The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay

The FVIII activity in patients treated with several extended half-life FVIII (EHL-FVIII) agents different when various activated partial thromboplastin time (APTT) reagents were used. The present study examined the difference in clot waveform analysis (CWA) findings and FVIII activity when various A...

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Main Authors: Hideo Wada MD, PhD, Katsuya Shiraki MD, PhD, Takeshi Matsumoto MD, PhD, Kohshi Ohishi MD, PhD, Hideto Shimpo MD, PhD, Yumi Sakano Mrs, Hiroko Nishii Mrs, Motomu Shimaoka MD, PhD
Format: Article
Language:English
Published: SAGE Publishing 2021-02-01
Series:Clinical and Applied Thrombosis/Hemostasis
Online Access:https://doi.org/10.1177/1076029620976913
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author Hideo Wada MD, PhD
Katsuya Shiraki MD, PhD
Takeshi Matsumoto MD, PhD
Kohshi Ohishi MD, PhD
Hideto Shimpo MD, PhD
Yumi Sakano Mrs
Hiroko Nishii Mrs
Motomu Shimaoka MD, PhD
author_facet Hideo Wada MD, PhD
Katsuya Shiraki MD, PhD
Takeshi Matsumoto MD, PhD
Kohshi Ohishi MD, PhD
Hideto Shimpo MD, PhD
Yumi Sakano Mrs
Hiroko Nishii Mrs
Motomu Shimaoka MD, PhD
author_sort Hideo Wada MD, PhD
collection DOAJ
description The FVIII activity in patients treated with several extended half-life FVIII (EHL-FVIII) agents different when various activated partial thromboplastin time (APTT) reagents were used. The present study examined the difference in clot waveform analysis (CWA) findings and FVIII activity when various APTT reagents and CWA were used. The CWA including FVIII activity was measured using 12 APTT reagents, and the FIX activation based on a small amount of tissue factor assay (sTF/FIX) were examined in reference plasma (RP), EHL-FVIII (Jivi ® ) and Kovaltry ® . The 3 APTT reagents were associated with high variation in the peak time and height in the CWA when analyzing low concentrations of FVIII. The peak time and height could not be measured with one APTT reagent, and there were marked differences in the CWA findings between Jivi ® and Kovaltry ® among APTT reagents. Several APTT reagents showed a markedly lower FVIII activity with Jivi ® than with Kovaltry ® . In the FVIII assay, the peak time measured with sTF/FIX did not differ markedly between Jivi ® and Kovaltry ® ; however, the FVIII activity in Jivi ® (as measured by the peak height) tended to be higher than in Kovaltry ® . The CWA findings for monitoring Jivi ® varied for monitoring Jivi ® depending on the APTT reagents used, and sTF/FIX assay may be able to measure the EHL-FVIII.
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spelling doaj.art-d6eccec4ac7c45dcafbd30ebab5ab8bd2022-12-21T20:18:20ZengSAGE PublishingClinical and Applied Thrombosis/Hemostasis1938-27232021-02-012710.1177/1076029620976913The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX AssayHideo Wada MD, PhD0Katsuya Shiraki MD, PhD1Takeshi Matsumoto MD, PhD2Kohshi Ohishi MD, PhD3Hideto Shimpo MD, PhD4Yumi Sakano Mrs5Hiroko Nishii Mrs6Motomu Shimaoka MD, PhD7 Associated Department with Mie Graduate School of Medicine, Mie Prefectural General Medical Center, Yokkaichi, Japan Associated Department with Mie Graduate School of Medicine, Mie Prefectural General Medical Center, Yokkaichi, Japan Department of Transfusion Medicine and Cell Therapy, Mie University Hospital, Tsu, Japan Department of Transfusion Medicine and Cell Therapy, Mie University Hospital, Tsu, Japan Mie Prefectural General Medical Center, Yokkaichi, Japan Department of Molecular Pathobiology and Cell Adhesion Biology, Mie University Graduate School of medicine, Tsu, Japan Department of Molecular Pathobiology and Cell Adhesion Biology, Mie University Graduate School of medicine, Tsu, Japan Department of Molecular Pathobiology and Cell Adhesion Biology, Mie University Graduate School of medicine, Tsu, JapanThe FVIII activity in patients treated with several extended half-life FVIII (EHL-FVIII) agents different when various activated partial thromboplastin time (APTT) reagents were used. The present study examined the difference in clot waveform analysis (CWA) findings and FVIII activity when various APTT reagents and CWA were used. The CWA including FVIII activity was measured using 12 APTT reagents, and the FIX activation based on a small amount of tissue factor assay (sTF/FIX) were examined in reference plasma (RP), EHL-FVIII (Jivi ® ) and Kovaltry ® . The 3 APTT reagents were associated with high variation in the peak time and height in the CWA when analyzing low concentrations of FVIII. The peak time and height could not be measured with one APTT reagent, and there were marked differences in the CWA findings between Jivi ® and Kovaltry ® among APTT reagents. Several APTT reagents showed a markedly lower FVIII activity with Jivi ® than with Kovaltry ® . In the FVIII assay, the peak time measured with sTF/FIX did not differ markedly between Jivi ® and Kovaltry ® ; however, the FVIII activity in Jivi ® (as measured by the peak height) tended to be higher than in Kovaltry ® . The CWA findings for monitoring Jivi ® varied for monitoring Jivi ® depending on the APTT reagents used, and sTF/FIX assay may be able to measure the EHL-FVIII.https://doi.org/10.1177/1076029620976913
spellingShingle Hideo Wada MD, PhD
Katsuya Shiraki MD, PhD
Takeshi Matsumoto MD, PhD
Kohshi Ohishi MD, PhD
Hideto Shimpo MD, PhD
Yumi Sakano Mrs
Hiroko Nishii Mrs
Motomu Shimaoka MD, PhD
The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
Clinical and Applied Thrombosis/Hemostasis
title The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
title_full The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
title_fullStr The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
title_full_unstemmed The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
title_short The Evaluation of APTT Reagents in Reference Plasma, Recombinant FVIII Products; Kovaltry® and Jivi® Using CWA, Including sTF/7FIX Assay
title_sort evaluation of aptt reagents in reference plasma recombinant fviii products kovaltry r and jivi r using cwa including stf 7fix assay
url https://doi.org/10.1177/1076029620976913
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