External Quality Assessment of Point-of-Care Methods: Model For Combined Assessment of Method Bias and Single-Participant Performance by the Use of Native Patient Samples and Noncommutable Control Materials
Abstract:BACKGROUND: An important objective in external quality assessment (EQA) is to evaluate systematic deviations between methods. However, this is not possible when noncommutable control materials are used. The aim of this study was to develop an EQA model that incorporates a method bias evaluation using native patient samples into EQA schemes in which noncommutable materials are used.
“…65 A further consideration for POC testing success is the implementation of appropriate quality control measures. Participation in external quality control programs or proficiency testing (EQA, external quality assessment) 66,67 is a possibility and can assist in monitoring quality of results. It is critical to follow the manufacturer's instructions in the use of external quality control materials for regular quality control surveillance.…”
Section: Poc Analytical Accuracy and Performance: Room For Improvementmentioning
Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like cardiovascular or renal disease. HbA1c testing is a vital step for effective diabetes management, however, given the low compliance to testing frequency and, commonly, a subsequent delay in the corresponding treatment modification, HbA1c at the point of care (POC) offers an opportunity for improvement of diabetes care. In this review, based on data from 1999 to 2016, we summarize the evidence supporting a further implementation of HbA1c testing at POC, discuss its limitations and propose recommendations for further development.
“…65 A further consideration for POC testing success is the implementation of appropriate quality control measures. Participation in external quality control programs or proficiency testing (EQA, external quality assessment) 66,67 is a possibility and can assist in monitoring quality of results. It is critical to follow the manufacturer's instructions in the use of external quality control materials for regular quality control surveillance.…”
Section: Poc Analytical Accuracy and Performance: Room For Improvementmentioning
Diabetes is a highly prevalent disease also implicated in the development of several other serious complications like cardiovascular or renal disease. HbA1c testing is a vital step for effective diabetes management, however, given the low compliance to testing frequency and, commonly, a subsequent delay in the corresponding treatment modification, HbA1c at the point of care (POC) offers an opportunity for improvement of diabetes care. In this review, based on data from 1999 to 2016, we summarize the evidence supporting a further implementation of HbA1c testing at POC, discuss its limitations and propose recommendations for further development.
“…First, external quality assurance programs often rely on noncommutable material with unknown matrix effects that blind participants from knowing whether their devices operate with bias. By adding knowledge about bias from prospective commutability studies at several facilities, Stavelin et al showed that more complete external quality assurance for POC testing could be achieved (26 ). DETECT enables calculation of this bias through use of the EMR and could be orchestrated by external quality assurance programs at minimal costs.…”
BACKGROUND:The electronic medical record (EMR) holds a promising source of data for active postmarket surveillance of diagnostic accuracy, particularly for pointof-care (POC) devices. Through a comparison with prospective bedside and laboratory accuracy studies, we demonstrate the validity of active surveillance via an EMR data mining method [Data Mining EMRs to Evaluate Coincident Testing (DETECT)], comparing POC glucose results to near-in-time central laboratory glucose results.
“…However, by these processes macromolecules are denatured and the matrix of materials is changed during the preparation [12,13]. The problems are especially severe for the EQA and PT organisers due to the need for large volumes of stable materials in small tubes to be distributed to all participating laboratories in each survey [14]. It is difficult to obtain such large volumes of fresh genuine human materials; so the organisers rely on outdated human materials, which are often supplemented with animal constituents or synthetic components [15].…”
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