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Implementation of an HIV-1 Triple-Target NAT Assay in the Routine Screening at Three German Red Cross Blood Centres.
Silke De Zolt1, Rolf Thermann1, Thorsten Bangsow1
1Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostika im Blutspendewesen mbH (GFE Blut), Frankfurt/M., Germany.
Summary
A new triple-target nucleic acid test (NAT) for HIV-1 effectively compensates for sequence mutations, significantly enhancing blood product safety. This advanced assay improves upon dual-target methods, ensuring reliable screening for transfusion-transmitted infections.
Area of Science:
- Virology
- Transfusion Medicine
- Molecular Diagnostics
Background:
- Nucleic acid testing (NAT) dramatically reduced transfusion-transmitted infections (TTIs) since the late 1990s.
- HIV-1 NAT test failures due to mutations led to a mandate for multi-target NAT assays in 2014.
- Most commercial assays are dual-target, with limited adoption of triple-target systems.
Purpose of the Study:
- To evaluate the performance of a novel triple-target NAT assay for HIV-1 detection.
- To assess the assay's ability to overcome sequence mutations causing false negatives.
- To determine the suitability of the triple-target assay for routine, high-throughput blood screening.
Main Methods:
- Testing the HIV-1 triple-target NAT assay v3 (GFE Blut) with mutated specimens and synthetic DNA.
- Evaluating mutations known to cause underquantification or false-negative results.
- Analyzing 2 years of routine screening data from German Red Cross blood centers.
Main Results:
- The triple-target assay successfully compensated for all tested mutations.
- The assay maintained sensitivity even with the loss of one amplicon.
- Routine testing data confirmed the assay's robust and reliable performance over two years.
Conclusions:
- The HIV-1 triple-target v3 assay demonstrates superior mutation compensation compared to dual-target assays.
- Its applicability to high-throughput screening enhances overall blood product safety.
- This assay represents a significant advancement in preventing transfusion-transmitted HIV-1.