title: Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting.
abstract: BACKGROUND
  Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known.
  
  
  RESULTS
  200 adults with documented HIV-1 (n=194) or HIV-2 infection (n=6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2 was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2, Determine HIV 1-2, Determine HIV-1/2 Ag/Ab Combo and INSTI HIV-1/HIV-2. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p=0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level<200 cp/ml was significantly associated with a false-negative result (p=0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p=0.04; 100%, p=0.004; and 100%, p=0.02, respectively).
  
  
  CONCLUSIONS
  When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.
authors.affiliation: Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France.
authors.forename: Juliette
authors.initials: J
authors.lastname: Pavie
authors.forename: Anne
authors.initials: A
authors.lastname: Rachline
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Loze
authors.forename: Laurence
authors.initials: L
authors.lastname: Niedbalski
authors.forename: Constance
authors.initials: C
authors.lastname: Delaugerre
authors.forename: Eric
authors.initials: E
authors.lastname: Laforgerie
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Plantier
authors.forename: Willy
authors.initials: W
authors.lastname: Rozenbaum
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Molina
authors.forename: François
authors.initials: F
authors.lastname: Simon
mesh_terms: D015492:AIDS Serodiagnosis / Q000379:methods*; D000293:Adolescent; D000328:Adult; D005060:Europe; D005260:Female; D005385:Fingers / Q000098:blood supply*; D015483:HIV Antibodies / Q000032:analysis / Q000097:blood; D015658:HIV Infections / Q000175:diagnosis*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012463:Saliva / Q000737:chemistry*; D012680:Sensitivity and Specificity; D055815:Young Adult
chemical_list: D015483:HIV Antibodies