type of acid–base disturbance in CKD patients in stages 4 and 5 is AGMA, which is observed in patients with better kidney function and is associated with compensatory hyperchloremia. The initiation of renal replacement therapy was significantly earlier for patients diagnosed with HAGMA compared to those diagnosed with AGMA. The more advanced the CKD, the higher the AG. [ABSTRACT FROM AUTHOR]

After three years of the SARS-CoV-2 pandemic, the demand for developing field-deployable point-of-care (PoC) molecular diagnostic tests has increased. Although RT-qPCR is the molecular diagnostic gold standard and is accurate, it is not readily applied to point-of-care testing (POCT). Meanwhile, rapid diagnostic kits have the disadvantage of low sensitivity. Recently, rapid isothermal nucleic acid amplification technology has emerged as an alternative for rapid diagnosis. Here, we developed a rapid SARS-CoV-2 reverse transcription loop-mediated isothermal amplification (RT-LAMP)-lateral flow assay (LFA) kit. This kit includes a Chelex-100/boiling nucleic acid extraction device and a one-step amplification detection apparatus capable of performing the entire process, from RNA extraction to detection, and diagnosing SARS-CoV-2 infection within 40 min without contamination. The detection limits of the rapid SARS-CoV-2 RT-LAMP-LFA kit were 100 plaque-forming units (PFUs) mL−1 and 10−1 PFU mL−1 for RNA samples extracted using the Chelex-100/boiling nucleic acid extraction device and commercial AdvansureTM E3 system, respectively. The sensitivity and specificity of the rapid SARS-CoV-2 RT-LAMP-LFA kit were 97.8% and 100%, respectively. Our SARS-CoV-2 RT-LAMP-LFA kit exhibited high sensitivity and specificity within 40 min without requiring laboratory instruments, suggesting that the kit could be used as a rapid POC molecular diagnostic test for SARS-CoV-2. [ABSTRACT FROM AUTHOR]

Background: A feeding tube (FT) is routinely placed in critically ill patients, and its correct placement is confirmed with a chest X-ray (CXR), which is considered the gold standard. This study evaluated the diagnostic accuracy of ultrasonography (USG) in verifying FT placement compared to a CXR in an intensive care unit (ICU). Method: This was a prospective single-blind study conducted on patients admitted to the ICU of a tertiary hospital in Malaysia. The FT placements were verified through a fogging test and USG at the neck and subxiphoid points. The results of confirmation of FT placement through USG were compared with those obtained using CXRs. Results: A total of 80 patients were included in this study. The FT positions were accurately confirmed by overall USG assessments in 71 patients. The percentage of FT placements correctly identified by neck USG was 97.5%, while the percentage of those identified by epigastric USG was 75%. The corresponding patients' CXRs confirmed correct FT placement in 76 patients. The overall USG assessment had a sensitivity of 92.11% and specificity of 75%, a positive predictive value of 98.59%, and a negative predictive value of 33.33%. The USG findings also showed a significant association between FT size and BMI. FTs with a size of 14Fr were better visualized (p = 0.008), and negative USG findings had a significantly higher BMI (p < 0.001). Conclusion: USG is a simple, safe, and reliable bedside assessment that offers relatively high sensitivity in confirming correct FT placement in critically ill patients. [ABSTRACT FROM AUTHOR]

