Diagnostic Accuracy of an Integrated AI Tool to Estimate Gestational Age From Blind Ultrasound Sweeps.

Importance: Accurate assessment of gestational age (GA) is essential to good pregnancy care but often requires ultrasonography, which may not be available in low-resource settings. This study developed a deep learning artificial intelligence (AI) model to estimate GA from blind ultrasonography sweeps and incorporated it into the software of a low-cost, battery-powered device. Objective: To evaluate GA estimation accuracy of an AI-enabled ultrasonography tool when used by novice users with no prior training in sonography. Design, Setting, and Participants: This prospective diagnostic accuracy study enrolled 400 individuals with viable, single, nonanomalous, first-trimester pregnancies in Lusaka, Zambia, and Chapel Hill, North Carolina. Credentialed sonographers established the "ground truth" GA via transvaginal crown-rump length measurement. At random follow-up visits throughout gestation, including a primary evaluation window from 14 0/7 weeks' to 27 6/7 weeks' gestation, novice users obtained blind sweeps of the maternal abdomen using the AI-enabled device (index test) and credentialed sonographers performed fetal biometry with a high-specification machine (study standard). Main Outcomes and Measures: The primary outcome was the mean absolute error (MAE) of the index test and study standard, which was calculated by comparing each method's estimate to the previously established GA and considered equivalent if the difference fell within a prespecified margin of ±2 days. Results: In the primary evaluation window, the AI-enabled device met criteria for equivalence to the study standard, with an MAE (SE) of 3.2 (0.1) days vs 3.0 (0.1) days (difference, 0.2 days [95% CI, -0.1 to 0.5]). Additionally, the percentage of assessments within 7 days of the ground truth GA was comparable (90.7% for the index test vs 92.5% for the study standard). Performance was consistent in prespecified subgroups, including the Zambia and North Carolina cohorts and those with high body mass index. Conclusions and Relevance: Between 14 and 27 weeks' gestation, novice users with no prior training in ultrasonography estimated GA as accurately with the low-cost, point-of-care AI tool as credentialed sonographers performing standard biometry on high-specification machines. These findings have immediate implications for obstetrical care in low-resource settings, advancing the World Health Organization goal of ultrasonography estimation of GA for all pregnant people. Trial Registration: ClinicalTrials.gov Identifier: NCT05433519.

Cost-effectiveness of point of care smoking cessation interventions in oncology clinics.

BACKGROUND: We examined the cost-effectiveness of providing systematic smoking cessation interventions to oncology patients at point-of-care. METHODS: A decision analytic model was completed from the healthcare payer's perspective and included all incident cancer cases involving patients who smoke in New Brunswick, Canada (n = 1040), cancer site stratifications, and risks of mortality, continued smoking, and cancer treatment failure over one year. Usual care (no cessation support) was compared to the standard Ottawa Model for Smoking Cessation (OMSC) intervention, and to OMSC plus unlimited cost-free stop smoking medication (OMSC + SSM), including nicotine replacement therapy, varenicline, or bupropion. Primary outcomes were incremental cost per quit (ICQ) and incremental cost per cancer treatment failure avoided (ICTFA). RESULTS: The ICQ was $C143 and ICTFA $C1193 for standard OMSC. The ICQ was $C503 and ICTFA was $C5952 for OMSC + SSM. The number needed to treat (NNT) to produce one quit was 9 for standard OMSC and 4 for OMSC + SSM, and the NNT to avoid one first-line treatment failure was 78 for OMSC and 45 for OMSC + SSM. Both were cost-effective in 100% of 1000 simulations. CONCLUSIONS: Given the high clinical benefits and low incremental costs, systematic smoking cessation interventions should be a standard component of first-line cancer treatment.

Economics of reducing response time to foreign-animal disease in the United States with point-of-care diagnostic tests.

