When rapid tests are most useful. Rapid tests can be particularly useful for testing women presenting in labor who have not been screened for HIV as part of prenatal care. They also can be used to determine the need for postexposure prophylaxis in the event of a needlestick injury. According to manufacturer’s data, the sensitivity of rapid tests ranges from 99.3% to 100% and specificity from 99.7% to 99.9%.12 However, in real-world experience these numbers have been slightly lower.12 By comparison, the sensitivity and specificity of the fourth-generation EIAs are 99.4% and 99.5%, respectively.14
The downside... A disadvantage of rapid HIV testing is that under current FDA-approval status and CDC guidance, tests performed on oral fluid must have serologic confirmation. In addition, patients tested during the “window period” of seroconversion (after infection occurs but before antibodies are detectable) will test negative with rapid HIV tests and must be reminded that repeat testing should be done within 4 to 6 weeks of their last potential exposure to the virus. In high-prevalence settings such as urban emergency departments (EDs), rapid HIV tests have detected a significant number of new infections.15 However, ED physicians and urgent care providers have been reluctant to perform HIV tests due to the lack of follow-up for most patients treated in these settings.
Over-the-counter (OTC) tests. Approved by the FDA in 2012, the OraQuick In-Home HIV Test is the only available OTC test for use at home. Patients can go to the company’s Web site at www.oraquick.com to learn more about HIV and testing, and the company offers 24-hour phone support. It’s not clear how many patients are taking advantage of this home testing option. The test costs approximately $40 and several studies suggest that this price may deter patients from using it.16 In addition, it is not clear how patients who test positive using an OTC test will access medical care or get appropriate medical follow-up.
New testing algorithm eliminates Western blot
Historically, a patient with a reactive (positive) EIA result would undergo the Western blot assay as a confirmatory test. Although the Western blot for HIV is highly specific (99.7%), it tests only for the IgG antibody. This could lead to a false negative test in a patient in whom IgG seroconversion has not yet occurred. Additionally, the time for HIV confirmation with the Western blot often is one week or longer.
Recently, the CDC has made available for public comment a diagnostic algorithm that removes the Western blot as a recommended test (FIGURE 2).17 This algorithm replaces the Western blot with an assay to differentiate HIV-1 and HIV-2 antibodies. Patients for whom this test is negative should undergo additional testing for HIV RNA to determine if HIV-1 is present. Positive HIV RNA would indicate acute or more recent infection. Studies suggest that this new algorithm is better than the existing algorithm at detecting HIV infections, and many reference labs have already adapted it.17,18
Choosing your words carefully when giving patients their results
Patients can be given the results of a rapid HIV test during their visit, but a positive result on a rapid test should be confirmed by serologic testing. When speaking with a patient who tests positive on a rapid test, consider using the phrase “preliminary positive” results. This allows the patient to more easily process the results, knowing that a confirmatory blood draw will be done. State laws vary regarding how patients can receive HIV test results. Most states allow negative serologic test results to be given over the telephone (or electronically). For positive tests, it is preferable to give these results at a face-to-face consultation so that you can ensure the patient will have access to medical care. For more on HIV testing and lab reporting laws by state, see http://www.cdc.gov/hiv/policies/law/states/index.html.
CORRESPONDENCE
Jeffrey T. Kirchner, DO, FAAFP, AAHIVS, Family and Community Medicine, Lancaster General Hospital, 555 N. Duke Street #3555, Lancaster, PA 17602; jtkirchn@lghealth.org