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Validation of an automated chromogenic assay of potency of factor VIII in commercial concentrates
Author(s) -
Collazo V.,
Alonso C.,
Frutos G.
Publication year - 2013
Publication title -
international journal of laboratory hematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.705
H-Index - 55
eISSN - 1751-553X
pISSN - 1751-5521
DOI - 10.1111/j.1751-553x.2012.01459.x
Subject(s) - potency , chromogenic , repeatability , spectrum analyzer , chromatography , coefficient of variation , chemistry , computer science , biochemistry , telecommunications , in vitro
Summary The determination of factor VIII ( FVIII ) potency in FVIII concentrates can be performed using both manual and automated methods. This work aimed to validate the use of the chromogenic kit C oamatic ® FVIII ( C hromogenix) on the automated ACL ® Elite PRO analyzer for evaluating the potency of FVIII in commercial preparations in pharmaceutical analytical laboratories. After setting the activation and reading times to 2 min and 3 min, respectively, the validation parameters, according to the International Conference on Harmonisation of Technical Requirements for Registration of P harmaceuticals for H uman U se guideline Q 2 ( R 1), were as follows: linearity, expressed by the adjusted model: log ( A bsorbance) = 1.848 + 0.777∙log ( C oncentration), with r 2 = 0.998; accuracy was verified ( P ‐value = 0.6959); and the coefficient of variation for repeatability and intermediate precision was ≤6.5%. The C oamatic ® FVIII kit method has been adapted to the ACL Elite PRO analyzer with improved performance compared with a manual microplate method.