Search

BACKGROUND: Infection rates in revision total hip arthroplasty are lower when antibiotic loaded cemented stems are utilized. Inspired by this technique, a point-of-care coating of antibiotic-loaded calcium sulfate (CaSO4) was applied to cementless revision stems in aseptic revision and 2nd stage reimplantation total hip arthroplasty. METHODS: One hundred eleven consecutive femoral stems were coated. Just prior to insertion, 10 cc of CaSO4 was mixed with 1 g vancomycin and 240 mg tobramycin with the paste applied to the stem. The results were compared to a matched cohort (N = 104) performed across the previous 5 years. The surgical methods were comparable, but for the stem coating. The study group was followed for a minimum of 3 years. RESULTS: In the study cohort of 111 patients, there were 69 aseptic revisions with one periprosthetic joint infection (PJI) (1.4%) and 42 second-stage reimplantations with 2 PJIs (4.8%). In the control cohort of 104 patients, there were 74 aseptic revisions with one PJI (1.4%) and 30 second-stage reimplantations with 7 PJIs (23.3%). There was no significant reduction in PJI rate in the aseptic revision subgroup (1.4% study vs 1.4% control group), P = 1.000. Antibiotic stem coating reduced PJI rate in the 2nd stage reimplantation subgroup (23.3% control vs 4.8% study group), P = .028. In both groups, there were no cases of aseptic stem loosening. CONCLUSIONS: Point-of-care antibiotic coating of cementless revision femoral stems reduces PJI infection rate in 2nd stage reimplantations only. We theorize that microbes persist in the endosteal cortices after resection and may contribute to infection recurrence.

Background: 3D printing has a wide range of applications and has brought significant change to many medical fields. However, ensuring quality assurance (QA) is essential for patient safety and requires a QA program that encompasses the entire production process. This process begins with imaging and continues on with segmentation, which is the conversion of Digital Imaging and Communications in Medicine (DICOM) data into virtual 3D-models. Since segmentation is highly influenced by manual intervention the influence of the users background on segmentation accuracy should be thoroughly investigated. Methods: Seventeen computed tomography (CT) scans of the pelvis with physiological bony structures were identified, anonymized, exported as DICOM data sets, and pelvic bones were segmented by four observers with different backgrounds. Landmarks were measured on DICOM images and in the segmentations. Intraclass correlation coefficients (ICCs) were calculated to assess inter-observer agreement, and the trueness of the segmentation results was analyzed by comparing the DICOM landmark measurements with the measurements of the segmentation results. The correlation between segmentation trueness and segmentation time was analyzed. Results: The lower limits of the 95% confidence intervals of the ICCs for the seven landmarks analyzed ranged from 0.511 to 0.986. The distance between the iliac crests showed the highest agreement between observers, while the distance between the ischial tuberosities showed the lowest. The distance between the upper edge of the symphysis and the promontory showed the lowest deviation between DICOM measurements and segmentation measurements (mean deviations < 1 mm), while the intertuberous distance showed the highest deviation (mean deviations 14.5—18.2 mm). Conclusions: Investigators with diverse backgrounds in segmentation and varying experience with slice images achieved pelvic bone segmentations with landmark measurements of mostly high agreement in a setup with high realism. In contrast, high variability was observed in the segmentation of the coccyx. In general, interobserver agreement was high, but due to measurement inaccuracies, landmark-based approaches cannot conclusively show that segmentation accuracy is within a clinically tolerable range of 2 mm for the pelvis. If the segmentation is performed by a very inexperienced user, the result should be reviewed critically by the clinician in charge. [ABSTRACT FROM AUTHOR]

Nearly 60 million people worldwide are infected with Hepatitis C Virus (HCV), a bloodborne pathogen which leads to liver cirrhosis and increases the risk of hepatocellular carcinoma. Those with limited access to healthcare resources, such as injection drug users and people in low- and middle-income countries, carry the highest burden. The current diagnostic algorithm for HCV is slow and costly, leading to a significant barrier in diagnosis and treatment for those most at risk from HCV. There remains no available vaccine for HCV, and infection is often asymptomatic until significant cirrhosis has occurred, which makes screening incredibly important to prevent liver damage and transmission. Recent investigation has sought to address these issues through improvements in various aspects of the diagnostic procedure, using methods such as isothermal amplification techniques for viral RNA amplification, the use of viral protein as an analyte, and the incorporation of streamlined, self-contained testing systems to reduce administrative skill requirements. This review provides a comprehensive overview of current commercial standards and novel improvements in HCV diagnostics, as well as a framework for future integration of these improvements to develop a one-step diagnostic that meets the needs of those most affected. [ABSTRACT FROM AUTHOR]

Objective: To compare the accuracy of a point‐of‐care coagulation analyzer (POCCA) with a reference laboratory coagulation analyzer (LabCA) and to evaluate for confounding factors that could alter the performance of the POCCA. Design: Prospective, observational study. Setting: Two university veterinary teaching hospitals. Animals: Forty‐three client‐owned dogs undergoing coagulation testing between April 2020 and June 2021. Methods: Samples were obtained from dogs undergoing coagulation testing as part of a diagnostic workup. Prothrombin time (PT) and activated partial thromboplastin time (aPTT) were measured on the POCCA and on the LabCA. PCV, platelet count, total plasma protein, hyperbilirubinemia, hemolysis, lipemia, and autoagglutination were recorded. Results: Moderate correlation was seen for PT and strong correlation was seen for aPTT between the POCCA and the LabCA (PT: 0.59, P < 0.0001; aPTT: 0.71, P < 0.0001). The POCCA results were consistent with normal or hypocoagulable samples for 30 of 38 PT and 33 of 37 aPTT results, as identified by the LabCA. Samples with PCV of 30%–55% were moderately correlated (PT: 0.63, P = 0.0004; aPTT: 0.63, P = 0.0003), but those outside that range were more likely to register an error message on the POCCA or provide disparate results. When hemolysis was present, there was a weak correlation between the POCCA and the LabCA for PT (rho: 0.38 [95% confidence interval: 0.19–0.76], P = 0.18) and a strong correlation for aPTT (rho: 0.86 [95% confidence interval: 0.62–0.95], P < 0.0001). Samples with hyperbilirubinemia were strongly correlated for PT (0.97, P = 0.002) but not for aPTT. Lipemia and autoagglutination were not observed. Conclusion: There was an acceptable correlation in patients with PCV within the manufacturer's recommended reference range; however, measurements on samples with PCV outside the reference range were inconsistent with the LabCA. Caution should be used when using the POCCA in patients with coagulopathy and anemia or other potential confounders. [ABSTRACT FROM AUTHOR]

