PMID- 32573889
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20230829
IS  - 1538-7836 (Electronic)
IS  - 1538-7836 (Linking)
VI  - 18
IP  - 10
DP  - 2020 Oct
TI  - Monitoring unfractionated heparin therapy: Lack of standardization of anti-Xa 
      activity reagents.
PG  - 2613-2621
LID - 10.1111/jth.14969 [doi]
AB  - INTRODUCTION: One of the main advantages of using anti-Xa instead of activated 
      partial thromboplastin time in monitoring of unfractionated heparin (UFH) therapy 
      relies on its hypothesized standardization, with a unique therapeutic range 
      defined to be 0.30 to 0.70 IU/mL. The aim of the present study was to compare the 
      inter-reagent agreement of anti-Xa activity. METHODS: Citrate tubes were obtained 
      from 104 inpatients on UFH. Plasma samples were stored frozen in aliquots at 
      -70 degrees C before being shipped to three accredited coagulation laboratories to be 
      evaluated for anti-Xa activity using their routine assay(s). Pooled normal 
      plasmas spiked with dilutions of the 6th International Standard of UFH to achieve 
      anti-Xa activities up to 1.0 IU/mL were evaluated using the same techniques. 
      RESULTS: In the plasmas from patients on UFH, the median anti-Xa activity ranged 
      from 0.37 IU/mL with one reagent to 0.57 IU/mL with another; results were in 
      between (0.45 IU/mL) using two other reagents. Comparisons of results obtained 
      using the different reagents demonstrated unacceptable bias up to 0.24 IU/mL 
      between some reagents (41% difference). The concordance as whether anti-Xa 
      activities measured using different reagents were within or outside the 
      therapeutic range was between 0.411 and 0.939 (kappa). Similar discrepancy was 
      demonstrated for anti-Xa activities when evaluating normal plasma spiked with the 
      International Standard. A discrepancy of the same order of magnitude was 
      demonstrated in the 2017 External Quality Assessment Program provided by the 
      External Quality Control in Assays and Tests exercises. CONCLUSIONS: The reported 
      discrepancy between test results obtained using different anti-Xa assays clearly 
      suggests a lack of standardization of that assay with potentially significant 
      impact on the patients' anticoagulation.
CI  - (c) 2020 International Society on Thrombosis and Haemostasis.
FAU - Smahi, Motalib
AU  - Smahi M
AD  - Hematology Department, Simone Veil Hospital, Eaubonne, France.
FAU - De Pooter, Neila
AU  - De Pooter N
AD  - Hematology Department, Centre Hospitalier, Grasse, France.
FAU - Hollestelle, Martine J
AU  - Hollestelle MJ
AD  - External quality Control for Assays and Tests (ECAT) Foundation, Voorschoten, The 
      Netherlands.
FAU - Toulon, Pierre
AU  - Toulon P
AD  - Hematology Department, Universite Cote d'Azur, CHU Nice, Nice, France.
LA  - eng
PT  - Journal Article
PL  - England
TA  - J Thromb Haemost
JT  - Journal of thrombosis and haemostasis : JTH
JID - 101170508
RN  - 0 (Anticoagulants)
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Indicators and Reagents)
RN  - 9005-49-6 (Heparin)
SB  - IM
MH  - Anticoagulants
MH  - Drug Monitoring
MH  - *Factor Xa Inhibitors
MH  - *Heparin
MH  - Humans
MH  - Indicators and Reagents
MH  - Partial Thromboplastin Time
MH  - Reference Standards
OTO - NOTNLM
OT  - aPTT
OT  - anti-Xa activity
OT  - monitoring
OT  - standardization
OT  - unfractionated heparin
EDAT- 2020/06/24 06:00
MHDA- 2021/05/15 06:00
CRDT- 2020/06/24 06:00
PHST- 2020/04/14 00:00 [received]
PHST- 2020/06/02 00:00 [revised]
PHST- 2020/06/08 00:00 [accepted]
PHST- 2020/06/24 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/06/24 06:00 [entrez]
AID - S1538-7836(22)01156-4 [pii]
AID - 10.1111/jth.14969 [doi]
PST - ppublish
SO  - J Thromb Haemost. 2020 Oct;18(10):2613-2621. doi: 10.1111/jth.14969.