title: Development of antibody functionalized magnetic nanoparticles for the immunoassay of carcinoembryonic antigen: a feasibility study for clinical use.
abstract: BACKGROUND
  Magnetic nanoparticles functionalized antibodies are used for in-vitro assays on bio-markers. This work demonstrates the synthesis of high-quality magnetic nanoparticles coated with antibodies against carcinoembryonic antigen (CEA). Various characterizations, such as particle size, particle suspension, bio-activity and the stability of bio-magnetic nanoparticles suspended in liquid, are studied. The properties for the assay of CEA molecules in serum are also studied. The assay method used is so-called immunomagnetic reduction.
  
  
  RESULTS
  The results show that the effects of common materials in serum that interfere with detected signals are not significant. The low-detection limit is 0.21 ng/ml, which is well below the clinical threshold of 2.5 ng/ml.
  
  
  CONCLUSIONS
  The dynamic range for the assay of CEA molecules in serum is 500 ng/ml. By assaying serum CEA molecules from 24 normal controls and 30 colorectal-cancer patients, the threshold for the serum-CEA concentration to diagnose colorectal cancer is 4.05 ng/ml, which results in a clinical sensitivity of 0.90 and specificity of 0.87.
authors.affiliation: MagQu Co., Ltd., Sindian Dist, New Taipei City, 231, Taiwan. elvis.yang@magqu.com.
authors.forename: Che-Chuan
authors.initials: CC
authors.lastname: Yang
authors.affiliation: MagQu Co., Ltd., Sindian Dist, New Taipei City, 231, Taiwan. syyang@magqu.com.
authors.forename: Shieh-Yueh
authors.initials: SY
authors.lastname: Yang
authors.affiliation: MagQu Co., Ltd., Sindian Dist, New Taipei City, 231, Taiwan. jessie.ho@magqu.com.
authors.forename: Chia-Shin
authors.initials: CS
authors.lastname: Ho
authors.affiliation: MagQu Co., Ltd., Sindian Dist, New Taipei City, 231, Taiwan. frank.chang@magqu.com.
authors.forename: Jui-Feng
authors.initials: JF
authors.lastname: Chang
authors.affiliation: MagQu Co., Ltd., Sindian Dist, New Taipei City, 231, Taiwan. fresh.liu@magqu.com.
authors.forename: Bing-Hsien
authors.initials: BH
authors.lastname: Liu
authors.affiliation: Department of Surgery & Hepatitis Research Center, National Taiwan University Hospital, Taipei, 100, Taiwan. skywing@ntuh.gov.tw.|Graduate Institute of Clinical Medicine, College of Medicine, National Taiwan University, Taipei, 100, Taiwan. skywing@ntuh.gov.tw.
authors.forename: Kai-Wen
authors.initials: KW
authors.lastname: Huang
mesh_terms: D000906:Antibodies / Q000737:chemistry* / Q000276:immunology; D014408:Biomarkers, Tumor / Q000097:blood* / Q000276:immunology; D002272:Carcinoembryonic Antigen / Q000097:blood*; D016022:Case-Control Studies; D015179:Colorectal Neoplasms / Q000097:blood*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D057230:Limit of Detection; D058185:Magnetite Nanoparticles / Q000737:chemistry; D010316:Particle Size; D013696:Temperature
chemical_list: D000906:Antibodies; D014408:Biomarkers, Tumor; D002272:Carcinoembryonic Antigen; D058185:Magnetite Nanoparticles