title: Evaluation in a clinical setting of the performances of a new rapid confirmatory assay for HIV1/2 serodiagnosis.
abstract: OBJECTIVE
  The performances of the new Geenius rapid confirmatory test (Bio-Rad) were evaluated with emphasis towards identifying acute infection (AHI) and discriminating HIV-1/2 in a clinical setting
  
  
  METHODS
  Serum samples from individuals attending the L. Spallanzani Institute in Rome, Italy, for HIV diagnosis (one year retrospective collection), repeatedly reactive at 4th generation HIV-1/2 screening assays, confirmed with HIV-1 and HIV-2 Western blot (New LAV I and II Bio-Rad), were retested with Geenius.
  
  
  RESULTS
  Of 6,200 samples, 406 resulted repeatedly reactive at screening, including samples from clinically confirmed AHI. New LAV I identified 378 HIV-1-positive samples. Of these, Geenius found 377 HIV-1-positive and one unclassified HIV-positive. New LAV I classified as indeterminate 18 samples, including 14 from AHI. Among these 14, Geenius results were: 12 positive, 1 indeterminate and 1 negative. Of the remaining, 2 resulted Geenius negative (false-positive screening results) and 2 HIV-2. Ten samples were New LAV I-negative (5 AHI). Geenius results were: 1 (AHI) positive and 9 negative. Geenius detected 110 additional positive samples with no p31 reactivity with respect to New LAV I, with an almost similar prevalence of low avidity samples. Geenius confirmed 3 out of 4 HIV-2 infections identified by New LAV II (one coinfected with HIV-1), while rated as HIV-1 the remaining sample, classified as coinfection by New LAV I and II.
  
  
  CONCLUSIONS
  Geenius allows fast, sensitive and accurate confirmation of HIV serodiagnosis, including AHI and HIV-2 infections. The high sensitivity, in particular towards AHI, could avoid additional sampling and molecular tests.
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy. Electronic address: isabella.abbate@inmi.it.
authors.forename: I
authors.initials: I
authors.lastname: Abbate
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Pergola
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Pisciotta
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Sciamanna
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Sias
authors.affiliation: CRAIDS and Clinical Department, INMI, L. Spallanzani, Rome, Italy.
authors.forename: N
authors.initials: N
authors.lastname: Orchi
authors.affiliation: Clinical Department, INMI, L. Spallanzani, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Libertone
authors.affiliation: Scientific Direction, INMI, L. Spallanzani, Rome, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Ippolito
authors.affiliation: Laboratory of Virology, INMI, L. Spallanzani, Rome, Italy.
authors.forename: M R
authors.initials: MR
authors.lastname: Capobianchi
mesh_terms: D015658:HIV Infections / Q000175:diagnosis*; D015497:HIV-1 / Q000302:isolation & purification*; D015498:HIV-2 / Q000302:isolation & purification*; D006801:Humans; D012189:Retrospective Studies; D012384:Rome; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D013997:Time Factors
keywords: Acute infection; Avidity; Diagnosis; HIV; Western blot