Measuring factor VIII activity in patients with severe haemophilia A treated with extended half-life concen-trates – comparison of selected assay results
Authors:
M.. Prudková 1-3; P. Smejkal 1,3; D. Chytrá 1,3; J. Zavřelová 1,3; G. Romanová 1-3; M. Penka 1,2; A. Buliková 1,2
Authors‘ workplace:
Oddělení klinické hematologie, FN Brno
1; Interní hematologická a onkologická klinika LF MU a FN Brno
2; Katedra laboratorních metod, LF MU, Brno
3
Published in:
Transfuze Hematol. dnes,30, 2024, No. Ahead of Print, p. 1-10.
Category:
Original Papers
doi:
https://doi.org/10.48095/cctahd2024prolekare.cz16
Overview
Introduction: Optimal substitutional treatment includes measuring FVIII activity (FVIII:C) using the one-stage clotting assay (OSA) or chromogenic substrate assay (CSA). However, with the advent of FVIII concentrates with an extended half-life, discrepancies between methods have increased due to modifications of the FVIII molecule. Aim: Evaluation of OSA and CSA discrepancy in patients treated with extended half-life FVIII concentrates. Method: FVIII:C measurement by OSA with reagents Cephascreen® (Diagnostica Stago) and Pathromtin® SL (Siemens Healthineers) and by CSA BIOPHENTM FVIII:C (Hyphen BioMed) in patients treated with efmoroctocog alfa, rurioctocog alfa pegol, turoctocog alfa pegol and damoctocog alfa pegol. Results: The results of both methods correlated well for efmoroctocog alfa, the differences being up to 21%. The results of rurioctocog alfa pegol in the range of 15–200% were slightly lower using OSA with both reagents, on average by 11% and 18%, while the results up to 10% were higher using OSA with an average difference of 54% for Cephascreen® and up to 75% for Pathromtin® SL. The results of turoctocog alfa pegol were lower using OSA in the range of 15–200%, on average by 36% and 25%. The samples with FVIII:C above 10% of damoctocog alfa pegol were slightly higher using OSA (Cephascreen® by 18%), but samples up to 10% were significantly higher, with Cephascreen® on average by 91% and by 100% with Pathromtin® SL. Conclusions: OSA Cephascreen® or Pathromtin® SL and CSA Hyphen correlate excellently in the case of efmoroctocog alfa. Of the other concentrates, the results correlate excellently in the case of rurioctocog alfa pegol (only Cephascreen®) and damoctocog alfa pegol, and only for FVIII:C > 10%.
Keywords:
haemophilia A – FVIII activity – EHL concentrates
Sources
-
- Young GA, Perry DJ; for The International Prophylaxis Study Group (IPSG). Laboratory assay measurement of modified clotting factor concentrates: a review of the literature and recommendations for practice. J Thromb Haemost. 2019;17:567–573.
- Marlar RA, Strandberg K, Shima M, Adcock DA. Clinical utility and impact of the use of the chromogenic vs one‐stage factor activity assays in haemophilia A and B. Eur J Haematol. 2020;104:3–14.
- Pruthi RK. Laboratory monitoring of new hemostatic agents for hemophilia. Semin Hematol. 2016;53:28–34.
- Smejkal P, Blatný J, Hajšmanová Z, et al. Konsenzuální doporučení Českého národního hemofilického programu (ČNHP) pro diagnostiku a léčbu pacientů s hemofilií, vydání 3., rok 2021. Transfuze Hematol Dnes. 2021;27(1):73–90.
- Gray E, Kitchen S, Bowyer A, et al. Laboratory measurement of factor replacement therapies in the treatment of congenital haemophilia: A United Kingdom Haemophilia Centre Doctors’ Organisation guideline. Haemophilia. 2020;26:6–16.
- Jeanpierre E, Pouplard C, Lasne D, et al. Factor VIII and IX assays for post‐infusion monitoring in hemophilia patients: Guidelines from the French BIMHO group (GFHT). Eur J Haematol. 2020;105:103–115.
- Peyvandi F, Kenet G, Pekrul I, Pruthi RK, Ramge P, Spannagl M. Laboratory testing in hemophilia: Impact of factor and non‐factor replacement therapy on coagulation assays. J Thromb Haemost. 2020;18:1242–1255.
- Augustsson C, Norström E, Andersson NG, Zetterberg E, Astermark J, Strandberg K. Monitoring standard and extended half‐life products in hemophilia: Assay discrepancies for factor VIII and IX in pre– and postinfusion samples. Res Pract Thromb Haemost. 2020;4:1114–1120.
- Collins P, Chalmers E, Chowdary P, et al. The use of enhanced half-life coagulation factor concentrates in routine clinical practise: guidance from UKHCDO. Haemophilia. 2016;22:487–498.
- Hubbard AR, Dodt J, Lee T, et al. Recommendations onthe potency labelling of factor VIII and factor IX concentrates. J Thromb Haemost. 2013;11:988–989.
- Peyvandi F, Oldenburg J, Friedman KD. A critical appraisal of one-stage and chromogenic assays of factor VIII activity. J Thromb Haemost. 2016;14:248–261.