Urinary tract infections (UTIs) are prevalent bacterial infections globally, posing significant challenges due to their frequency, recurrence, and antibiotic resistance. This review delves into the advancements in UTI diagnostics over the past decade, particularly focusing on the development of biosensor technologies. The emergence of biosensors, including microfluidic, optical, electrochemical, immunosensors, and nanotechnology-based sensors, offers enhanced diagnostic accuracy, reduced healthcare costs. Despite these advancements, challenges such as technical limitations, the need for cross-population validation, and economic barriers for widespread implementation persist. The integration of artificial intelligence and smart devices in UTI diagnostics, highlighting the innovative approaches and their implications for patient care. The article envisions a future where multidisciplinary research and innovation overcome current obstacles, fully leveraging the potential of biosensor technologies to transform biosensor-based UTIs diagnosis. The ultimate goal is to achieve rapid, accurate, and non-invasive diagnostics, making healthcare more accessible and effective. [ABSTRACT FROM AUTHOR]

Neonatal infectious disease continues to result in high rates of infant morbidity and mortality. Early- and late-onset disease represent difficult to detect and difficult to treat illnesses, particularly when antimicrobial resistant pathogens are present. Newborns are immunodeficient and are at increased risk of vertical and horizontal infection, with preterm infants increasingly susceptible. Additional risk factors associated with infection include prolonged use of a central catheter and/or ventilation, congenital abnormalities, admittance to intensive care units, and the use of broad-spectrum antibiotics. There is increasing recognition of the importance of the host microbiome and dysbiosis on neonatal infectious disease, including necrotising enterocolitis and sepsis in patients. Current diagnostic methods rely on blood culture, which is unreliable, time consuming, and can result in false negatives. There is a lack of accurate and reliable diagnostic tools available for the early detection of infectious disease in infants; therefore, efficient triage and treatment remains challenging. The application of biomarkers, machine learning, artificial intelligence, biosensors, and microfluidics technology, may offer improved diagnostic methodologies. Point-of-care devices, such diagnostic methodologies, may provide fast, reliable, and accurate diagnostic aids for neonatal patients. This review will discuss neonatal infectious disease as impacted by antimicrobial resistance and will highlight novel point-of-care diagnostic options. [ABSTRACT FROM AUTHOR]

Current diagnostic and prognostic tests for prostate cancer require specialised laboratories and have low specificity for prostate cancer detection. As such, recent advancements in electrochemical devices for point of care (PoC) prostate cancer detection have seen significant interest. Liquid-biopsy detection of relevant circulating and exosomal nucleic acid markers presents the potential for minimally invasive testing. In combination, electrochemical devices and circulating DNA and RNA detection present an innovative approach for novel prostate cancer diagnostics, potentially directly within the clinic. Recent research in electrochemical impedance spectroscopy, voltammetry, chronoamperometry and potentiometric sensing using field-effect transistors will be discussed. Evaluation of the PoC relevance of these techniques and their fulfilment of the WHO's REASSURED criteria for medical diagnostics is described. Further areas for exploration within electrochemical PoC testing and progression to clinical implementation for prostate cancer are assessed. [ABSTRACT FROM AUTHOR]

Here, we report a rapid and accurate optical method for detecting cells from liquid samples in a label-free manner. The working principle of the method is based on the interference of parts of a conical laser beam, coming from a single-mode optical fiber directly, and reflected from a flat glass surface. The glass is functionalized by antibodies against the cells to be detected from the liquid sample. Cells bound to that surface modify the reflected beam, and hence, change the resulting interference pattern, too. By registering and interpreting the variation in the image, the presence of cells from the sample can be detected. As for a demonstration, cell suspensions from a U937 cell line were used in glass chambers functionalized by antibodies (TMG6-5 (mIgG1)) to which the cells specifically bind. The limit of detection (LOD) of the method was also estimated. This proof-of-concept setup offers a cost-effective and easy-to-use way of rapid and specific detection of any type of cells (including pathogens) from suspensions (e.g., body fluids). The possible portability of the device predicts its applicability as a rapid test in clinical diagnostics. [ABSTRACT FROM AUTHOR]

The potential threat posed by disease outbreaks to diagnostic instruments demands the development of more effective biosensor technologies to counteract the risks. Diseases like SARS-CoV-2, Ebola, malaria, cholera, and many more have demonstrated beyond the limits of health care that new advancements are required for early detection and diagnosis. The rising number of diseases outbreaks has led to an increasing demand for biosensors that are more effective and quicker to utilize in healthcare settings. A biosensor incorporated with microfluidic chips offers an improved detection compared to traditional or classical biosensors. Microfluidic chips improve the performance of the biosensors by allowing automation, mixing, separation, throughput processing, and transport of the analytes to desired reactors. A biosensor incorporated with a microfluidic chip has improved sensitivity, easy operation and can use small volumes of samples to process the results. The effectiveness of biosensors depends also on the materials used in its fabrication and there are many materials used for fabrication which are reviewed in this work. This paper reviews the potential advantages of the use of microfluidic chips to enhance the performance of biosensors, materials used to fabricate the chips, and potential electrodes incorporated into microfluidic chips which improve the detection time by shortening the processing time for biosensors at the point of care service. This work also reviews new technologies which are not previously addressed other reviews including, integration of cell-imprinted polymers with microfluidic sensors and delved into future technologies outlook.Article Highlights: Highlight 1: This work reviews biosensors integrated with microfluidic chips. Highlight 2: The work reviews different materials used to fabricate microfluidic chips and their impact on biosensing. Highlight 3: The works also highlight the integration of electrodes into microfluidic chips to improve biosensor performance. [ABSTRACT FROM AUTHOR]

Clostridioides difficile detection in community settings is time-intensive, resulting in delays in diagnosing and quarantining infected individuals. However, with the advent of semi-automated devices and improved algorithms in recent decades, the ability to discern CDI infection from asymptomatic carriage has significantly improved. This, in turn, has led to efficiently regulated monitoring systems, further reducing endemic risk, with recent concerns regarding a possible surge in hospital-acquired Clostridioides difficile infections post-COVID failing to materialize. This review highlights established and emerging technologies used to detect community-acquired Clostridioides difficile in research and clinical settings. [ABSTRACT FROM AUTHOR]

