Oksana PenezinaNeil X. KruegerIsaac R. Rodriguez-ChavezMichael P. BuschJohn HuralJerome H. KimRobert J. O'ConnellEric HunterSaid AboudKeith HigginsVictor KovalenkoDavid ClaphamDavid CraneAndrew E. LevinSupachai Rerks-NgarmPunnee PitisuttithumSorachai NitayaphanJaranit KaewkungwalCharla AndrewsWilliam KilembeEtienne KaritaSusan AllenPatricia MunseriAgricola JoachimMuhammad BakariFred MhaluEric ArisCharlotta NilssonGunnel BiberfeldMerlin RobbMary MarovichEric SandstromImmunetics, Inc.National Institute of Dental and Craniofacial ResearchBlood Systems Research InstituteFred Hutchinson Cancer Research CenterWalter Reed Army Institute of ResearchArmed Forces Research Institute of Medical Sciences, ThailandEmory UniversityMuhimbili University of Health and Allied SciencesGlobal Solutions for Infectious DiseasesThailand Ministry of Public HealthMahidol UniversityMuhimbili National HospitalKarolinska InstitutetSwedish Institute for Communicable Disease ControlHJF2018-11-092018-11-092014-01-01Clinical and Vaccine Immunology. Vol.21, No.3 (2014), 391-3981556679X155668112-s2.0-84896767491https://repository.li.mahidol.ac.th/handle/20.500.14594/33513Vaccine-induced seropositivity (VISP) or seroreactivity (VISR), defined as the reaction of antibodies elicited by HIV vaccines with antigens used in HIV diagnostic immunoassays, can result in reactive assay results for vaccinated but uninfected individuals, with subsequent misclassification of their infection status. The eventual licensure of a vaccine will magnify this issue and calls for the development of mitigating solutions in advance. An immunoassay that discriminates between antibodies elicited by vaccine antigens and those elicited by infection has been developed to address this laboratory testing need. The HIV Selectest is based on consensus and clade-specific HIV peptides that are omitted in many HIV vaccine constructs. The assay was redesigned to enhance performance across worldwide clades and to simplify routine use via a standard kit format. The redesigned assay was evaluated with sera from vaccine trial participants, HIV-infected and uninfected individuals, and healthy controls. The HIV Selectest exhibited specificities of 99.5% with sera from uninfected recipients of 6 different HIV vaccines and 100% with sera from normal donors, while detecting HIV-1 infections, including intercurrent infections, with 95 to 100% sensitivity depending on the clade, with the highest sensitivities for clades A and C. HIV Selectest sensitivity decreased in very early seroconversion specimens, which possibly explains the slightly lower sensitivity observed for asymptomatic blood donors than for clinical HIV cases. Thus, the HIV Selectest provides a new laboratory tool for use in vaccine settings to distinguish the immune response to HIV vaccine antigens from that due to true infection. Copyright © 2014, American Society for Microbiology. All Rights Reserved.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyImmunology and MicrobiologyMedicineArticleSCOPUS10.1128/CVI.00748-13