title: Evaluation of a new, fully automated immunoassay for detection of HTLV-I and HTLV-II antibodies.
abstract: Screening blood donations for human T-lymphotropic virus types I and II (HTLV-I/II) continues to be important in protecting the safety of blood products and controlling the global spread of these retroviruses. We have developed a fully automated, third generation chemiluminescent immunoassay, ARCHITECT rHTLV-I/II, for detection of antibodies to HTLV-I/II. The assay utilizes recombinant proteins and synthetic peptides and is configured in a double antigen sandwich assay format. Specificity of the assay was 99.98% (9,254/9,256, 95% CI = 99.92-100%) with the negative specimens from the general population including blood donors, hospital patients and pregnant women from the US, Japan and Nicaragua. The assay demonstrated 100% sensitivity by detecting 498 specimens from individuals infected with HTLV-I (n = 385) and HTLV-II (n = 113). ARCHITECT rHTLV-I/II results were in complete agreement with the Murex HTLV-I/II reference assay and 99.7% agreement with the Genelabs HTLV Blot 2.4 confirmatory assay. Analytical sensitivity of the assay was equivalent to Murex HTLV-I/II assay based on end point dilutions. Furthermore, using a panel of 397 specimens from Japan, the ARCHITECT rHTLV-I/II assay exhibited distinct discrimination between the antibody negative (Delta Value = -7.6) and positive (Delta Value = 7.6) populations. Based on the excellent specificity and sensitivity, the new ARCHITECT rHTLV-I/II assay should be an effective test for the diagnosis of HTLV-I/II infection and also for blood donor screening.
authors.affiliation: Abbott Diagnostics, AIDS Research and Retrovirus Discovery, Abbott Park, Illinois 60064-6015, USA. xiaoxing.qiu@abbott.com
authors.forename: Xiaoxing
authors.initials: X
authors.lastname: Qiu
authors.forename: Steven
authors.initials: S
authors.lastname: Hodges
authors.forename: Teresa
authors.initials: T
authors.lastname: Lukaszewska
authors.forename: Shigeo
authors.initials: S
authors.lastname: Hino
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Arai
authors.forename: Julie
authors.initials: J
authors.lastname: Yamaguchi
authors.forename: Priscilla
authors.initials: P
authors.lastname: Swanson
authors.forename: Gerald
authors.initials: G
authors.lastname: Schochetman
authors.forename: Sushil G
authors.initials: SG
authors.lastname: Devare
mesh_terms: D001331:Automation; D001782:Blood Donors; D015481:HTLV-I Antibodies / Q000097:blood* / Q000276:immunology; D015490:HTLV-I Infections / Q000175:diagnosis*; D015482:HTLV-II Antibodies / Q000097:blood* / Q000276:immunology; D015491:HTLV-II Infections / Q000175:diagnosis*; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D015481:HTLV-I Antibodies; D015482:HTLV-II Antibodies