Background: Globally, around 7 to 20 million people are believed to be suffering from coinfection with both hepatitis B virus (HBV) and hepatitis C virus (HCV). The loop-mediated isothermal amplification (LAMP) approach, introduced by Notomi and colleagues, has undergone substantial advancements as an effective molecular tool that enables the simultaneous analysis of multiple samples in a single tube. Methods: The present study examined the simultaneous detection of HBV and HCV in a single tube using melt curve analysis multiplex LAMP (mLAMP), which is based on the identification of unique melting peak temperatures. Selected regions for primer design including the S gene of HBV and the UTR gene of HCV. Primer optimization is initially performed through individual HBV and HCV LAMP analysis. Following the optimization process, the mLAMP assay was evaluated by optimizing the multiplex reaction mixture, determining the reaction time, and analyzing the limit of detection (LOD). The results are also analyzed using lateral flow dipsticks (LFD), which enable the visual detection of HBV and HCV by adding 20 pmol FITC-labeled LF primers into the reaction mixture prior the mLAMP. Results: The LOD for the mLAMP assay was determined as 10 copies/µl, and no cross-reactivity with other microorganisms was detected. The detection results obtained from patient plasma were also visually demonstrated using LFD, and displayed significant concordance with those obtained from Real-Time Polymerase Chain Assay. The mLAMP assay revealed a diagnostic sensitivity of 95% for detecting the HBV, and LOD is 90% for HCV. The overall diagnostic sensitivity of the mLAMP assay for both viruses was 85%. The assay confirmed a specificity of 100%. Conclusion: The mLAMP assay displays significant promise for analyzing coinfected samples by simultaneously detecting the dual targets HBV and HCV within a set temperature of 62 °C, all within a time frame of 1 h. Additionally, when paired with disposable LFD, the mLAMP assay enables rapid visual detection of assay results in a matter of minutes. The result contributes to the mLAMP assay being highly suitable for coinfection screening, particularly in field conditions. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical utility of point‐of‐care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). Design: Prospective cohort study. Setting: Antenatal clinics at King's College Hospital. Population: Women screened for GDM between March and June 2020. Methods: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse‐It 5.40.2. Main outcome measures: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. Results: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%–99%) and 97% (93%–98%) at fasting and 97% (91%–99%) and 79% (71%–84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. Conclusions: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h. [ABSTRACT FROM AUTHOR]

Blood transfusion is a common therapeutic intervention in hospitalized patients. There are numerous indications for transfusion, including anemia and coagulopathy with deficiency of single or multiple coagulation components such as platelets or coagulation factors. Nevertheless, the practice of transfusion in critically ill patients has been controversial mainly due to a lack of evidence and the need to consider the appropriate clinical context for transfusion. Further, transfusion carries many risk factors that must be balanced with benefits. Therefore, transfusion practice in ICU patients has constantly evolved, and we endeavor to present a contemporary review of transfusion practices in this population guided by clinical trials and expert guidelines. [ABSTRACT FROM AUTHOR]

Abstract Nearly 60 million people worldwide are infected with Hepatitis C Virus (HCV), a bloodborne pathogen which leads to liver cirrhosis and increases the risk of hepatocellular carcinoma. Those with limited access to healthcare resources, such as injection drug users and people in low- and middle-income countries, carry the highest burden. The current diagnostic algorithm for HCV is slow and costly, leading to a significant barrier in diagnosis and treatment for those most at risk from HCV. There remains no available vaccine for HCV, and infection is often asymptomatic until significant cirrhosis has occurred, which makes screening incredibly important to prevent liver damage and transmission. Recent investigation has sought to address these issues through improvements in various aspects of the diagnostic procedure, using methods such as isothermal amplification techniques for viral RNA amplification, the use of viral protein as an analyte, and the incorporation of streamlined, self-contained testing systems to reduce administrative skill requirements. This review provides a comprehensive overview of current commercial standards and novel improvements in HCV diagnostics, as well as a framework for future integration of these improvements to develop a one-step diagnostic that meets the needs of those most affected. Graphical Abstract

Abstract Background Globally, around 7 to 20 million people are believed to be suffering from coinfection with both hepatitis B virus (HBV) and hepatitis C virus (HCV). The loop-mediated isothermal amplification (LAMP) approach, introduced by Notomi and colleagues, has undergone substantial advancements as an effective molecular tool that enables the simultaneous analysis of multiple samples in a single tube. Methods The present study examined the simultaneous detection of HBV and HCV in a single tube using melt curve analysis multiplex LAMP (mLAMP), which is based on the identification of unique melting peak temperatures. Selected regions for primer design including the S gene of HBV and the UTR gene of HCV. Primer optimization is initially performed through individual HBV and HCV LAMP analysis. Following the optimization process, the mLAMP assay was evaluated by optimizing the multiplex reaction mixture, determining the reaction time, and analyzing the limit of detection (LOD). The results are also analyzed using lateral flow dipsticks (LFD), which enable the visual detection of HBV and HCV by adding 20 pmol FITC-labeled LF primers into the reaction mixture prior the mLAMP. Results The LOD for the mLAMP assay was determined as 10 copies/µl, and no cross-reactivity with other microorganisms was detected. The detection results obtained from patient plasma were also visually demonstrated using LFD, and displayed significant concordance with those obtained from Real-Time Polymerase Chain Assay. The mLAMP assay revealed a diagnostic sensitivity of 95% for detecting the HBV, and LOD is 90% for HCV. The overall diagnostic sensitivity of the mLAMP assay for both viruses was 85%. The assay confirmed a specificity of 100%. Conclusion The mLAMP assay displays significant promise for analyzing coinfected samples by simultaneously detecting the dual targets HBV and HCV within a set temperature of 62 °C, all within a time frame of 1 h. Additionally, when paired with disposable LFD, the mLAMP assay enables rapid visual detection of assay results in a matter of minutes. The result contributes to the mLAMP assay being highly suitable for coinfection screening, particularly in field conditions.

Introduction: Thrombotic and haemorrhagic complications have been reported following transcatheter aortic valve implantation (TAVI). However, few reports have studied perioperative changes in coagulation and platelet function after TAVI. Furthermore, there are no clear guidelines for antithrombotic therapy. This study aimed to examine the perioperative changes in coagulation and platelet contribution to clot strength after TAVI using thromboelastography (TEG 6s; Hemonetics). Methods: This prospective observational study included 15 patients scheduled to undergo TAVI for severe aortic stenosis. TEG 6s global haemostasis was used to record three measurements: on the day of surgery (immediately before the operation) and postoperative days 1 and 3. The reaction time R to thrombosis; K and α, which represent the rate of thrombosis; and the maximum amplitude (MA) were measured from the kaolin thromboelastography (TEG) curves. The coagulation index (CI) was calculated from the measurement results to assess thrombotic tendency. In addition, MA was converted to elastic clot strength, and platelet function was assessed by the difference, Gp, in elastic strength depending on platelet activation. Results: R and K decreased, and α tended to increase in kaolin TEG on days 1 and 3 after TAVI, indicating elevated coagulation function compared with the preoperative period, but MA and CI did not show significant changes. Gp decreased significantly on days 1 and 3, suggesting a decrease in the platelet contribution to clot strength. Conclusions: Compared with the preoperative period, coagulation tended to increase, and platelet contribution to clot strength decreased from days 1 to 3 after TAVI. [ABSTRACT FROM AUTHOR]

