Abstract Number: PB0655
Meeting: ISTH 2020 Congress
Background: In order to ensure compliance with local regulatory agencies (COFRAC guideline in France) inter-instrument comparison must be performed during initial validation and on an ongoing way. For intra and inter-sites comparison, access to available samples which cover the full measuring range is a challenge.
Aims: The aim of this study is to evaluate the same frozen plasmas kits for instruments comparisons in the same laboratory and in two differents laboratories distant from 30km.
Methods: Four set of plasmas were tested at the same time on both instruments on site 1 and 2 at day 0 and 7 and on site 1 at day 15.
Prothrombin time (2 reagents), activated partial thromboplastin time (4 reagents), fibrinogen and factor V were tested on set A (n=30 samples); INR on set B (n=5, 2 reagents); unfractionated heparin (UFH) and low molecular weight heparin anti-Xa activities on set C (n=10) and D-dimer and fibrin monomers on set D (n=20). The Bland and Altman plot and the laboratory criteria (2.8*SD) were used for comparisons.
Results: All parameters were consistent except for UFH anti-Xa activity on day 0. Lack of correlation on the UFH set could be related to plasma stabilization after thawing, a good correlation was then observed on day 7 and 15.
Conclusions: Using frozen plasmas limit some matrix biases when quality control are used for correlation and allows being compliant with regulations that make difficult to use patient samples or answer to the impossibility for some structures to obtain samples in extreme values. The 4 sets are appropriate for methods validation and comparison of intra and inter-sites instruments. For each assay, chronometric, chromogenic or immunoturbidimetric, samples cover the whole measuring range, except for fibrin monomers. These samples remain to be evaluated at day 60 and 90 to allow for a more accurate comparison and a prospective follow-up.
To cite this abstract in AMA style:Flaujac C, Amouroux I, Manzi P, Doan S, Germain L, Dieu J, Pinheiro Vaz S, Plu P, Saksik E, Zia-Chahabi S. Real-time Intra-site and Multi-site Correlations and Evaluation of Time Stability with the Same Frozen Plasmas Kits which Cover the Full Measuring Range for Routine Tests and Anticoagulant Monitoring Tests [abstract]. Res Pract Thromb Haemost. 2020; 4 (Suppl 1). https://abstracts.isth.org/abstract/real-time-intra-site-and-multi-site-correlations-and-evaluation-of-time-stability-with-the-same-frozen-plasmas-kits-which-cover-the-full-measuring-range-for-routine-tests-and-anticoagulant-monitoring/. Accessed December 6, 2021.
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