HIV-Selectest Enzyme Immunoassay and Rapid Test: Ability To Detect Seroconversion following HIV-1 Infection

Khurana, Surender; Norris, Philip J.; Busch, Michael P.; Haynes, Barton F.; Park, Susan; Sasono, Pretty; Mlisana, Koleka; Karim, Salim Safurdeen. Abdool; Hecht, Frederick M.; Mulenga, Joseph; Chomba, Elwyn; Hunter, Eric; Allen, Susan; Nemo, George J.; Rodriguez-Chavez, Isaac R.; Margolick, Joseph B.; Golding, Hana

doi:10.1128/jcm.01573-09

Cited by 8 publications

(7 citation statements)

References 10 publications

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“…A test that identifies the conserved epitopes not included in vaccine trials is currently in development to address this need [72,73]. The assay sensitivity is comparable to antibody-detecting rapid tests [74], which is encouraging.…”

Section: Virus-and Vaccine-induced Antibodiesmentioning

confidence: 87%

HIV Diagnostics: Challenges and Opportunities

Wong

Hewlett

2010

HIV Ther.

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Accurate HIV diagnostic testing continues to pose challenges, but there are also opportunities for assay performance improvements in key areas for specific intended-use settings. The genetic diversity of HIV can result in false and discordant results in assays that fail to detect new variant strains. The use of antiretroviral therapies has resulted in drug-resistant variants that require monitoring by sequencing and genotyping methods. Nucleic acid testing is the most sensitive and reliable platform for detection, but it is costly and limited to centralized testing facilities, making implementation difficult in resource-limited settings where HIV has hit the hardest. Rapid antibody tests suitable for point-of-care use are becoming more accessible in resource-limited settings, but these tests may not detect HIV during the acute infection stage. Emerging antigen/antibody combination assays are viable alternatives to nucleic acid testing for diagnosis of recent infections. Although patient monitoring (e.g., via CD4+ T-cell count and viral load determination) and infant diagnoses still rely on clinical laboratory-based testing, point-of-care options are being developed. There are other technical challenges to HIV diagnostic testing and emerging biodetection technologies that may be able to address them, but they are not yet proven.

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Section: Virus-and Vaccine-induced Antibodiesmentioning

confidence: 87%

HIV Diagnostics: Challenges and Opportunities

Wong

Hewlett

2010

HIV Ther.

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“…This phenomenon is similar to the observation made for the corresponding sequences in the cytoplasmic domain sequence of HIV-gp41 envelope, which were not recognized by serum antibodies from individuals vaccinated with HIV envelope-based vaccines but were strongly reactive to serum antibodies from HIV-infected individuals. These findings led to development of a novel serodiagnostic assay termed HIV-Selectest for differential diagnosis of true HIV infections in the face of HIV vaccine-induced antibodies that is currently being developed for feasibility studies (13,14).…”

Section: Discussionmentioning

confidence: 99%

H5N1-SeroDetect EIA and Rapid Test: a Novel Differential Diagnostic Assay for Serodiagnosis of H5N1 Infections and Surveillance

Khurana

Sasono

Fox

et al. 2011

J Virol

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Continuing evolution of highly pathogenic (HP) H5N1 influenza viruses in wild birds with transmission to domestic poultry and humans poses a pandemic threat. There is an urgent need for a simple and rapid serological diagnostic assay which can differentiate between antibodies to seasonal and H5N1 strains and that could provide surveillance tools not dependent on virus isolation and nucleic acid technologies. Here we describe the establishment of H5N1 SeroDetect enzyme-linked immunosorbent assay (ELISA) and rapid test assays based on three peptides in HA2 (488-516), PB1-F2 (2-75), and M2e (2-24) that are highly conserved within H5N1 strains. These peptides were identified by antibody repertoire analyses of H5N1 influenza survivors in Vietnam using whole-genome-fragment phage display libraries (GFPDLs). Highly pathogenic avian influenza (HPAI) A viruses of the H5N1 subtype are still causing widespread infections and significant lethality in bird populations throughout Southeast Asia, with spread into Central Asia, Africa, and Europe (5). In unvaccinated chickens, H5N1 infectiousness develops very quickly after infection (0.25 day) and transmission among birds is very efficient (3, 18). Numerous instances of human transmission have occurred, resulting in severe disease or death (9,23,24,26,28). As of 2 August 2011, there have been 563 human cases of H5N1 infection, resulting in 330 deaths (mortality ϭ 59%).In the absence of preexisting immunity against these strains, it is feared that further adaptation of the HPAI viruses for human-to-human transmission will result in a global pandemic. Currently, the only assay for diagnosis of H5N1 infection is a reverse transcription-PCR (RT-PCR)-based nucleic acid detection assay that involves isolation of viral RNA from infected individuals and cannot diagnose patients more than 2 to 3 weeks post-H5N1 infection, as RNA is not detectable after the clearance of virus. Therefore, H5N1 virus is detected in individuals mainly during the period of acute illness. Hence, the number of human H5N1 influenza cases is likely underreported, missing nonsymptomatic H5N1 virus exposure cases (household and contact cases and also people exposed to poultry and environmental sources). Currently available serologic tests include hemagglutination inhibition (HI), microneutralization (MN) assay, enzyme-linked immunosorbent assay (ELISA), and the agar gel precipitation test. However, these assays suffer from low sensitivity, are labor-intensive, and often require specialized biocontainment facilities, which prevents the usage of these assays for rapid screening outside a central laboratory setting. The development of a simple and rapid serodiagnostic method that can detect antibodies soon after infection as well as antibodies lasting long (months to years) after H5N1 infection is urgently required for large-scale surveillance of humans and domestic poultry and could provide an early warning of an impending pandemic with HP H5N1 viruses. Moreover, it is very important to differentiate between vaccin...

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“… 43 This powerful tool can be used for population screening by blood banks and can protect participants of HIV clinical trials from the physical, emotional, and economic or social harms of being falsely diagnosed with an HIV infection. 13 , 43 OWH funded a portion of the tool's development to guarantee that it would have high sensitivity in both women and men. The tool is undergoing redevelopment to improve its function across multiple clades of HIV-1 virus, so that it can be used to help manage global aspects of the HIV epidemic.…”

Section: Research To Improve Clinical Trialsmentioning

confidence: 99%

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

Obias-Manno

Scott

Kaczmarczyk

et al. 2016

Journal of Women's Health

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The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

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HIV-Selectest Enzyme Immunoassay and Rapid Test: Ability To Detect Seroconversion following HIV-1 Infection

Cited by 8 publications

References 10 publications

HIV Diagnostics: Challenges and Opportunities

HIV Diagnostics: Challenges and Opportunities

H5N1-SeroDetect EIA and Rapid Test: a Novel Differential Diagnostic Assay for Serodiagnosis of H5N1 Infections and Surveillance

The Food and Drug Administration Office of Women's Health: Impact of Science on Regulatory Policy: An Update

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