Abstract Background Measuring collagenase activity is crucial in the field of joint health and disease management. Collagenases, enzymes responsible for collagen degradation, play a vital role in maintaining the balance between collagen synthesis and breakdown in joints. Dysregulation of collagenase activity leads to joint tissue degradation and diseases such as rheumatoid arthritis and osteoarthritis. The development of methods to measure collagenase activity is essential for diagnosis, disease severity assessment, treatment monitoring, and identification of therapeutic targets. Results This study aimed to validate a rapid collagenase activity detection technique using synovial fluid samples. Antibody microarray analysis was initially performed to quantify the levels of matrix metalloproteinase-9 (MMP-9), a major collagenase in joints. Subsequently, the developed gelatin-based test utilizing fluorescence measurement was used to determine collagenase activity. There was a significant correlation between the presence of MMP-9 and collagenase activity. In addition, Lower Limit of Detection and Upper Limit of Detection can be preliminary estimated as 8 ng/mL and 48 ng/mL respectively. Conclusions The developed technique offers a potential point-of-care assessment of collagenase activity, providing real-time information for clinicians and researchers. By accurately quantifying collagenase activity, healthcare professionals can optimize patient care, improve treatment outcomes, and contribute to the understanding and management of joint-related disorders. Further research and validation are necessary to establish the full potential of this rapid collagenase activity detection method in clinical practice.

Abstract Background Joint access is essential for arthrocentesis, or joint aspiration of fluids. Joint treatments that are not performed properly can result in avoidable patient issues such as damage to the muscles, tendons, and blood vessels surrounding the joint. The use of ultrasound has become the gold standard for this procedure and proven to be a support in the skill learning process. However, success with this equipment, particularly in small joints like the wrist, depends on a clinician's capacity to recognize the crucial landmarks that guide these procedures. Prior to executing on a real patient, task trainers have proven to be an effective way for doctors to practice and prepare for procedures. However, shortcomings of current solutions include high purchase costs, incompatibility with ultrasound imaging, and low reusability. In addition, since this is a procedure that is not performed frequently, there may not be space or resources available in healthcare facilities to accommodate one at the point of care. This study aimed to close the existing gap by developing a DIY ultrasound compatible task trainer for wrist joint access training. Results We developed a novel ultrasound compatible wrist joint model that can be made from sustainable materials and reusable parts, thus reducing the costs for acquisition and environmental impact. Our model, which was produced utilizing small-batch production methods, is made up of 3D-printed bones enclosed in an ultrasound-compatible gelatin mixture. It can be easily remade after each practice session, removing needle tracks that are visible under ultrasound for conventional phantoms. The ultrasonic properties of this model were tested through pixel brightness analysis and visual inspection of simulated anatomical structures. Conclusion Our results report the advantages and limitations of the proposed model regarding production, practice, and ultrasound compatibility. While future work entails the transfer to patients of the same skill, this reusable and replicable model has proven, when presented to experts, to be successful in representing the physical characteristics and ultrasound profile of significant anatomical structures. This novel DIY product could be an effective alternative to teach procedures in the context of resource-restrained clinical simulation centers.

Abstract Current strategies to promptly, effectively, and equitably screen people with tuberculosis (TB) and link them to diagnosis and care are insufficient; new approaches are required to find the millions of people around the world with TB who are missed each year. Interventions also need to be designed considering how people interact with health care facilities and where appropriate should be suitable for use in the community. Here, the historical, new, and reemerging technologies that are being utilised for TB diagnosis globally are discussed, whilst highlighting that how we use and evaluate tests is just as important as the tests themselves.

Introduction: Self-coalescing microfluidic devices represent an exciting opportunity for leveraging viscous dominated flow phenomena to reconstitute a series of reagents with a single sample infusion. In a self-coalescing microfluidic device, spatially separated dried reagents are reconstituted using a single infusion. Due to the unique device geometry, the reagents remain spatially separated after infusion. As such, self-coalescing microfluidic devices have the potential to simplify point-of-care testing by simultaneously performing multiple colorimetric tests in one device. The current versions of these devices use standard, more costly microfabrication processes and are too small to be easily read by eye. Methods: Here, we created a low cost and scaled up version of a self-coalescing microfluidic device by using laser-cut-roll-based silicone tape. In addition to eliminating the need for cleanrooms, our approach simplifies the integration of assay reagents since they can be spotted onto a coverslip and covered with the tape microfluidic device. We empirically optimized our device, finding that flow rate significantly influenced the formation of self-coalescence as well as proper reagent reconstitution. Results and Discussion: When flow rates were too slow or fast, reagents would streak, leading to inadvertent mixing between different spatial locations. Our studies further revealed that geometry had a stronger influence on device operation in low-flow conditions. Our final optimized device exhibited a 100% success rate, demonstrated through self-coalescence with no reagent streaking at 100 μL/min, which enabled the isotropic diffusion of reagents. Furthermore, the spots are spatially separated and large enough to be visualized by the naked eye and captured by a smartphone camera for downstream analysis. Taken together, our innovative device leverages the advantages of sticker microfluidics and low-cost manufacturing methods to offer standalone functionality. This approach has the potential to significantly impact point-ofcare diagnostics, particularly in resource-limited regions. By enabling multiplexed diagnostic assays through our novel technology, we aim to provide accessible and affordable healthcare solutions. [ABSTRACT FROM AUTHOR]

Background and Aims Strategies to assess patients with suspected acute myocardial infarction (AMI) using a point-of-care (POC) high-sensitivity cardiac troponin I (hs-cTnI) assay may expedite emergency care. A 2-h POC hs-cTnI strategy for emergency patients with suspected AMI was derived and validated. Methods In two international, multi-centre, prospective, observational studies of adult emergency patients (1486 derivation cohort and 1796 validation cohort) with suspected AMI, hs-cTnI (Siemens Atellica® VTLi) was measured at admission and 2 h later. Adjudicated final diagnoses utilized the hs-cTn assay in clinical use. A risk stratification algorithm was derived and validated. The primary diagnostic outcome was index AMI (Types 1 and 2). The primary safety outcome was 30-day major adverse cardiac events incorporating AMI and cardiac death. Results Overall, 81 (5.5%) and 88 (4.9%) patients in the derivation and validation cohorts, respectively, had AMI. The 2-h algorithm defined 66.1% as low risk with a sensitivity of 98.8% [95% confidence interval (CI) 89.3%–99.9%] and a negative predictive value of 99.9 (95% CI 99.2%–100%) for index AMI in the derivation cohort. In the validation cohort, 53.3% were low risk with a sensitivity of 98.9% (95% CI 92.4%–99.8%) and a negative predictive value of 99.9% (95% CI 99.3%–100%) for index AMI. The high-risk metrics identified 5.4% of patients with a specificity of 98.5% (95% CI 96.6%–99.4%) and a positive predictive value of 74.5% (95% CI 62.7%–83.6%) for index AMI. Conclusions A 2-h algorithm using a POC hs-cTnI concentration enables safe and efficient risk assessment of patients with suspected AMI. The short turnaround time of POC testing may support significant efficiencies in the management of the large proportion of emergency patients with suspected AMI. [ABSTRACT FROM AUTHOR]

