Validation of the Hemo_Control instrument for determination of B-haemoglobin concentration in primary health care.
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.
Aakre
Kristin
K
Laboratory of Clinical Biochemistry, Haukeland University Hospital, Bergen, Norway. kristin.moberg.aakre@helse-bbergen.no
Bliksrud
Yngve
Y
Frøyshov
Bess
B
Hager
Helle
H
Hansen
Anne
A
Janukonyte
Jurgita
J
Lauterlein
Jens-Jacob
JJ
Lilleholt
Kristin
K
Løhne
Kari
K
Männistö
Tuija
T
Miettola
Satu
S
Pelanti
Jonna
J
Samson
Mie
M
Skauby
Ragnhild
R
Tuuti
Eija
E
Zelvyte
Inga
I
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
D006454:Hemoglobins; C020622:hemoglobin B