Performance evaluation of three automated human immunodeficiency virus antigen–antibody combination immunoassays

Performance of the Liaison XL Murex HIV Ab/Ag Test on Clinical Samples Representing Current Epidemic HIV Variants

“…S ince the discovery of HIV, many tests have been marketed for the diagnosis of HIV infection, and the performance of these tests has been extensively evaluated (1)(2)(3). First-, second-, and third-generations assays, which detect only antibodies against HIV, lack the sensitivity to detect primary infections and may fail to detect recent non-B subtype infections or divergent variants (1,4).…”

PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation

“…36,[154][155][156][158][159][160][161][162] Five studies reported differences in window period time from third-generation Ab and polymerase chain reaction (PCR) assays using seroconversion 292  PHS Guideline Public Health Reports / July-August 2013 / Volume 128 panels. Fourth-generation assays were reactive and ranged from 0 to 6.15 days before thirdgeneration Ab assays.…”

HIV-1 Diversity and Its Implications in Diagnosis, Transmission, Disease Progression, and Antiretroviral Therapy

“…These assays provide an advantage for detection of infection during the window period prior to seroconversion since the diagnostic window may be reduced by an average of 5 days relative to an IgM-sensitive EIA (Fiebig et al, 2003;Weber et al, 1998). However, some fourth-generation assays showed low sensitivity in the detection of p24 antigen from some non-subtype B HIV-1 strains (A, C, F, H, CRF01_AE, O) (Kwon et al, 2006;Ly et al, 2007;Ly et al, 2004;Ly et al, 2001;Weber, 2002). This low sensitivity in antigen detection may be attributed to differences in viral epitopes of the different HIV genetic forms which may not be recognized by the monoclonal antibody used in the assay (Plantier et al, 2009a).…”

“…Key epitope(s) targeted by these assays might be modified or eliminated by the occurrence of natural polymorphisms within the IDR region associated with the genetic variation of HIV-1, ultimately leading to reduced sensitivity or lack of antibody detection (Brennan et al, 2006;Gaudy et al, 2004). A few cases of false-negative results involving, for example, subtypes B, C, and F, and resulting from major mutations of the IDR epitope have been described (Aghokeng et al, 2009;Gaudy et al, 2004;Ly et al, 2007;Ly et al, 2004;Ly et al, 2001;Zouhair et al, 2006).…”