Background: Measuring collagenase activity is crucial in the field of joint health and disease management. Collagenases, enzymes responsible for collagen degradation, play a vital role in maintaining the balance between collagen synthesis and breakdown in joints. Dysregulation of collagenase activity leads to joint tissue degradation and diseases such as rheumatoid arthritis and osteoarthritis. The development of methods to measure collagenase activity is essential for diagnosis, disease severity assessment, treatment monitoring, and identification of therapeutic targets. Results: This study aimed to validate a rapid collagenase activity detection technique using synovial fluid samples. Antibody microarray analysis was initially performed to quantify the levels of matrix metalloproteinase-9 (MMP-9), a major collagenase in joints. Subsequently, the developed gelatin-based test utilizing fluorescence measurement was used to determine collagenase activity. There was a significant correlation between the presence of MMP-9 and collagenase activity. In addition, Lower Limit of Detection and Upper Limit of Detection can be preliminary estimated as 8 ng/mL and 48 ng/mL respectively. Conclusions: The developed technique offers a potential point-of-care assessment of collagenase activity, providing real-time information for clinicians and researchers. By accurately quantifying collagenase activity, healthcare professionals can optimize patient care, improve treatment outcomes, and contribute to the understanding and management of joint-related disorders. Further research and validation are necessary to establish the full potential of this rapid collagenase activity detection method in clinical practice. [ABSTRACT FROM AUTHOR]

Thailand's hospitals face overcrowding, particularly with non-communicable disease (NCD) patients, due to a doctor shortage and an aging population. Most literature showed implementation merely on web or mobile application to teleconsult with physicians. Instead, in this work, we developed and implemented a telemedicine health kiosk system embedded with non-invasive biosensors and time-series predictors to improve NCD indicators over an eight-month period. Two cohorts were randomly selected: a control group with usual care and a telemedicine-using group. The telemedicine-using group showed significant improvements in average fasting blood glucose (148 to 130 mg/dL) and systolic blood pressure (152 to 138 mmHg). Data mining with the Apriori algorithm revealed correlations between diseases, occupations, and environmental factors, informing public health policies. Communication between kiosks and servers used LoRa, 5G, and IEEE802.11, which are selected based on the distance and signal availability. The results support telemedicine kiosks as effective for NCD management, significantly improving key NCD indicators, average blood glucose, and blood pressure. [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]

Introduction: Assisted partner services (APS) is an effective strategy for increasing HIV testing, new diagnosis, and linkage to care among sexual partners of people living with HIV (PLWH). APS can be resource intensive as it requires community tracing to locate each partner named and offer them testing. There is limited evidence for the effectiveness of offering HIV self‐testing (HIVST) as an option for partner testing within APS. Methods: We conducted a cluster randomized controlled trial comparing provider‐delivered HIV testing (Standard APS) versus offering partners the option of provider‐delivered testing or HIVST (APS+HIVST) at 24 health facilities in Western Kenya. Facilities were randomized 1:1 and we conducted intent‐to‐treat analyses using Poisson generalized linear mixed models to estimate intervention impact on HIV testing, new HIV diagnoses, and linkage to care. All models accounted for clustering at the clinic level and new diagnoses and linkage models were adjusted for individual‐level age, sex, and income a priori. Results: From March to December 2021, 755 index clients received APS and named 5054 unique partners. Among these, 1408 partners reporting a prior HIV diagnosis were not eligible for HIV testing and were excluded from analyses. Of the remaining 3646 partners, 96.9% were successfully contacted for APS and tested for HIV: 2111 (97.9%) of 2157 in the APS+HIVST arm and 1422 (95.5%) of 1489 in the Standard APS arm. In the APS+HIVST arm, 84.6% (1785/2111) tested via HIVST and 15.4% (326/2111) received provider‐delivered testing. Overall, 16.7% of the 3533 who tested were newly diagnosed with HIV (APS+HIVST = 357/2111 [16.9%]; Standard APS = 232/1422 [16.3%]). Of the 589 partners who were newly diagnosed, 90.7% were linked to care (APS+HIVST = 309/357 [86.6%]; Standard APS = 225/232 [97.0%]). There were no significant differences between the two arms in HIV testing (relative risk [RR]: 1.02, 95% CI: 0.96–1.10), new HIV diagnoses (adjusted RR [aRR]: 1.03, 95% CI: 0.76–1.39) or linkage to care (aRR: 0.88, 95% CI: 0.74–1.06). Conclusions: There were no differences between APS+HIVST and Standard APS, demonstrating that integrating HIVST into APS continues to be an effective strategy for identifying PLWH by successfully reaching and HIV testing >95% of elicited partners, newly diagnosing with HIV one in six of those tested, >90% of whom were linked to care. Clinical Trial Number: NCT04774835 [ABSTRACT FROM AUTHOR]

Reverse transcription loop‐mediated isothermal amplification (RT‐LAMP) is a molecular amplification method that can detect SARS‐CoV‐2 in a shorter time than the current gold‐standard molecular diagnostic reverse transcription‐polymerase chain reaction (RT‐PCR). However, previously developed RT‐LAMP assays have mostly relied on highly subjective visual colorimetric interpretation. In this study, an RT‐LAMP assay was developed with quantitative measurement of reaction pH using a novel portable pH biosensor compared to qualitative colorimetric interpretation and gel electrophoresis, with 57 clinical COVID‐19 samples used for validation of the test. The LoD of the assay is 103 copies/μL. The highest sensitivity was found in the qualitative methods (93.75%), while the highest specificity and likelihood ratio was found in the pH sensor (87.5% and 6.72). On the sensor measurement, a significant difference (p < 0.0001) was observed between the average pH of the RT‐PCR (+) COVID‐19 (6.15 ± 0.27), while the average pH of the RT‐PCR (−) samples (6.72 ± 0.22). Correlation analysis revealed a strong correlation (r = 0.78, p < 0.0001) between the Ct values obtained from RT‐PCR with the biosensor pH readout. RT‐LAMP with the quantitative pH sensor readout method has the potential to be further developed as an objective molecular assay for rapid and simple detection of SARS‐CoV‐2. [ABSTRACT FROM AUTHOR]

