Protocol for preliminary, multicenteric validation of “PoCOsteo device”: A point of care tool for proteomic and genomic study of osteoporosis
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PROVIDER: S-EPMC10978377 | biostudies-literature | 2024 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe measurement of lactate in emergency medical services has the potential for earlier detection of shock and can be performed with a point-of-care handheld device. Validation of a point-of-care handheld device is required for prehospital implementation.AimThe primary aim was to validate the accuracy of Lactate Pro 2 in healthy volunteers and in haemodynamically compromised intensive care patients. The secondary aim was to evaluate which sample site, fingertip or earlobe, is most accurate compared to arterial lactate.MethodsArterial, venous and capillary blood samples from fingertips and earlobes were collected from intensive care patients and healthy volunteers. Arterial and venous blood lactate samples were analysed on a stationary hospital blood gas analyser (ABL800 Flex) as the reference device and compared to the Lactate Pro 2. We used the Bland-Altman method to calculate the limits of agreement and used mixed effect models to compare instruments and sample sites. A total of 49 intensive care patients with elevated lactate and 11 healthy volunteers with elevated lactate were included.ResultsThere was no significant difference in measured lactate between Lactate Pro 2 and the reference method using arterial blood in either the healthy volunteers or the intensive care patients. Capillary lactate measurement in the fingertip and earlobe of intensive care patients was 47% (95% CI (29 to 68%), p < 0.001) and 27% (95% CI (11 to 45%), p < 0.001) higher, respectively, than the corresponding arterial blood lactate. In the healthy volunteers, we found that capillary blood lactate in the fingertip was 14% higher than arterial blood lactate (95% CI (4 to 24%), p = 0.003) and no significant difference between capillary blood lactate in the earlobe and arterial blood lactate.ConclusionOur results showed that the handheld Lactate Pro 2 had good agreement with the reference method using arterial blood in both intensive care patients and healthy volunteers. However, we found that the agreement was poorer using venous blood in both groups. Furthermore, the earlobe may be a better sample site than the fingertip in intensive care patients.
| S-EPMC7437027 | biostudies-literature
Project description:IntroductionThe HORIZON 2020 project PoCOsteo aims (1) to develop a multidimensional fracture risk assessment tool which would take into account all factors known to be related to an individual's fracture risk. The fracture risk model is intended to be developed in two different populations, namely a European and a Middle Eastern one; (2) to develop a medical device, which would measure and/or quantify proteomic as well as genomic factors as present in whole blood samples collected through finger prick; (3) to test the clinical applicability and the validity of prototypes of the to be developed point of care device at both clinical centres.Methods and analysisThis article presents the protocol of this prospective cohort that will be carried out independently at two different centres (Division of Endocrinology and Diabetology at the Medical University of Graz (MUG) as a clinic-based cohort, and Endocrinology and Metabolism Research Institute (EMRI) at the Tehran University of Medical Sciences (TUMS) as a population-based cohort). The final aim is to develop a fracture risk assessment model, which would include clinical risk factors, biochemical markers of bone turnover, as well as specific genomic factors. The derivation cohorts will consist of individuals aged 50 years and above. The period of observation for each patient will be 12 months; an extension phase, which would last for another 2 years, is also planned.Ethics and disseminationThese studies are conducted in accordance with the World Medical Association Declaration of Helsinki. The Iranian part was approved by the Research Ethics Committee of EMRI, TUMS. The Austrian part was approved by the Ethics Committee of the Medical University of Graz. Based on the gathered information, a multidimensional fracture assessment tool will be designed which will later be added to the PoCOsteo device.
| S-EPMC7528352 | biostudies-literature
Project description:A major challenge for malaria is the lack of tools for accurate and timely diagnosis in the field which are critical for case management and surveillance. Microscopy along with rapid diagnostic tests are the current mainstay for malaria diagnosis in most endemic regions. However, these methods present several limitations. This study assessed the accuracy of Gazelle, a novel rapid malaria diagnostic device, from samples collected from the Peruvian Amazon between 2019 and 2020. Diagnostic accuracy was compared against microscopy and two rapid diagnostic tests (SD Bioline and BinaxNOW) using 18ssr nested-PCR as reference test. In addition, a real-time PCR assay (PET-PCR) was used for parasite quantification. Out of 217 febrile patients enrolled and tested, 180 specimens (85 P. vivax and 95 negatives) were included in the final analysis. Using nested-PCR as the gold standard, the sensitivity and specificity of Gazelle was 88.2% and 97.9%, respectively. Using a cutoff of 200 parasites/μl, Gazelle's sensitivity for samples with more than 200 p/uL was 98.67% (95%CI: 92.79% to 99.97%) whereas the sensitivity for samples lower than 200 p/uL (n = 10) was 12.5% (95%CI: 0.32% to 52.65%). Gazelle's sensitivity and specificity were statistically similar to microscopy (sensitivity = 91.8, specificity = 100%, p = 0.983) and higher than both SD Bioline (sensitivity = 82.4, specificity = 100%, p = 0.016) and BinaxNOW (sensitivity = 71.8%, specificity = 97.9%, p = 0.002). The diagnostic accuracy of Gazelle for malaria detection in P. vivax infections was comparable to light microscopy and superior to both RDTs even in the presence of low parasitemia infections. The performance of Gazelle makes it a valuable tool for malaria diagnosis and active case detection that can be utilized in different malaria-endemic regions.
