[Histonet] Dako HercepTest Kit

Cindy Bulmer cjbulmer <@t> sbcglobal.net
Tue Oct 16 11:17:30 CDT 2012


Hello Histonet,

Regarding the negative reagent control on the HercepTest Kit from Dako,
order # K5207.  We wrote CAP about this and this was their reply:

CAP would still require the laboratory to abide by any manufacturer
instructions that may be more stringent than the CAP requirement.

Since this kit is FDA approved, and the negative control reagent is included in the kit, our facility has decided to continue to do the negative reagent control.


Hope this helps,

Cindy

Cynthia Bulmer HT(ASCP)QIHC

IHC Supervisor, CTPL

Waco, TX


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