Plasma Clotting Factor Assays Using Parallel-Line Bioassay Principles

• Plasma Clotting Factor Assays Using Parallel-Line Bioassay Principles

AUTHOR(S)

Chris GARDINER^*1, Ryosuke NARISADA^{*2, *3} and Ian MACKIE^*4
*1 Specialist Laboratory Medicine, Centre for Laboratory Medicine, St James’s University Hospital
*2 Medical Affairs 2, Medical & Scientific Affairs, Sysmex Corporation
*3 HYPHEN BioMed, SAS
*4 University College London

SUMMARY

The quantification of clotting factors by one-stage factor assays (OSFA) is frequently performed in clinical laboratories to assess bleeding tendency, to investigate unexpected prolongation of the prothrombin time (PT) and/or activated partial thromboplastin time (APTT), or to monitor factor replacement therapy.

OSFA performed on Automated Blood Coagulation Analysers CS-1600, CS-2500, and CS-5100 (Sysmex Corporation, Kobe, Japan; hereinafter Sysmex) and Automated Blood Coagulation Analysers CN-3000, CN-6000, CN-3500, and CN-6500 (Sysmex) include a MDA (Multi Dilution Analysis) option.

Parallelism assessment of OSFA results is necessary to avoid falsely elevated and/or falsely reduced factor activities due to the presence of sample activation and coagulation inhibitors, respectively.

KEY WORDS

One-Stage Factor Assays (OSFA), Multi Dilution Analysis (MDA), Parallel, Parallelism

NOTE(S)

This article is based on current regulatory requirements in the UK. (as of Nov. 2025)
The specifications, performances, and functions described here may be different depending on the regions or the countries due to regulatory, legal and/or local guidelines. For more details, please contact your regional affiliates or distributors.