| S-EPMC8219132 | biostudies-literature
Project description:BACKGROUND:The management quality of healthcare facilities has consistently been linked to facility performance, but available tools to measure management are costly to implement, often hospital-specific, not designed for low- and middle-income countries (LMICs), nor widely deployed. We addressed this gap by developing the PRImary care facility Management Evaluation Tool (PRIME-Tool), a primary health care facility management survey for integration into routine national surveys in LMICs. We present an analysis of the tool's psychometric properties and suggest directions for future improvements. METHODS:The PRIME-Tool assesses performance in five core management domains: Target setting, Operations, Human resources, Monitoring, and Community engagement. We evaluated two versions of the PRIME-Tool. We surveyed 142 primary health care (PHC) facilities in Ghana in 2016 using the first version (27 items) and 148 facilities in 2017 using the second version (34 items). We calculated floor and ceiling effects for each item and conducted exploratory factor analyses to examine the factor structure for each year and version of the tool. We developed a revised management framework and PRIME-tool as informed by these exploratory results, further review of management theory literature, and co-author consensus. RESULTS:The majority (17 items in 2016, 23 items in 2017) of PRIME-Tool items exhibited ceiling effects, but only three (2 items in 2016, 3 items in 2017) showed floor effects. Solutions suggested by factor analyses did not fully fit our initial hypothesized management domains. We found five groupings of items that consistently loaded together across each analysis and named these revised domains as Supportive supervision and target setting, Active monitoring and review, Community engagement, Client feedback for improvement, and Operations and financing. CONCLUSION:The revised version of the PRIME-Tool captures a range of important and actionable information on the management of PHC facilities in LMIC contexts. We recommend its use by other investigators and practitioners to further validate its utility in PHC settings. We will continue to refine the PRIME-Tool to arrive at a parsimonious tool for tracking PHC facility management quality. Better understanding the functional components of PHC facility management can help policymakers and frontline managers drive evidence-based improvements in performance.
| S-EPMC6896786 | biostudies-literature
Project description:Early detection of oral cancer in low-resource settings necessitates a Point-of-Care screening tool that empowers Frontline-Health-Workers (FHW). This study was conducted to validate the accuracy of Convolutional-Neural-Network (CNN) enabled m(mobile)-Health device deployed with FHWs for delineation of suspicious oral lesions (malignant/potentially-malignant disorders). The effectiveness of the device was tested in tertiary-care hospitals and low-resource settings in India. The subjects were screened independently, either by FHWs alone or along with specialists. All the subjects were also remotely evaluated by oral cancer specialist/s. The program screened 5025 subjects (Images: 32,128) with 95% (n = 4728) having telediagnosis. Among the 16% (n = 752) assessed by onsite specialists, 20% (n = 102) underwent biopsy. Simple and complex CNN were integrated into the mobile phone and cloud respectively. The onsite specialist diagnosis showed a high sensitivity (94%), when compared to histology, while telediagnosis showed high accuracy in comparison with onsite specialists (sensitivity: 95%; specificity: 84%). FHWs, however, when compared with telediagnosis, identified suspicious lesions with less sensitivity (60%). Phone integrated, CNN (MobileNet) accurately delineated lesions (n = 1416; sensitivity: 82%) and Cloud-based CNN (VGG19) had higher accuracy (sensitivity: 87%) with tele-diagnosis as reference standard. The results of the study suggest that an automated mHealth-enabled, dual-image system is a useful triaging tool and empowers FHWs for oral cancer screening in low-resource settings.
| S-EPMC9395355 | biostudies-literature
Project description:BackgroundUser-friendly information at the point of care for health care professionals should be well structured, rapidly accessible, comprehensive, and trustworthy. The reliability of information and the associated methodological process must be clear. There is no standard tool to evaluate the trustworthiness of such point-of-care (POC) information.ObjectiveWe aim to develop and validate a new tool for assessment of trustworthiness of evidence-based POC resources to enhance the quality of POC resources and facilitate evidence-based practice.MethodsWe designed the Critical Appraisal of Point-of-Care Information (CAPOCI) tool based on the criteria important for assessment of trustworthiness of POC information, reported in a previously published review. A group of health care professionals and methodologists (the authors of this paper) defined criteria for the CAPOCI tool in an iterative process of discussion and pilot testing until consensus was reached. In the next step, all criteria were subject to content validation with a Delphi study. We invited an international panel of 10 experts to rate their agreement with the relevance and wording of the criteria and to give feedback. Consensus was reached when 70% of the experts agreed. When no consensus was reached, we reformulated the criteria based on the experts' comments for a next round of the Delphi study. This process was repeated until consensus was reached for each criterion. In a last step, the interrater reliability of the CAPOCI tool was calculated with a 2-tailed Kendall tau correlation coefficient to quantify the agreement between 2 users who piloted the CAPOCI tool on 5 POC resources. Two scoring systems were tested: a 3-point ordinal scale and a 7-point Likert scale.ResultsAfter validation, the CAPOCI tool was designed with 11 criteria that focused on methodological quality and author-related information. The criteria assess authorship, literature search, use of preappraised evidence, critical appraisal of evidence, expert opinions, peer review, timeliness and updating, conflict of interest, and commercial support. Interrater agreement showed substantial agreement between 2 users for scoring with the 3-point ordinal scale (τ=.621, P<.01) and scoring with the 7-point Likert scale (τ=.677, P<.01).ConclusionsThe CAPOCI tool may support validation teams in the assessment of trustworthiness of POC resources. It may also provide guidance for producers of POC resources.
