Assessment of Point-of-Care Testing Accuracy in Community Healthcare Centers

Thesis Abstract

The rapid expansion of point-of-care (POC) testing in community healthcare centers has significantly enhanced access to diagnostic services; however, concerns regarding the accuracy and reliability of these tests threaten the quality of patient care and clinical decision-making. This study aims to comprehensively assess the accuracy of POC testing in community healthcare centers, focusing on evaluating the precision, sensitivity, specificity, and overall agreement of commonly used POC diagnostic devices for parameters such as blood glucose levels, hemoglobin, and lipid profiles. The specific objectives include determining the prevalence of accuracy deviations among POC devices, identifying factors influencing test performance, and evaluating clinical outcomes associated with POC testing discrepancies. Employing a cross-sectional descriptive design, the study was conducted across eight community healthcare centers within a metropolitan region with a population of approximately two million residents. The sample comprised 400 patients who underwent POC testing for blood glucose, hemoglobin, and lipid profiles over a six-month period. A systematic sampling technique was employed to select participants based on eligibility criteria, including adults aged 18–65 presenting for routine testing. Data collection involved simultaneous sample analysis using validated laboratory reference methods (gold standard) and POC devices, with each participant undergoing paired testing for each parameter. The primary data collection instruments included calibrated portable POC devices, laboratory analyzers, and structured data collection forms capturing demographic and clinical details. To ensure validity and reliability, POC devices were calibrated daily, and standardized protocols for sample collection and testing were adhered to, following manufacturer guidelines and WHO standards. The analytical framework incorporated descriptive statistics to summarize demographic and clinical characteristics, while inferential analyses utilized Bland-Altman plots to assess agreement between POC and laboratory results, and Cohen’s kappa statistics to evaluate categorical concordance. Multiple regression analyses were employed to identify factors influencing device accuracy, such as operator experience, environmental conditions, and device maintenance. Statistical significance was set at p<0.05, with data processed using SPSS version 26.0. Ethical considerations included obtaining approval from relevant institutional review boards, securing informed consent from all participants, and maintaining confidentiality throughout the study. Expected findings indicate variability in POC device accuracy, with some devices demonstrating high levels of sensitivity and specificity comparable to laboratory standards, while others show significant deviations, especially in resource-constrained settings. The study anticipates identifying critical factors affecting test precision, such as inadequate operator training, environmental factors (temperature and humidity), and insufficient device maintenance. These discrepancies are projected to influence clinical decisions, potentially leading to misdiagnoses or inappropriate management of conditions like diabetes and cardiovascular risk factors. This research makes a substantial contribution to the existing body of knowledge by providing empirical evidence on the accuracy of POC testing in community settings, revealing the strengths and limitations of current devices used in resource-limited environments. It underscores the importance of quality assurance protocols, operator training, and environmental controls in safeguarding test validity. The findings are expected to inform policy development for POC testing standards and facilitate the design of targeted interventions to improve diagnostic accuracy at the community level. Overall, the study concludes that ensuring the accuracy of POC tests is essential for optimizing patient outcomes, and recommends the implementation of routine device calibration, ongoing personnel training, and comprehensive quality management systems in community healthcare centers to enhance diagnostic reliability and healthcare delivery quality.