Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples
Abstract Background Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). Objectives The aim...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-10-01
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| Series: | Research and Practice in Thrombosis and Haemostasis |
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| Online Access: | https://doi.org/10.1002/rth2.12421 |
| _version_ | 1797717005601603584 |
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| author | Cecilia Augustsson Eva Norström Nadine Gretenkort Andersson Eva Zetterberg Jan Astermark Karin Strandberg |
| author_facet | Cecilia Augustsson Eva Norström Nadine Gretenkort Andersson Eva Zetterberg Jan Astermark Karin Strandberg |
| author_sort | Cecilia Augustsson |
| collection | DOAJ |
| description | Abstract Background Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). Objectives The aim of this study was to evaluate and compare different factor assays and global coagulation methods. Methods Factor VIII (FVIII) and IX (FIX) activities and global assay parameters were analyzed in pre‐ and postinfusion samples (5 patients 2 samples/product/method). Results Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA. The correlation was excellent (r2 ≥ .97) while biases of 42%‐72% of mean (CSA‐OSA) were obtained. With FVIII (OSA) as independent variable, the correlations to kaolin clot time (CT) and thrombin generation assay (TGA) peak were modest (r2 = .71‐.72 and .64‐.65, respectively), except for Nuwiq for which there was a poor correlation to TGA peak (r2 = .08). Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA‐OSA), and the correlation was excellent (r2 = .96). With FIX (CSA) as independent variable for both Alprolix and Refixia, the correlations to Innovin CT and TGA peaks were weak (r2 = .33‐.45 and .44‐.76, respectively). Conclusions Our data show that factor activity assays differ between methods used and agents. These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half‐life products. Global assays gave complementary information indicated by the modest correlations to factor activities. |
| first_indexed | 2024-03-12T08:29:53Z |
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| institution | Directory Open Access Journal |
| issn | 2475-0379 |
| language | English |
| last_indexed | 2024-03-12T08:29:53Z |
| publishDate | 2020-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Research and Practice in Thrombosis and Haemostasis |
| spelling | doaj.art-8c504c13862e485fb1d0c5ebf971860e2023-09-02T17:46:49ZengElsevierResearch and Practice in Thrombosis and Haemostasis2475-03792020-10-01471114112010.1002/rth2.12421Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samplesCecilia Augustsson0Eva Norström1Nadine Gretenkort Andersson2Eva Zetterberg3Jan Astermark4Karin Strandberg5Division of Laboratory Medicine, Coagulation Department of Clinical Chemistry and Pharmacology University and Regional Laboratories Region Skåne Malmö SwedenDivision of Laboratory Medicine, Coagulation Department of Clinical Chemistry and Pharmacology University and Regional Laboratories Region Skåne Malmö SwedenDepartment of Hematology, Oncology and Radiation Physics Center for Thrombosis and Hemostasis Skåne University Hospital Lund University Malmö SwedenDepartment of Hematology, Oncology and Radiation Physics Center for Thrombosis and Hemostasis Skåne University Hospital Lund University Malmö SwedenDepartment of Hematology, Oncology and Radiation Physics Center for Thrombosis and Hemostasis Skåne University Hospital Lund University Malmö SwedenDivision of Laboratory Medicine, Coagulation Department of Clinical Chemistry and Pharmacology University and Regional Laboratories Region Skåne Malmö SwedenAbstract Background Monitoring hemophilia treatment with extended half‐life products is challenging for coagulation laboratories since factor assays may show substantial differences between results obtained with the one‐stage assay (OSA) and the chromogenic substrate assay (CSA). Objectives The aim of this study was to evaluate and compare different factor assays and global coagulation methods. Methods Factor VIII (FVIII) and IX (FIX) activities and global assay parameters were analyzed in pre‐ and postinfusion samples (5 patients 2 samples/product/method). Results Samples containing FVIII products (NovoEight, Elocta, and Nuwiq) gave higher levels when measured with CSA compared to OSA. The correlation was excellent (r2 ≥ .97) while biases of 42%‐72% of mean (CSA‐OSA) were obtained. With FVIII (OSA) as independent variable, the correlations to kaolin clot time (CT) and thrombin generation assay (TGA) peak were modest (r2 = .71‐.72 and .64‐.65, respectively), except for Nuwiq for which there was a poor correlation to TGA peak (r2 = .08). Samples containing Alprolix, a FIX product, gave a smaller difference between activity levels (CSA‐OSA), and the correlation was excellent (r2 = .96). With FIX (CSA) as independent variable for both Alprolix and Refixia, the correlations to Innovin CT and TGA peaks were weak (r2 = .33‐.45 and .44‐.76, respectively). Conclusions Our data show that factor activity assays differ between methods used and agents. These discrepancies indicate the value of having more than one type of assay available in the coagulation laboratory when monitoring hemophilia treatment with extended half‐life products. Global assays gave complementary information indicated by the modest correlations to factor activities.https://doi.org/10.1002/rth2.12421blood coagulation testscoagulantsdrug monitoringfactor IXfactor VIIIhemophilia A |
| spellingShingle | Cecilia Augustsson Eva Norström Nadine Gretenkort Andersson Eva Zetterberg Jan Astermark Karin Strandberg Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples Research and Practice in Thrombosis and Haemostasis blood coagulation tests coagulants drug monitoring factor IX factor VIII hemophilia A |
| title | Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples |
| title_full | Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples |
| title_fullStr | Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples |
| title_full_unstemmed | Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples |
| title_short | Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre‐ and postinfusion samples |
| title_sort | monitoring standard and extended half life products in hemophilia assay discrepancies for factor viii and ix in pre and postinfusion samples |
| topic | blood coagulation tests coagulants drug monitoring factor IX factor VIII hemophilia A |
| url | https://doi.org/10.1002/rth2.12421 |
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