Research Paper on Chromogenic and One-Stage Assays to Evaluate the Performance of Extended Half-Life Coagulation Factor VIII, FC Fusion Protein in Saudi Hemophilia A Patients

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Title: Chromogenic and One-Stage Assays to Evaluate the Performance of Extended Half-Life Coagulation Factor VIII, FC Fusion Protein in Saudi Hemophilia A Patients

Abstract: Background.)e chromogenic assay is another two-stage test that uses purified coagulation factors followed by factor Xa-specific chromogenic substrate is another way to measure factor VIII activity (FVIII: C) in patients with hemophilia A. As a recombinant extended half-life coagulation factor, Extended Half-Life Elocta® was used in this study to measure FVIII:C levels in hemophilia patients. The aim of the study was to determine whether there was any discrepancy or correlation between the chromogenic and one-stage assays. Methods. In a study, we compared the measurements of FVIII:C levels made using one-stage versus chromogenic assays at various drug concentrations. From the hospital files, information about FVIII: C levels, dosage, and the time between administration and measurement was obtained. The correlation, mean differences, and discrepancy between the two assays were calculated. The time interval until reaching 1% FVIII: C was predicted using a linear regression analysis. Results. The study consisted of 56 samples from 14 patients. 13 of the patients were receiving Elocta® as a preventative measure, and one patient was being given Elocta® on demand. The chromogenic and one-stage assays disagreed in one-third of these samples, but the other two assays were highly correlated. The time since the most recent Elocta® injection was a significant predictor of FVIII:C levels ( 0.366, P 0.001). Mean differences were significant at both the individual and time interval levels. Conclusion. Our results indicated a significant difference between the two assays, with the one-stage assay measuring lower FVIII:C levels than the chromogenic assay predicted. Levels of FVIII: C reach 1% after 5.4 days following the last Elocta® administration, but the measurements of FVIII levels by the two assays were inconsistent in one-third of the samples.

Paper Quality: SCOPUS / Web of Science Level Research Paper

Subject: Medicine

Sub Category: Hematology

Writer Experience: 20+ Years

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