BACKGROUND: As low probability events, United States producers, value chain actors, and veterinary services (VS) have limited experience with identifying foreign animal disease (FAD), which can allow FADs to spread undetected. Point-of-care (POC) diagnostic testing may help reduce the time from detecting an initial suspect case to implementing actionable interventions compared to the current approach of only using laboratory diagnostic testing for disease diagnosis and confirmation. To evaluate the value of the reduced response time, we compare the associated costs between the two diagnostic approaches while accounting for the uncertainty surrounding the size of a FAD event. METHODS: We apply a state-contingent approach (SCA) to model the uncertainty surrounding a FAD through alternative events, where the event defines the scale of outbreak size and its duration. We apply this approach within a cost-benefit framework (CBA) to determine the economic value from the two testing investment strategies to help explain the policymaker's response (and costs) to alternative FAD events while also considering the cost impacts on the producers from each event. RESULTS: Compared to the current laboratory strategy, a POC strategy that reduces response time by 0.5-days (swine, cattle scenarios) and 1.5-days (poultry scenario) may provide cost-saving to both producers and public response efforts. The benefit-cost analysis further suggests that despite the higher fixed costs to adopt the POC strategy, the swine and cattle sectors may benefit while the benefits may not be as pronounced in the poultry sector. DISCUSSION: POC testing that can reduce the time between detection and response during a FAD event may be a sound strategy for public expenditure and provide cost-savings for producers, especially when minimal fixed costs are incurred. However, to fully determine the value of POC testing, the consequences (costs) associated with potential actions if something goes wrong, (e.g. false positive results), should be considered in future studies.

Colorimetric detection of serum creatinine on a miniaturized platform using hue-saturation-value space analysis.

Chronic kidney disease (CKD) is a widespread condition with considerable health and economic impacts globally. However, existing methodologies for serum creatinine assessment often involve prolonged wait times and sophisticated equipment, such as spectrometers, hindering real-time diagnosis and care. Innovative solutions like point-of-care (POC) devices are emerging to address these challenges. In this context, there is a recognized need for remote, regular, automated, and low-cost analysis of serum creatinine levels, given its role as a critical parameter for CKD diagnosis and management. This study introduces a miniaturized system with integrated heater elements designed for precise serum creatinine measurement. The system operates based on the Jaffe method and accurate serum creatinine measurement within a microreservoir chip. Smartphone-based image processing using the hue-saturation-value (HSV) color space was applied to captured images of microreservoirs. The creatinine analyses were conducted in serum with a limit of detection of ~ 0.4 mg/dL and limit of quantification of ~ 1.3 mg/dL. Smartphone-based image processing employing the HSV color space outperformed spectrometric analysis for creatinine measurement conducted in serum. This pioneering technology and smartphone-based processing offer the potential for decentralized renal function testing, which could significantly contribute to improved patient care. The miniaturized system offers a low-cost alternative ($87 per device), potentially reducing healthcare expenditures (~ $0.5 per test) associated with CKD diagnosis and management. This innovation could greatly improve access to diagnosis and monitoring of CKD, especially in regions where access to sophisticated laboratory equipment is limited.

Towards the development of cost-effective point-of-care diagnostic tools for poverty-related infectious diseases in sub-Saharan Africa.

In this review, we examine the current landscape of point-of-care testing (POCT) diagnostic tools designed for poverty-related infectious diseases (PRIDs) in sub-Saharan Africa (sSA) while delineating key avenues for future advancements. Our analysis encompasses both established and emerging diagnostic methods for PRIDs, addressing the persistent challenges in POCT tool development and deployment, such as cost, accessibility, and reliability. We emphasize recent advancements in POCT diagnostic tools as well as platforms poised to enhance diagnostic testing in sSA. Recognizing the urgency for affordable and widely accessible POCT diagnostic tools to detect PRIDs in sSA, we advocate for a multidisciplinary approach. This approach integrates current and emerging diagnostic methods, explicitly addressing challenges hindering point-of-care (POC) tool development. Furthermore, it recognizes the profound impact of misdiagnosis on public and global health, emphasizing the need for effective tools. To facilitate the successful development and implementation of POCT diagnostic tools in sSA, we propose strategies including the creation of multi-analyte detection POCT tools, the implementation of education and training programs, community engagement initiatives, fostering public-private collaborations, and the establishment of reliable supply chains. Through these concerted efforts, we aim to accelerate the development of POCT in the sSA region, ensuring its effectiveness and accessibility in addressing the diagnostic challenges associated with PRIDs.

Cost-effectiveness of point-of-care diagnostics for AMR: a systematic review.

