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Performance of Factor VIII Extended Half-Life Product Measurements in External Quality Assessment Programmes.

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Current laboratory assays for monitoring Factor VIII (FVIII) levels in haemophilia A patients show inconsistencies with new extended half-life (EHL) products. These assay variations can lead to inaccurate patient treatment and potential clinical risks.

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Area of Science:

  • Clinical diagnostics
  • Haemophilia A management
  • Pharmacodynamics

Background:

  • Improved treatments for haemophilia A enhance patient quality of life.
  • Monitoring patient Factor VIII (FVIII) levels is crucial for preventing under- or overtreatment.
  • New extended half-life (EHL) products present challenges for laboratory monitoring.

Purpose of the Study:

  • To investigate discrepancies in FVIII assay results across a global cohort of laboratories.
  • To identify challenges posed by novel FVIII EHL products in routine laboratory monitoring.
  • To assess the performance of common laboratory assays with EHL FVIII products.

Main Methods:

  • A global study in 2023 involved distributing spiked samples to numerous laboratories.
  • Five different FVIII EHL products were tested.
  • External quality assessment (EQA) schemes (ECAT, NEQAS, RCPAQAP) facilitated sample distribution.

Main Results:

  • Laboratories utilized one-stage assays (OSA) or chromogenic assays (CA).
  • Specific reagents were commonly used for OSA (e.g., IL Hemosil Synthasil, Siemens Actin FS) and CA (e.g., Chromogenix Coamatic FVIII, Siemens chromogenic FVIII).
  • Results indicated that current OSA and CA do not consistently quantify FVIII levels for certain EHL products.

Conclusions:

  • Existing OSA and CA show variability in detecting FVIII levels with EHL products, leading to potential under- or overestimation.
  • Inconsistent results suggest limitations in current assay methodologies for novel FVIII therapies.
  • Further clarification is needed regarding assay result interpretation, particularly for products like Afstyla Lonoctocog alfa, concerning correction factors.