Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing

Nico Lelie, Roberta Bruhn, Michael Busch, Marion Vermeulen, Wai-Chiu Tsoi, Steven Kleinman, Charl Coleman , Ravi Reddy, Arthur Bird, Russell Cable, Heidi Goubran , Faten Moftah , Magdy El Ekiaby , Paola Ghiazza , Paola Manzini , Flavia Favilli , Cecilia Peduzzi , Roberto Roig , Manolo Alvarez , Silvia Sauleda & 28 others Christoph Niederhauser, Snezna Levicnik , Polona Nograsek , Sussanne Wessberg, Sussane Elkblom, Mervi Lankinen , Henrik Ulm , Lene Holm Harritshøj, Christian Nielsen , Steffen Jørgensen, Christian Erikstrup, Joan O’Riordan , Ewa Brojer , Piotr Grabarczyk , Jolanta Gdowska, Dariusz Pitotrowski , Sally Lam, Diane Teo, Sze Sze Chua , Che Kit Lin, Abdul Hamid Bon , Sally Lam Tsuey Peng, Peter Flanagan , Stewart Brown, Philip Kiely, Clive Seed , Emma Castro , Rocio Gonzales

Research output: Contribution to journal › Journal article › Research › peer-review

Abstract

BACKGROUND: Twenty-two users of individual donation nucleic acid amplification technology (ID-NAT) in six geographical regions provided detailed hepatitis B virus (HBV) infection data in first-time, lapsed, and repeat donations and classified confirmed HBV-positive donors into different infection categories. These data were used to compare the clinical sensitivity of hepatitis B surface antigen (HBsAg) and HBV-DNA testing. STUDY DESIGN AND METHODS: In total 10,981,776 donations from South Africa, Egypt, the Mediterranean, North and Central Europe, South East Asia, and Oceania were screened for HBV-DNA using the Ultrio assay (Grifols/Hologic) and for HBsAg using a chemiluminescence immunoassay, and 9455 HBVinfected donations were identified. HBsAg-negative window period (WP), HBsAg-positive and occult HBV infection (OBI) stages were determined using supplemental serology, quantitative polymerase chain reaction, and replicate multiplex and discriminatory HBV NAT test strategies. For two regions, additional data sets using the more sensitive Ultrio Plus assay were assessed. RESULTS: Regional HBV detection rates in first-time donors varied between 0.08% and 1.07%, with WP NAT yield rates varying between 1:7700 and 1:294,000 and OBI NATyield rates varying from 1:3900 to 1:59,000. HBsAg CLIA detected 97.0% of infections in first-time donors, 62.7% in lapsed donors, and 41.0% in repeat donors; whereas Ultrio detected 93.1%, 95.0%, and 98.3% of infections in these respective groups. HBV-DNA detection rates in HBsAg-positive donors varied from 90.2% to 96.3% between regions but increased significantly (range, 95.2-98.2%) with the Ultrio Plus assay. CONCLUSION: ID-NATand serology are complementary in detecting HBV infection in first-time donors, but HBV-DNA is superior to HBsAg detection in repeat donors.
Original languageEnglish
JournalTransfusion
Volume57
Issue number1
Pages (from-to)24-35
ISSN0041-1132
DOIs
Publication statusPublished - Jan 2017

