Characterization of HBV DNA +/HBsAg - blood donors in Poland identified by triplex NAT

Ewa Brojer; Piotr Grabarczyk; Grzegorz Liszewski; Maria Mikulska; Jean Pierre Allain; Magdalena Letowska; D. Kubicka-Russel; A. Kopacz; A. Gronowska; B. Boczkowska-Radziwon; M. Dobrowolna; B. Zalewicz; B. Wyrwińska; M. Tarnawska; S. Dyla̧g; Z. Sitarz-Zelazna; J. Kuśmierczyk; J. Raś; H. Radwan-Wieczorek; J. Korzeniowska; B. Sȩkowska; A. Rumas; G. Kula; I. Rajca-Biernacka; M. Krug-Janiak; J. Kulbaka-Myrczek; H. Kaczor; A. Krygowska; A. Dobrecka; D. Stȩpień-Razzu; A. ŚWider-Michalska; U. Zarówna; J. Gawȩda; D. Malka; E. Świa̧tek; M. Fabisz-Kołodzińiska

doi:10.1002/hep.21413

Characterization of HBV DNA ⁺/HBsAg ^- blood donors in Poland identified by triplex NAT

Ewa Brojer, Piotr Grabarczyk, Grzegorz Liszewski, Maria Mikulska, Jean Pierre Allain, Magdalena Letowska, D. Kubicka-Russel, A. Kopacz, A. Gronowska, B. Boczkowska-Radziwon, M. Dobrowolna, B. Zalewicz, B. Wyrwińska, M. Tarnawska, S. Dyla̧g, Z. Sitarz-Zelazna, J. Kuśmierczyk, J. Raś, H. Radwan-Wieczorek, J. KorzeniowskaB. Sȩkowska, A. Rumas, G. Kula, I. Rajca-Biernacka, M. Krug-Janiak, J. Kulbaka-Myrczek, H. Kaczor, A. Krygowska, A. Dobrecka, D. Stȩpień-Razzu, A. ŚWider-Michalska, U. Zarówna, J. Gawȩda, D. Malka, E. Świa̧tek, M. Fabisz-Kołodzińiska

Research output: Contribution to journal › Article › peer-review

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Abstract

Nucleic acid testing (NAT) for hepatitis B virus (HBV) has been performed in Poland since 2005 on samples seronegative for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV), and anti-human immunodeficiency virus (anti-HIV). Tools included 24-donation pool testing (PT) using Cobas Amplicor or in individual donations (ID) by Procleix Ultrio. Seven of 761,666 (1:108,800) and 21/250,191 (1:11,900) HBV DNA-positive donations were identified and confirmed by alternative methods. HBV DNA load ranged between 11.6 and 4.6 × 10 ⁴ IU/mL in 11 samples and could not be quantified in 17 samples. HBV genotypes A (56%) and D (4%) were found. The analysis of combined results from index, follow-up, and look-back samples identified four groups: (1) Two cases tested HBsAg positive with alternative, more sensitive, assays; (2) Four cases were in the pre-seroconversion window period; (3) Eight cases had a fluctuating pattern of HBV DNA and anti-HBs detection (recovered infection); and (4) twelve cases carried anti-HBc without anti-HBs, which might correspond to either chronic or recovered "occult" HBV infection. One donor with no HBV markers in the follow-up was excluded, and another was in the window period preceding anti-HBs. HBV NAT identified more confirmed positive donors than HCV or HIV NAT, and 1:250,000 could not be detected by anti-HBc screening. Serological and molecular studies on follow-up and look-back samples are important to classify donors. In conclusion, further studies are needed to determine whether the considerably higher yield of HBV DNA detection obtained with individual donation screening improves blood safety compared with anti-HBc screening.

Original language	English
Pages (from-to)	1666-1674
Number of pages	9
Journal	Hepatology
Volume	44
Issue number	6
DOIs	https://doi.org/10.1002/hep.21413
State	Published - Dec 2006
Externally published	Yes

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10.1002/hep.21413

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Brojer, E., Grabarczyk, P., Liszewski, G., Mikulska, M., Allain, J. P., Letowska, M., Kubicka-Russel, D., Kopacz, A., Gronowska, A., Boczkowska-Radziwon, B., Dobrowolna, M., Zalewicz, B., Wyrwińska, B., Tarnawska, M., Dyla̧g, S., Sitarz-Zelazna, Z., Kuśmierczyk, J., Raś, J., Radwan-Wieczorek, H., ... Fabisz-Kołodzińiska, M. (2006). Characterization of HBV DNA ⁺/HBsAg ^- blood donors in Poland identified by triplex NAT. Hepatology, 44(6), 1666-1674. https://doi.org/10.1002/hep.21413

