Open AccessA review of guidelines for evaluating a minor modification to a validated assay
Author(s) -
M. M. Reising,
Charles Tong,
B. Harris,
K. L. Toohey-Kurth,
Beryl Crossley,
D. Mulrooney,
Rebecca L. Tallmadge,
Katrine Schumann,
Adam Lock,
Carmelo Loiacono
Publication year - 2021
Publication title -
revista científica y técnica - oficina internacional de epizootias/scientific and technical review - international office of epizootics/revue scientifique et technique - office international des épizooties
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.292
H-Index - 88
eISSN - 1608-0637
pISSN - 0253-1933
DOI - 10.20506/rst.40.1.3219
Subject(s) - humanities , philosophy , systematic error , comparability , mathematics , statistics , combinatorics
Any modification to a validated assay must be evaluated in terms of the impact on the assay's performance characteristics and whether the assay remains fit for the intended purpose. The comparison is referred to as a 'method comparison', 'method comparability', 'method change', or 'comparative validation'. This review presents recommendations and examples of studies found in the current literature as a means of assessing minor modifications. In addition, the authors discuss common statistical approaches used for these comparisons.