title: An alternative strategy to western blot as a confirmatory diagnostic test for HIV infection.
abstract: In China, western blot (WB) is the recommended procedure for the diagnosis of HIV infection. However, this technique is time consuming and labor intensive, and its complexity restricts wide application in resource-limited regions.
  
  
  
  The aim of this study was to evaluate the efficacy of a dry blood spots (DBS)-urine paired enzyme-linked immunosorbent assay (ELISA) test, instead of WB, for HIV antibody detection.
  
  
  
  Plasma, DBS, and urine samples were collected from 1213 subjects from different populations. Two diagnostic testing strategies were conducted in parallel. The equivalence of the paired ELISA and WB strategies was assessed.
  
  
  
  A diagnosis of HIV was determined in 250 subjects according to the paired ELISA test, and in 249 according to the WB strategy. The discordant case was judged HIV-positive during follow-up. In total, 18 subjects were diagnosed with possible HIV using the paired ELISA test, among whom, 11 subjects tested negative with WB, and one was confirmed to be HIV-positive during follow-up. For the remaining 945 subjects, both strategies indicated a negative result. The kappa test indicated good conformity (kappa=0.954) between the two diagnostic strategies.
  
  
  
  The DBS-urine paired ELISA could be applied as an alternative to WB in HIV diagnosis, which would be valuable in resource-limited regions owing to the associated affordability and ease of use.
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China; Department of Clinical Laboratory, Beijing Youan Hospital, Capital Medical University, Beijing, China.
authors.forename: Xia
authors.initials: X
authors.lastname: Feng
authors.affiliation: Center for Disease Control and Prevention in Dehong, Dehong, China.
authors.forename: Jibao
authors.initials: J
authors.lastname: Wang
authors.affiliation: Department of Pathogenic Biology, Hebei Medical University, Shijiazhuang, China.
authors.forename: Zhiyun
authors.initials: Z
authors.lastname: Gao
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China.
authors.forename: Yu
authors.initials: Y
authors.lastname: Tian
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China.
authors.forename: Ling
authors.initials: L
authors.lastname: Zhang
authors.affiliation: Center for Disease Control and Prevention in Yunnan Province, Kunming, China.
authors.forename: Huichao
authors.initials: H
authors.lastname: Chen
authors.affiliation: Department of Clinical Laboratory, Beijing Youan Hospital, Capital Medical University, Beijing, China.
authors.forename: Tong
authors.initials: T
authors.lastname: Zhang
authors.affiliation: Center for Disease Control and Prevention in Liangshan, Liangshan, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Xiao
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China.
authors.forename: Jun
authors.initials: J
authors.lastname: Yao
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China.
authors.forename: Wenge
authors.initials: W
authors.lastname: Xing
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China.
authors.forename: Maofeng
authors.initials: M
authors.lastname: Qiu
authors.affiliation: National HIV/HCV Reference Laboratory, National Center for AIDS/STD Control and Prevention, China CDC, Beijing, China. Electronic address: jiangyan03@263.net.
authors.forename: Yan
authors.initials: Y
authors.lastname: Jiang
mesh_terms: D001774:Blood Chemical Analysis; D015153:Blotting, Western / Q000379:methods*; D002681:China; D003955:Diagnostic Tests, Routine / Q000379:methods*; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods*; D005260:Female; D015483:HIV Antibodies / Q000032:analysis* / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D014556:Urine / Q000737:chemistry
chemical_list: D015483:HIV Antibodies
keywords: ELISA; HIV; Substitutive strategy; Western blot