Haemoglobin A1c point-of-care analysers for professional use
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World Health Organization
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vi, 24 p.
This technical specification provides guidance for manufacturers of in vitro diagnostic (IVD) medical devices seeking WHO prequalification for point-of-care (POC) analysers intended for the quantitative measurement of haemoglobin A1c (HbA1c) in venous or capillary whole blood. The document applies to devices used by health professionals for monitoring response to therapy in people with diabetes mellitus and as an aid in the diagnosis of type 2 diabetes. It defines the intended use of eligible devices and explains the principles underpinning WHO prequalification, including the evidence required to demonstrate that an assay performs reliably in its intended settings and users. The publication specifies the minimum analytical and clinical performance requirements to support WHO prequalification submissions. It details expectations for specimen validation, metrological traceability, accuracy, precision, analytical specificity, measuring range, software, usability, stability and clinical performance studies, following the International Medical Device Regulators Forum Table of Contents format. The guidance also outlines study design considerations, reporting requirements and the use of recognized reference methods and international standards, promoting a harmonized approach to generating evidence for the evaluation of HbA1c point-of-care diagnostic devices.
This technical specification provides guidance for manufacturers of in vitro diagnostic (IVD) medical devices seeking WHO prequalification for point-of-care (POC) analysers intended for the quantitative measurement of haemoglobin A1c (HbA1c) in venous or capillary whole blood. The document applies to devices used by health professionals for monitoring response to therapy in people with diabetes mellitus and as an aid in the diagnosis of type 2 diabetes. It defines the intended use of eligible devices and explains the principles underpinning WHO prequalification, including the evidence required to demonstrate that an assay performs reliably in its intended settings and users. The publication specifies the minimum analytical and clinical performance requirements to support WHO prequalification submissions. It details expectations for specimen validation, metrological traceability, accuracy, precision, analytical specificity, measuring range, software, usability, stability and clinical performance studies, following the International Medical Device Regulators Forum Table of Contents format. The guidance also outlines study design considerations, reporting requirements and the use of recognized reference methods and international standards, promoting a harmonized approach to generating evidence for the evaluation of HbA1c point-of-care diagnostic devices.