An immunoassay (IA) that simultaneously detects both antibody to human immunodeficiency virus (HIV) and HIV p24 antigen (Architect HIV Ag/Ab Combo) was evaluated for its ability to detect HIV infection by using a panel of specimens collected from individuals recently infected with HIV type 1 (HIV-1). This IA was found to be capable of detecting the majority (89%) of infections, including 80% of those considered acute infections based on the presence of HIV RNA and the lack of detectable antibody to HIV. Substantial improvements in detection of recent infections by the Architect HIV Ag/Ab Combo relative to previous generations of IAs as well as the capacity to detect acute infections have important implications for HIV prevention strategies.
Background
It is hypothesized that sexually transmitted diseases (STDs) increase the risk of HIV acquisition. Yet, difficulties establishing an accurate temporal relation and controlling confounders have obscured this relationship. In an attempt to overcome prior methodologic shortcomings, we explored the use of different study designs to examine the relationship between STDs and HIV acquisition.
Methods
Acutely HIV-infected patients were included as cases and compared to 1) HIV-uninfected patients (matched case-control), 2) newly diagnosed, chronically HIV-infected patients (infected analysis), and 3) themselves at prior clinic visits when they tested HIV-negative (case-crossover). We used t-tests to compare the average number of STDs and logistic regression to determine independent correlates and the odds of acute HIV infection.
Results
Between October 2003 and March 2007, 13,662 male patients who had sex with men were tested for HIV infection at San Francisco's municipal STD clinic and 350 (2.56%) HIV infections were diagnosed. Among the HIV-infected patients, 36 (10.3%) cases were identified as acute. We found consistently higher odds of having had an STD within the 12 months (matched case-control, OR 5.2 [2.2-12.6]; infected analysis, OR 1.4 [1.0-2.0]; case-crossover, OR 1.3 [0.5-3.1]) and 3 months (matched case-control, OR 34.5 [4.1-291.3]; infected analysis, OR 2.3 [1.1-4.8]; case-crossover OR 1.8 [0.6-5.6]) prior to HIV testing among acutely HIV-infected patients. We found higher odds of acute HIV infection among patients with concurrent rectal gonorrhea (17.0 [2.6 - 111.4], p<0.01) or syphilis (5.8 [1.1 - 32.3], p=0.04) when compared to those HIV-uninfected.
Conclusions
Acute HIV infection was associated with a recent or concurrent STD, particularly rectal gonorrhea, among men at San Francisco's municipal STD clinic. Given the complex relationship between STDs and HIV infection, no single design will appropriately control for all the possible confounders; studies using complementary designs are required.
The integration of HIV nucleic acid amplification, recent infection, and antiretroviral resistance testing enhanced HIV/STD surveillance. The high proportion of NNRTI mutations detected suggests they may be more common in source partners or more fit for transmission than other forms of drug-resistant HIV-1. Primary antiretroviral resistance monitoring in STD clinic patients may guide the selection of treatment and post-exposure prophylaxis regimens active against viruses being transmitted in the community, and provide health departments with surveillance data in a sentinel population at risk of HIV transmission.
We have evaluated four current Food and Drug Administration-cleared rapid tests for human immunodeficiency virus (HIV)-specific antibodies with a panel of specimens from recently infected individuals. Recent infection was detected by RNA-based screening coupled with enzyme immunoassay-based testing. We found that the sensitivities of the various rapid tests vary greatly with regard to their ability to detect HIV-specific antibodies in recently infected individuals.The persistence of the human immunodeficiency virus (HIV) pandemic is in part the result of the inability to comprehensively test all at-risk individuals. Even when at-risk individuals submit to laboratory testing, the inherent limitations of laboratory-based testing can lead to the failure to identify or inform infected individuals. Such limitations include the window periods associated with antibody-based testing (the time between infection and the generation of detectable antibodies in the blood) and the limited sensitivities of certain antibody tests (2,3,11,22). Moreover, the turnaround time associated with the logistics of laboratory-based testing can result in patients not obtaining their test results (6,7,9,17,20). Point-ofcare testing (rapid testing) for HIV infection seeks to broaden the capacity of the public health and medical communities to identify and to inform infected individuals. Rapid tests are easy to perform and can give conclusive results within minutes, making them amenable for use in outreach centers, emergency rooms, doctor's offices, and clinics.
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