title: Nanoparticle-Based biobarcode amplification assay (BCA) for sensitive and early detection of human immunodeficiency type 1 capsid (p24) antigen.
abstract: Nanotechnology-based techniques are being widely evaluated in medical testing and could provide a new generation of diagnostic assays due to their high degrees of sensitivity, high specificity, multiplexing capabilities, and ability to operate without enzymes. In this article, we have modified a nanoparticle-based biobarcode amplification (BCA) assay for early and sensitive detection of HIV-1 capsid (p24) antigen by using antip24 antibody-coated microplates to capture viral antigen (p24) and streptavidin-coated nanoparticle-based biobarcode DNAs for signal amplification, followed by detection using a chip-based scanometric method. The modified BCA assay exhibited a linear dose-dependent pattern within the detection range of 0.1 to 500 pg/ml and was approximately 150-fold more sensitive than conventional enzyme-linked immunosorbent assay (ELISA). No false positive results were observed in 30 HIV-1-negative samples, while all 45 HIV-1 RNA positive samples were found HIV-1 p24 antigen positive by the BCA assay. In addition, the BCA assay detected HIV-1 infection 3 days earlier than ELISA in seroconversion samples. Preliminary evaluation based on testing a small number of samples indicates that the HIV-1 p24 antigen BCA may provide a new tool for sensitive and early detection of HIV-1 p24 antigen in settings where HIV-1 RNA testing is currently not routinely performed.
authors: Lab of Molecular Virology, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD 20892, USA. shixing.tang@fda.hhs.gov
authors: Shixing
authors: S
authors: Tang
authors: Jiangqin
authors: J
authors: Zhao
authors: James J
authors: JJ
authors: Storhoff
authors: Philip J
authors: PJ
authors: Norris
authors: Richard F
authors: RF
authors: Little
authors: Robert
authors: R
authors: Yarchoan
authors: Susan L
authors: SL
authors: Stramer
authors: Tim
authors: T
authors: Patno
authors: Marc
authors: M
authors: Domanus
authors: Arindam
authors: A
authors: Dhar
authors: Chad A
authors: CA
authors: Mirkin
authors: Indira K
authors: IK
authors: Hewlett
mesh_terms: D015483:HIV Antibodies; D016655:HIV Core Protein p24 / Q000032:analysis* / Q000276:immunology; D015658:HIV Infections / Q000175:diagnosis* / Q000276:immunology; D015497:HIV-1; D006801:Humans; D007159:Immunologic Tests / Q000379:methods*; D053758:Nanoparticles; D021141:Nucleic Acid Amplification Techniques / Q000379:methods*; D012680:Sensitivity and Specificity; D013997:Time Factors; D019562:Viral Load
chemical_list: D015483:HIV Antibodies; D016655:HIV Core Protein p24