Comparison of the types of candidate reference samples for quality control of human epidermal growth factor receptor 2 status detection.
BACKGROUND
Human epidermal growth factor receptor 2 (HER2) is as a target gene for trastuzumab in patients with breast cancer. Accurate determination of HER2 status and strict quality control are necessary to ensure reproducibility and accuracy of the techniques used for the determination of HER2 status.


METHODS
We used three different types of samples: formalin-fixed and paraffin-embedded (FFPE) samples prepared from cell lines, agarose gel samples using cell lines, and xenograft tumor samples. One cell line for FFPE or xenografts did not overexpress HER2, while the others showed different levels of HER2 overexpression. We compared the morphology, HER2 gene amplification status, and HER2 protein expression status of these samples with those of clinical specimens.


RESULTS
We successfully produced three kinds of samples for quality control. Cells from the cell line-sample sections were dispersed while those from the agarose gel-sample sections and xenograft tumor sample sections (prepared from the both cell lines) were concentrated in one area. The FISH results for all three kinds of samples were as expected. The IHC results of the cell line samples and xenograft tumor samples were as expected, but the staining level of the agarose gel samples, using HER2-overexpressed cell lines was weak which might be regarded as a false negative result.


CONCLUSIONS
Xenograft tumor samples might be used as an additional option for quality control in FISH and IHC. However, it might not replace the clinical specimen quality controls directly.
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Yulong
Y
Li
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Rui
R
Zhang
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Yanxi
Y
Han
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Tian
T
Lu
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Jiansheng
J
Ding
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Kuo
K
Zhang
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Guigao
G
Lin
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China.
Jiehong
J
Xie
National Center for Clinical Laboratories, Beijing Hospital, National Center of Gerontology, No1 Dahua Road, Dongdan, Beijing, 100730, People's Republic of China. jmli@nccl.org.cn.|Graduate School, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, People's Republic of China. jmli@nccl.org.cn.|Beijing Engineering Research Center of Laboratory Medicine, Beijing Hospital, National Center of Gerontology, Beijing, 100730, People's Republic of China. jmli@nccl.org.cn.
Jinming
J
Li
D000818:Animals; D014408:Biomarkers, Tumor / Q000235:genetics* / Q000378:metabolism*; D001943:Breast Neoplasms / Q000201:enzymology* / Q000235:genetics* / Q000473:pathology; D004587:Electrophoresis, Agar Gel; D005260:Female; D005404:Fixatives; D005557:Formaldehyde; D005784:Gene Amplification; D064593:Heterografts; D006801:Humans; D007150:Immunohistochemistry / Q000592:standards*; D017404:In Situ Hybridization, Fluorescence / Q000592:standards*; D061986:MCF-7 Cells; D016513:Mice, SCID; D009368:Neoplasm Transplantation; D016612:Paraffin Embedding; D011237:Predictive Value of Tests; D011786:Quality Control; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000235:genetics* / Q000378:metabolism*; D015203:Reproducibility of Results; D016707:Tissue Fixation / Q000379:methods; D014162:Transfection
D014408:Biomarkers, Tumor; D005404:Fixatives; D005557:Formaldehyde; D018719:Erb-b2 Receptor Tyrosine Kinases; C508053:ERBB2 protein, human
Agarose gel; Cell lines; Clinical specimens; FISH; IHC; Quality control; Xenograft