BACKGROUND: Antimicrobial resistance (AMR) is a major threat to global health. By 2050, it is forecast that AMR will cause 10 million deaths and cost 100 trillion USD annually. Point-of-care tests (POCTs) may represent a cost-effective approach to reduce AMR. OBJECTIVES: We systematically reviewed which POCTs addressing AMR have undergone economic evaluation in primary and secondary healthcare globally, how these POCTs have been economically evaluated, and which are cost-effective in reducing antimicrobial prescribing or the burden of AMR. Clinical cost-effectiveness was additionally addressed. METHODS: This systematic review, accordant with PRISMA guidelines, was pre-registered on PROSPERO (CRD42022315192). MEDLINE, PubMed, Embase, Cochrane Library, and Google Scholar were searched from 2000 to 2023 for relevant publications. Quality assessment was performed using the Consensus of Health Economic Criteria. RESULTS: The search strategy identified 1421 studies, of which 20 met the inclusion criteria. The most common POCTs assessed were for respiratory infections (n = 10), STIs (n = 3), and febrile patients in low- and middle-income countries (n = 3). All studies assessed costs from a healthcare provider perspective; five additionally considered the societal cost of AMR.Eighteen studies identified POCT strategies that reduced antimicrobial prescribing. Of these, 10 identified POCTs that would be considered cost-effective at a willingness-to-pay (WTP) threshold of £33.80 per antibiotic prescription avoided. Most POCT strategies improved clinical outcomes (n = 14); the remainder were clinically neutral. CONCLUSIONS: There is evidence that some POCTs are cost-effective in reducing antimicrobial prescribing, with potential concomitant clinical benefits. Such interventions-especially CRP POCTs in both high- and low-income settings-merit further, large-scale clinical evaluation.

In situ off-line extracorporeal photopheresis conducted in a real-life situation at a Hemobiotherapy Department in France: A comparison of costs vs on-line procedure.

BACKGROUND: The off-line extracorporeal photopheresis (ECP) procedure requires photosensitization in an external cell therapy laboratory as per the French regulatory requirement. This regulation results in higher time and costs compared with the on-line alternative performed entirely at the patient's bedside. Recently, full in situ execution of the off-line procedure has been implemented in the Pitié-Salpêtrière Hospital Hemobiotherapy Department (Paris, France). This report summarizes the center's experience regarding the organizational and costs impacts of this change compared with the on-line procedure. MATERIAL AND METHODS: ECP was broken down into stages, and several procedures were monitored prospectively in real-life settings. The total costs associated with both procedures were the sum of the fixed costs and variable costs related to all stages of the procedures, nursing-time costs, property costs, and patient-related production loss costs. RESULTS: Eight off-line ECP and fourteen on-line ECP procedures were monitored during five consecutive days. Procedure duration was not different (median 137.5 vs 154.0 minutes, P = .29). Times and costs associated with nursing were higher but offset by lower fixed costs of the off-line ECP. Total direct costs per procedure associated with using the off-line ECP were significantly lower than those of the on-line procedure (459.6 ± 7.1 EUR vs 953.8 ± 6.5 EUR; P = .0002). Similar results were observed when including the costs of patient production loss. CONCLUSIONS: As a competitive time procedure, the in situ off-line method proved to be cost-efficient by effectively offering similar patient treatment per year compared with the on-line procedure.

The RADxSM Tech Process: Accelerating Innovation for COVID-19 Testing.

In the wake of the COVID-19 pandemic, the need for rapid and accurate diagnostic testing across populations quickly became evident. In response, the National Institutes of Health (NIH) was determined not only to invest heavily in this area but to change the process by which grant proposals were reviewed and funded in order to spur faster development of viable technologies. The Rapid Acceleration of Diagnostics (RADx) initiative was designed to speed innovation, commercialization, and implementation of potential COVID-19 diagnostic technology. As part of this effort, the RADx Tech initiative focuses on the development, validation, and commercialization of innovative point-of-care, home-based, and clinical lab-based tests that can detect SARS-CoV-2. This effort was enabled through the NIH's National Institute of Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technology Research Network (POCTRN).

Impact of an epic-integrated point-of-care ultrasound workflow on ultrasound performance, compliance, and potential revenue.

