title: Development of an immunoassay for differentiating human immunodeficiency virus infections--from vaccine-induced immune response in Tiantan vaccine trials in China.
abstract: OBJECTIVE
  To develop a Rapid Flow-through assay for distinguishing replicating Tiantan vaccine-generated serological response from true HIV infection.
  
  
  METHODS
  A Rapid Flow-through Test including gp41, gp36, sk1, sk2 and sk3 antigens was established and the performance of the assay was evaluated in clinical studies and compared with ELISA assay.
  
  
  RESULTS
  Sk1, sk2 and sk3 peptides performed at 100% specificity and slightly but not significantly different sensitivities between ELISA assay (92%, 76% and 41%) and Flow-through Test Kit (92%, 75% and 40%) in diagnosing HIV-1 infections. Of particular importance, Tiantan vaccine recipients that gave false-positive results in gp41 serodetection scored negative for sk1, sk2 and sk3 antibodies.
  
  
  CONCLUSIONS
  The Rapid Flow-through Test could be a robust tool in both diagnosing HIV-1/2 infections and differentiating between vaccines induced immunity and immunity resulting from natural exposure, thus serving as potential implementation in HIV vaccine trials.
authors.affiliation: Department of Clinical Laboratory, Yongchuan Hospital, Chongqing Medical University, Chongqing, China.
authors.forename: Zuowei
authors.initials: Z
authors.lastname: Yuan
authors.forename: Weixian
authors.initials: W
authors.lastname: Chen
authors.forename: Juan
authors.initials: J
authors.lastname: Zhang
authors.forename: Jun
authors.initials: J
authors.lastname: Zhang
authors.forename: Tingxiu
authors.initials: T
authors.lastname: Xiang
authors.forename: Jieli
authors.initials: J
authors.lastname: Hu
authors.forename: Zhijuan
authors.initials: Z
authors.lastname: Wu
authors.forename: Xi
authors.initials: X
authors.lastname: Du
authors.forename: Ailong
authors.initials: A
authors.lastname: Huang
authors.forename: Jian
authors.initials: J
authors.lastname: Zheng
mesh_terms: D016915:AIDS Vaccines / Q000276:immunology*; D000595:Amino Acid Sequence; D000914:Antibodies, Viral / Q000097:blood; D017321:Clinical Trials, Phase I as Topic; D004797:Enzyme-Linked Immunosorbent Assay; D000939:Epitopes / Q000276:immunology; D005189:False Positive Reactions; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D015497:HIV-1 / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D008969:Molecular Sequence Data; D010446:Peptide Fragments / Q000276:immunology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D014611:Vaccination; D014613:Vaccines, Attenuated / Q000276:immunology*
chemical_list: D016915:AIDS Vaccines; D000914:Antibodies, Viral; D000939:Epitopes; D010446:Peptide Fragments; D011933:Reagent Kits, Diagnostic; D014613:Vaccines, Attenuated