HIV testing algorithms : a status report

HIV Testing Algorithms: A Status Report outlines a menu of testing algorithms, for both laboratory and point-of-contact laboratory settings based on the testing technology and data available in 2009. Since its publication, there have been several developments in the field of HIV diagnostics including the FDA-approval of antigen/antibody combination assays and the evaluation of new data. The Status Report was a great step forward in the process of updating the algorithm, and it remains an important source of historical information regarding the rationale for diagnostic strategies. The approval of antigen/antibody combination (fourth generation) immunoassay technology and the proceedings of the 2010 HIV Diagnostics Conference led to significant progress in the development of HIV testing strategies, and the release of updated recommendations for laboratory HIV testing superseded those in the Status Report.Date on cover: April 2009.Update: March 2010.Since HIV Testing Algorithms: A Status Report was published in April, 2009, several developments have occurred that necessitated an update to the report. At several points in the laboratory algorithms section of the report (pp. 25-31, 32, 39, 41), the April 2009 version stated that a plasma specimen is required to conduct HIV nucleic acid amplification testing (NAAT). The qualitative RNA NAAT that is FDAapproved as a supplemental test can now be used with serum specimens as well as plasma. Several instances in the Status Report (pp. 25, 29, 38, 39) also state that it may be necessary to repeat a positive NAAT for confirmation. This is only recommended with tests that are not FDA-approved for supplemental testing, or with specimens that are negative for HIV antibody."Since HIV Testing Algorithms: A Status Report was published in April, 2009, several developments have occurred that necessitated an update to the report. At several points in the laboratory algorithms section of the report (pp. 25-31, 32, 39, 41), the April 2009 version stated that a plasma specimen is required to conduct HIV nucleic acid amplification testing (NAAT). The qualitative RNA NAAT that is FDA-approved as a supplemental test can now be used with serum specimens as well as plasma. Several instances in the Status Report (pp. 25, 29, 38, 39) also state that it may be necessary to repeat a positive NAAT for confirmation. This is only recommended with tests that are not FDA-approved for supplemental testing, or with specimens that are negative for HIV antibody. To avoid any confusion between the original and updated versions of the status report, additions and changes to the text have been highlighted; deleted text has been struck through. March 18, 2010 "Includes bibliographical references (p. 49-52).In 1989 the Centers for Disease Control and Prevention (CDC) and the Association of Public Health Laboratories (APHL) released recommendations for a sequential, two-test algorithm for serodiagnosis of HIV-1 infection. In this algorithm, screening is conducted with an enzyme immunoassay (EIA). Specimens repeatedly reactive by EIA are subjected to a more specific supplemental test, either a Western blot (WB) or an indirect immunofluorescence assay (IFA). Over the past two decades, many advances in HIV diagnostics have been achieved: less complex rapid tests have been FDA-approved for screening at the point of contact (POC) with the patient, more sensitive and specific laboratory-based tests are available, and more complex rapid tests can detect HIV-2. The 'HIV Testing Algorithms: Status Report' describes a menu of HIV testing algorithms that have the potential to augment and provide alternatives to the algorithm currently used to diagnose HIV infection. APHL and CDC convened two working groups of HIV diagnostic subject matter experts to develop these new algorithms. This report describes algorithms to use in POC and laboratory settings, as well as supporting evidence, limitations, and additional data needed to substantiate the algorithms as of April 2009. This document does not contain recommendations from either CDC or APHL.Berry Bennett, Bernard Branson, Kevin Delaney, Michele Owen, Michael Pentella, Barbara Werner."A publication from the Association of Public Health Laboratories and the Centers for Disease Control & Prevention.