Acute severe cardiac valve emergencies, such as acute severe mitral regurgitation (AMR) and acute severe aortic regurgitation (AAR), present significant challenges in terms of diagnosis and management. Handheld point-of-care ultrasound devices have emerged as potentially pivotal tools in ensuring the prompt and accurate diagnosis of these left-sided valve emergencies by emergency physicians, particularly in resource-limited settings. Despite the increased utilisation of point-of-care ultrasound by emergency physicians for the management of patients in states of acute cardiorespiratory failure, current diagnostic protocols cannot perform sufficient quantitative assessments of the left-sided cardiac valves. This review elucidates and evaluates the diagnostic utility of handheld point-of-care focused-echocardiography (HoPE) in native AMR and AAR by reviewing the relevant literature and the use of clinical case examples from the Emergency Department at Port Shepstone Regional Hospital (PSRH-ED)—a rural, resource-limited hospital located in KwaZulu-Natal, South Africa. Combining the findings of the review and clinical case illustrations, this review proceeds to synthesise a novel, Bayesian-inspired, iterative diagnostic framework that integrates HoPE into the evaluation of patients with acute cardiorespiratory failure and suspected severe left-sided valve lesions. [ABSTRACT FROM AUTHOR]

With the rising number of older adults residing at home, there is a growing need for risk assessment and patient management in home nursing. This study aims to develop point-of-care test (POCT) reagents that can aid in risk assessment and home care, especially in settings with limited resources. Our focus was on creating a C-reactive protein (CRP) POCT, which can accurately diagnose clinically significant judgment values in home nursing. Additionally, we assessed the utility of the HemoCue WBC DIFF system in providing differential counts of white blood cells (WBC). These performances were compared with a laboratory test using blood samples from patients with pneumonia. The CRP POCT showed a comparable result to that of a laboratory method, with an average kappa index of 0.883. The leukocyte count showed good agreement with the reference method. While the correlation coefficients for both neutrophil and lymphocyte counts were deemed acceptable, it was observed that the measured values tended to be smaller in cases where the cell count was higher. This proportional error indicates a weak correlation with the neutrophil-to-lymphocyte ratio. CRP POCT and WBC counts provided reliable and accurate judgments. These tools may benefit risk management for older adults at home, patients with dementia who cannot communicate, and those living in depopulated areas. [ABSTRACT FROM AUTHOR]

Obstructive sleep apnea (OSA) is a sleeping disorder caused by complete or partial disturbance of breathing during the night. Existing screening methods include questionnaire-based evaluations which are time-consuming, vary in specificity, and are not globally adopted. Point-of-care ultrasound (PoCUS), on the other hand, is a painless, inexpensive, portable, and useful tool that has already been introduced for the evaluation of upper airways by anesthetists. PoCUS could also serve as a potential screening tool for the diagnosis of OSA by measuring different airway parameters, including retropalatal pharynx transverse diameter, tongue base thickness, distance between lingual arteries, lateral parapharyngeal wall thickness, palatine tonsil volume, and some non-airway parameters like carotid intima–media thickness, mesenteric fat thickness, and diaphragm characteristics. This study reviewed previously reported studies to highlight the importance of PoCUS as a potential screening tool for OSA. [ABSTRACT FROM AUTHOR]

The early detection of infectious diseases and microorganisms is critical for effective disease treatment, control, and prevention. Currently, nucleic acid testing and antigen–antibody serum reaction are the two methods most commonly used for the detection of infectious diseases. The former is highly accurate, specific, and sensitive, but it is time-consuming, expensive, and has special technician and instrument requirements. The latter is rapid and economical, but it may not be accurate and sensitive enough. Therefore, it is necessary to develop a quick and on-site diagnostic test for point-of-care testing (POCT) to enable the clinical detection of infectious diseases that is accurate, sensitive, convenient, cheap, and portable. Here, CRISPR/Cas-based detection methods are detailed and discussed in depth. The powerful capacity of these methods will facilitate the development of diagnostic tools for POCT, though they still have some limitations. This review explores and highlights POCT based on the class 2 CRISPR/Cas assay, such as Cas12 and Cas13 proteins, for the detection of infectious diseases. We also provide an outlook on perspectives, multi-application scenarios, clinical applications, and limitations for POCT based on class 2 CRISPR/Cas technology. [ABSTRACT FROM AUTHOR]

