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Performance of the automated and rapid HemosIL D-Dimer HS on the ACL TOP analyzer.
Blood Coagul Fibrinolysis. 2008 Dec; 19(8):817-21.BC

Abstract

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.

Authors+Show Affiliations

Sezione di Chimica Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università di Verona, Verona, Italy. gsalvagno77@yahoo.itNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article

Language

eng

PubMed ID

19002050

Citation

Salvagno, Gian L., et al. "Performance of the Automated and Rapid HemosIL D-Dimer HS On the ACL TOP Analyzer." Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis, vol. 19, no. 8, 2008, pp. 817-21.
Salvagno GL, Lippi G, Montagnana M, et al. Performance of the automated and rapid HemosIL D-Dimer HS on the ACL TOP analyzer. Blood Coagul Fibrinolysis. 2008;19(8):817-21.
Salvagno, G. L., Lippi, G., Montagnana, M., Poli, G., Giavarina, D., Manzato, F., & Guidi, G. C. (2008). Performance of the automated and rapid HemosIL D-Dimer HS on the ACL TOP analyzer. Blood Coagulation & Fibrinolysis : an International Journal in Haemostasis and Thrombosis, 19(8), 817-21. https://doi.org/10.1097/MBC.0b013e32830f1bae
Salvagno GL, et al. Performance of the Automated and Rapid HemosIL D-Dimer HS On the ACL TOP Analyzer. Blood Coagul Fibrinolysis. 2008;19(8):817-21. PubMed PMID: 19002050.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Performance of the automated and rapid HemosIL D-Dimer HS on the ACL TOP analyzer. AU - Salvagno,Gian L, AU - Lippi,Giuseppe, AU - Montagnana,Martina, AU - Poli,Giovanni, AU - Giavarina,Davide, AU - Manzato,Franco, AU - Guidi,Gian C, PY - 2008/11/13/pubmed PY - 2009/1/1/medline PY - 2008/11/13/entrez SP - 817 EP - 21 JF - Blood coagulation & fibrinolysis : an international journal in haemostasis and thrombosis JO - Blood Coagul. Fibrinolysis VL - 19 IS - 8 N2 - 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. SN - 1473-5733 UR - https://www.unboundmedicine.com/medline/citation/19002050/Performance_of_the_automated_and_rapid_HemosIL_D_Dimer_HS_on_the_ACL_TOP_analyzer_ L2 - http://dx.doi.org/10.1097/MBC.0b013e32830f1bae DB - PRIME DP - Unbound Medicine ER -