@article{5e2d188d26ac4c96ae46ec59410eb91c,

title = "Characterization of HBV DNA +/HBsAg - blood donors in Poland identified by triplex NAT",

abstract = "Nucleic acid testing (NAT) for hepatitis B virus (HBV) has been performed in Poland since 2005 on samples seronegative for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV), and anti-human immunodeficiency virus (anti-HIV). Tools included 24-donation pool testing (PT) using Cobas Amplicor or in individual donations (ID) by Procleix Ultrio. Seven of 761,666 (1:108,800) and 21/250,191 (1:11,900) HBV DNA-positive donations were identified and confirmed by alternative methods. HBV DNA load ranged between 11.6 and 4.6 × 10 4 IU/mL in 11 samples and could not be quantified in 17 samples. HBV genotypes A (56%) and D (4%) were found. The analysis of combined results from index, follow-up, and look-back samples identified four groups: (1) Two cases tested HBsAg positive with alternative, more sensitive, assays; (2) Four cases were in the pre-seroconversion window period; (3) Eight cases had a fluctuating pattern of HBV DNA and anti-HBs detection (recovered infection); and (4) twelve cases carried anti-HBc without anti-HBs, which might correspond to either chronic or recovered {"}occult{"} HBV infection. One donor with no HBV markers in the follow-up was excluded, and another was in the window period preceding anti-HBs. HBV NAT identified more confirmed positive donors than HCV or HIV NAT, and 1:250,000 could not be detected by anti-HBc screening. Serological and molecular studies on follow-up and look-back samples are important to classify donors. In conclusion, further studies are needed to determine whether the considerably higher yield of HBV DNA detection obtained with individual donation screening improves blood safety compared with anti-HBc screening.",

author = "Ewa Brojer and Piotr Grabarczyk and Grzegorz Liszewski and Maria Mikulska and Allain, {Jean Pierre} and Magdalena Letowska and D. Kubicka-Russel and A. Kopacz and A. Gronowska and B. Boczkowska-Radziwon and M. Dobrowolna and B. Zalewicz and B. Wyrwi{\'n}ska and M. Tarnawska and S. Dyl{\c a}g and Z. Sitarz-Zelazna and J. Ku{\'s}mierczyk and J. Ra{\'s} and H. Radwan-Wieczorek and J. Korzeniowska and B. Sȩkowska and A. Rumas and G. Kula and I. Rajca-Biernacka and M. Krug-Janiak and J. Kulbaka-Myrczek and H. Kaczor and A. Krygowska and A. Dobrecka and D. Stȩpie{\'n}-Razzu and A. {\'S}Wider-Michalska and U. Zar{\'o}wna and J. Gawȩda and D. Malka and E. {\'S}wi{\c a}tek and M. Fabisz-Ko{\l}odzi{\'n}iska",

year = "2006",

month = dec,

doi = "10.1002/hep.21413",

language = "אנגלית",

volume = "44",

pages = "1666--1674",

journal = "Hepatology",

issn = "0270-9139",

publisher = "Lippincott Williams and Wilkins",

number = "6",

}

Brojer, E, Grabarczyk, P, Liszewski, G, Mikulska, M, Allain, JP, Letowska, M, Kubicka-Russel, D, Kopacz, A, Gronowska, A, Boczkowska-Radziwon, B, Dobrowolna, M, Zalewicz, B, Wyrwińska, B, Tarnawska, M, Dyla̧g, S, Sitarz-Zelazna, Z, Kuśmierczyk, J, Raś, J, Radwan-Wieczorek, H, Korzeniowska, J, Sȩkowska, B, Rumas, A, Kula, G, Rajca-Biernacka, I, Krug-Janiak, M, Kulbaka-Myrczek, J, Kaczor, H, Krygowska, A, Dobrecka, A, Stȩpień-Razzu, D, ŚWider-Michalska, A, Zarówna, U, Gawȩda, J, Malka, D, Świa̧tek, E & Fabisz-Kołodzińiska, M 2006, 'Characterization of HBV DNA ⁺/HBsAg ^- blood donors in Poland identified by triplex NAT', Hepatology, vol. 44, no. 6, pp. 1666-1674. https://doi.org/10.1002/hep.21413

TY - JOUR

T1 - Characterization of HBV DNA +/HBsAg - blood donors in Poland identified by triplex NAT

AU - Brojer, Ewa

AU - Grabarczyk, Piotr

AU - Liszewski, Grzegorz

AU - Mikulska, Maria

AU - Allain, Jean Pierre

AU - Letowska, Magdalena

AU - Kubicka-Russel, D.