Introduction: Austere environments include the wilderness and many lower- and middle-income countries, with many of these countries facing unrest and war. The access to advanced diagnostic equipment is often unaffordable, even if available, and the equipment is often liable to break down. Methods: A short review paper examining the options available to medical professionals to undertake clinical and point-of-care diagnostic testing in resource-constrained environments that also illustrates the development of mobile advanced diagnostic equipment. The aim is to provide an overview of the spectrum and functionality of these devices beyond clinical acumen. Results: Details and examples of products covering all aspects of diagnostic testing are provided. Where relevant, reliability and cost implications are discussed. Conclusions: The review highlights the need for more cost-effective accessible and utilitarian products and devices that will bring cost-effective health care to many in lower- and middle-income or austere environments. [ABSTRACT FROM AUTHOR]

Background: In 2020, health systems across the world responded to the COVID-19 pandemic by making rapid changes to reduce the risk of exposure in patients and healthcare professionals. The use of point-of-care tests (POCT) has been a central strategy in dealing with the COVID-19 pandemic. The aims of this study were to evaluate the impact of POCT strategy (1) on maintaining elective surgeries by removing the risk of delayed pre-appointment testing and turn-around times and (2) on time dedicated for end-to-end appointment and management, and (3) to assess the feasibility of using the ID NOW® among healthcare professionals and patients in a primary care setting, requiring pre-surgical appointment and minor ENT surgery in the Townsend House Medical Centre (THMC), Devon, United Kingdom. Methods: A logistic regression was performed to identify factors associated with the risk of canceled or delayed surgeries and medical appointments. Second, a multivariate linear regression analysis was conducted to calculate changes in the time dedicated to administrative tasks. A questionnaire was developed to assess the acceptance of POCT in patients and staff. Results: 274 patients were included in this study; 174 (63.5%) in Group 1 (Usual Care) and 100 (36.5%) in Group 2 (Point of Care). Multivariate logistic regression showed that the percentage of postponed or canceled appointments was similar between the two groups (adjusted OR = 0.65, [95%CI: 0.22–1.88]; p = 0.42). Similar results were observed for the percentage of postponed or canceled scheduled surgeries (adjusted OR = 0.47, [95%CI: 0.15–1.47]; p = 0.19). The time dedicated to administrative tasks was significantly lowered by 24.7 min in G2 compared to G1 (p < 0.001). 79 patients in G2 (79.0%) completed the survey, and the majority agreed or strongly agreed that it improved care management (79.7%), decreased administrative time (65.8%), reduced the risk of canceled appointments (74.7%) and the traveling time to do COVID-19 test (91.1%). Having point-of-care testing in the clinic in the future seemed more than welcome by 96.6% of patients; 93.6% declared to be less stressed by having the test at the clinic than waiting for the results of the test realized elsewhere. The five healthcare professionals of the primary care center completed the survey, and all agreed that the POCT positively influences the workflow and can be successfully implemented into routine primary care. Conclusions: Our study shows that NAAT-based point-of-care SARS-CoV-2 testing significantly improved flow management in a primary care setting. POC testing was a feasible and well-accepted strategy by patients and providers. [ABSTRACT FROM AUTHOR]

Point-of-care thoracic ultrasound at the patient's bedside has increased significantly recently, especially in pediatric settings. Its low cost, rapidity, simplicity, and repeatability make it a practical examination to guide diagnosis and treatment choices, especially in pediatric emergency departments. The fields of application of this innovative imaging method are many and include primarily the study of lungs but also that of the heart, diaphragm, and vessels. This manuscript aims to describe the most important evidence for using thoracic ultrasound in the pediatric emergency setting. [ABSTRACT FROM AUTHOR]

