title: Validation of the Hemo_Control instrument for determination of B-haemoglobin concentration in primary health care.
abstract: OBJECTIVE
  The aim of this study was to evaluate the analytical performance of a new portable haemoglobinometer, Hemo_Control (EKF-diagnostic, GmbH, Germany), which measures haemoglobin concentration in venous and capillary samples.
  
  
  METHODS
  The within series and between series imprecision of the Hemo_Control instrument were calculated after measuring the concentration of venous samples under standardized conditions; by experienced laboratory technicians in a hospital laboratory, and venous and capillary samples under conditions similar to where the instrument is intended for use; by personnel at two primary health care centres. The bias of the Hemo_Control instrument was calculated as the difference between its results and results obtained with a Coulter LH 750 instrument traceable to the ICSH reference method.
  
  
  RESULTS
  The uncertainty of the Hemo_Control instrument for venous samples was lower than the quality goal of +/- 5% considered acceptable for patient care. High within series imprecision (5.5%) was observed for measurements of capillary blood samples in one of the primary care centres, whereas adequate analytical performance was obtained at the other centre. The Hemo_Control instrument showed negligible bias of +0.8 g/L for both venous and capillary samples in primary health care.
  
  
  CONCLUSIONS
  The observed uncertainty indicates that Hemo_Control is appropriate for near patient testing using venous samples. Capillary samples may be used if sampling skills are adequate.
authors.affiliation: Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. kristin.moberg.aakre@helse-bbergen.no
authors.forename: Kristin
authors.initials: K
authors.lastname: Aakre
authors.forename: Yngve
authors.initials: Y
authors.lastname: Bliksrud
authors.forename: Bess
authors.initials: B
authors.lastname: Frøyshov
authors.forename: Helle
authors.initials: H
authors.lastname: Hager
authors.forename: Anne
authors.initials: A
authors.lastname: Hansen
authors.forename: Jurgita
authors.initials: J
authors.lastname: Janukonyte
authors.forename: Jens-Jacob
authors.initials: JJ
authors.lastname: Lauterlein
authors.forename: Kristin
authors.initials: K
authors.lastname: Lilleholt
authors.forename: Kari
authors.initials: K
authors.lastname: Løhne
authors.forename: Tuija
authors.initials: T
authors.lastname: Männistö
authors.forename: Satu
authors.initials: S
authors.lastname: Miettola
authors.forename: Jonna
authors.initials: J
authors.lastname: Pelanti
authors.forename: Mie
authors.initials: M
authors.lastname: Samson
authors.forename: Ragnhild
authors.initials: R
authors.lastname: Skauby
authors.forename: Eija
authors.initials: E
authors.lastname: Tuuti
authors.forename: Inga
authors.initials: I
authors.lastname: Zelvyte
mesh_terms: D002196:Capillaries / Q000502:physiology; D006452:Hemoglobinometry / Q000295:instrumentation*; D006454:Hemoglobins / Q000032:analysis*; D006801:Humans; D007755:Laboratories, Hospital; D011320:Primary Health Care; D014680:Veins / Q000502:physiology
chemical_list: D006454:Hemoglobins; C020622:hemoglobin B