Monica M. Parker, PhD

Disclosures

January 24, 2017

In This Article

Introduction

New York State's Blueprint to End the AIDS Epidemic, announced by Governor Andrew Cuomo in June 2014, includes identifying undiagnosed HIV-infected individuals and linking them to healthcare so that they can be treated with antiretroviral therapy and achieve viral suppression. This treatment will both improve the health of those infected with HIV and reduce their risk for transmitting the virus to others.

Accurate and timely diagnosis of anyone with HIV infection is fundamental to the treatment-as-prevention strategy and to reducing new infections in New York to below epidemic levels by 2020. The New York State Department of Health AIDS Institute's recent HIV testing guideline describes the advances in HIV diagnostic methods that are central to accurate diagnosis or exclusion of HIV infection.

Rationale

Beginning in the late 1980s and early 1990s, the highly specific antibody-based Western blot test was used exclusively to establish a diagnosis of HIV infection. The test provided assurance that false-positive results would be rare, during a time when the consequences of being diagnosed with HIV infection were dire. However, a positive result could be produced only after a person had been infected for 6-8 weeks—the amount of time required, on average, to develop sufficient antibodies.[1]

Since then, antiretroviral therapy has evolved, and HIV is now considered a manageable chronic disease. However, despite the many positive developments in HIV care and treatment, the persistently high incidence of HIV transmission in the United States is now associated with the early and acute stages of infection, when antibody-based tests are unable to detect infection but an individual's viral load is often very high.[2,3,4,5,6]

To address this situation, a concerted effort was made among public health agencies to develop a new testing algorithm that provided the following: (1) earlier and more accurate detection of HIV-1, including acute infection; (2) faster turnaround time for results; (3) more accurate diagnosis of HIV-2 infection; and (4) fewer indeterminate and inconclusive results requiring follow-up testing.[7] After years of evaluation, in June 2014, the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) issued an updated algorithm and recommendations for laboratories that perform HIV diagnostic testing.[7] The new laboratory testing algorithm included not only antibody-based testing but also assessment for antigens and HIV RNA, two markers that can be detected earlier in infection. The new recommendations also used a defined testing sequence to maximize sensitivity, specificity, and turnaround time.

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