Testing Reports for Health Care Providers If the RNA test is positive, HIV-1 infection is present and the patient is likely to be in the acute or very early stage of infection. If HIV antibodies are not confirmed, the laboratory should reflex to an HIV-1 RNA (nucleic acid test or NAT) detection test to distinguish between a false positive screening result and an acute HIV infection. If this test is positive for HIV-1 antibodies or HIV-2 antibodies, HIV antibodies are confirmed, and clinicians may proceed with tests appropriate for initial evaluation of an infected individual. The first is a supplemental test that has been FDA-approved to detect and differentiate HIV-1 and HIV-2 antibodies. In the new algorithm, confirmation is provided by a specific sequence of supplemental tests. When the 4th generation test result is "Reactive" this is considered to be a presumptive positive result and additional testing is required for confirmation. The benefit of this technology is that it can detect HIV-1 during the acute state via antigen detection as well as chronic stages of infection via antibody detection. The new algorithm is intended to begin with an HIV-1/2 immunoassay capable of detecting HIV antigens (Ag) and antibodies (Ab), commonly referred to as an Ag/Ab combo or 4th generation immunoassay. The HIV Diagnostic Testing Algorithm is a multi-test algorithm, incorporating tests that detect HIV antigens, antibodies and RNA, and the final interpretation is based on a combination of test results rather than a single confirmatory test such as the Western blot.Īn important factor in HIV diagnostic testing is the sensitivity of the initial test. This algorithm differs significantly from the conventional strategy of antibody screening followed by the Western Blot. The new HIV Diagnostic Testing Algorithm is described in Attachment 1. Attachment 2: Interpreting Clinical Laboratory Results from the HIV Diagnostic Testing Algorithm (PDF, 20 KB, 1pg.).Attachment 1: The HIV Diagnostic Testing Algorithm (PDF, 110 KB, 1pg.).The New York State Department of Health (NYSDOH) recently provided interim guidance to NYS-permitted laboratories, and this letter provides information for clinicians on use of the new algorithm. 2,3,4 Recommendations from the Centers for Disease Control and Prevention (CDC) for its use are anticipated. A new HIV Diagnostic Testing Algorithm has been verified through scientific studies 1 and offers several advantages over the traditional enzyme immunoassay (EIA)-Western blot algorithm, including earlier and more accurate detection of HIV infections, the ability to differentiate between HIV-1 and HIV-2 infections, and lower costs. While these traditional confirmatory tests continue to have a role in HIV diagnosis, technological developments over the past few years have allowed assessment of testing algorithms that do not rely on these methods. In the past, HIV diagnostic testing was based solely on antibody detection and tests such as Western Blot of IFA (immunofluorescent antibody) were required to confirm HIV antibodies following a reactive screening test. The purpose of this letter is to update clinicians about a new HIV Diagnostic Testing Algorithm for diagnosis of HIV infection. Information for Clinicians on a New Diagnostic Testing Algorithm for Human Immunodeficiency Virus (HIV) Infection All Health Care Professionals & Patient Safety.Clinical Guidelines, Standards & Quality of Care.Health & Safety in the Home, Workplace & Outdoors.Birth, Death, Marriage & Divorce Records.
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