Cite this

Lelie, Nico ; Bruhn, Roberta ; Busch, Michael ; Vermeulen, Marion ; Tsoi, Wai-Chiu ; Kleinman, Steven ; Coleman , Charl ; Reddy, Ravi ; Bird, Arthur ; Cable, Russell ; Goubran , Heidi ; Moftah , Faten ; Ekiaby , Magdy El ; Ghiazza , Paola ; Manzini , Paola ; Favilli , Flavia ; Peduzzi , Cecilia ; Roig , Roberto ; Alvarez , Manolo ; Sauleda , Silvia ; Niederhauser, Christoph ; Levicnik , Snezna ; Nograsek , Polona ; Wessberg, Sussanne ; Elkblom, Sussane ; Lankinen , Mervi ; Ulm , Henrik ; Harritshøj, Lene Holm ; Nielsen , Christian ; Jørgensen, Steffen ; Erikstrup, Christian ; O’Riordan , Joan ; Brojer , Ewa ; Grabarczyk , Piotr ; Gdowska, Jolanta ; Pitotrowski , Dariusz ; Lam, Sally ; Teo, Diane ; Chua , Sze Sze ; Lin, Che Kit ; Bon , Abdul Hamid ; Peng, Sally Lam Tsuey ; Flanagan , Peter ; Brown, Stewart ; Kiely, Philip ; Seed , Clive ; Castro , Emma ; Gonzales, Rocio. / Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing. In: Transfusion. 2017 ; Vol. 57, No. 1. pp. 24-35.
@article{2a5a2576f60e48f2b4b17ef2bf0ccd9a,
title = "Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing",
abstract = "BACKGROUND: Twenty-two users of individual donation nucleic acid amplification technology (ID-NAT) in six geographical regions provided detailed hepatitis B virus (HBV) infection data in first-time, lapsed, and repeat donations and classified confirmed HBV-positive donors into different infection categories. These data were used to compare the clinical sensitivity of hepatitis B surface antigen (HBsAg) and HBV-DNA testing. STUDY DESIGN AND METHODS: In total 10,981,776 donations from South Africa, Egypt, the Mediterranean, North and Central Europe, South East Asia, and Oceania were screened for HBV-DNA using the Ultrio assay (Grifols/Hologic) and for HBsAg using a chemiluminescence immunoassay, and 9455 HBVinfected donations were identified. HBsAg-negative window period (WP), HBsAg-positive and occult HBV infection (OBI) stages were determined using supplemental serology, quantitative polymerase chain reaction, and replicate multiplex and discriminatory HBV NAT test strategies. For two regions, additional data sets using the more sensitive Ultrio Plus assay were assessed. RESULTS: Regional HBV detection rates in first-time donors varied between 0.08{\%} and 1.07{\%}, with WP NAT yield rates varying between 1:7700 and 1:294,000 and OBI NATyield rates varying from 1:3900 to 1:59,000. HBsAg CLIA detected 97.0{\%} of infections in first-time donors, 62.7{\%} in lapsed donors, and 41.0{\%} in repeat donors; whereas Ultrio detected 93.1{\%}, 95.0{\%}, and 98.3{\%} of infections in these respective groups. HBV-DNA detection rates in HBsAg-positive donors varied from 90.2{\%} to 96.3{\%} between regions but increased significantly (range, 95.2-98.2{\%}) with the Ultrio Plus assay. CONCLUSION: ID-NATand serology are complementary in detecting HBV infection in first-time donors, but HBV-DNA is superior to HBsAg detection in repeat donors.",
author = "Nico Lelie and Roberta Bruhn and Michael Busch and Marion Vermeulen and Wai-Chiu Tsoi and Steven Kleinman and Charl Coleman and Ravi Reddy and Arthur Bird and Russell Cable and Heidi Goubran and Faten Moftah and Ekiaby, {Magdy El} and Paola Ghiazza and Paola Manzini and Flavia Favilli and Cecilia Peduzzi and Roberto Roig and Manolo Alvarez and Silvia Sauleda and Christoph Niederhauser and Snezna Levicnik and Polona Nograsek and Sussanne Wessberg and Sussane Elkblom and Mervi Lankinen and Henrik Ulm and Harritsh{\o}j, {Lene Holm} and Christian Nielsen and Steffen J{\o}rgensen and Christian Erikstrup and Joan O’Riordan and Ewa Brojer and Piotr Grabarczyk and Jolanta Gdowska and Dariusz Pitotrowski and Sally Lam and Diane Teo and Chua, {Sze Sze} and Lin, {Che Kit} and Bon, {Abdul Hamid} and Peng, {Sally Lam Tsuey} and Peter Flanagan and Stewart Brown and Philip Kiely and Clive Seed and Emma Castro and Rocio Gonzales",
year = "2017",
month = "1",
doi = "10.1111/trf.13819",
language = "English",
volume = "57",
pages = "24--35",
journal = "Transfusion",
issn = "0041-1132",
publisher = "Wiley-Blackwell Publishing, Inc",
number = "1",