In the post-pandemic era, point-of-care (POC) diagnosis of diseases is an important research frontier. Modern portable electrochemical (bio)sensors enable the design of POC diagnostics for the identification of diseases and regular healthcare monitoring. Herein, we present a critical review of the electrochemical creatinine (bio)sensors. These sensors either make use of biological receptors such as enzymes or employ synthetic responsive materials, which provide a sensitive interface for creatinine-specific interactions. The characteristics of different receptors and electrochemical devices are discussed, along with their limitations. The major challenges in the development of affordable and deliverable creatinine diagnostics and the drawbacks of enzymatic and enzymeless electrochemical biosensors are elaborated, especially considering their analytical performance parameters. These revolutionary devices have potential biomedical applications ranging from early POC diagnosis of chronic kidney disease (CKD) and other kidney-related illnesses to routine monitoring of creatinine in elderly and at-risk humans. [ABSTRACT FROM AUTHOR]

Airway management is a common and critical procedure in acute settings, such as the Emergency Department (ED) or Intensive Care Unit (ICU) of hospitals. Many of the traditional physical examination methods have limitations in airway assessment. Point-of-care ultrasound (POCUS) has emerged as a promising tool for airway management due to its familiarity, accessibility, safety, and non-invasive nature. It can assist physicians in identifying relevant anatomy of the upper airway with objective measurements of airway parameters, and it can guide airway interventions with dynamic real-time images. To date, ultrasound has been considered highly accurate for assessment of the difficult airway, confirmation of proper endotracheal intubation, prediction of post-extubation laryngeal edema, and preparation for cricothyrotomy by identifying the cricothyroid membrane. This review aims to provide a comprehensive overview of the key evidence on the use of ultrasound in airway management. Databases including PubMed and Embase were systematically searched. A search strategy using a combination of the term "ultrasound" combined with several search terms, i.e., "probe", "anatomy", "difficult airway", "endotracheal intubation", "laryngeal edema", and "cricothyrotomy" was performed. In conclusion, POCUS is a valuable tool with multiple applications ranging from pre- and post-intubation management. Clinicians should consider using POCUS in conjunction with traditional exam techniques to manage the airway more efficiently in the acute setting. [ABSTRACT FROM AUTHOR]

Loop-mediated isothermal amplification (LAMP), as the rank one alternative to a polymerase chain reaction (PCR), has been widely applied in point-of-care testing (POCT) due to its rapid, simple, and cost-effective characteristics. However, it is difficult to achieve real-time monitoring and multiplex detection with the traditional LAMP method. In addition, these approaches that use turbidimetry, sequence-independent intercalating dyes, or pH-sensitive indicators to indirectly reflect amplification can result in false-positive results if non-specific amplification occurs. To fulfill the needs of specific target detection and one-pot multiplex detection, a variety of probe-based LAMP assays have been developed. This review focuses on the principles of these assays, summarizes their applications in pathogen detection, and discusses their features and advantages over the traditional LAMP methods. [ABSTRACT FROM AUTHOR]

Tuberculosis (TB) is one of the leading causes of infectious mortality from a single infectious agent, Mycobacterium tuberculosis (MTB). This study evaluated the performance of the newly developed BZ TB/NTM NALF assay, which integrated loop-mediated isothermal amplification and lateral flow immunochromatographic assay technologies, for the detection of MTB. A total of 80 MTB-positive samples and 115 MTB-negative samples were collected, all of which were confirmed by TB real-time PCR (RT-PCR) using either AdvanSureTM TB/NTM RT-PCR Kit or Xpert® MTB/RIF Assay. The performance of the BZ TB/NTM NALF assay was evaluated by calculating its sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) in comparison to those of the RT-PCR methods. Compared to the RT-PCR, the sensitivity, specificity, PPV, and NPV of BZ TB/NTM NALF assay were 98.7%, 99.1%, 98.7%, and 99.1%, respectively. The concordance rate between BZ TB/NTM NALF and RT-PCR was 99.0%. Rapid and simple detection of MTB is essential for global case detection and further elimination of TB. The performance of the BZ TB/NTM NALF Assay is acceptable with a high concordance with RT-PCR, indicating that it is reliable for use in a low-resource environment. [ABSTRACT FROM AUTHOR]

