Recombinant Factor C Validation—Simpler Than You Think!

T Uhlig, KL Williams, B Tindall - PDA Journal of Pharmaceutical …, 2021 - journal.pda.org
Some users have been hesitant to take on the validation of alternative methods. However,
recombinant factor C (rFC) tests are so highly analogous to the horseshoe crab-sourced …

[CITATION][C] rFC Validation-Simpler than you thought

T Uhlig, KL Williams, B Tindall - PDA Journal of Pharmaceutical …, 2021 - journal.pda.org
Some users have been hesitant to take on the validation of alternative methods. However,
recombinant factor C (rFC) tests are so highly analogous to the horseshoe crab-sourced …

[HTML][HTML] A Study on the Application of Recombinant Factor C (rFC) Assay Using Biopharmaceuticals

DH Kang, SY Yun, SY Eum, KE Yoon, SR Ryu, C Lee… - Microorganisms, 2024 - mdpi.com
Gram-negative bacterial endotoxins can cause pathophysiological effects such as high fever
when introduced into the bloodstream. Therefore, endotoxin testing is necessary when …

[PDF][PDF] LAL and rFC Comparison Study Caveats

K Williams - Simplifying Progress, 2020 - researchgate.net
If we want to scientifically understand the dynamics of LAL and rFC in terms of equivalency,
then we must be able to sort out some conflicting data. Five broad claims have been made …

Activated protein C assays: A review

J Oto, Á Fernández-Pardo, M Miralles, E Plana… - Clinica Chimica …, 2020 - Elsevier
Activated protein C (APC) acts as an “on demand” anticoagulant, reducing thrombin
formation. Reduced plasma levels of APC or protein C (PC) are associated with an …

Counterpoint: Food and Drug Administration guidance for C-reactive protein assays: matching claims with performance data

JV Callaghan, SI Gutman - Clinical Chemistry, 2006 - academic.oup.com
Dr. Rifai and coauthors seem to have misunderstood the guidance proffered by the US Food
and Drug Administration (FDA) 1 and the laboratory safety tip addressing the issue of …

Protein C assay performance: an analysis of North American specialized coagulation laboratory association proficiency testing results

JM Baron, SM Johnson… - American journal of …, 2012 - academic.oup.com
To determine the performance and frequency of protein C reagents currently used by clinical
laboratories, we analyzed North American Specialized Coagulation Laboratory Association …

[HTML][HTML] A quantitative assay system for protein C activity, the regulator of blood coagulation, based on a chromogenic method mimicking the blood coagulation …

R Matsuda, R Someya, M Kobayashi, E Nakao… - Practical Laboratory …, 2023 - Elsevier
Background and aims Protein C is a plasma protein, and its active form regulates blood
coagulation. The recommended unit of protein C activity is IU/mL; however, some …

High-sensitivity C-reactive protein: product claims and the Food and Drug Administration

RS Ayash - Clinical Chemistry, 2001 - academic.oup.com
Several articles in recent issues of Clinical Chemistry have made reference to the Dade
Behring N High Sensitivity CRP (hs-CRP) assay and have indicated that it has been …

MASAC Document 228-Statement Regarding Use of Various Clotting Factor Assays to Monitor Factor Replacement Therapy

NHF GO - hemophilia.org
There is wide variability of factor activity level resultsdepending upon the assay selected to
perform the task (ie one stage assays vs. chromogenic assays). In certain scenarios, a …