OBJECTIVES: The purpose of this study was to describe the design and impact of a point-of-care ultrasound (PoCUS) workflow integrated into the electronic medical record (EMR) on PoCUS utilization, documentation compliance, and resultant revenue potential. METHODS: This was a single-center retrospective study at an academic center. The study period spanned from December 1, 2018 to June 30, 2019 (pre-implementation) to August 1, 2019 to February 29, 2020 (post-implementation). The implementation date was July 11, 2019 at which time a PoCUS workflow was integrated into the EMR in the emergency department without the purchase of middleware. Prior to this new workflow, a non-automated workflow was in place. PoCUS scan data were extracted from the EMR and archived examinations. The mean number of PoCUS examinations performed per month per 100 ED visits before and after implementation of the new workflow were compared using an unpaired t-test, stratified by all health care professionals, and attending physicians alone. The rate of documentation compliance before and after implementation of the new workflow were compared using a chi square contingency test. Potential revenue was calculated for each period by multiplying the number of eligible examinations by the respective 2020 Medicare conversion factor Relative Value Units. RESULTS: Utilization of PoCUS from pre-implementation to post-implementation increased 28.7% from 5.01 to 6.45 mean examinations per month per 100 ED visits by all health care professionals (p = 0.063), and 75.1% from 2.01 to 3.52 by attending physicians (p = 0.0001). Examinations in compliance with workflow requirements increased from 153 (14.7%) to 1307 (94.0%). The rate of workflow compliance improved from 14.7% to 94.0% of examinations (p < 0.0001). Potential revenue increased from $546.01 to $22,014.47. CONCLUSIONS: The implementation of a middleware-free PoCUS workflow at our institution was associated with increased PoCUS utilization, documentation compliance, and potential revenue.

A rapid, point-of-care red blood cell agglutination assay detecting antibodies against SARS-CoV-2.

The COVID-19 pandemic has caused significant morbidity and mortality. There is an urgent need for serological tests to detect antibodies against SARS-CoV-2, which could be used to assess past infection, evaluate responses to vaccines in development, and determine individuals who may be protected from future infection. Current serological tests developed for SARS-CoV-2 rely on traditional technologies such as enzyme-linked immunosorbent assays (ELISA) and lateral flow assays, which have not scaled to meet the demand of hundreds of millions of antibody tests so far. Herein, we present an alternative method of antibody testing that depends on one protein reagent being added to patient serum/plasma or whole blood with direct, visual readout. Two novel fusion proteins, RBD-2E8 and B6-CH1-RBD, were designed to bind red blood cells (RBCs) via a single-chain variable fragment (scFv), thereby displaying the receptor-binding domain (RBD) of SARS-CoV-2 spike protein on the surface of RBCs. Mixing mammalian-derived RBD-2E8 and B6-CH1-RBD with convalescent COVID-19 patient serum and RBCs led to visible hemagglutination, indicating the presence of antibodies against SARS-CoV-2 RBD. B6-CH1-RBD made in bacteria was not as effective in inducing agglutination, indicating better recognition of RBD epitopes from mammalian cells. Given that our hemagglutination test uses methods routinely used in hospital clinical labs across the world for blood typing, we anticipate the test can be rapidly deployed at minimal cost. We anticipate our hemagglutination assay may find extensive use in low-resource settings for detecting SARS-CoV-2 antibodies.

Lateral flow immunoassay for furazolidone point-of-care testing: Cater to the call of saving time, labor, and cost by coomassie brilliant blue labeling.

Furazolidone (FZD) and its metabolite called 3-amino-2-oxazolidinone (AOZ) would induce carcinogenic and mutagenic effects to human. In this work, to develop a novel, stable, and simple point of care testing (POCT) with a potential to social applied for FZD detection, we utilized the aspect of protein staining of coomassie brilliant blue (CBB) to exploit a new CBB-LFIA strategy free of NPs. Only one mixing step is needed during the probe manufacturing process, which requires just 2 h and is a great time saving strategy compared with other methods (requiring 4-33 h for probe preparation). Besides, the cost of CBB-LFIA is 300 times lesser than other LFIA with respect to obtaining the label. The developed CBB-LFIA was successfully applied to detect AOZ with a detection limit of 2 ng mL-1, without any influence from other potential interfering compounds. The proposed CBB-LFIA exhibited prominent practical application, and possesses considerable utilization potential in the related field.

Near Point-of-Care HIV Viral Load: Targeted Testing at Large Facilities.