Asthma is a heterogenous disorder characterized by presence of different phenotypes and endotypes. Up to 10% of the individuals suffer from severe asthma and are at increased risk of morbidity and mortality. Fractional exhaled nitric oxide (FeNO) is a cost-effective, point of care biomarker that is used to detect type 2 airway inflammation. Guidelines have proposed to measure FeNO as an adjunct to diagnostic evaluation in individuals with suspected asthma and to monitor airway inflammation. FeNO has lower sensitivity, suggesting that it may not be a good biomarker to rule out asthma. FeNO may also be used to predict response to inhaled corticosteroids, predict adherence and deciding on biologic therapy. Higher levels of FeNO have been associated with lower lung function and increased risk for future asthma exacerbations and its predictive value increases when combined with other standard measurements of asthma assessment. [ABSTRACT FROM AUTHOR]

There is increasing recognition that point-of-care ultrasound (POCUS), performed by the clinician at the bedside, can be a natural extension of the clinical examination—the modern abdominal "stethoscope" and provides an opportunity to expedite the care pathway for patients with acute gallbladder disease. The primary aims of this study were to benchmark the accuracy of surgeon-performed POCUS in suspected acute gallbladder disease against standard radiology or pathology reports and to compare time to POCUS diagnosis with time to definitive imaging. This prospective single-arm observational cohort study was conducted in four hospitals in Ireland, Italy, and Portugal to assess the accuracy of POCUS against standard radiology in patients with suspected acute biliary disease (ClinicalTrials.govIdentifier: NCT02682368). The findings of surgeon-performed POCUS were compared with those on definitive imaging or surgery. Of 100 patients recruited, 89 were suitable for comparative analysis, comparing POCUS with radiological findings in 84 patients and with surgical/histological findings in five. The overall global accuracy of POCUS was 88.7% (95% CI, 80.3–94.4%), with a sensitivity of 94.7% (95% CI, 85.3–98.9%), a specificity of 78.1% (95% CI, 60.03–90.7%), a positive likelihood ratio (LR+) of 4.33 and negative likelihood ratio (LR) of 0.07. The mean time from POCUS to the final radiological report was 11.9 h (range 0.06–54.9). In five patients admitted directly to surgery, the mean time between POCUS and incision was 2.30 h (range 1.5–5), which was significantly shorter than the mean time to formal radiology report. Sixteen patients were discharged from the emergency department, of whom nine did not need follow-up. Our study is one of the very few to demonstrate a high concordance between surgeon-performed POCUS of patients without a priori radiologic diagnosis of gallstone disease and shows that the expedited diagnosis afforded by POCUS can be reliably leveraged to deliver earlier definitive care for patients with acute gallbladder pathology, as the general surgeon skilled in POCUS is uniquely positioned to integrate it into their bedside assessment. [ABSTRACT FROM AUTHOR]

Aim of the study: We evaluated and compared blood gas analysis (EGA) non-conformities (NC) considered operator-dependent performed in Point-Of-Care (POC) analyzer as quality indicators (IQ) of the pre-analytical phase. To this end, four different NC registered in the resuscitation departments of the Hospital Polyclinic Bari from the beginning of the pandemic (March 2020) until February 2022 were evaluated. The results obtained were compared with those recorded in the pre-COVID period (March 2018–February 2020) to check if there were differences in number and type. Material and methods: GEM 4000 series blood gas analyzers (Instrumentation Laboratory, Bedford, MA, United States) are installed with integrated Intelligent Quality Management (iQM®), which automatically identify and log pre-analytical errors. All blood gas analyzers are connected to the company intranet and interfaced with the GEM Web Plus (Werfen Instrumentation Laboratory, Bedford, MA, United States) data management information system, which allows the core laboratory to remotely supervise all decentralized POC stations. The operator-dependent process NC were expressed in terms of absolute and relative proportions (percentiles and percentage changes). For performance evaluation, the Mann–Whitney U test, Chi-squared test and Six-Sigma Metric calculation for performance classification were performed. Results: In the COVID period, 31,364 blood gas tests were performed vs. 16,632 tests in the pre-COVID period. The NC related to the suitability of the EGA sample and manageable by the operators were totals of 652 (3.9%) and 749 (2.4%), respectively, in the pre-COVID and COVID periods. The pre-analytical phase IQs used did not show statistically significant differences in the two periods evaluated. The Sigma evaluation did not show an increase in error rates. Conclusions: Considering the increase in the number of EGAs performed in the two periods, the training procedures performed by the core laboratory staff were effective; the clinical users of the POC complied with the indications and procedures shared with the core laboratory without increasing the operator-dependent NCs. Furthermore, the core laboratory developed monitoring activities capable of guaranteeing the maintenance of the pre-analytical quality. [ABSTRACT FROM AUTHOR]

