Sensitivity of Five Rapid HIV Tests on Oral Fluid or Finger-Stick Whole Blood: A Real-Time Comparison in a Healthcare Setting

• Published in: PloS one Vol. 5; no. 7; p. e11581
• Main Authors: Pavie, Juliette, Rachline, Anne, Loze, Bénédicte, Niedbalski, Laurence, Delaugerre, Constance, Laforgerie, Eric, Plantier, Jean-Christophe, Rozenbaum, Willy, Chevret, Sylvie, Molina, Jean-Michel, Simon, François
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 19.07.2010; Public Library of Science (PLoS)
• Subjects: Acquired immune deficiency syndrome; Adolescent; Adult; Adults; AIDS; AIDS Serodiagnosis - methods; Analysis; Antibodies; Antiretroviral agents; Antiretroviral drugs; Antiretroviral therapy; Blood; Clinical trials; Developing countries; Disease prevention; Europe; Female; Finger; Fingers - blood supply; Health aspects; Health care; Health surveillance; Highly active antiretroviral therapy; HIV; HIV Antibodies - analysis; HIV Antibodies - blood; HIV infections; HIV Infections - diagnosis; HIV tests; Human immunodeficiency virus; Human immunodeficiency virus 1; Human immunodeficiency virus 2; Humans; Immunoglobulins; Infection; Infections; Infectious Diseases/HIV Infection and AIDS; Infectious Diseases/Sexually Transmitted Diseases; Infectious Diseases/Viral Infections; LDCs; Male; Medical laboratories; Medical tests; Middle Aged; Patients; Public health; Quality control; Ribonucleic acid; RNA; Saliva - chemistry; Savings banks; Sensitivity; Sensitivity and Specificity; Therapy; Virology/Diagnosis; Viruses; Young Adult; Europe; France
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0011581

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. 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). 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.