}

Lelie, N, Bruhn, R, Busch, M, Vermeulen, M, Tsoi, W-C, Kleinman, S, Coleman , C, Reddy, R, Bird, A, Cable, R, Goubran , H, Moftah , F, Ekiaby , ME, Ghiazza , P, Manzini , P, Favilli , F, Peduzzi , C, Roig , R, Alvarez , M, Sauleda , S, Niederhauser, C, Levicnik , S, Nograsek , P, Wessberg, S, Elkblom, S, Lankinen , M, Ulm , H, Harritshøj, LH, Nielsen , C, Jørgensen, S, Erikstrup, C, O’Riordan , J, Brojer , E, Grabarczyk , P, Gdowska, J, Pitotrowski , D, Lam, S, Teo, D, Chua , SS, Lin, CK, Bon , AH, Peng, SLT, Flanagan , P, Brown, S, Kiely, P, Seed , C, Castro , E & Gonzales, R 2017, 'Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing', Transfusion, vol. 57, no. 1, pp. 24-35. https://doi.org/10.1111/trf.13819

Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing. / Lelie, Nico; Bruhn, Roberta; Busch, Michael; Vermeulen, Marion; Tsoi, Wai-Chiu; Kleinman, Steven; Coleman , Charl; Reddy, Ravi; Bird, Arthur; Cable, Russell; Goubran , Heidi; Moftah , Faten; Ekiaby , Magdy El; Ghiazza , Paola; Manzini , Paola; Favilli , Flavia; Peduzzi , Cecilia; Roig , Roberto; Alvarez , Manolo; Sauleda , Silvia; Niederhauser, Christoph; Levicnik , Snezna; Nograsek , Polona ; Wessberg, Sussanne; Elkblom, Sussane; Lankinen , Mervi; Ulm , Henrik; Harritshøj, Lene Holm; Nielsen , Christian; Jørgensen, Steffen; Erikstrup, Christian; O’Riordan , Joan ; Brojer , Ewa; Grabarczyk , Piotr; Gdowska, Jolanta; Pitotrowski , Dariusz; Lam, Sally; Teo, Diane; Chua , Sze Sze ; Lin, Che Kit; Bon , Abdul Hamid; Peng, Sally Lam Tsuey ; Flanagan , Peter; Brown, Stewart; Kiely, Philip; Seed , Clive; Castro , Emma; Gonzales, Rocio.

In: Transfusion, Vol. 57, No. 1, 01.2017, p. 24-35.

Research output: Contribution to journal › Journal article › Research › peer-review

