title: [Sensitivity of the COBAS AmpliScreen™ HIV-1 test v1.5 for HIV-1 detection].
abstract: The introduction of nucleic acid amplification techniques (NAT) in blood banks was intended to reduce the residual risk of transfusion-transmitted infections. Co-circulation of a great diversity of HIV-1 variants in Argentina portrays the need to assess the sensitivity of serological and molecular assays available for their detection. In this study, we evaluated the sensitivity of the COBAS AmpliScreen™ HIV-1 Test, version 1.5 (Roche) for the detection of HIV-1 RNA in plasma samples of infected individuals from Argentina. The results of this study reveal that this technique has high sensitivity for the detection of HIV-1 RNA under assay conditions: using mini-pool testing, pools ≥ 50 RNA copies per ml achieved ≥ 92 % sensitivity, whereas in the standard procedure, samples ≥ 207 RNA copies/ml achieved 100 % sensitivity. Moreover, the COBAS AmpliScreen™ HIV-1 Test, version 1.5 (Roche) is suitable for detecting prevailing HIV-1 variants.
authors.affiliation: Laboratorio Virus Linfotrópicos Humanos. Retrovirus: HIV y HTLV, Instituto de Virología "Dr. J. M. Vanella", Facultad de Ciencias Médicas, Universidad Nacional de Córdoba (UNC), Córdoba, Argentina; Fundación Banco Central de Sangre, Laboratorio de Biología Molecular, Córdoba, Argentina. Electronic address: luciapilarg@yahoo.com.ar.
authors.forename: Lucía P
authors.initials: LP
authors.lastname: Gomez
authors.affiliation: Laboratorio Virus Linfotrópicos Humanos. Retrovirus: HIV y HTLV, Instituto de Virología "Dr. J. M. Vanella", Facultad de Ciencias Médicas, Universidad Nacional de Córdoba (UNC), Córdoba, Argentina; Fundación Banco Central de Sangre, Laboratorio de Biología Molecular, Córdoba, Argentina.
authors.forename: Marcos C
authors.initials: MC
authors.lastname: Balangero
authors.affiliation: Laboratorio Virus Linfotrópicos Humanos. Retrovirus: HIV y HTLV, Instituto de Virología "Dr. J. M. Vanella", Facultad de Ciencias Médicas, Universidad Nacional de Córdoba (UNC), Córdoba, Argentina; Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: Gonzalo
authors.initials: G
authors.lastname: Castro
authors.affiliation: Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: Silvia
authors.initials: S
authors.lastname: Kademian
authors.affiliation: Cátedra de Estadística y Biometría, Facultad de Ciencias Exactas Físicas y Naturales, UNC, Córdoba, Argentina.
authors.forename: Arnaldo
authors.initials: A
authors.lastname: Mangeaud
authors.affiliation: Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: María G
authors.initials: MG
authors.lastname: Barbas
authors.affiliation: Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: Analía
authors.initials: A
authors.lastname: Cudolá
authors.affiliation: Fundación Banco Central de Sangre, Laboratorio de Biología Molecular, Córdoba, Argentina; Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: Juan F
authors.initials: JF
authors.lastname: de León
authors.affiliation: Fundación Banco Central de Sangre, Laboratorio de Biología Molecular, Córdoba, Argentina.
authors.forename: Horacio
authors.initials: H
authors.lastname: Carrizo
authors.affiliation: Laboratorio Virus Linfotrópicos Humanos. Retrovirus: HIV y HTLV, Instituto de Virología "Dr. J. M. Vanella", Facultad de Ciencias Médicas, Universidad Nacional de Córdoba (UNC), Córdoba, Argentina; Fundación Banco Central de Sangre, Laboratorio de Biología Molecular, Córdoba, Argentina; Laboratorio Central de la provincia de Córdoba, Biología Molecular, Ministerio de Salud, Córdoba, Argentina.
authors.forename: Sandra V
authors.initials: SV
authors.lastname: Gallego
mesh_terms: D001118:Argentina / Q000453:epidemiology; D058731:Blood Safety; D003124:Colorimetry / Q000379:methods*; D060005:Genotyping Techniques; D015658:HIV Infections / Q000097:blood / Q000453:epidemiology / Q000821:virology*; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000302:isolation & purification*; D006801:Humans; D008403:Mass Screening / Q000379:methods; D012367:RNA, Viral / Q000097:blood*; D011933:Reagent Kits, Diagnostic; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity; D014461:Ultracentrifugation; D019562:Viral Load; D014766:Viremia / Q000821:virology*
chemical_list: D012367:RNA, Viral; D011933:Reagent Kits, Diagnostic
keywords: COBAS AmpliScreen; HIV-1; NAT