Abbott D-dimer assay: analytical performance and diagnostic accuracy in management of venous thromboembolism.
Scand J Clin Lab Invest
; 84(1): 53-61, 2024 Feb.
Article
em En
| MEDLINE
| ID: mdl-38362664
ABSTRACT
This study aimed to assess analytical characteristics and diagnostic accuracy in management of venous thromboembolism (VTE) in the Emergency Department (ED) of the Abbott D-dimer assay applied on the Alinity c clinical chemistry analyzer (Abbott Laboratories, Chicago, IL) compared to the INNOVANCE D-dimer assay (Siemens Healthineers, Marburg, Germany). Precision was determined at three concentration levels following the CLSI EP15-A3 protocol. Method comparison and diagnostic accuracy were assessed using samples obtained from 85 patients who were referred for diagnostic imaging and D-dimer testing due to clinically suspected VTE. Within-run coefficients of variation (CVs) were 3.0%, 0.5% and 0.5% at D-dimer concentrations of 0.54, 1.42 and 2.68 mg/L FEU, while respective between-run CVs were 2.0%, 3.4% and 2.7%, hence fulfilling the desirable biological variation criteria for imprecision (<12.6%). Passing-Bablok regression analysis yielded a small proportional difference between the two compared assays (y = 1.09 (95% confidence interval (CI) 1.01-1.18) x + 0.09 (95%CI -0.09 to 0.16)), while Bland-Altman analysis showed significant negative absolute (-0.6 mg/L FEU, 95%CI -0.9 to -0.3) and relative mean bias (-14.1%, 95%CI -20.3 to -7.9). Spearman's ρ was 0.979 (95%CI 0.967-0.986). Inter-assay agreement relative to the cut-off was 92% (kappa coefficient = 0.547 (95%CI 0.255-0.839)). Diagnostic sensitivity, specificity, positive and negative predictive values of the Abbott assay were 100%, 9.2%, 25.3% and 100%, respectively, compared to the following data for the INNOVANCE assay 95.0%, 15.4%, 25.7% and 90.9%. Abbott D-dimer assay has shown excellent analytical precision, high comparability with the INNOVANCE D-dimer and high NPV at manufacturer's cut-off.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Tromboembolia Venosa
Tipo de estudo:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
Limite:
Humans
Idioma:
En
Revista:
Scand J Clin Lab Invest
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Croácia