INTRODUCTION: Point-of-care (POC) technologies in resource-limited settings can circumvent challenges of centralized laboratory testing, improving clinical management. However, higher device costs and uncertain indications for use have inhibited scaling up POC modalities. To address this gap, we investigated the feasibility and cost of targeted near-POC viral load (VL) testing in 2 large HIV clinics in Lilongwe, Malawi. METHODS: VL testing using GeneXpert was targeted for patients suspected of treatment failure or returning to care after a previously elevated VL (>1000 copies/mL). Descriptive analysis of retrospective clinical and cost data is presented. RESULTS: Two thousand eight hundred thirteen near-POC VL tests were conducted. One thousand five hundred eleven (54%) tests were for patients for whom results and reason for the test were documented: 57% (794/1389) of tests were to confirm a previously high VL, and 33% (462/1389) were due to clinical indications. Sixty-one percent (926/1511) of patients had a high VL, of whom 78% (719/926) had a recorded clinical action: 77% (557/719) switched to second line antiretroviral therapy, and 15% (194/719) were referred for intensive adherence counseling. Eighty-two percent (567/687) of patients received a clinical action on the same day as testing. The "all-in" cost was $33.71 for a valid POC VL test, compared with an international benchmark for a centralized VL test of $28.62. CONCLUSION: Targeted, near-POC VL testing was feasible and consistently enabled prompt clinical action. The difference between the "all-in" cost of near-POC VL and centralized testing of $5.09 could be further reduced in an optimized national program by combining targeted near-POC testing and centralized testing.

Point-of-care characterization and risk-based management of oral lesions in primary dental clinics: A simulation model.

OBJECTIVES: Oral potentially malignant disorders (OPMDs) encompass histologically benign, dysplastic, and cancerous lesions that are often indistinguishable by appearance and inconsistently managed. We assessed the potential impact of test-and-treat pathways enabled by a point-of-care test for OPMD characterization. MATERIALS AND METHODS: We constructed a decision-analytic model to compare life expectancy of test-treat strategies for 60-year-old patients with OPMDs in the primary dental setting, based on a trial for a point-of-care cytopathology tool (POCOCT). Eight strategies of OPMD detection and evaluation were compared, involving deferred evaluation (no further characterization), prompt OPMD characterization using POCOCT measurements, or the commonly recommended usual care strategy of routine referral for scalpel biopsy. POCOCT pathways differed in threshold for additional intervention, including surgery for any dysplasia or malignancy, or for only moderate or severe dysplasia or cancer. Strategies with initial referral for biopsy also reflected varied treatment thresholds in current practice between surgery and surveillance of mild dysplasia. Sensitivity analysis was performed to assess the impact of variation in parameter values on model results. RESULTS: Requisite referral for scalpel biopsy offered the highest life expectancy of 20.92 life-years compared with deferred evaluation (+0.30 life-years), though this outcome was driven by baseline assumptions of limited patient adherence to surveillance using POCOCT. POCOCT characterization and surveillance offered only 0.02 life-years less than the most biopsy-intensive strategy, while resulting in 27% fewer biopsies. When the probability of adherence to surveillance and confirmatory biopsy was ≥ 0.88, or when metastasis rates were lower than reported, POCOCT characterization extended life-years (+0.04 life-years) than prompt specialist referral. CONCLUSION: Risk-based OPMD management through point-of-care cytology may offer a reasonable alternative to routine referral for specialist evaluation and scalpel biopsy, with far fewer biopsies. In patients who adhere to surveillance protocols, POCOCT surveillance may extend life expectancy beyond biopsy and follow up visual-tactile inspection.

A low-cost smart system for electrophoresis-based nucleic acids detection at the visible spectrum.

