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Transfus Med Hemother. 2016 May;43(3):183-9. doi: 10.1159/000446290. Epub 2016 May 11.

Implementation of an HIV-1 Triple-Target NAT Assay in the Routine Screening at Three German Red Cross Blood Centres.

Transfusion medicine and hemotherapy : offizielles Organ der Deutschen Gesellschaft fur Transfusionsmedizin und Immunhamatologie

Silke De Zolt, Rolf Thermann, Thorsten Bangsow, Lutz Pichl, Benjamin Müller, Christine Jork, Marijke Weber-Schehl, Doris Hedges, Ingo Schupp, Patrick Unverzagt, Katrin de Rue, W Kurt Roth

Affiliations

  1. Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
  2. DRK Blutspendedienst West, Hagen, Germany.
  3. DRK Blutspendedienst NSTOB, Springe, Germany.
  4. Blutspendedienst des Bayerischen Roten Kreuzes, Wiesentheid, Germany.

PMID: 27403090 PMCID: PMC4924456 DOI: 10.1159/000446290

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.

CONCLUSION: 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.

Keywords: Blood safety; HIV-1 triple-target NAT; HIV-1 variants; High throughput testing; Multi-target PCR; NAT

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