AU - Kopacz, A.

AU - Gronowska, A.

AU - Boczkowska-Radziwon, B.

AU - Dobrowolna, M.

AU - Zalewicz, B.

AU - Wyrwińska, B.

AU - Tarnawska, M.

AU - Dyla̧g, S.

AU - Sitarz-Zelazna, Z.

AU - Kuśmierczyk, J.

AU - Raś, J.

AU - Radwan-Wieczorek, H.

AU - Korzeniowska, J.

AU - Sȩkowska, B.

AU - Rumas, A.

AU - Kula, G.

AU - Rajca-Biernacka, I.

AU - Krug-Janiak, M.

AU - Kulbaka-Myrczek, J.

AU - Kaczor, H.

AU - Krygowska, A.

AU - Dobrecka, A.

AU - Stȩpień-Razzu, D.

AU - ŚWider-Michalska, A.

AU - Zarówna, U.

AU - Gawȩda, J.

AU - Malka, D.

AU - Świa̧tek, E.

AU - Fabisz-Kołodzińiska, M.

PY - 2006/12

Y1 - 2006/12

N2 - Nucleic acid testing (NAT) for hepatitis B virus (HBV) has been performed in Poland since 2005 on samples seronegative for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV), and anti-human immunodeficiency virus (anti-HIV). Tools included 24-donation pool testing (PT) using Cobas Amplicor or in individual donations (ID) by Procleix Ultrio. Seven of 761,666 (1:108,800) and 21/250,191 (1:11,900) HBV DNA-positive donations were identified and confirmed by alternative methods. HBV DNA load ranged between 11.6 and 4.6 × 10 4 IU/mL in 11 samples and could not be quantified in 17 samples. HBV genotypes A (56%) and D (4%) were found. The analysis of combined results from index, follow-up, and look-back samples identified four groups: (1) Two cases tested HBsAg positive with alternative, more sensitive, assays; (2) Four cases were in the pre-seroconversion window period; (3) Eight cases had a fluctuating pattern of HBV DNA and anti-HBs detection (recovered infection); and (4) twelve cases carried anti-HBc without anti-HBs, which might correspond to either chronic or recovered "occult" HBV infection. One donor with no HBV markers in the follow-up was excluded, and another was in the window period preceding anti-HBs. HBV NAT identified more confirmed positive donors than HCV or HIV NAT, and 1:250,000 could not be detected by anti-HBc screening. Serological and molecular studies on follow-up and look-back samples are important to classify donors. In conclusion, further studies are needed to determine whether the considerably higher yield of HBV DNA detection obtained with individual donation screening improves blood safety compared with anti-HBc screening.

AB - Nucleic acid testing (NAT) for hepatitis B virus (HBV) has been performed in Poland since 2005 on samples seronegative for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (anti-HCV), and anti-human immunodeficiency virus (anti-HIV). Tools included 24-donation pool testing (PT) using Cobas Amplicor or in individual donations (ID) by Procleix Ultrio. Seven of 761,666 (1:108,800) and 21/250,191 (1:11,900) HBV DNA-positive donations were identified and confirmed by alternative methods. HBV DNA load ranged between 11.6 and 4.6 × 10 4 IU/mL in 11 samples and could not be quantified in 17 samples. HBV genotypes A (56%) and D (4%) were found. The analysis of combined results from index, follow-up, and look-back samples identified four groups: (1) Two cases tested HBsAg positive with alternative, more sensitive, assays; (2) Four cases were in the pre-seroconversion window period; (3) Eight cases had a fluctuating pattern of HBV DNA and anti-HBs detection (recovered infection); and (4) twelve cases carried anti-HBc without anti-HBs, which might correspond to either chronic or recovered "occult" HBV infection. One donor with no HBV markers in the follow-up was excluded, and another was in the window period preceding anti-HBs. HBV NAT identified more confirmed positive donors than HCV or HIV NAT, and 1:250,000 could not be detected by anti-HBc screening. Serological and molecular studies on follow-up and look-back samples are important to classify donors. In conclusion, further studies are needed to determine whether the considerably higher yield of HBV DNA detection obtained with individual donation screening improves blood safety compared with anti-HBc screening.

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DO - 10.1002/hep.21413

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SN - 0270-9139

VL - 44

SP - 1666

EP - 1674

JO - Hepatology

JF - Hepatology

IS - 6

ER -

Characterization of HBV DNA ⁺/HBsAg ^- blood donors in Poland identified by triplex NAT

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