Abstract Number: PB0564
Meeting: ISTH 2020 Congress
Background: Deficiency of coagulation factors FII, FV and FVII causes prolonged prothrombin time (PT) and bleeding disorders of variable severity depending on factor level activity. We performed a multicentre evaluation of three PT one-stage factor assays for quantitative determination of FII, FV and FVII activity (Roche Diagnostics).
Aims: Evaluate the analytical performances of FII, FV and FVII factor assays on the cobas t 711 analyser.
Methods: Experiments were performed at three laboratories using 3.2% citrated, anonymised, ethically approved, residual/commercially purchased plasma samples. Five human plasma pools (HPPs) and two controls were used for determination of assay repeatability (1 run/site; n=21 replicates per sample), intermediate precision and total reproducibility (5 aliquots/sample per day over 5 days); coefficients of variation (CV) were calculated. Lot-to-lot variability (3 reagent lots) and method comparison (versus Siemens Coagulation FII/FV/FVII Deficient Plasma [with Dade Innovin] on Sysmex CS-5100 analyser), using three sets of ≥120 samples, were evaluated by Passing-Bablok and Deming regression, respectively, and Pearson’s r calculated. Reference ranges were determined (one site) using fresh plasma samples from healthy individuals aged ≥18 years, not receiving anticoagulant medication.
Results: Across sites, CV ranges for repeatability for each assay were: FII, 0.6-3.0%; FV, 0.8-2.5%; FVII, 1.0-1.7%. High intermediate precision (CV: FII, 1.0-2.0%; FV, 1.1-7.0%; FVII, 1.3-3.5%), and good reproducibility (CV: FII, 1.7-2.6%; FV, 2.7-6.1%; FVII, 1.9-3.3%) were shown for each assay. All assays demonstrated excellent lot-to-lot variability (Pearson’s r, 0.998-1.000; Table 1) and high agreement with comparator assays (Pearson’s r, 0.989-0.997; Table 2). Among healthy individuals (n=200), 2.5th and 97.5th percentiles for coagulation factor activity were: FII, 78.4-124 IU/dL; FV, 64.0-143 IU/dL; FVII, 56.1-158 IU/dL.
Conclusions: FII, FV and FVII factor assays demonstrated robust analytical performance on the cobas t 711 analyser, supporting use in routine laboratory practice.
|Lot||A vs B||C vs A||B vs C||A vs B||C vs A||B vs C||A vs B||C vs A||B vs C|
[Table 1. Lot-to-lot comparisons for the Roche FII, FV and FVII factor assays]
[Table 2. Method comparisons between the Roche and Siemens FII, FV and FVII factor assays]
To cite this abstract in AMA style:Geisen U, Quehenberger P, Jilma P, Lowe A, Jones R, Buechsel M, Creaghan J, Rozsnyai G, Kitchen S. Multicentre Performance Evaluation and Reference Ranges for the Quantitative Determination of Factors II, V and VII by One-Stage Factor Assay on the Cobas t 711 Analyser [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/multicentre-performance-evaluation-and-reference-ranges-for-the-quantitative-determination-of-factors-ii-v-and-vii-by-one-stage-factor-assay-on-the-cobas-t-711-analyser/. Accessed December 6, 2023.
« Back to ISTH 2020 Congress
ISTH Congress Abstracts - https://abstracts.isth.org/abstract/multicentre-performance-evaluation-and-reference-ranges-for-the-quantitative-determination-of-factors-ii-v-and-vii-by-one-stage-factor-assay-on-the-cobas-t-711-analyser/