Rapid HIV antibody tests recently approved by the Food and Drug Administration can help reduce unrecognized infections by improving access to testing in both clinical and nonclinical settings and increase the proportion of those tested who learn their results. Four rapid HIV antibody tests are now available in the United States; two are approved for use at point-of-care sites outside a traditional laboratory. All four tests are interpreted visually. Sites offering rapid HIV testing must periodically run external controls (known HIV-positive and HIV-negative specimens) and provide persons who undergo rapid testing a subject information sheet. This paper reviews the operating and performance characteristics, quality assurance and laboratory requirements, and HIV counseling implications of the currently available rapid HIV tests.
Acute infection with human immunodeficiency virus (HIV) is often accompanied by a flu-like illness, and early identification and treatment may help control the infection and prevent transmission. We enrolled patients who presented to an urban urgent care center with any symptoms of a viral illness and any recent potential risk for HIV infection, and we tested them for acute HIV infection using enzyme-linked immunosorbent and RNA assays. Of 499 patients enrolled over a 1-year period, acute HIV infection was diagnosed in 5 (1.0%; 95% confidence interval [CI], 0.1%-1.9%), and chronic HIV infection was diagnosed in 6 (1.2%; 95% CI, 0.2%-2.2%). There were no false-positive results of the RNA assay. No signs or symptoms reliably distinguished patients with acute HIV infection from those who were HIV uninfected. Given the importance of this diagnosis, testing for acute HIV infection using RNA and antibody assays should be offered to all patients in similar settings with viral symptoms and any risk factors for HIV infection.
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