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Standardisation of the FVIII Nijmegen-Bethesda – dream or reality?

Development of inhibitor antibodies interfering with the function of FVIII replacement products is one of the most significant complications in the treatment of haemophilia A. Here, Eleanor Foxton and Áine McCormick consider several approaches to assay standardisation and EQA performance.

The FVIII Nijmegen-Bethesda assay (NBA) is used to quantify factor VIII (FVIII) inhibitors in patients with congenital or acquired haemophilia A. In-house FVIII NBA using chromogenic FVIII measurement has given a consistent low bias in ECAT Foundation external quality assessment (EQA) exercises and quality control (QC) material, leading to a methodology review. The aim of this short study is to reduce low bias seen with in-house NBA and standardise methodology using a CE-marked kit.

Materials and methods

Two suitable commercial kits were identified: FVIII Inhibitor kit (Technoclone) and CRYOcheck Factor VIII Inhibitor kit (Precision BioLogic). Both were tested against an in-house method using comparison of patient samples and FVIII Inhibitor plasma (Technoclone). Local practice includes the use of a chromogenic assay (Biophen FVIII, Hyphen BioMed) to measure residual FVIII activity using the CS2100 coagulation analyser (Sysmex).

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Upcoming Events

Digital Pathology & AI Congress: Europe

The Intercontinental London Hotel, The O2, London SE10 0TW
7-8 December

POCT Innovators: The Power to Disrupt Series

Cloth Hall Court, Leeds. UK
20 March, 2024

USCAP 113th Annual Meeting

Baltimore Convention Center, Baltimore, Maryland, USA
23-28 March, 2024

ECCMID 2024 - European Congress of Clinical Microbiology and Infectious Diseases

Fira Gran Via, 08038 Barcelona, Spain
27-30 April 2024

British Society for Microbial Technology Annual Microbiology Conference

Royal Air Force Museum, Hendon, London
2 May 2024

Access the latest issue of Pathology In Practice on your mobile device together with an archive of back issues.

Download the FREE Pathology In Practice app from your device's App store

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