Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays.

Abstract:

CONTEXT:Estrogen receptor and progesterone receptor status is assessed on all newly diagnosed, invasive breast carcinomas and in recurrences to determine patient eligibility for hormonal therapy, but 10% to 20% of estrogen receptor and progesterone receptor test results are discordant when tested in multiple laboratories. OBJECTIVE:To define the analytic (technical) validation requirements for estrogen receptor and progesterone receptor immunohistochemistry assays used to select patients for hormonal therapy. DATA SOURCES:Literature review and expert consensus. CONCLUSIONS:A standardized process for initial test validation is described. We believe adoption of this process will improve the accuracy of hormone-receptor testing, reduce interlaboratory variation, and minimize false-positive and false-negative results. Required ongoing assay assessment procedures are also described.

journal_name

Arch Pathol Lab Med

authors

Fitzgibbons PL,Murphy DA,Hammond ME,Allred DC,Valenstein PN

doi

10.1043/1543-2165-134.6.930

subject

Has Abstract

pub_date

2010-06-01 00:00:00

pages

930-5

issue

6

eissn

0003-9985

issn

1543-2165

pii

10.1043/1543-2165-134.6.930

journal_volume

134

pub_type

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