Personalized point-of-care testing (POCT) devices, such as wearable sensors, enable quick access to health monitoring without the use of complex instruments. Wearable sensors are gaining popularity owing to their ability to offer regular and continuous monitoring of physiological data by dynamic, non-invasive assessments of biomarkers in biofluids such as tear, sweat, interstitial fluid and saliva. Current advancements have concentrated on the development of optical and electrochemical wearable sensors as well as advances in non-invasive measurements of biomarkers such as metabolites, hormones and microbes. For enhanced wearability and ease of operation, microfluidic sampling, multiple sensing, and portable systems have been incorporated with materials that are flexible. Although wearable sensors show promise and improved dependability, they still require more knowledge about interaction between the target sample concentrations in blood and non-invasive biofluids. In this review, we have described the importance of wearable sensors for POCT, their design and types of these devices. Following which, we emphasize on the current breakthroughs in the application of wearable sensors in the realm of wearable integrated POCT devices. Lastly, we discuss the present obstacles and forthcoming potentials including the use of Internet of Things (IoT) for offering self-healthcare using wearable POCT. [ABSTRACT FROM AUTHOR]

Two-dimensional (2D) nanomaterials with chemical and structural diversity have piqued the interest of the scientific community due to their superior photonic, mechanical, electrical, magnetic, and catalytic capabilities that distinguish them from their bulk counterparts. Among these 2D materials, two-dimensional (2D) transition metal carbides, carbonitrides, and nitrides with a general chemical formula of Mn+1XnTx (where n = 1–3), together known as MXenes, have gained tremendous popularity and demonstrated competitive performance in biosensing applications. In this review, we focus on the cutting-edge advances in MXene-related biomaterials, with a systematic summary on their design, synthesis, surface engineering approaches, unique properties, and biological properties. We particularly emphasize the property–activity–effect relationship of MXenes at the nano–bio interface. We also discuss the recent trends in the application of MXenes in accelerating the performance of conventional point of care (POC) devices towards more practical approaches as the next generation of POC tools. Finally, we explore in depth the existing problems, challenges, and potential for future improvement of MXene-based materials for POC testing, with the goal of facilitating their early realization of biological applications. [ABSTRACT FROM AUTHOR]

As part of a multinational study to evaluate the Bioline Hepatitis C virus (HCV) point-of-care (POC) testing in sub-Saharan Africa (SSA), this narrative review summarises regulatory standards and quality indicators for validating and approving HCV clinical diagnostics. In addition, this review also provides a summary of their diagnostic evaluations using the REASSURED criteria as the benchmark and its implications on the WHO HCV elimination goals 2030. [ABSTRACT FROM AUTHOR]

