PMID- 30184324
OWN - NLM
STAT- MEDLINE
DCOM- 20190219
LR  - 20190320
IS  - 1751-553X (Electronic)
IS  - 1751-5521 (Linking)
VI  - 41
IP  - 1
DP  - 2019 Feb
TI  - The importance of commutability in material used for quality control purposes.
PG  - 39-45
LID - 10.1111/ijlh.12918 [doi]
AB  - External Quality Assessment (EQA) is an important part of laboratory quality 
      assurance. Spiking of normal plasma is sometimes employed to mimic clinical 
      samples. It is important that spiked material gives similar results to clinical 
      samples (ie, is commutable) to ensure appropriate conclusions can be drawn from 
      EQA exercises. We describe here data from UK National External Quality Assessment 
      Scheme for Blood Coagulation (NEQAS BC) exercises where spiked samples were 
      tested alongside samples from patients to explore commutability of artificial 
      material. Normal plasma was spiked with unfractionated heparin (UFH), low 
      molecular weight heparin (LMWH), Dabigatran or Rivaroxaban. Factor VIII (FVIII) 
      deficient plasma was spiked with FVIII concentrate. Spiked samples and ex vivo 
      patient material were sent to laboratories for testing. For LMWH, good agreement 
      was seen between results for samples from patient plasma and plasma spiked with 
      heparin. For UFH, APTT ratios differed between spiked and patient samples for the 
      same drug concentration, with no correlation in ranking of reagents. Precision 
      for patient and spiked material for Rivaroxaban and Dabigatran assays was 
      comparable. However, the pattern of results for some Dabigatran assay kits 
      differed between spiked and patient samples. For FVIII assays, results obtained 
      with spiked and postinfusion samples gave comparable results. Spiked material is 
      suitable for EQA if commutability is demonstrated. Our data show commutability 
      for plasma spiked with Rivaroxaban, LWMH and some FVIII concentrates. For some 
      tests, notably APTT for UFH, marked differences between patient and spiked 
      samples indicate not all tests can be evaluated using artificial samples.
CI  - (c) 2018 John Wiley & Sons Ltd.
FAU - Jennings, Ian
AU  - Jennings I
AUID- ORCID: 0000-0002-3112-3076
AD  - UK NEQAS (Blood Coagulation), Sheffield, UK.
FAU - Kitchen, Dianne
AU  - Kitchen D
AD  - UK NEQAS (Blood Coagulation), Sheffield, UK.
FAU - Kitchen, Steve
AU  - Kitchen S
AUID- ORCID: 0000-0002-6826-8519
AD  - UK NEQAS (Blood Coagulation), Sheffield, UK.
FAU - Woods, Timothy
AU  - Woods T
AD  - UK NEQAS (Blood Coagulation), Sheffield, UK.
FAU - Walker, Isobel
AU  - Walker I
AD  - UK NEQAS (Blood Coagulation), Sheffield, UK.
LA  - eng
PT  - Journal Article
DEP - 20180905
PL  - England
TA  - Int J Lab Hematol
JT  - International journal of laboratory hematology
JID - 101300213
SB  - IM
MH  - Blood Coagulation Tests
MH  - Clinical Laboratory Techniques/*standards
MH  - Humans
MH  - Medical Laboratory Science/standards
MH  - *Quality Assurance, Health Care
MH  - *Quality Control
EDAT- 2018/09/06 06:00
MHDA- 2019/03/21 06:00
CRDT- 2018/09/06 06:00
PHST- 2018/05/11 00:00 [received]
PHST- 2018/07/13 00:00 [revised]
PHST- 2018/07/25 00:00 [accepted]
PHST- 2018/09/06 06:00 [pubmed]
PHST- 2019/03/21 06:00 [medline]
PHST- 2018/09/06 06:00 [entrez]
AID - 10.1111/ijlh.12918 [doi]
PST - ppublish
SO  - Int J Lab Hematol. 2019 Feb;41(1):39-45. doi: 10.1111/ijlh.12918. Epub 2018 Sep 
      5.