title: Performance of OraQuick Advance Rapid HIV-1/2 Antibody Test for detection of antibodies in oral fluid and serum/plasma in HIV-1+ subjects carrying different HIV-1 subtypes and recombinant variants.
abstract: BACKGROUND
  Rapid, simple, low-cost, sensitive, and specific tests are needed to detect antibodies to all HIV-1 subtypes, especially in developing countries.
  
  
  OBJECTIVE
  To evaluate the performance of a rapid diagnostic test for detection of HIV-1/2 antibodies in oral fluids and sera/plasma from subjects from geographic areas infected with different HIV-1 variants.
  
  
  METHODS
  OraQuick Rapid HIV-1/2 Diagnostic Test was evaluated in sera and oral fluids from 100 subjects from Spain and South-America. It was also assessed in 56 plasma and 39 oral fluid specimens from 56 Africans carrying HIV-1 non-B subtypes or inter-subtype recombinants defined by phylogenetic analysis at pol and gp41 coding regions. All patients were previously diagnosed as HIV-1 positive by serological tests (Abbott AxSYM HIV-1/2; Western Blot HIV-1/HIV-2 and Pepti-LAV, BIO-RAD).
  
  
  RESULTS
  OraQuick provided positive results in all 156 serum/plasma specimens regardless of the infecting HIV-1 subtype, and in 136/139 (97.8%) oral fluids. The three oral specimens (2.2%) that yielded false-negative results by OraQuick were taken from one subtype B-infected Spaniard and from two subtype D-infected Africans. The last two were also negative by Pepti-LAV using plasma samples. Ten additional sera and 32 oral fluids from HIV-negative individuals yielded negative results by OraQuick. This rapid test showed good sensitivity for detecting anti-HIV-1 antibodies in oral fluids and in serum/plasma specimens from subjects carrying different HIV-1 subtypes and recombinant variants.
  
  
  CONCLUSIONS
  OraQuick demonstrated its utility for detecting infections due to HIV-1 subtypes and recombinants common in developing countries.
authors.affiliation: Department of Infectious Diseases, Hospital Carlos III, Madrid, Spain. aholguin.hciii@salud.madrid.org
authors.forename: Africa
authors.initials: A
authors.lastname: Holguín
authors.forename: Maite
authors.initials: M
authors.lastname: Gutiérrez
authors.forename: Nieves
authors.initials: N
authors.lastname: Portocarrero
authors.forename: Pablo
authors.initials: P
authors.lastname: Rivas
authors.forename: Margarita
authors.initials: M
authors.lastname: Baquero
mesh_terms: D000349:Africa; D001769:Blood / Q000276:immunology*; D005188:False Negative Reactions; D005260:Female; D015483:HIV Antibodies / Q000032:analysis* / Q000097:blood*; D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000145:classification* / Q000276:immunology; D015498:HIV-2 / Q000276:immunology; D006801:Humans; D008297:Male; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013020:South America; D013030:Spain; D013183:Sputum / Q000276:immunology*
chemical_list: D015483:HIV Antibodies; D011933:Reagent Kits, Diagnostic