Volume 50, Issue 12 pp. 2695-2706

Efficacy of individual nucleic acid amplification testing in reducing the risk of transfusion-transmitted hepatitis B virus infection in Switzerland, a low-endemic region

Martin Stolz

Martin Stolz

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Caroline Tinguely

Caroline Tinguely

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Mauro Graziani

Mauro Graziani

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Stefano Fontana

Stefano Fontana

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Peter Gowland

Peter Gowland

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Andreas Buser

Andreas Buser

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Martine Michel

Martine Michel

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Giorgia Canellini

Giorgia Canellini

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Max Züger

Max Züger

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Philippe Schumacher

Philippe Schumacher

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Nico Lelie

Nico Lelie

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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Christoph Niederhauser

Christoph Niederhauser

From the Blood Transfusion Service SRC Berne, Berne, Switzerland; the Blood Transfusion Service SRC Basel, Basel, Switzerland; the Blood Transfusion Service SRC Geneva, Geneva, Switzerland; the Blood Transfusion Service SRC Vaud, Lausanne, Switzerland; the Blood Transfusion Service SRC North East Switzerland, Münsterlingen, Switzerland; the Blood Transfusion Service Solothurn, Solothurn, Switzerland; and Novartis Diagnostics, Suresnes, France.

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First published: 03 December 2010
Citations: 19
Christoph Niederhauser, Blood Transfusion Service SRC Berne, Murtenstrasse 133, Berne, Switzerland; e-mail: [email protected].

Abstract

BACKGROUND: The risk of transfusion-transmitted hepatitis B virus (HBV) in Switzerland by testing blood donors for hepatitis B surface antigen (HBsAg) alone has been historically estimated at 1:160,000 transfusions. The Swiss health authorities decided not to introduce mandatory antibody to hepatitis B core antigen (anti-HBc) testing but to evaluate the investigation of HBV nucleic acid testing (NAT).

STUDY DESIGN AND METHODS: Between June 2007 and February 2009, a total of 306,000 donations were screened routinely for HBsAg and HBV DNA by triplex individual-donation (ID)-NAT (Ultrio assay on Tigris system, Gen-Probe/Novartis Diagnostics). ID-NAT repeatedly reactive donors were further characterized for HBV serologic markers and viral load by quantitative polymerase chain reaction. The relative sensitivity of screening for HBsAg, anti-HBc, and HBV DNA was assessed. The residual HBV transmission risk of NAT with or without anti-HBc and HBsAg was retrospectively estimated in a mathematical model.

RESULTS: From the 306,000 blood donations, 31 were repeatedly Ultrio test reactive and confirmed HBV infected, of which 24 (77%) and 27 (87%) were HBsAg and anti-HBc positive, respectively. Seven HBV-NAT yields were identified (1:44,000), two pre-HBsAg window period (WP) donations (1:153,000) and five occult HBV infections (1:61,000). Introduction of ID-NAT reduced the risk of HBV WP transmission in repeat donors from 1:95,000 to 1:296,000.

CONCLUSIONS: Triplex NAT screening reduced the HBV WP transmission risk approximately threefold. NAT alone was more efficacious than the combined use of HBsAg and anti-HBc. The data from this study led to the decision to introduce sensitive HBV-NAT screening in Switzerland. Our findings may be useful in designing more efficient and cost-effective HBV screening strategies in low-prevalence countries.

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