Performance of the automated and rapid HemosIL D-Dimer HS on the ACL TOP analyzer.
We evaluated the analytical performance of the new commercial HemosIL D-Dimer HS, a latex-enhanced turbidimetric immunoassay, from Instrumentation Laboratory for D-dimer measurement on the ACL TOP automated analyzer. The recommended cut-off for this immunoassay is 243 ng/ml. The within-run and between-run coefficients of variations of D-Dimer HS for low, intermediate and high D-dimer concentrations were: 3.3-6.6%, 2.3-2.6%, 2.4-3.2%, respectively. The assay was proven linear in a range of D-dimer concentrations comprised between 319 and 2274 ng/ml. Results of 171 citrated plasma samples were compared with those of the reference commercial immunoassay VIDAS D-Dimer. Although the nonparametric regression according to the method of Passing and Bablok and the relative Spearman's correlation coefficient were excellent (HemosIL D-Dimer HS = 1.30 x VIDAS - 384; r = 0.964, P < 0.001), some discrepancies could be observed in Bland-Altman plots analysis. On the basis of the present evaluation, we conclude that the analytical performance and the main technical features of new HemosIL D-Dimer HS assay make it a suitable method for the rapid quantification of D-dimer in clinical laboratories. Further studies are however needed to confirm the safety of the assay and to determine the most optimal cutoff level in patients with venous thromboembolism.
Salvagno
Gian L
GL
Sezione di Chimica Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università di Verona, Verona, Italy. gsalvagno77@yahoo.it
Lippi
Giuseppe
G
Montagnana
Martina
M
Poli
Giovanni
G
Giavarina
Davide
D
Manzato
Franco
F
Guidi
Gian C
GC
D001331:Automation; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis*; D006801:Humans; D007118:Immunoassay / Q000295:instrumentation* / Q000592:standards; D054556:Venous Thromboembolism / Q000175:diagnosis
D005338:Fibrin Fibrinogen Degradation Products; C036309:fibrin fragment D