Introduction/aim: To evaluate whether patients with haemophilia (PwH) can be enabled to perform ultrasonography (US) of their knees without supervision according to the Haemophilia Early Arthropathy Detection with Ultrasound (HEAD‐US) protocol and whether they would be able to recognize pathologies. Methods: Five PwH (mean age 29.6 years, range 20–48 years) were taught the use of a portable US device and the HEAD‐US protocol. Subsequently, the patients performed US unsupervised at home three times a week for a total of 6 weeks with a reteaching after 2 weeks. All images were checked for mapping of the landmarks defined in the HEAD‐US protocol by a radiologist. In a final test after the completion of the self‐sonography period, participants were asked to identify scanning plane and potential pathology from US images of other PwH. Results: On the images of the self‐performed scans, 82.7% of the possible anatomic landmarks could be identified and 67.5% of the requested images were unobjectionable, depicting 100% of the required landmarks. There was a highly significant improvement in image quality following reteaching after 2 weeks (74.80 ± 36.88% vs. 88.31 ± 19.87%, p <.001). In the final test, the participants identified the right scanning plane in 85.0% and they correctly identified pathology in 90.0% of images. Conclusion: Appropriately trained PwH can perform the HEAD‐US protocol of their knee with high quality and are capable to identify pathologic findings on these standardized images. Asynchronous tele‐sonography could enable early therapy adjustment and thereby possibly reduce costs. [ABSTRACT FROM AUTHOR]

There is a significant need to develop new environmentally friendly, extraction-free sample collection mediums that can effectively preserve and protect genetic material for point-of-care and/or self-collection, home-collection, and mail-back testing. Systematic evolution of ligands by exponential enrichment (SELEX) was used to create anti-ribonuclease (RNase) deoxyribonucleic acid (DNA) aptamers against purified RNase A conjugated to paramagnetic carboxylated beads. Following eight rounds of SELEX carried out under various stringency conditions, e.g., selection using Xtract-Free™ (XF) specimen collection medium and elevated ambient temperature of 28 °C, a panel of five aptamers was chosen following bioinformatic analysis using next-generation sequencing. The efficacy of aptamer inactivation of RNase was assessed by monitoring ribonucleic acid (RNA) integrity via fluorometric and real-time RT-PCR analysis. Inclusion of aptamers in reaction incubations resulted in an 8800- to 11,200-fold reduction in RNase activity, i.e., digestion of viral RNA compared to control. Thus, anti-RNase aptamers integrated into XF collection medium as well as other commercial reagents and kits have great potential for ensuring quality intact RNA for subsequent genomic analyses. [ABSTRACT FROM AUTHOR]

Background: Joint access is essential for arthrocentesis, or joint aspiration of fluids. Joint treatments that are not performed properly can result in avoidable patient issues such as damage to the muscles, tendons, and blood vessels surrounding the joint. The use of ultrasound has become the gold standard for this procedure and proven to be a support in the skill learning process. However, success with this equipment, particularly in small joints like the wrist, depends on a clinician's capacity to recognize the crucial landmarks that guide these procedures. Prior to executing on a real patient, task trainers have proven to be an effective way for doctors to practice and prepare for procedures. However, shortcomings of current solutions include high purchase costs, incompatibility with ultrasound imaging, and low reusability. In addition, since this is a procedure that is not performed frequently, there may not be space or resources available in healthcare facilities to accommodate one at the point of care. This study aimed to close the existing gap by developing a DIY ultrasound compatible task trainer for wrist joint access training. Results: We developed a novel ultrasound compatible wrist joint model that can be made from sustainable materials and reusable parts, thus reducing the costs for acquisition and environmental impact. Our model, which was produced utilizing small-batch production methods, is made up of 3D-printed bones enclosed in an ultrasound-compatible gelatin mixture. It can be easily remade after each practice session, removing needle tracks that are visible under ultrasound for conventional phantoms. The ultrasonic properties of this model were tested through pixel brightness analysis and visual inspection of simulated anatomical structures. Conclusion: Our results report the advantages and limitations of the proposed model regarding production, practice, and ultrasound compatibility. While future work entails the transfer to patients of the same skill, this reusable and replicable model has proven, when presented to experts, to be successful in representing the physical characteristics and ultrasound profile of significant anatomical structures. This novel DIY product could be an effective alternative to teach procedures in the context of resource-restrained clinical simulation centers. [ABSTRACT FROM AUTHOR]

With the steady increase in allergy prevalence worldwide, there is a strong need for novel diagnostic tools for precise, fast, and less invasive testing methods. Herein, a miniatured fluorescence-based biosensing system is developed for the rapid and quantitative detection of allergen-specific immunoglobulin-E. An antibody-based fluorescence assay in a microfluidic-patterned slide, combined with a custom-made portable fluorescence reader for image acquisition and user-friendly software for the data analysis, enables obtaining results for multiple allergens in just ~1 h with only 80 μL of blood serum. The multiplexed detection of common birch, timothy grass, cat epithelia, house dust mite, and dog epithelia shows quantitative IgE-mediated allergic responses to specific allergens in control serum samples with known total IgE concentration. The responses are verified with different control tests and measurements with a commercial fluorescence reader. These results open the door to point-of-care allergy screening for early diagnosis and broader access and for large-scale research in allergies. [ABSTRACT FROM AUTHOR]

Background: To support clinical decision-making at the point of care, the "best next step" based on Standard Operating Procedures (SOPs) and actual accurate patient data must be provided. To do this, textual SOPs have to be transformed into operable clinical algorithms and linked to the data of the patient being treated. For this linkage, we need to know exactly which data are needed by clinicians at a certain decision point and whether these data are available. These data might be identical to the data used within the SOP or might integrate a broader view. To address these concerns, we examined if the data used by the SOP is also complete from the point of view of physicians for contextual decision-making. Methods: We selected a cohort of 67 patients with stage III melanoma who had undergone adjuvant treatment and mainly had an indication for a sentinel biopsy. First, we performed a step-by-step simulation of the patient treatment along our clinical algorithm, which is based on a hospital-specific SOP, to validate the algorithm with the given Fast Healthcare Interoperability Resources (FHIR)-based data of our cohort. Second, we presented three different decision situations within our algorithm to 10 dermatooncologists, focusing on the concrete patient data used at this decision point. The results were conducted, analyzed, and compared with those of the pure algorithmic simulation. Results: The treatment paths of patients with melanoma could be retrospectively simulated along the clinical algorithm using data from the patients' electronic health records. The subsequent evaluation by dermatooncologists showed that the data used at the three decision points had a completeness between 84.6% and 100.0% compared with the data used by the SOP. At one decision point, data on "patient age (at primary diagnosis)" and "date of first diagnosis" were missing. Conclusions: The data needed for our decision points are available in the FHIR-based dataset. Furthermore, the data used at decision points by the SOP and hence the clinical algorithm are nearly complete compared with the data required by physicians in clinical practice. This is an important precondition for further research focusing on presenting decision points within a treatment process integrated with the patient data needed. [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]

