Evaluation of a new thromboplastin reagent STA-NeoPTimal on a STA R Max analyzer for the measurement of prothrombin time, international normalized ratio and extrinsic factor levels.
Blood Coagulation
/ drug effects
Blood Coagulation Tests
/ instrumentation
Humans
International Normalized Ratio
/ instrumentation
Liver Failure
/ blood
Preoperative Period
Prothrombin Time
/ instrumentation
Reproducibility of Results
Sensitivity and Specificity
Thromboplastin
Vitamin K
/ administration & dosage
apixaban
burned
preoperative
rivaroxaban
thromboplastin
Journal
International journal of laboratory hematology
ISSN: 1751-553X
Titre abrégé: Int J Lab Hematol
Pays: England
ID NLM: 101300213
Informations de publication
Date de publication:
Oct 2020
Oct 2020
Historique:
received:
14
01
2020
revised:
17
04
2020
accepted:
21
04
2020
pubmed:
20
5
2020
medline:
9
2
2021
entrez:
20
5
2020
Statut:
ppublish
Résumé
We aimed at evaluating the performance of a new prothrombin time (PT) reagent (STA-NeoPTimal) with two other PT reagents (STA-Neoplastine R and STA-Neoplastine CI Plus) and the reference PT reagent used in our laboratory (ReadiPlasTin). Evaluation consisted in intra- and interassay precision assessment, determination of sensitivity to unfractionated heparin (UFH) or enoxaparin in spiked samples and to direct oral anticoagulants (DOACs) in patients (n = 43). Method comparison of the 4 PT reagents, factor II, V, VII and X assays was tested on normal (n = 20) and abnormal samples: VKA (n = 47), preoperative (n = 23), liver failure (n = 12) and burned patients (n = 37). Analytical performance met manufacturers' criteria for all reagents. All PT reagents gave correlation coefficients >0.8 and even >0.9 in many situations. In some VKA samples, differences ≥ 0.5 INR units were found in samples within and above therapeutic ranges. For burned patients, PT correlations were good but with some minimal bias (<5.0%) while factor assays gave very consistent results (R > .8 and mainly >0.9). As expected, poor responsiveness of the PT to DOAC concentrations was observed with all four assays. The STA-NeoPTimal showed comparable performance to ReadiPlasTin, making it suitable for VKA control, detection of factors II, V, VII, X deficiency and assessment of liver disease coagulopathy. However, for patients receiving VKA, some significant differences were observed. We confirmed the inability of the PT assay to detect residual DOAC concentrations. Finally, burned patients results showed that recombinant thromboplastins were less sensitive to factor deficiencies in comparison to extraction thromboplastins.
Substances chimiques
Vitamin K
12001-79-5
Thromboplastin
9035-58-9
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
650-660Informations de copyright
© 2020 John Wiley & Sons Ltd.
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