Many Point-of-Care devices have been released over the past decade. However, data regarding their analytical performances in real-world situations remains scarce. Herein, we aimed to assess the analytical performances of the i-STAT Alinity system. We conducted an analytical performances study with the i-STAT Alinity device using cartridges CG4+ (pH, Pco2, Po2, lactate, bicarbonate and base excess); CHEM8+ (Na, K, Cl, ionized Ca, urea, creatinine, glucose, hematocrit and hemoglobin) and PT/INR (prothrombin time and international normalized ratio). We assessed the imprecision and compared the results to those obtained on existing instruments in the central laboratory. We found that the within-lab coefficients of variation (CV) were very low (<2%) or low (2–5%), except for creatinine and PT (CV = 5.2% and CV = 6.3%, respectively). For almost all the parameters, the results were strongly (R2 = 90–95%) or very strongly (R2 > 95%) correlated with those of the existing laboratory instruments, and the biases were very low (<2%) or low (2–5%). However, correlations of the PT and INR measurements with existing instruments were lower (R2 = 86.0% and 89.7%), and biases in the Po2 (7.9%), creatinine (5.4%) and PT (−6.6%) measurements were higher. The i-STAT Alinity appeared as a convenient device for measurements of numerous parameters. However, clinicians should interpret Po2, creatinine and PT results with caution. [ABSTRACT FROM AUTHOR]

Introduction: Thrombotic complications, such as pulmonary embolism, are common in COVID-19 patients. Point-of-care ultrasound is a highly recommended tool for orientation in critically ill patients with suspected or confirmed complications. Methods: An observational study was conducted on 32 consecutive patients with confirmed pulmonary embolism and COVID-19 infection treated in the Intensive Care Unit of the University Hospital Medical Center "Bežanijska kosa", Belgrade, Serbia, between April 2021 and March 2022. Predictors of the need for oxygen support were determined, while point-of-care echocardiographic parameters and various anamnestic, laboratory, and clinically significant parameters were correlated with the Pulmonary Embolism Severity Index (PESI) score. Results: More than two-thirds of patients in our study had PE symptoms present at hospital admission (68.8%). The majority of patients had segmental pulmonary embolism (48.4%), with high to very high PESI score values in 31.3% of patients. Pneumonia was present in 68.8% of the study population. The PESI score was negatively correlated with diastolic blood pressure and SaO2 at the time of PE diagnosis, LV ejection fraction, and PVAT. A positive correlation was found between the PESI score, maximum CRP, and D-dimer at the time of PTE diagnosis. A larger right ventricular diameter was associated with a greater need for oxygen support. Conclusion: Point-of-care echocardiography is a valuable tool for the risk assessment of COVID-19 patients with pulmonary embolism. Right ventricular size stood out as a significant marker of disease severity. [ABSTRACT FROM AUTHOR]

Infectious diseases are the world's greatest killers, accounting for millions of deaths worldwide annually, especially in low-income countries. As the risk of emerging infectious diseases is increasing, it is critical to rapidly diagnose infections in the early stages and prevent further transmission. However, current detection strategies are time-consuming and have exhibited low sensitivity. Numerous studies revealed the advantages of point-of-care testing, such as those which are rapid, user-friendly and have high sensitivity and specificity, and can be performed at a patient's bedside. The Lateral Flow Immunoassay (LFIA) is the most popular diagnostic assay that fulfills the POCT standards. However, conventional AuNPs-LFIAs are moderately sensitive, meaning that rapid detection remains a challenge. Here, we review quantum dot (QDs)-based LFIA for highly sensitive rapid diagnosis of infectious diseases. We briefly describe the principles of LFIA, strategies for applying QDs to enhance sensitivity, and the published performance of the QD-LFIA tested against several infectious diseases. [ABSTRACT FROM AUTHOR]