| S-EPMC8527381 | biostudies-literature
Project description:The rapid detection and identification of infectious disease pathogens is a critical need for healthcare in both developed and developing countries. As we gain more insight into the genomic basis of pathogen infectivity and drug resistance, point-of-care nucleic acid testing will likely become an important tool for global health. In this paper, we present an inexpensive, handheld, battery-powered instrument designed to enable pathogen genotyping in the developing world. Our Microfluidic Biomolecular Amplification Reader (µBAR) represents the convergence of molecular biology, microfluidics, optics, and electronics technology. The µBAR is capable of carrying out isothermal nucleic acid amplification assays with real-time fluorescence readout at a fraction of the cost of conventional benchtop thermocyclers. Additionally, the µBAR features cell phone data connectivity and GPS sample geotagging which can enable epidemiological surveying and remote healthcare delivery. The µBAR controls assay temperature through an integrated resistive heater and monitors real-time fluorescence signals from 60 individual reaction chambers using LEDs and phototransistors. Assays are carried out on PDMS disposable microfluidic cartridges which require no external power for sample loading. We characterize the fluorescence detection limits, heater uniformity, and battery life of the instrument. As a proof-of-principle, we demonstrate the detection of the HIV-1 integrase gene with the µBAR using the Loop-Mediated Isothermal Amplification (LAMP) assay. Although we focus on the detection of purified DNA here, LAMP has previously been demonstrated with a range of clinical samples, and our eventual goal is to develop a microfluidic device which includes on-chip sample preparation from raw samples. The µBAR is based entirely around open source hardware and software, and in the accompanying online supplement we present a full set of schematics, bill of materials, PCB layouts, CAD drawings, and source code for the µBAR instrument with the goal of spurring further innovation toward low-cost genetic diagnostics.
| S-EPMC3731356 | biostudies-literature
Project description:A simple, rapid, and sensitive point-of-care (POC) device for the on-site detection of doxorubicin was developed. The proposed method relies on the naked-eye detection of the intrinsic fluorescence of the drug in a lateral flow device (LFD) configuration, exploiting the biological recognition of DNA probes and avoiding the use of expensive antibodies and sophisticated instrumentations. The POC assay does not require any pre-treatment or purification step and provides an immediate visual readout, achieving a limit of detection as low as ca. 1 ng doxorubicin, outperforming several laboratory-based instrumental techniques. The POC method was proven useful for the detection of trace amounts of the drug both in the case of water solutions (to simulate surface contaminations) and in urine samples, opening promising perspectives for routine monitoring of doxorubicin, with potential benefit to healthcare workers and personalized chemotherapies.
| S-EPMC9599782 | biostudies-literature
Project description:The ability to accurately predict ovulation at-home using low-cost point-of-care diagnostics can be of significant help for couples who prefer natural family planning. Detecting ovulation-specific hormones in urine samples and monitoring basal body temperature are the current commonly home-based methods used for ovulation detection; however, these methods, relatively, are expensive for prolonged use and the results are difficult to comprehend. Here, we report a smartphone-based point-of-care device for automated ovulation testing using artificial intelligence (AI) by detecting fern patterns in a small volume (<100 μL) of saliva that is air-dried on a microfluidic device. We evaluated the performance of the device using artificial saliva and human saliva samples and observed that the device showed >99% accuracy in effectively predicting ovulation.
| S-EPMC6321627 | biostudies-literature
Project description:The identification of patients with aggressive cancer who require immediate therapy is a health challenge in low-income and middle-income countries. Limited pathology resources, high healthcare costs and large-case loads call for the development of advanced standalone diagnostics. Here, we report and validate an automated, low-cost point-of-care device for the molecular diagnosis of aggressive lymphomas. The device uses contrast-enhanced microholography and a deep-learning algorithm to directly analyse percutaneously obtained fine-needle aspirates. We show the feasibility and high accuracy of the device in cells, as well as the prospective validation of the results in 40 patients clinically referred for image-guided aspiration of nodal mass lesions suspicious for lymphoma. Automated analysis of human samples with the portable device should allow for the accurate classification of patients with benign and malignant adenopathy.
| S-EPMC6291220 | biostudies-literature