Which lab assays are used to accurately diagnose early HIV infection?

Answer

A key feature of HIV infection is the prolonged clinical latency that occurs prior to significant immune deficiency.^{[5, 6, 7, 8, 9]}During this period, which is highly variable but generally lasts several years from the time of initial infection, the individual may exhibit few or no symptoms but is still able to transmit the infection to others. Early detection is important to minimize these risks.

Accurate diagnosis of HIV infection has evolved over time and has historically relied on detection of antibodies specific to HIV-1 or HIV-2 infection. The period immediately following HIV infection, before the development of antibodies, is the “window period” during which an antibody test result may be negative. Newer fourth-generation HIV tests combine antibody and antigen detection. These combination immunoassays allow earlier HIV detection, as they detect both HIV-1 and HIV-2 antibodies, as well as HIV-1 p24 antigen.^[10]The p24 antigen is a viral capsid protein that arises in early infection, before development of HIV antibodies.

Importantly, clinicians should be aware that HIV testing should include assays that are specific for both HIV-1 and HIV-2. Most worldwide HIV infections are due to HIV-1. HIV-2 should be considered in individuals from West Africa or in persons with sex partners from West Africa. Some HIV antibody tests are specific only for HIV-1 antibodies. HIV-2 should also be considered in people with clinical evidence of HIV infection who are HIV-1–negative or have indeterminate testing results. Monitoring HIV-2 infection is difficult, as available viral load testing is specific for HIV-1.

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Media Gallery

Schematic of enzyme-linked immunoassay (ELISA) technique. 1) viral antigen is bound to a solid substrate. 2) Patient serum with specific antibodies is added and binds to the antigen. 3) After removal of excess antibody, a detection antibody is added, to confirm binding of patient antibodies.

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Author

Philip A Chan, MD, MS Assistant Professor of Medicine, The Warren Alpert Medical School of Brown University; Assistant Professor of Behavioral and Social Sciences, Brown University School of Public Health; Medical Director, Center for HIV/AIDS, Viral Hepatitis, STDs and TB, Rhode Island Department of Health; Director, The Miriam Hospital Pre-exposure Prophylaxis (PrEP) Clinic; Director, The Miriam Hospital Sexually Transmitted Diseases Clinic; Attending Physician, Rhode Island Hospital, The Miriam Hospital, and Women’s and Infants Hospital

Philip A Chan, MD, MS is a member of the following medical societies: American Sexually Transmitted Diseases Association, Infectious Diseases Society of America, National Coalition of STD Directors

Disclosure: Nothing to disclose.

Coauthor(s)

Michaela A Maynard, MPH, MSN, NP-C, WHNP-BC RI Nurse Practitioner, Division of Infectious Diseases, The Miriam Hospital; Research Associate, Department of Medicine, The Warren Alpert Medical School of Brown University

Michaela A Maynard, MPH, MSN, NP-C, WHNP-BC is a member of the following medical societies: American Association of Nurse Practitioners

Disclosure: Nothing to disclose.

Chief Editor

John Bartlett, MD Professor Emeritus, Johns Hopkins University School of Medicine

John Bartlett, MD is a member of the following medical societies: Alpha Omega Alpha, American College of Clinical Pharmacology, American College of Physicians, American Society for Microbiology, American Society of Tropical Medicine and Hygiene, American Thoracic Society, American Venereal Disease Association, Association of American Physicians, Infectious Diseases Society of America, Society of Critical Care Medicine

Disclosure: Nothing to disclose.

Additional Contributors

Nicholas John Bennett, MBBCh, PhD, MA(Cantab), FAAP Assistant Professor of Pediatrics, Co-Director of Antimicrobial Stewardship, Medical Director, Division of Pediatric Infectious Diseases and Immunology, Connecticut Children's Medical Center

Nicholas John Bennett, MBBCh, PhD, MA(Cantab), FAAP is a member of the following medical societies: Alpha Omega Alpha, American Academy of Pediatrics

Disclosure: Received research grant from: Cubist<br/>Received income in an amount equal to or greater than $250 from: Horizon Pharmaceuticals, Shire<br/>Medico legal consulting for: Various.

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