title: Implementation of an HIV-1 Triple-Target NAT Assay in the Routine Screening at Three German Red Cross Blood Centres.
abstract: BACKGROUND
  Blood product safety was significantly improved by the introduction of NAT testing in the late 1990s, resulting in a strong decrease of transfusion-transmitted infections (TTIs). Due to the occurrence of HIV-1 NAT test failures as a consequence of mismatch mutations in the amplicon regions of mono-target NAT assays, the Paul Ehrlich Institute mandated the implementation of multi-target NAT assays for HIV-1 in 2014. Commercial suppliers mostly developed dual-target NAT assays, with only one implementing a triple-target NAT assay.
  
  
  METHODS
  The HIV-1 triple-target NAT assay v3 (GFE Blut) was tested on mutated specimens and synthetic DNA bearing mutations that resulted in sample underquantification or false-negative test results. In addition, data from 2 years routine testing at three German Red Cross Blood centres were analysed.
  
  
  RESULTS
  The HIV-1 triple-target PCR could compensate for all mutations tested and could compensate the loss of one amplicon without a significant loss of sensitivity. Data from 2 years routine testing showed a solid performance.
  
  
  CONCLUSIONS
  The HIV-1 triple-target v3 assay (GFE Blut) can compensate mutations in target sequences better than a dual-target assay and is applicable to high-throughput screening, thus increasing blood product safety.
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Silke De
authors.initials: SD
authors.lastname: Zolt
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Rolf
authors.initials: R
authors.lastname: Thermann
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Thorsten
authors.initials: T
authors.lastname: Bangsow
authors.affiliation: DRK Blutspendedienst West, Hagen, Germany.
authors.forename: Lutz
authors.initials: L
authors.lastname: Pichl
authors.affiliation: DRK Blutspendedienst West, Hagen, Germany.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Müller
authors.affiliation: DRK Blutspendedienst NSTOB, Springe, Germany.
authors.forename: Christine
authors.initials: C
authors.lastname: Jork
authors.affiliation: Blutspendedienst des Bayerischen Roten Kreuzes, Wiesentheid, Germany.
authors.forename: Marijke
authors.initials: M
authors.lastname: Weber-Schehl
authors.affiliation: Blutspendedienst des Bayerischen Roten Kreuzes, Wiesentheid, Germany.
authors.forename: Doris
authors.initials: D
authors.lastname: Hedges
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Ingo
authors.initials: I
authors.lastname: Schupp
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Unverzagt
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: Katrin
authors.initials: K
authors.lastname: de Rue
authors.affiliation: Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
authors.forename: W Kurt
authors.initials: WK
authors.lastname: Roth
keywords: Blood safety; HIV-1 triple-target NAT; HIV-1 variants; High throughput testing; Multi-target PCR; NAT