Evaluation of an automated chromogenic assay for Factor VIII clotting activity measurement in patients affected by haemophilia A. Issue 3 (2nd May 2019)

• Record Type: Journal Article
• Authors: Novembrino, Cristina; Boscolo Anzoletti, Massimo; Mancuso, Maria Elisa; Shinohara, Sho; Peyvandi, Flora
• Is Part Of: Haemophilia. Volume 25:Issue 3(2019)
• Page Start: 521
• Page End: 526
• Publication Date: 2019-05-02
• Subjects: analytical performance -- chromogenic assay -- diagnostic accuracy -- Factor VIII -- haemophilia A; Hemophilia -- Periodicals; 616.1572005
• DOI: 10.1111/hae.13746
• Languages: English
• ISSNs: 1351-8216

Abstract

Abstract : Introduction: The original one‐stage clotting assay is still the most widely used method to measure Factor VIII clotting activity (FVIII:C) in patients with haemophilia A (HA), although the use of chromogenic assays is increasing significantly. Aim: Evaluation of the analytical performance and diagnostic accuracy of BIOPHEN™ FVIII:C (HYPHEN BioMed, Neuville‐sur‐Oise, France) assay on Sysmex CS‐2400 (Sysmex, Kobe, Japan) analyser. Methods: Sixty patients with haemophilia A (HA; any severity) and 120 healthy Italian subjects were included. All the assays were performed on citrate platelet‐poor plasmas stored at −80°C. Chromogenic BIOPHEN™ FVIII:C was compared with the one‐stage assay using Actin FS and Factor VIII deficient plasma (Siemens Healthcare Diagnostics, Marburg, Germany) on Sysmex CS‐2400 and with another chromogenic automated assay (COAMATIC™ Factor VIII, CHROMOGENIX on ACL TOP analyzer; Instrumentation Laboratory, Milan, Italy). Results: Intra‐assay and inter‐assay coefficient of variation were <6%. Linearity was good up to 1/128 dilution ( r = 0.99); mean recovery was 91.7% and limit of detection was 0.2%. BIOPHEN™ FVIII:C assay showed a good correlation and diagnostic agreement with the chromogenic COAMATIC™ assay: the Spearmen's Rank correlation coefficient was 0.98 and the inter‐rate agreement K Cohen coefficient was 0.61. The K coefficient was 0.91 when BIOPHEN™ FVIII:C was compared with the historical classification of the patients, demonstrating an optimal diagnostic accuracy in HA. Conclusions: BIOPHEN™ FVIII:C showed good analytical performance and diagnostic accuracy and could be considered suitable for the introduction in routine analytical panel of coagulation for the diagnosis of HA patients.