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Clinical utility and impact of the use of the chromogenic vs one-stage factor activity assays in haemophilia A and B

Marlar, Richard A. ; Strandberg, Karin LU ; Shima, Midori and Adcock, Dorothy M. (2019) In European Journal of Haematology
Abstract

Treatment of haemophilia A/B patients comprises factor VIII (FVIII) or factor IX (FIX) concentrate replacement therapy, respectively. FVIII and FIX activity levels can be measured in clinical laboratories using one-stage activated partial thromboplastin time (aPTT)-based clotting or two-stage chromogenic factor activity assays. We discuss strengths and limitations of these assays, providing examples of clinical scenarios to highlight some of the challenges associated with their current use for diagnostic and monitoring purposes. Substantial inter-laboratory variability has been reported for one-stage assays when measuring the activity of factor replacement products due to the wide range of currently available aPTT reagents, calibration... (More)

Treatment of haemophilia A/B patients comprises factor VIII (FVIII) or factor IX (FIX) concentrate replacement therapy, respectively. FVIII and FIX activity levels can be measured in clinical laboratories using one-stage activated partial thromboplastin time (aPTT)-based clotting or two-stage chromogenic factor activity assays. We discuss strengths and limitations of these assays, providing examples of clinical scenarios to highlight some of the challenges associated with their current use for diagnostic and monitoring purposes. Substantial inter-laboratory variability has been reported for one-stage assays when measuring the activity of factor replacement products due to the wide range of currently available aPTT reagents, calibration standards, factor-deficient plasmas, assay conditions and instruments. Chromogenic activity assays may avoid some limitations associated with one-stage assays, but their regulatory status, perceived higher cost, and lack of laboratory expertise may influence their use. Haemophilia management guidelines recommend the differential application of one or both assays for initial diagnosis and disease severity characterisation, post-infusion monitoring and replacement factor potency labelling. Efficient communication between clinical and laboratory staff is crucial to ensure application of the most appropriate assay to each clinical situation, correct interpretation of assay results and, ultimately, accurate diagnosis and optimal and safe treatment of haemophilia A or B patients.

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author
; ; and
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
chromogenic assay, factor activity assays, haemophilia A, haemophilia B, one-stage assay
in
European Journal of Haematology
publisher
Wiley-Blackwell
external identifiers
  • scopus:85075027692
  • pmid:31606899
ISSN
0902-4441
DOI
10.1111/ejh.13339
language
English
LU publication?
no
id
f233d7a6-1a94-4df8-b205-f331948f39a1
date added to LUP
2019-12-10 11:28:29
date last changed
2020-12-01 03:32:33
@article{f233d7a6-1a94-4df8-b205-f331948f39a1,
  abstract     = {<p>Treatment of haemophilia A/B patients comprises factor VIII (FVIII) or factor IX (FIX) concentrate replacement therapy, respectively. FVIII and FIX activity levels can be measured in clinical laboratories using one-stage activated partial thromboplastin time (aPTT)-based clotting or two-stage chromogenic factor activity assays. We discuss strengths and limitations of these assays, providing examples of clinical scenarios to highlight some of the challenges associated with their current use for diagnostic and monitoring purposes. Substantial inter-laboratory variability has been reported for one-stage assays when measuring the activity of factor replacement products due to the wide range of currently available aPTT reagents, calibration standards, factor-deficient plasmas, assay conditions and instruments. Chromogenic activity assays may avoid some limitations associated with one-stage assays, but their regulatory status, perceived higher cost, and lack of laboratory expertise may influence their use. Haemophilia management guidelines recommend the differential application of one or both assays for initial diagnosis and disease severity characterisation, post-infusion monitoring and replacement factor potency labelling. Efficient communication between clinical and laboratory staff is crucial to ensure application of the most appropriate assay to each clinical situation, correct interpretation of assay results and, ultimately, accurate diagnosis and optimal and safe treatment of haemophilia A or B patients.</p>},
  author       = {Marlar, Richard A. and Strandberg, Karin and Shima, Midori and Adcock, Dorothy M.},
  issn         = {0902-4441},
  language     = {eng},
  month        = {10},
  publisher    = {Wiley-Blackwell},
  series       = {European Journal of Haematology},
  title        = {Clinical utility and impact of the use of the chromogenic vs one-stage factor activity assays in haemophilia A and B},
  url          = {http://dx.doi.org/10.1111/ejh.13339},
  doi          = {10.1111/ejh.13339},
  year         = {2019},
}