title: Inclusion of human immunodeficiency virus Type 2 (HIV-2) in a multiplex transcription-mediated amplification assay does not affect detection of HIV-1 and hepatitis B and C virus genotypes: a multicenter performance evaluation study.
abstract: BACKGROUND
  The Ultrio Elite assay (Hologic/Grifols) runs on the Panther blood screening system and is comparable to the Ultrio Plus assay apart from the addition of oligonucleotides for human immunodeficiency virus Type 2 (HIV-2) detection. In this multicenter evaluation study the analytical sensitivity and genotype detection efficiency of the two assay versions were compared.
  
  
  METHODS
  The analytical sensitivity and genotype detection efficiency were analyzed by replicate (18-303) testing of 27 hepatitis B virus (HBV), hepatitis C virus (HCV), HIV-1, and HIV-2 standard dilution panels calibrated in international units (IUs) and copies/mL. A wider range of subgenotypes was tested at 25 copies/mL. Specificity was evaluated in 30,756 donor samples.
  
  
  RESULTS
  The 95% lower limits of detection (LODs) in Ultrio Elite assay on WHO standards were 4.6, 7.3, 23.5, and 23.3 IU/mL for HBV, HCV, HIV-1, and HIV-2, respectively, and ranged from 13 to 44, 7 to 23, 6 to 15, and 9 copies/mL on genotype panels of the respective viruses. Comparable LODs had been previously found on the same panels with the Ultrio Plus assay. The specificity was 99.95% on initial test and 100% in the repeat test algorithm.
  
  
  CONCLUSIONS
  The change in the oligonucleotide design of the Ultrio Elite assay to enable HIV-2 detection has not affected the analytical sensitivity for the other viruses regardless of the genotype. Genotype reference panels are instrumental to compare the sensitivity of nucleic acid test assay versions and could serve as an alternative to seroconversion panels.
authors.affiliation: Institute of Haematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Piotr
authors.initials: P
authors.lastname: Grabarczyk
authors.affiliation: Sanquin Blood Supply Foundation, Amsterdam, the Netherlands.
authors.forename: Marco
authors.initials: M
authors.lastname: Koppelman
authors.affiliation: Irish Blood Transfusion Service, Dublin, Ireland.
authors.forename: Fiona
authors.initials: F
authors.lastname: Boland
authors.affiliation: Banc de Sang i Teixits, Barcelona, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Sauleda
authors.affiliation: Etablissement Français du Sang, Tours, France.
authors.forename: Cécile
authors.initials: C
authors.lastname: Fabra
authors.affiliation: Lodi Hospital, Lodi, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Cambie
authors.affiliation: Institute of Haematology and Transfusion Medicine, Warsaw, Poland.
authors.forename: Aneta
authors.initials: A
authors.lastname: Kopacz
authors.affiliation: Irish Blood Transfusion Service, Dublin, Ireland.
authors.forename: Karen
authors.initials: K
authors.lastname: O'Riordan
authors.affiliation: Biologicals Quality Control, Rijswijk, the Netherlands.
authors.forename: Harry
authors.initials: H
authors.lastname: van Drimmelen
authors.affiliation: Irish Blood Transfusion Service, Dublin, Ireland.
authors.forename: Joan
authors.initials: J
authors.lastname: O'Riordan
authors.affiliation: Lelie Research, Paris, France.
authors.forename: Nico
authors.initials: N
authors.lastname: Lelie
mesh_terms: D001782:Blood Donors; D046148:Donor Selection / Q000379:methods*; D005260:Female; D005838:Genotype; D015497:HIV-1; D015498:HIV-2; D016174:Hepacivirus; D006515:Hepatitis B virus; D006801:Humans; D008297:Male; D060885:Multiplex Polymerase Chain Reaction / Q000379:methods*; D012367:RNA, Viral / Q000097:blood*; D012189:Retrospective Studies; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods*; D012680:Sensitivity and Specificity
chemical_list: D012367:RNA, Viral