Nucleic acid detection by electrophoresis is still a quick and accessible technique for many diagnosis methods, primarily at research laboratories or at the point of care units. Standard protocols detect DNA/RNA molecules through specific bound chemical dyes using a UV-transilluminator or UV-photo documentation system. However, the acquisition costs and availability of these devices, mainly the ones with photography and internet connection capabilities, can be prohibitive, especially in developing countries public health units. Also, ultraviolet radiation is a common additional risk factor to professionals that use electrophoresis-based nucleic acid detection. With that in mind, this work describes the development of a low-cost DNA/RNA detection smart system capable of obtaining qualitative and semi-quantitative data from gel analysis. The proposed device explores the visible light absorption range of commonly used DNA/RNA dyes using readily available parts, and simple manufacturing processes, such as light-emitting diodes (LEDs) and 3D impression. By applying IoT techniques, our system covers a wide range of color spectrum in order to detect bands from various commercially used dyes, using Bluetooth communication and a smartphone for hardware control, image capturing, and sharing. The project also enables process scalability and has low manufacturing and maintenance costs. The use of LEDs at the visible spectrum can achieve very reproducible images, providing a high potential for rapid and point-of-care diagnostics as well as applications in several fields such as healthcare, agriculture, and aquaculture.

Cost-effectiveness of Autonomous Point-of-Care Diabetic Retinopathy Screening for Pediatric Patients With Diabetes.

Importance: Screening for diabetic retinopathy is recommended for children with type 1 diabetes (T1D) and type 2 diabetes (T2D), yet screening rates remain low. Point-of-care diabetic retinopathy screening using autonomous artificial intelligence (AI) has become available, providing immediate results in the clinic setting, but the cost-effectiveness of this strategy compared with standard examination is unknown. Objective: To assess the cost-effectiveness of detecting and treating diabetic retinopathy and its sequelae among children with T1D and T2D using AI diabetic retinopathy screening vs standard screening by an eye care professional (ECP). Design, Setting, and Participants: In this economic evaluation, parameter estimates were obtained from the literature from 1994 to 2019 and assessed from March 2019 to January 2020. Parameters included out-of-pocket cost for autonomous AI screening, ophthalmology visits, and treating diabetic retinopathy; probability of undergoing standard retinal examination; relative odds of undergoing screening; and sensitivity, specificity, and diagnosability of the ECP screening examination and autonomous AI screening. Main Outcomes and Measures: Costs or savings to the patient based on mean patient payment for diabetic retinopathy screening examination and cost-effectiveness based on costs or savings associated with the number of true-positive results identified by diabetic retinopathy screening. Results: In this study, the expected true-positive proportions for standard ophthalmologic screening by an ECP were 0.006 for T1D and 0.01 for T2D, and the expected true-positive proportions for autonomous AI were 0.03 for T1D and 0.04 for T2D. The base case scenario of 20% adherence estimated that use of autonomous AI would result in a higher mean patient payment ($8.52 for T1D and $10.85 for T2D) than conventional ECP screening ($7.91 for T1D and $8.20 for T2D). However, autonomous AI screening was the preferred strategy when at least 23% of patients adhered to diabetic retinopathy screening. Conclusions and Relevance: These results suggest that point-of-care diabetic retinopathy screening using autonomous AI systems is effective and cost saving for children with diabetes and their caregivers at recommended adherence rates.

Clinical, Operative, and Economic Outcomes of the Point-of-Care Blood Gases in the Nephrology Department of a Third-Level Hospital.

CONTEXT.­: Point-of-care testing allows rapid analysis and short turnaround times. To the best of our knowledge, the present study assesses, for the first time, clinical, operative, and economic outcomes of point-of-care blood gas analysis in a nephrology department. OBJECTIVE.­: To evaluate the impact after implementing blood gas analysis in the nephrology department, considering clinical (differences in blood gas analysis results, critical results), operative (turnaround time, elapsed time between consecutive blood gas analysis, preanalytical errors), and economic (total cost per process) outcomes. DESIGN.­: A total amount of 3195 venous blood gas analyses from 688 patients of the nephrology department before and after point-of-care blood gas analyzer installation were included. Blood gas analysis results obtained by ABL90 FLEX PLUS were acquired from the laboratory information system. Statistical analyses were performed using SAS 9.3 software. RESULTS.­: During the point-of-care testing period, there was an increase in blood glucose levels and a decrease in pCO2, lactate, and sodium as well as fewer critical values (especially glucose and lactate). The turnaround time and the mean elapsed time were shorter. By the beginning of this period, the number of preanalytical errors increased; however, no statistically significant differences were found during year-long monitoring. Although there was an increase in the total number of blood gas analysis requests, the total cost per process decreased. CONCLUSIONS.­: The implementation of a point-of-care blood gas analysis in a nephrology department has a positive impact on clinical, operative, and economic terms of patient care.