title: Method evaluation of pepsinogen I/II assay based on chemiluminescent immunoassays and comparison with other test methods.
abstract: BACKGROUND
  Serum pepsinogen (PG) I and the PG I/PG II ratio have been used for atrophic gastritis (AG) diagnosis for decades. Low levels of PG I and/or PG I/PG II are closely related to AG and predict the risk of gastric cancer. We evaluated the performance of the chemiluminescent immunoassay-based Architect Pepsinogen I/II assay.
  
  
  METHODS
  The evaluation consisted of determination of the precision, linearity, limit of blank (LoB), limit of detection (LoD) and method comparison with Eiken and Biohit assays.
  
  
  RESULTS
  The total CVs were below 5% for both PG I and PG II. Acceptable linearity was observed for PG I and PG II in their respective reportable ranges. The PG I LoB was 0.317ng/mL and the PG II LoB was 0.418ng/mL, and LoDs were 0.412ng/mL and 0.497ng/mL, respectively. Correlation analysis indicated that results of the Architect assay were comparable to those of the Eiken and Biohit assays, but the three methods lead to different estimations of the cancer risk.
  
  
  CONCLUSIONS
  The overall analytical performance of Architect Pepsinogen I/II assay is acceptable for the detection of patients with suspected AG. The categorization results of gastric cancer risk showed some difference among test methods suggesting the need for harmonization among the methods from vendors.
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Eun-Jung
authors.initials: EJ
authors.lastname: Cho
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Hyun-Ki
authors.initials: HK
authors.lastname: Kim
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Tae-Dong
authors.initials: TD
authors.lastname: Jeong
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Dae-Hyun
authors.initials: DH
authors.lastname: Ko
authors.affiliation: Health Screening & Promotion Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Suh Eun
authors.initials: SE
authors.lastname: Bae
authors.affiliation: Health Screening & Promotion Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Jong-Soo
authors.initials: JS
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: wlee1@amc.seoul.kr.
authors.forename: Woochang
authors.initials: W
authors.lastname: Lee
authors.affiliation: Health Screening & Promotion Center, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Jae Won
authors.initials: JW
authors.lastname: Choe
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Sail
authors.initials: S
authors.lastname: Chun
authors.affiliation: Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Hwoon-Yong
authors.initials: HY
authors.lastname: Jung
authors.affiliation: Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
authors.forename: Won-Ki
authors.initials: WK
authors.lastname: Min
mesh_terms: D005260:Female; D006801:Humans; D007118:Immunoassay; D008163:Luminescent Measurements; D008297:Male; D008875:Middle Aged; D020116:Pepsinogen A / Q000097:blood*; D020115:Pepsinogen C / Q000097:blood*; D013274:Stomach Neoplasms / Q000097:blood* / Q000175:diagnosis
chemical_list: D020115:Pepsinogen C; D020116:Pepsinogen A
keywords: Atrophic gastritis; Chemiluminescent immunoassay; Gastric cancer; Method evaluation; Pepsinogen