PMID- 18948825
OWN - NLM
STAT- MEDLINE
DCOM- 20090715
LR  - 20161020
IS  - 1533-4058 (Electronic)
IS  - 1533-4058 (Linking)
VI  - 16
IP  - 6
DP  - 2008 Dec
TI  - Monoplex LightCycler polymerase chain reaction quantitation of the HER2 gene for 
      quality assurance of HER2/neu testing by immunohistochemistry and fluorescence in 
      situ hybridization.
PG  - 562-7
LID - 10.1097/PAI.0b013e318171923a [doi]
AB  - BACKGROUND: Assessment of HER2 by immunohistochemistry (IHC) or fluorescence in 
      situ hybridization (FISH) is a standard practice for breast carcinomas. Testing 
      is associated with a 20% disagreement between laboratories. The College of 
      American Pathologists (CAP) guidelines for HER2 testing include validation of 
      HER2 test methods by achieving 95% concordance with another validated method. Our 
      laboratory requires IHC 3+ FISH nonamplified specimens to undergo retesting by 
      polymerase chain reaction (PCR). A random sample of IHC 2+ cases are routinely 
      tested by PCR. We found this practice useful for resolving discrepancies in HER2 
      testing. METHODS: At clinician request, seventy-nine 3+ and one hundred 
      forty-eight 2+ cases were tested by FISH. In 22 cases, IHC was 3+ but FISH was 
      nonamplified. These 22 cases underwent HER2 LightCycler monoplex polymerase chain 
      reaction (MPCR) testing. Seventeen 2+ nonamplified cases were tested by MPCR. 
      RESULTS: Twenty-one 3+, FISH nonamplified cases were found to be MPCR 
      nonamplified. One IHC 3+, FISH nonamplified case was MPCR amplified. Seventeen 
      2+, FISH nonamplified cases were MPCR nonamplified. In all but one case, FISH and 
      MPCR were concordant. DISCUSSION: American Society of Clinical Oncology/CAP 
      guidelines propose validation of testing procedures by showing 95% concordance 
      with a validated test for positive and negative assays. Specific actions are not 
      recommended to resolve discordances between tests. Our laboratory uses 3 
      different modalities for HER2 testing. We have found that our 2 methods for 
      testing gene amplification status show a higher degree of concordance between 
      themselves than either did with IHC. Review of the 3+ IHC nonamplified cases 
      showed them to have a dark, granular circumferential staining pattern.
FAU - Layfield, Lester J
AU  - Layfield LJ
AD  - Department of Pathology, University of Utah School of Medicine, Salt Lake City, 
      UT 84112, USA. layfiel@aruplab.com
FAU - Willmore-Payne, Carlynn
AU  - Willmore-Payne C
FAU - Isom, Gary
AU  - Isom G
FAU - Holden, Joseph A
AU  - Holden JA
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Appl Immunohistochem Mol Morphol
JT  - Applied immunohistochemistry & molecular morphology : AIMM
JID - 100888796
SB  - IM
MH  - Breast Neoplasms/*diagnosis/genetics/pathology
MH  - Carcinoma/*diagnosis/genetics/pathology
MH  - Diagnostic Errors/prevention & control/standards
MH  - Female
MH  - *Genes, erbB-2
MH  - Humans
MH  - Immunohistochemistry/*methods/standards
MH  - In Situ Hybridization, Fluorescence/*methods/standards
MH  - Polymerase Chain Reaction/*methods
MH  - Predictive Value of Tests
MH  - Reproducibility of Results
EDAT- 2008/10/25 09:00
MHDA- 2009/07/16 09:00
CRDT- 2008/10/25 09:00
PHST- 2008/10/25 09:00 [pubmed]
PHST- 2009/07/16 09:00 [medline]
PHST- 2008/10/25 09:00 [entrez]
AID - 10.1097/PAI.0b013e318171923a [doi]
PST - ppublish
SO  - Appl Immunohistochem Mol Morphol. 2008 Dec;16(6):562-7. doi: 
      10.1097/PAI.0b013e318171923a.