PMID- 32441664
OWN - NLM
STAT- MEDLINE
DCOM- 20210823
LR  - 20210823
IS  - 1437-4331 (Electronic)
IS  - 1434-6621 (Linking)
VI  - 58
IP  - 11
DP  - 2020 Oct 25
TI  - Quality performance for indirect Xa inhibitor monitoring in patients using 
      international external quality data.
PG  - 1921-1930
LID - 10.1515/cclm-2020-0130 [doi]
AB  - Objectives Chromogenic anti-activated factor X (FXa) assays are currently the 
      "gold standard" for monitoring indirect anticoagulants. However, anti-FXa has 
      been shown to vary according to the choice of reagents. In the present study, the 
      performance of anti-FXa measurement was evaluated in order to gain more insight 
      into the clinical applications. Furthermore, the longitudinal coefficient of 
      variation (CV) was studied to investigate whether there is improvement over time. 
      Methods Laboratory tests results were evaluated for samples spiked with 
      unfractionated heparin (UFH), low-molecular-weight-heparin (LMWH), fondaparinux 
      and danaparoid sodium. External quality assessment (EQA) data from multiple years 
      were used from more than 100 laboratories. Results Comparison of the results for 
      all methods showed significant differences in measured values between the 
      frequently used methods (ANOVA: p < 0.001). The largest differences were observed 
      for LMWH and UFH measurements. These differences may be caused by differences in 
      method composition, such as the addition of dextran sulphate. Substantial 
      interlaboratory variation in anti-FXa monitoring was observed for all parameters, 
      particularly at low concentrations. Our results showed that below 0.35 IU/mL, the 
      CVs for UFH and LMWH increase dramatically and results below this limit should be 
      used with caution. Conclusions Our study demonstrates that the choice of the 
      anti-FXa method is particularly important for UFH and LMWH measurement. The 
      variation in measurements may have an effect on clinical implications, such as 
      therapeutic ranges. Furthermore, the longitudinal EQA data demonstrated a 
      constant performance and, in at least 50% of the cases, improvement in the CV% of 
      the anti-Xa results over time.
FAU - Hollestelle, Martine J
AU  - Hollestelle MJ
AD  - External Quality Control for Assays and Tests (ECAT) Foundation, Voorschoten, The 
      Netherlands.
FAU - van der Meer, Felix J M
AU  - van der Meer FJM
AD  - Department of Thrombosis and Hemostasis, Leiden University Medical Center, 
      Leiden, The Netherlands.
FAU - Meijer, Piet
AU  - Meijer P
AD  - External Quality Control for Assays and Tests (ECAT) Foundation, Voorschoten, The 
      Netherlands.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PL  - Germany
TA  - Clin Chem Lab Med
JT  - Clinical chemistry and laboratory medicine
JID - 9806306
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 24967-94-0 (Dermatan Sulfate)
RN  - 9007-28-7 (Chondroitin Sulfates)
RN  - 9050-30-0 (Heparitin Sulfate)
RN  - BI6GY4U9CW (danaparoid)
RN  - J177FOW5JL (Fondaparinux)
SB  - IM
MH  - Blood Chemical Analysis/methods
MH  - Chondroitin Sulfates/*blood
MH  - Dermatan Sulfate/*blood
MH  - Drug Monitoring
MH  - Factor Xa Inhibitors/*blood
MH  - Fondaparinux/*blood
MH  - Heparin, Low-Molecular-Weight/*blood
MH  - Heparitin Sulfate/*blood
MH  - Humans
MH  - Quality Control
OTO - NOTNLM
OT  - anti-FXa
OT  - danaparoid sodium
OT  - external quality assurance
OT  - fondaparinux
OT  - low-molecular-weight-heparin (LMWH)
OT  - unfractionated heparin (UFH)
EDAT- 2020/05/23 06:00
MHDA- 2021/08/24 06:00
CRDT- 2020/05/23 06:00
PHST- 2020/02/07 00:00 [received]
PHST- 2020/04/30 00:00 [accepted]
PHST- 2020/05/23 06:00 [pubmed]
PHST- 2021/08/24 06:00 [medline]
PHST- 2020/05/23 06:00 [entrez]
AID - cclm-2020-0130 [pii]
AID - 10.1515/cclm-2020-0130 [doi]
PST - ppublish
SO  - Clin Chem Lab Med. 2020 Oct 25;58(11):1921-1930. doi: 10.1515/cclm-2020-0130.