title: Development of NIST standard reference material 2373: Genomic DNA standards for HER2 measurements.
abstract: NIST standard reference material (SRM) 2373 was developed to improve the measurements of the HER2 gene amplification in DNA samples. SRM 2373 consists of genomic DNA extracted from five breast cancer cell lines with different amounts of amplification of the HER2 gene. The five components are derived from the human cell lines SK-BR-3, MDA-MB-231, MDA-MB-361, MDA-MB-453, and BT-474. The certified values are the ratios of the HER2 gene copy numbers to the copy numbers of selected reference genes DCK, EIF5B, RPS27A, and PMM1. The ratios were measured using quantitative polymerase chain reaction and digital PCR, methods that gave similar ratios. The five components of SRM 2373 have certified HER2 amplification ratios that range from 1.3 to 17.7. The stability and homogeneity of the reference materials were shown by repeated measurements over a period of several years. SRM 2373 is a well characterized genomic DNA reference material that can be used to improve the confidence of the measurements of HER2 gene copy number.
authors.affiliation: Bioassay Methods Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Hua-Jun
authors.initials: HJ
authors.lastname: He
authors.affiliation: Bioassay Methods Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Jamie L
authors.initials: JL
authors.lastname: Almeida
authors.affiliation: Statistical Engineering Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Steve P
authors.initials: SP
authors.lastname: Lund
authors.affiliation: Applied Genetics Group, Biomolecular Measurements Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Carolyn R
authors.initials: CR
authors.lastname: Steffen
authors.affiliation: Bioassay Methods Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Steve
authors.initials: S
authors.lastname: Choquette
authors.affiliation: Bioassay Methods Group, Biosystems and Biomaterials Division, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899, USA.
authors.forename: Kenneth D
authors.initials: KD
authors.lastname: Cole
keywords: Calibrator; Cancer; Digital PCR; HER2; Nucleic acid; Reference material