In today's world, which is entangled with numerous foodborne pathogenic bacteria and viruses, it appears to be essential to rethink detection methods of these due to the importance of food safety in our lives. The vast majority of detection methods for foodborne pathogenic bacteria and viruses have suffered from sensitivity and selectivity due to the small size of these pathogens. Besides, these types of sensing approaches can improve on-site detection platforms in the fields of food safety. In recent, microfluidics systems as new emerging types of portable sensing approaches can introduce efficient and simple biodevice by integration with several analytical methods such as electrochemical, optical and colorimetric techniques. Additionally, taking advantage of aptamer as a selective bioreceptor in the sensing of microfluidics system has provided selective, sensitive, portable and affordable sensing approaches. Furthermore, some papers use increased data transferability ability and computational power of these sensing platforms by exploiting smartphones. In this review, we attempted to provide an overview of the current state of the recent aptasensor based on microfluidic for screening of foodborne pathogenic bacteria and viruses. Working strategies, benefits and disadvantages of these sensing approaches are briefly discussed. [ABSTRACT FROM AUTHOR]

OBJECTIVE To evaluate the relationship in equine practice between the time delay for charge entry (time between when work was performed and when the invoice charges were entered) and the total amount of the invoice. SAMPLE A total of 67,597 invoices from 3 hospitals were included for analysis. METHODS Analysis of 67,597 invoices from 49 doctors working out of 3 hospitals was performed. Variables collected included invoice total, date of work, date of invoice entry, month of work, invoice category (A = ambulatory daytime, E = after-hours, 1 = hospital), and veterinarian. Time delay to invoice entry was the difference between the day of work and the day of charge entry. A generalized additive model was used to describe the relationship between the time delay for invoice entry and the invoice type, month of work, and invoice category. The best model was selected using the Akaike information criterion. RESULTS In the selected model, total invoice amount was associated with time delay for charge entry and invoice category. Invoices entered on the same day of work were 299 + $345, as compared to those entered the next day (255 + $271) and those entered > 1 day after the work was performed (193 + $196; P < .0001). CLINICAL RELEVANCE If the observed relationship between time delay (time between work performed and invoice entry) and total invoice amount is causal, equine practitioners may have significant opportunity to improve revenues by simply entering charges on the same day the work is performed. [ABSTRACT FROM AUTHOR]

In recent times, the demand for innovative, insignificantly invasive diagnostic and therapeutic biomedical tools has reached enhanced attention. Rapid Diagnostic Tests (RDTs) for diagnosis, which are non-invasive, inexpensive, simple, and deliver results accurately in less than 20 minutes, have heightened the accessibility to parasite-based analysis globally. Microneedle (MN) arrays are a fast-developing and promising technology for drug delivery and extraction of Interstitial fluid (ISF) employed for numerous diagnostic and clinical therapies. This review gives a broad overview of the characteristics and history of Microneedles (MNs) patches together with their applications in drug delivery and transdermal rapid diagnostic purposes, classifications, and categories based on the design of fabrication from previous works of literature spanning the period 2018-2023. Utilizing PubMed, Scopus, Google Scholar, and Wiley online library search engines, an online search for scientific publications published between 2018 and 2023 was conducted using the keywords "microneedle patch" and "rapid diagnostic tests." 175 articles in all were found when the search terms were used. The acquired results were then narrowed to 64 citations in this review by applying the inclusion principle. Pictorial and tabular representations highlight the various features of Microneedle patches used in interstitial fluid testing and extraction that have been documented experimentally, including numerous applications of Microneedle patches, showing their dimensions, applications, fabrication methods, and findings made. Finally, research on bio-microneedles and bio-inspired MN are reviewed. The research findings indicate that dissolving microneedles has become increasingly popular since they have several benefits over other microneedles. It is among the most well-known microneedles, and since it degrades naturally, it is a superior option for diagnosis and long-term treatment. [ABSTRACT FROM AUTHOR]

Current strategies to promptly, effectively, and equitably screen people with tuberculosis (TB) and link them to diagnosis and care are insufficient; new approaches are required to find the millions of people around the world with TB who are missed each year. Interventions also need to be designed considering how people interact with health care facilities and where appropriate should be suitable for use in the community. Here, the historical, new, and reemerging technologies that are being utilised for TB diagnosis globally are discussed, whilst highlighting that how we use and evaluate tests is just as important as the tests themselves. [ABSTRACT FROM AUTHOR]

Background: Home INR testing (patient self-testing) is feasible and effective for warfarin patients but little is known about real-world differences in outcomes for patients using PST versus laboratory-based INR monitoring. Objective: To compare the safety/efficacy of patient self-testing of real-world warfarin therapy versus office/lab-based monitoring of therapy. Design/Setting/Participants/Exposure: A retrospective claims-based analysis of warfarin patients enrolled in the MarketScan® Commercial Claims and Encounters and Medicare databases between January 1, 2013, and March 30, 2020. Stratification was based on INR testing method: patient self-testing versus testing at physicians' offices/local laboratory. The probability of adverse events in each cohort was determined after adjusting for demographic and baseline clinical characteristics using a repeated measures analysis. Main Measures: Rates of all adverse events: deep venous thrombosis, pulmonary embolism, bleeding, and stroke. A secondary outcome of interest was emergency department visits. Key Results: A total of 37,837 patients were included in the analysis: 1592 patients in the patient self-testing group and 36,245 in the office-based therapy group. After adjusting for demographic and baseline clinical characteristics, patients in the office-based group had statistically significantly higher rates of all adverse events (incidence rate ratio [IRR]=2.07, 95% CI [1.82, 2.36]), and specific adverse events including thromboembolism (IRR=4.38, 95% CI [3.29, 5.84]), major bleed (IRR=1.45, 95% CI [1.28, 1.64]), and stroke (IRR=1.30, 95% CI [1.05, 1.61]) than patients in the patient self-testing group. Office-based patients also had a statistically significant higher rate of emergency department visits than patient self-testing patients (IRR = 1.65, 95% CI [1.47, 1.84]). Conclusions/Relevance: This analysis of real-world claims data shows lower rates of stroke, thromboembolism, and major bleeding, as well as fewer emergency department visits, with patient self-testing compared to office-based/lab INR monitoring. Our finding that PST is safe and effective among current users suggests that more patients may benefit from its use. [ABSTRACT FROM AUTHOR]