- Škorňová I, Slavík L, et al. Faktory vnitřní koagulační cesty (FVIII, FIX, FXI a FXII). In: Hemostáza: laboratorní metody, jejich využití a interpretace ve vybraných klinických situacích. 2. vyd. Olomouc, Univerzita Palackého v Olomouci, 2021; 66-73.
- Srivasta A, Santagostino E, Dougall A, et al. WFH Guidelines for the management of hemophilia, 3rd edition. https:/ / onlinelibrary. wiley.com/ doi/ 10.1111/ hae.14046, přístup 25.10.2023.
- Bowyer AE, Duncan EM, Antovic JP. Role of chromogenic assays in haemophilia A and B diagnosis. Haemophilia. 2018;24:578–583.
- Souhrn údajů o přípravku Elocta®. https:// www.ema.europa.eu/en/documents/product-information/elocta-epar-product-information_ cs.pdf, přístup 3.11.2023
- Lambert T, Benson G, Dolan G, et al. Practical aspects of extended half-life products for the treatment of haemophilia. Ther Adv Hematol. 2018;9:295–308.
- Souhrn údajů o přípravku Adynovi®. https://www.ema.europa.eu/en/documents/product-information/ adynovi-epar-product-information_cs.pdf, přístup 3.11.2023
- Turecek PL, Romender-Finger S, Apostol C, et al. A world-wide survey and field study in clinical haemostasis laboratories to evaluate FVIII:C aktivity assay variability of ADYNOVATE and OBIZUR in comparison with ADVATE. Haemophilia. 2016;22:957–965.
- Souhrn údajů o přípravku Esperoct®. https://www.ema.europa.eu/en/documents/product--information/esperoct-epar-product-information_cs.pdf, přístup 3.11.2023
- Ezban M, Hansen M, Kjalke M. An overview of turoctocog alfa pegol (N8‐GP; ESPEROCT®) assay performance: Implications for postadministration monitoring. Haemophilia. 2020;26:156–163.
- Church N, Leong L, Katterle Y, et al. Factor VIII activity of BAY 94‐9027 is accurately measured with most commonly used assays: Results from an international laboratory study. Haemophilia. 2018;24:823–832.
- Souhrn údajů o přípravku Jivi®. https://www. ema.europa.eu/ en/ documents/product-information/ jivi-epar-product-information_cs.pdf, přístup 3.11.2023
- Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15:155–163.
- Lowe A, Jennings I, Kitchen S. One stage and chromogenic FVIII assay results at trough levels: a UK national external quality assessment scheme for blood coagulation (UK NEQAS BC) exercise. Haemophilia. 2020; 26:27.
- Hillarp A, Bowyer A, Ezban M, Persson P, Kitchen S. Measuring FVIII aktivity of glycopegylated recombinant factor VIII, N8-GP, with commercially available one-stage clottting and chromogenic assay kits: a two-centre study. Haemophilia. 2017;23:458–465.
- Pickering W, Hansen M, Kjalke M, Ezban M. Factor VIII chromogenic assays can be used for potency labeling and postadministration monitoring of N8‐GP. J Thromb Haemost. 2016;14:1579–1587.
- Van den Bossche D, Peerlinck K, Jacquemin M. New challenges and best practices for the laboratory monitoring of factor VIII and factor IX replacement. Int J Lab Hem. 2018;40(Suppl. 1):21–29.
- Cinotti S, Paladino E, Morfini M. Accuracy of FVIII:C assay by one-stage method can be improved using hemophilic plasma as diluent. J Thromb Haemost. 2006;4:828–833.
-
PODÍL AUTORŮ NA PŘÍPRAVĚ RUKOPISU
MP – laboratorní diagnostika, napsání rukopisu
SP, RG – léčba pacientů, revize rukopisu
CHD, ZJ – laboratorní diagnostika, revize rukopisu
ZJ – laboratorní diagnostika, revize rukopisu
PM, BA – revize rukopisu
ČESTNÉ PROHLÁŠENÍ
Autoři práce prohlašují, že v souvislosti s tématem, vznikem a publikací tohoto článku nejsou ve střetu zájmů a vznik ani publikace článku nebyly podpořeny žádnou farmaceutickou firmou.
PODĚKOVÁNÍ
Podpořeno MZ ČR-RVO (FNBr, 65269705) a grantem MUNI/A/1558/2023.
Do redakce doručeno dne: 31. 1. 2024.
Přijato po recenzi dne: 8. 7. 2024.Mgr. Marie Prudková
Oddělení klinické hematologie FN Brno
Jihlavská 340/20 625 00 Brno
e-mail: prudkova.marie@fnbrno.cz
Labels
Haematology Internal medicine Clinical oncologyArticle was published in
Transfusion and Haematology Today
2024 Issue Ahead of Print
Most read in this issue
- Primary mediastinal large B-cell lymphoma
- Measuring factor VIII activity in patients with severe haemophilia A treated with extended half-life concen-trates – comparison of selected assay results