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.
Evaluation of an automated chromogenic assay for Factor VIII clotting activity measurement in patients affected by haemophilia A / C. Novembrino, M. Boscolo Anzoletti, M.E. Mancuso, S. Shinohara, F. Payvandi. - In: HAEMOPHILIA. - ISSN 1351-8216. - 25:3(2019 May), pp. 521-526.
Evaluation of an automated chromogenic assay for Factor VIII clotting activity measurement in patients affected by haemophilia A
C. NovembrinoPrimo
;M.E. Mancuso;F. Payvandi
Ultimo
2019
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.File | Dimensione | Formato | |
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