Objectives: In our center, an unusual rate of patients had abnormalities of hemostasis in immediate postoperative period of cardiac surgery. Our objectives were to identify the cause of these sudden hemostasis abnormalities and to evaluate the performances of point of care coagulation testing. Methods: In this prospective and descriptive study, we included 33 consecutive patients undergoing elective cardiac surgery for 1 month. Heparin-induced anticoagulation and calculation of the protamine dose were tested by the Hemostasis Management System Plus device (Medtronic, Minneapolis, MN, USA). Fifteen minutes after the end of the protamine infusion, activated clotting time (ACT), activated partial thromboplastin time and anti Xa activity were measured. In case of unusual clinical bleeding, a Quantra analysis (Stago, HemoSonics LLC, Charlottesville, VA) was added. Results: Residual antiXa activity >0.2 IU/mL after neutralization was present in 44% of patients. Our investigation concluded incomplete heparin reversal. There was no association between cellular reinfusate and the presence of heparin. The unusual rate of hemostasis abnormalities was explained by a less efficient protamine reversal of heparin. ACT and Clot Time Ratio (CTR, Quantra system) correlated with AntiXa with Spearman's coefficients of 0.85 (p <.0001) and 0.95 (p =.0012), respectively. About ACT, a threshold of 150 seconds had a sensitivity of 85% [58–97] and a specificity of 85% [58–97%] for detection of AntiXa>0.2. For CTR, a threshold of 1.4 had a sensitivity of 67% [30–94] and a specificity of 100% [18–100]. Conclusion: The use of point of care coagulation testing is effective in detecting incomplete reversal of heparin. [ABSTRACT FROM AUTHOR]

Swine viral diseases have the capacity to cause significant losses and affect the sector's sustainability, a situation further exacerbated by the lack of antiviral drugs and the limited availability of effective vaccines. In this context, a novel point-of-care (POC) diagnostic device incorporating photonic integrated circuits (PICs), microfluidics and information, and communication technology into a single platform was developed for the field diagnosis of African swine fever (ASF) and classical swine fever (CSF). The device targets viral particles and has been validated using oral fluid and serum samples. Sensitivity, specificity, accuracy, precision, positive likelihood ratio (PLR), negative likelihood ratio (NLR), and diagnostic odds ratio (DOR) were calculated to assess the performance of the device, and PCR was the reference method employed. Its sensitivities were 80.97% and 79%, specificities were 88.46% and 79.07%, and DOR values were 32.25 and 14.21 for ASF and CSF, respectively. The proposed POC device and PIC sensors can be employed for the pen-side detection of ASF and CSF, thus introducing novel technological advancements in the field of animal diagnostics. The need for proper validation studies of POC devices is highlighted to optimize animal biosecurity. [ABSTRACT FROM AUTHOR]

Introduction: Haemoglobin (Hb) and packed cell volume (PCV) are tests used in the assessment of anaemia. The Veri-Q haemoglobin meter is a new device in the point-of-care market used for the quantitative measurement of haemoglobin and packed cell volume. This study aimed to evaluate the performance of the Veri-Q haemoglobin meter for the assessment of haemoglobin and packed cell volume. Materials and Methods: Haemoglobin and packed cell volume estimations of one hundred and eleven participants were determined using the Veri-Q Red haemoglobin meter and statistically compared with those obtained from the conventional method (gold standard). Results: One hundred and eleven undergraduate students participated in this study, of whom 72 (64.9%) were females and 39 (35.1%) were males. The mean haemoglobin values calculated using the Veri-Q haemoglobin meter (11.97 ± 1.95 g/dl) were significantly lower than the values obtained with the conventional method (12.35 ± 1.66 g/dl) (t= 4.7549; p=0.0001). Similar results were obtained with packed cell volume estimation. The performance indices of the Veri-Q haemoglobin meter were as follows: sensitivity (75.41% for Hb and 77.05% for PCV), specificity (28.0% for Hb and PCV), positive predictive value (PPV) (56.1% for Hb and 56.63% for PCV), negative predictive value (48.28% for Hb and 50% for PCV). The prevalence of anemia in this study was 54.05%. Positive Likelihood Ratio (1.05 for Hb and 1.07 for PCV), Negative Likelihood Ratio (0.88 for Hb and 0.82 for PCV), Accuracy (54.05% for Hb and 54.95% for PCV). The Receiver Operative Characteristics (ROC) Area Under Curve (AUC) was 0.996 for Hb and 0.984 for PCV. A significant but weak positive correlation was found to exist between haemoglobin estimations using conventional and Veri-Q methods (r=0.3013, P =0.01); PCV (R=0.2512, P =0.07). The sensitivity of the device can be described as moderate while the specificity is low. The accuracy of the device is just average. Conclusion: The Veri-Q haemoglobin meter demonstrates an average level of accuracy and a high AUC, making it potentially useful for field epidemiological studies.

Esta revisión se centra en describir nuevos sistemas de diagnóstico molecular de tipo POC disponibles en el mercado que pueden implementarse fácilmente en farmacias comunitarias y tienen el potencial de ampliar la cartera de servicios farmacéuticos y hacer una contribución significativa a la mejora de la salud pública. El conocimiento de nuevas técnicas de diagnóstico molecular distintas de la PCR es relativamente desconocido. Sin embargo, las opciones disponibles son diversas y han alcanzado suficiente madurez tecnológica para su uso a gran escala. La pandemia de SARS-CoV-2 ha sacado al mercado pruebas de diagnóstico que, en algunos casos, se han utilizado exclusivamente en investigación durante décadas. La tecnología isotérmica de amplificación de ácidos nucleicos sigue evolucionando y es probable que en los próximos años seamos testigos de un aumento exponencial de su uso, así como del desarrollo de nuevas mejoras que simplifiquen y reduzcan aún más el coste de cada ensayo. Igualmente, no podemos obviar el hecho de que durante la pandemia de COVID-19, el público se ha habituado a autodiagnosticarse a través de canales de distribución masiva como las farmacias comunitarias, lo que puede abrir el sector a otras enfermedades —como las de transmisión sexual o salud animal—, el control de alimentos, la contaminación del agua y del aire (hongos) o la presencia de alérgenos. El conocimiento de estas nuevas tecnologías es esencial estrategia de vigilancia tecnológica e inteligencia competitiva del sector farmacéutico.