Multicentre evaluation of a new point-of-care test for the quantitative determination of D-dimer.
Imprecision studies, interference testing and multicentre method comparisons using patient samples were carried out with of a new point-of-care test for D-dimer (CARDIAC D-Dimer). The CV of the within-series and the day-to-day imprecision with blood samples and control materials were between 7% and 13%. Compared with Tina-quant D-Dimer, CARDIAC D-Dimer showed a good correlation and accuracy (n=353; r=0.91; y=1.06x-0.03), compared with STA LIATEST D-Dimer some poorer accuracy (n=304; r=0.91; y=1.12x-0.03). No interference was detected for different hematocrit values (16% to 51%) and in investigations with hemoglobin (up to 0.13 mmol/l), biotin (up to 30 microg/l), bilirubin (up to 340 micromol/l), intralipid (up to 31.1 mmol/l) and rheumatic factor (up to 79 IU/ml). Overdosing or underdosing by 10 microl did not affect the test result. The diagnostic sensitivity of CARDIAC D-Dimer for the detection of acute venous thromboembolic diseases was 100% in our study. With CARDIAC D-Dimer reliable quantitative D-dimer results can be easily obtained. Because of the good analytical and clinical agreement with Tina-quant D-Dimer, it should be suitable for ruling out venous thromboembolic diseases.
Dempfle
C
C
Klinik für Innere Medizin I, Universitätsklinikum Mannheim, Mannheim, Germany. dempfle@verw.ma.uni-heidelberg.de
Schraml
M
M
Besenthal
I
I
Hansen
R
R
Gehrke
J
J
Korte
W
W
Risch
M
M
Quehenberger
P
P
Handler
S
S
Minar
E
E
Schulz
I
I
Zerback
R
R
D019963:Clinical Chemistry Tests / Q000592:standards*; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D019095:Point-of-Care Systems; D011786:Quality Control; D015203:Reproducibility of Results
D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D