PMID- 32426926
OWN - NLM
STAT- MEDLINE
DCOM- 20210208
LR  - 20210208
IS  - 1751-553X (Electronic)
IS  - 1751-5521 (Linking)
VI  - 42
IP  - 5
DP  - 2020 Oct
TI  - 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.
PG  - 650-660
LID - 10.1111/ijlh.13236 [doi]
AB  - INTRODUCTION: 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). METHODS: 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). 
      RESULTS: 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. CONCLUSION: 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.
CI  - (c) 2020 John Wiley & Sons Ltd.
FAU - Mullier, Francois
AU  - Mullier F
AUID- ORCID: 0000-0001-6947-6099
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Paridaens, Marie-Sophie
AU  - Paridaens MS
AD  - Queen Astrid Military Hospital in Brussels, Brussels, Belgium.
FAU - Evrard, Jonathan
AU  - Evrard J
AUID- ORCID: 0000-0003-4255-1591
AD  - Department of Pharmacy, Universite de Namur, Namur, Belgium.
FAU - Baudar, Justine
AU  - Baudar J
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Guldenpfennig, Maite
AU  - Guldenpfennig M
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Devroye, Celia
AU  - Devroye C
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Miller, Laurence
AU  - Miller L
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Chatelain, Bernard
AU  - Chatelain B
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
FAU - Lessire, Sarah
AU  - Lessire S
AD  - Department of Anesthesiology, Universite catholique de Louvain, CHU UCL Namur, 
      Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute for Life 
      Sciences (NARILIS), Yvoir, Belgium.
FAU - Jacqmin, Hugues
AU  - Jacqmin H
AUID- ORCID: 0000-0003-0901-3732
AD  - Department of Laboratory Medicine, Universite catholique de Louvain, CHU UCL 
      Namur, Namur Thrombosis and Hemostasis Center (NTHC), Namur Research Institute 
      for Life Sciences (NARILIS), Yvoir, Belgium.
LA  - eng
PT  - Journal Article
DEP - 20200519
PL  - England
TA  - Int J Lab Hematol
JT  - International journal of laboratory hematology
JID - 101300213
RN  - 12001-79-5 (Vitamin K)
RN  - 9035-58-9 (Thromboplastin)
SB  - IM
MH  - Blood Coagulation/drug effects
MH  - Blood Coagulation Tests/instrumentation/methods/standards
MH  - Humans
MH  - International Normalized Ratio/*instrumentation/*methods/standards
MH  - Liver Failure/blood/diagnosis
MH  - Preoperative Period
MH  - Prothrombin Time/*instrumentation/*methods/standards
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
MH  - *Thromboplastin
MH  - Vitamin K/administration & dosage
OTO - NOTNLM
OT  - apixaban
OT  - burned
OT  - preoperative
OT  - rivaroxaban
OT  - thromboplastin
EDAT- 2020/05/20 06:00
MHDA- 2021/02/09 06:00
CRDT- 2020/05/20 06:00
PHST- 2020/01/14 00:00 [received]
PHST- 2020/04/17 00:00 [revised]
PHST- 2020/04/21 00:00 [accepted]
PHST- 2020/05/20 06:00 [pubmed]
PHST- 2021/02/09 06:00 [medline]
PHST- 2020/05/20 06:00 [entrez]
AID - 10.1111/ijlh.13236 [doi]
PST - ppublish
SO  - Int J Lab Hematol. 2020 Oct;42(5):650-660. doi: 10.1111/ijlh.13236. Epub 2020 May 
      19.