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Rapid Diagnostic Testing for HIV:
Clinical Implications of a New Diagnostic Tool

PART I:
RAPID DIAGNOSTIC TESTING FOR HIV: CLINICAL IMPLICATIONS

HIV counseling and testing needs to be integrated into the routine medical care of patients.6 Clinicians frequently have patients to whom HIV testing should be offered. These include:

  • Pregnant women,
  • Persons with a possible acute occupational exposure,
  • Patients with a known sexual or needle-sharing exposure to the virus,
  • Patients in settings serving populations at increased behavioral or clinical risk,
  • Patients in areas in which the prevalence of HIV disease is 1% or greater,
  • Patients with a self-reported HIV risk behavior, such as injection drug use, men who have sex with men, and unprotected vaginal or anal intercourse with more than one sexual partner or with a partner who may be infected with HIV,
  • Patients who specifically request an HIV test,
  • Patients with clinical signs or symptoms of HIV disease (e.g., fever, illness of unknown origin, oral thrush, unexplained lymphadenopathy with or without weight loss, psoriasis, or laboratory values suggestive of HIV disease, e.g., low white blood count, anemia), and
  • Patients with a diagnosis suggesting increased risk of HIV disease such as opportunistic infections, tuberculosis, cervical or anal cancer, Kaposi’s sarcoma, lymphoma, recurrent pneumonia or bacteremia, hepatitis B, hepatitis C, or a sexually transmitted disease should be offered counseling and testing.7.8

The major focus of HIV prevention and control has been to promote the acceptance of risk reducing behaviors through prevention counseling and testing and to facilitate linkage to medical prevention and other support services.6 Testing has played a major role in reducing the transmission of HIV. The percentage of adults in the United States who obtain an HIV test has remained 10 – 12% per year for more than a decade.9

Early and rapid diagnosis of HIV began to assume particular importance as effective combination antiretroviral therapy became available. Combination therapy contributes to reducing the risk of vertical and occupational HIV transmission while improving the quality of life and the longevity of persons infected with HIV disease. A significant reduction in the lag time between risk exposure and the availability of testing results required the evolution of a new approach to HIV testing – the rapid HIV test. Six rapid HIV tests have been approved by the United States Food and Drug Administration (FDA) for commercial use: the Single Use Diagnostic System for HIV-1, (SUDS, Abbott Laboratories, Abbott Park, IL—no longer marketed), OraQuick® HIV1 and the OraQuick® Advance HIV-1/HIV-2, (OraSure Technologies, Bethlehem, PA), Reveal™ G2 Rapid HIV-1 Antibody Test (MedMira Laboratories, Halifax, Nova Scotia), Uni-Gold™ Recombigen® HIV (Trinity Biotech plc (Wicklow, Ireland), and Multispot HIV-1/HIV-2 (Bio-Rad Laboratories, Hercules, CA). Additional rapid HIV tests are under consideration by the FDA.

Because rapid point-of-care testing offers the advantage that people do not need to return to obtain their test results; more people know their HIV status, and if infected, can be referred for treatment, prevention programs, and social services much more rapidly. People who know they are infected with HIV are more likely to practice risk-reduction, especially, if a brief behavioral intervention is conducted at the patient visit.6 Rapid HIV testing offers the advantage of providing test results at the time of the behavioral intervention.

Rapid diagnostic HIV testing has several clinical applications. This paper describes rapid HIV testing and its role in:

  1. reducing vertical HIV transmission for women who present in labor with unknown HIV status,
  2. reducing the risk of occupational transmission of HIV,
  3. as part of the initial evaluation of a patient for non-occupational postexposure prophylaxis, and
  4. assisting in diagnosis and counseling of patients with HIV disease.

Rapid HIV testing plays a crucial role in time-sensitive decisions regarding the need for prophylaxis to reduce transmission in cases of occupational exposures and women presenting in labor with unknown HIV status.10 Detailed information on these rapid HIV tests, their interpretation, counseling, and laboratory licensure requirements is provided in the second part of this article: “Rapid Testing: A New Diagnostic Tool for HIV.”