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Background: Point-of-care (POC) devices could be used to measure hemoglobin A1c (HbA1c) in the doctors' office, allowing immediate feedback of results to patients. Reports have raised concerns about the analytical performance of some of these devices. We carried out a systematic review and meta-analysis using a novel approach to compare the accuracy and precision of POC HbA1c devices.

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Three of 7 hemoglobin A1c point-of-care instruments do not meet generally accepted analytical performance criteria.

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August 2014

Department of Clinical Chemistry, Isala, Zwolle, the Netherlands; European Reference Laboratory for Glycohemoglobin, Zwolle, the Netherlands.

Background: In 2009, we investigated the conformance of 8 hemoglobin A(1c) (Hb A(1c)) point-of-care (POC) instruments. Since then, instruments have improved and new devices are available on the market. In this second study, we evaluated the performance of DCA Vantage, Afinion, InnovaStar, Quo-Lab, Quo-Test, Cobas B101, and B-analyst Hb A(1c) POC instruments.

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Haemoglobin A1c: comparing performance of two point of care devices with laboratory analyser.

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Department of Diabetes & Endocrine, Cardiovascular Diabetes and Nutrition Research Centre, Institute for Medical Research, Jalan Pahang, Kuala Lumpur, 50588, Malaysia.

Background: Measurement of HbA1c has been widely used for long-term monitoring and management of diabetes control. There is increasing use of point-of-care (POC) devices for measuring HbA1c where quicker results would allow immediate clinical management decisions to be made. Therefore, it is important to evaluate and compare the performance of such devices to the reference laboratory method.

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Background: Hemoglobin A(1c) (Hb A(1c)) point-of-care (POC) instruments are widely used to provide rapid-turnaround results in diabetic care centers. We investigated the conformance of various Hb A(1c) POC instruments (In2it from Bio-Rad, DCA Vantage from Siemens, Afinion and Nycocard from Axis-Shield, Clover from Infopia, InnovaStar from DiaSys, A1CNow from Bayer, and Quo-Test from Quotient Diagnostics) with generally accepted performance criteria for Hb A(1c).

Methods: The CLSI protocols EP-10, EP-5, and EP-9 were applied to investigate imprecision, accuracy, and bias.

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