A biomarker for risk stratification and disease severity assessment in SARS-CoV-2 infections has not yet been established. Point of care testing (POCT) of butyrylcholinesterase (BChE) enables early detection of systemic inflammatory responses and correlates with disease severity in sepsis and burns. In acute care or resource-limited settings, POCT facilitates rapid clinical decision making, a particularly beneficial aspect in the management of pandemic situations. In this prospective observational study, POCT-measured BChE activity was assessed in 52 critically ill COVID-19 patients within 24 h of ICU admission and on the third and seventh day after ICU admission. Forty (77%) of these patients required venovenous extracorporeal membrane oxygenation (vvECMO). In critically ill COVID-19 patients, BChE activity is significantly decreased compared with healthy subjects, but also compared with other inflammatory conditions such as sepsis, burns, or trauma. POCT BChE activity reflects the severity of organ dysfunction and allows prediction of 28-day mortality in critically ill COVID-19 patients. Implementing early POCT BChE measurement could facilitate risk stratification and support admission and transfer decisions in resource-limited settings. [ABSTRACT FROM AUTHOR]

Point-of-Care ultrasound (POCUS) is based on target ultrasound that is performed wherever a patient is being treated, and by a non-radiologist directly involved in the patient's care. It is used either for quick diagnosis or procedural guidance. Abdominal pain is one of the most common complaints in emergency departments, and POCUS can help in the differentiation of patients who need additional diagnostic tests or hospital treatment, which eventually reduces the overall costs of health care. POCUS has high sensitivity and specificity in abdominal pathology, it can be helpful in the evaluation of biliary, intestinal, and urinary tract, and it is especially used in trauma. Additionally, the gold standard for abdominal aortic aneurysm detection, follow up and screening is precisely this diagnostic procedure. Unfortunately, the quality of ultrasound examination can be affected by the experience of the physician performing it and the patient's body weight. There is no doubt that POCUS is being increasingly recognized, but all motivated physicians should be provided with dedicated tutors and enough time for learning. This would certainly help to implement this diagnostic method as a routine in emergency and critical care departments, and significantly shorten the time until definitive diagnosis. [ABSTRACT FROM AUTHOR]

The complex and lengthy protocol of current viral nucleic acid extraction processes limits their use outside laboratory settings. Here, we describe a rapid and reliable method for extracting nucleic acids from viral samples using a rotating blade and magnetic beads. The viral membrane can be instantly lysed using a high-speed rotating blade, and nucleic acids can be immediately isolated using a silica magnetic surface. The process was completed within 60 s by this method. Routine washing and eluting processes were subsequently conducted within 5 min. The results achieved by this method were comparable to those of a commercially available method. When the blade-based lysis and magnetic bead adsorption processes were performed separately, the RNA recovery rate was very low, and the Ct value was delayed compared to simultaneous lysis and RNA adsorption. Overall, this method not only dramatically shortens the conventional extraction time but also allows for its convenient use outside the laboratory, such as at remote field sites and for point-of-care testing. [ABSTRACT FROM AUTHOR]

The current levels of breast cancer in African women have contributed to the high mortality rates among them. In South Africa, the incidence of breast cancer is also on the rise due to changes in behavioural and biological risk factors. Such low survival rates can be attributed to the late diagnosis of the disease due to a lack of access and the high costs of the current diagnostic tools. Breast cancer is asymptomatic at early stages, which is the best time to detect it and intervene to prevent high mortality rates. Proper risk assessment, campaigns, and access to adequate healthcare need to be prioritised among patients at an early stage. Early detection of breast cancer can significantly improve the survival rate of breast cancer patients, since therapeutic strategies are more effective at this stage. Early detection of breast cancer can be achieved by developing devices that are simple, sensitive, low-cost, and employed at point-of-care (POC), especially in low-income countries (LICs). Nucleic-acid-based lateral flow assays (NABLFAs) that combine molecular detection with the immunochemical visualisation principles, have recently emerged as tools for disease diagnosis, even for low biomarker concentrations. Detection of circulating genetic biomarkers in non-invasively collected biological fluids with NABLFAs presents an appealing and suitable method for POC testing in resource-limited regions and/or LICs. Diagnosis of breast cancer at an early stage will improve the survival rates of the patients. This review covers the analysis of the current state of NABLFA technologies used in developing countries to reduce the scourge of breast cancer. [ABSTRACT FROM AUTHOR]