TY - JOUR

T1 - Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing

AU - Lelie, Nico

AU - Bruhn, Roberta

AU - Busch, Michael

AU - Vermeulen, Marion

AU - Tsoi, Wai-Chiu

AU - Kleinman, Steven

AU - Coleman , Charl

AU - Reddy, Ravi

AU - Bird, Arthur

AU - Cable, Russell

AU - Goubran , Heidi

AU - Moftah , Faten

AU - Ekiaby , Magdy El

AU - Ghiazza , Paola

AU - Manzini , Paola

AU - Favilli , Flavia

AU - Peduzzi , Cecilia

AU - Roig , Roberto

AU - Alvarez , Manolo

AU - Sauleda , Silvia

AU - Niederhauser, Christoph

AU - Levicnik , Snezna

AU - Nograsek , Polona

AU - Wessberg, Sussanne

AU - Elkblom, Sussane

AU - Lankinen , Mervi

AU - Ulm , Henrik

AU - Harritshøj, Lene Holm

AU - Nielsen , Christian

AU - Jørgensen, Steffen

AU - Erikstrup, Christian

AU - O’Riordan , Joan

AU - Brojer , Ewa

AU - Grabarczyk , Piotr

AU - Gdowska, Jolanta

AU - Pitotrowski , Dariusz

AU - Lam, Sally

AU - Teo, Diane

AU - Chua , Sze Sze

AU - Lin, Che Kit

AU - Bon , Abdul Hamid

AU - Peng, Sally Lam Tsuey

AU - Flanagan , Peter

AU - Brown, Stewart

AU - Kiely, Philip

AU - Seed , Clive

AU - Castro , Emma

AU - Gonzales, Rocio

PY - 2017/1

Y1 - 2017/1

N2 - BACKGROUND: Twenty-two users of individual donation nucleic acid amplification technology (ID-NAT) in six geographical regions provided detailed hepatitis B virus (HBV) infection data in first-time, lapsed, and repeat donations and classified confirmed HBV-positive donors into different infection categories. These data were used to compare the clinical sensitivity of hepatitis B surface antigen (HBsAg) and HBV-DNA testing. STUDY DESIGN AND METHODS: In total 10,981,776 donations from South Africa, Egypt, the Mediterranean, North and Central Europe, South East Asia, and Oceania were screened for HBV-DNA using the Ultrio assay (Grifols/Hologic) and for HBsAg using a chemiluminescence immunoassay, and 9455 HBVinfected donations were identified. HBsAg-negative window period (WP), HBsAg-positive and occult HBV infection (OBI) stages were determined using supplemental serology, quantitative polymerase chain reaction, and replicate multiplex and discriminatory HBV NAT test strategies. For two regions, additional data sets using the more sensitive Ultrio Plus assay were assessed. RESULTS: Regional HBV detection rates in first-time donors varied between 0.08% and 1.07%, with WP NAT yield rates varying between 1:7700 and 1:294,000 and OBI NATyield rates varying from 1:3900 to 1:59,000. HBsAg CLIA detected 97.0% of infections in first-time donors, 62.7% in lapsed donors, and 41.0% in repeat donors; whereas Ultrio detected 93.1%, 95.0%, and 98.3% of infections in these respective groups. HBV-DNA detection rates in HBsAg-positive donors varied from 90.2% to 96.3% between regions but increased significantly (range, 95.2-98.2%) with the Ultrio Plus assay. CONCLUSION: ID-NATand serology are complementary in detecting HBV infection in first-time donors, but HBV-DNA is superior to HBsAg detection in repeat donors.

AB - BACKGROUND: Twenty-two users of individual donation nucleic acid amplification technology (ID-NAT) in six geographical regions provided detailed hepatitis B virus (HBV) infection data in first-time, lapsed, and repeat donations and classified confirmed HBV-positive donors into different infection categories. These data were used to compare the clinical sensitivity of hepatitis B surface antigen (HBsAg) and HBV-DNA testing. STUDY DESIGN AND METHODS: In total 10,981,776 donations from South Africa, Egypt, the Mediterranean, North and Central Europe, South East Asia, and Oceania were screened for HBV-DNA using the Ultrio assay (Grifols/Hologic) and for HBsAg using a chemiluminescence immunoassay, and 9455 HBVinfected donations were identified. HBsAg-negative window period (WP), HBsAg-positive and occult HBV infection (OBI) stages were determined using supplemental serology, quantitative polymerase chain reaction, and replicate multiplex and discriminatory HBV NAT test strategies. For two regions, additional data sets using the more sensitive Ultrio Plus assay were assessed. RESULTS: Regional HBV detection rates in first-time donors varied between 0.08% and 1.07%, with WP NAT yield rates varying between 1:7700 and 1:294,000 and OBI NATyield rates varying from 1:3900 to 1:59,000. HBsAg CLIA detected 97.0% of infections in first-time donors, 62.7% in lapsed donors, and 41.0% in repeat donors; whereas Ultrio detected 93.1%, 95.0%, and 98.3% of infections in these respective groups. HBV-DNA detection rates in HBsAg-positive donors varied from 90.2% to 96.3% between regions but increased significantly (range, 95.2-98.2%) with the Ultrio Plus assay. CONCLUSION: ID-NATand serology are complementary in detecting HBV infection in first-time donors, but HBV-DNA is superior to HBsAg detection in repeat donors.

UR - https://onlinelibrary.wiley.com/doi/full/10.1111/trf.13819

U2 - 10.1111/trf.13819

DO - 10.1111/trf.13819

M3 - Journal article

VL - 57

SP - 24

EP - 35

JO - Transfusion

JF - Transfusion

SN - 0041-1132

IS - 1

ER -

Lelie N, Bruhn R, Busch M, Vermeulen M, Tsoi W-C, Kleinman S et al. Detection of different categories of hepatitis B virus (HBV) infection in a multi-regional study comparing the clinical sensitivity of hepatitis B surface antigen and HBV-DNA testing. Transfusion. 2017 Jan;57(1):24-35. https://doi.org/10.1111/trf.13819

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