Abstract
BackgroundHealth 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.Methods and Findings200 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).ConclusionWhen 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.
Highlights
Late diagnosis of human immunodeficiency virus (HIV) infection, resulting in delayed patient management, is associated with poorer survival [1]
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
In the United States, the Centers for Diseases Control and Prevention have recommended extending HIV antibody testing to people aged 13–64 years [6]. Such a program would be implemented in a variety of healthcare settings, such as hospital emergency departments, and could involve disposable rapid HIV diagnostic tests, the patient receiving the necessary information at the same site [6]
Summary
Late diagnosis of human immunodeficiency virus (HIV) infection, resulting in delayed patient management, is associated with poorer survival [1]. In the United States, the Centers for Diseases Control and Prevention have recommended extending HIV antibody testing to people aged 13–64 years [6] Such a program would be implemented in a variety of healthcare settings, such as hospital emergency departments, and could involve disposable rapid HIV diagnostic tests, the patient receiving the necessary information at the same site [6]. Medical laboratories have been using these rapid tests for more than two decades to test serum and plasma, in developing countries and for emergency diagnosis [7] They are simple to use but lack sensitivity relative to reference enzyme immunoassays (EIA), during primary HIV infection and infection by variant strains [8]. Several HIV rapid tests are licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known
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