Editorial

Editorial

Manufacturers of IVD materials must ensure that their products are stable. Since 2009 they have been guidedby EP25-A,(4),which describesbest practices for measuring IVD reagent stability in real time (over the time frame to be tested) and with accelerated stability protocols. [...]they design a conf...

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Veröffentlicht in:Clinical chemistry (Baltimore, Md.) Md.), 2016-08, Vol.62 (8), p.1049
Hauptverfasser: Budd, Jeffrey R, Holland, Mark D
Format: Artikel
Sprache:eng
Schlagworte:
Aqueous solutions
Calibration
Design
Laboratories
Quality
Studies
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Zusammenfassung:Manufacturers of IVD materials must ensure that their products are stable. Since 2009 they have been guidedby EP25-A,(4),which describesbest practices for measuring IVD reagent stability in real time (over the time frame to be tested) and with accelerated stability protocols. [...]they design a confirmatory real-time study with sufficient power to serve as the gold standard of comparative stability results.
ISSN:0009-9147
1530-8561
DOI:10.1373/clinchem.2016.260372