title: Performance of point-of-care HbA1c test devices: implications for use in clinical practice - a systematic review and meta-analysis.
abstract: 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.
  
  
  METHODS
  Medline, Embase and Web of Science databases were searched in June 2015 for published reports comparing POC HbA1c devices with laboratory methods. Two reviewers screened articles and extracted data on bias, precision and diagnostic accuracy. Mean bias and variability between the POC and laboratory test were combined in a meta-analysis. Study quality was assessed using the QUADAS2 tool.
  
  
  RESULTS
  Two researchers independently reviewed 1739 records for eligibility. Sixty-one studies were included in the meta-analysis of mean bias. Devices evaluated were A1cgear, A1cNow, Afinion, B-analyst, Clover, Cobas b101, DCA 2000/Vantage, HemoCue, Innovastar, Nycocard, Quo-Lab, Quo-Test and SDA1cCare. Nine devices had a negative mean bias which was significant for three devices. There was substantial variability in bias within devices. There was no difference in bias between clinical or laboratory operators in two devices.
  
  
  CONCLUSIONS
  This is the first meta-analysis to directly compare performance of POC HbA1c devices. Use of a device with a mean negative bias compared to a laboratory method may lead to higher levels of glycemia and a lower risk of hypoglycaemia. The implications of this on clinical decision-making and patient outcomes now need to be tested in a randomized trial.
authors.forename: Jennifer A
authors.initials: JA
authors.lastname: Hirst
authors.forename: Julie H
authors.initials: JH
authors.lastname: McLellan
authors.forename: Christopher P
authors.initials: CP
authors.lastname: Price
authors.forename: Emma
authors.initials: E
authors.lastname: English
authors.forename: Benjamin G
authors.initials: BG
authors.lastname: Feakins
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Stevens
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Farmer
mesh_terms: D006442:Glycated Hemoglobin / Q000032:analysis*; D006801:Humans; D019095:Point-of-Care Systems; D017410:Practice Guidelines as Topic
chemical_list: D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human