open access

Vol 3, No 2 (2010)
Research paper
Published online: 2010-06-02
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Molecular biology techniques for testing hepatitis B virus, hepatitis C virus and human immunodeficiency virus in 6-donation pools regardless of serological test results and alanine aminotransferase values

Elżbieta Ćwikowska, Izabela Michalczak, Karolina Stasik-Pierechod, Danuta Pruszkowska, Barbara Wyrwińska, Małgorzata Szafran
Journal of Transfusion Medicine 2010;3(2):55-61.

open access

Vol 3, No 2 (2010)
ORIGINAL PAPERS
Published online: 2010-06-02

Abstract

Background: In Polish Blood Banks molecular biology techniques (NAT) for testing hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) are performed either in individual blood donations or in six-donation pools. The aim of such screening is to identify infected donors when serological markers cannot yet be detected, especially in the early infection period. Until now, pooled plasma samples for NAT testing were prepared only from sero-negative donations with AlAT values within normal range. The aim of this study was to analyze NAT testing in consecutive donor pools regardless of the serological test results. Special emphasis was put on the frequency of non-confirmed results, the reagents consumption as well as time required for donation release.
Material and methods: Within the six-month period (19.08.2008 to 28.02.2009), we tested 22,794 donations (3799 pools) negative in serological screening tests; AlAT values within normal range (algorithm 1). Another 6,264 samples (1044 pools) were tested simultaneously with serological methods and NAT techniques (algorithm 2). In both algorithms, NAT analyses were performed in six-donation plasma pools using the Cobas TaqScreen MPX in the cobas s 201 system.
Results: Twenty positive pools were found in the 1044 (1.1%) donation-pools tested simultaneously by NAT and serological methods. All NAT positive samples were detected in first time donors with positive results of serological markers. In the remaining samples, no molecular markers were detected either in sero positive (6 HBsAg, 11 anti-HCV, 3 HIV Ag/Ab) samples or in samples with AlAT values above reference range (n = 105). No donors within serological window for HCV, HBV, HIV or with occult infection were identified in this study period.
Conclusions: Testing/screening performed according to algorithm 2 demonstrated no statistically significant increase of unrepeatable NAT positive results as compared to the period when testing/screening was performed according to algorithm 1, however more reagents were used (by about 12.7 %). The entire costs of reagents were covered by the Supplier therefore the blood bank expenditures for donation release did not increase and algorithm 2 allowed for accelerated release of most donations.
J. Transf. Med. 2010; 2: 55-61

Abstract

Background: In Polish Blood Banks molecular biology techniques (NAT) for testing hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV) are performed either in individual blood donations or in six-donation pools. The aim of such screening is to identify infected donors when serological markers cannot yet be detected, especially in the early infection period. Until now, pooled plasma samples for NAT testing were prepared only from sero-negative donations with AlAT values within normal range. The aim of this study was to analyze NAT testing in consecutive donor pools regardless of the serological test results. Special emphasis was put on the frequency of non-confirmed results, the reagents consumption as well as time required for donation release.
Material and methods: Within the six-month period (19.08.2008 to 28.02.2009), we tested 22,794 donations (3799 pools) negative in serological screening tests; AlAT values within normal range (algorithm 1). Another 6,264 samples (1044 pools) were tested simultaneously with serological methods and NAT techniques (algorithm 2). In both algorithms, NAT analyses were performed in six-donation plasma pools using the Cobas TaqScreen MPX in the cobas s 201 system.
Results: Twenty positive pools were found in the 1044 (1.1%) donation-pools tested simultaneously by NAT and serological methods. All NAT positive samples were detected in first time donors with positive results of serological markers. In the remaining samples, no molecular markers were detected either in sero positive (6 HBsAg, 11 anti-HCV, 3 HIV Ag/Ab) samples or in samples with AlAT values above reference range (n = 105). No donors within serological window for HCV, HBV, HIV or with occult infection were identified in this study period.
Conclusions: Testing/screening performed according to algorithm 2 demonstrated no statistically significant increase of unrepeatable NAT positive results as compared to the period when testing/screening was performed according to algorithm 1, however more reagents were used (by about 12.7 %). The entire costs of reagents were covered by the Supplier therefore the blood bank expenditures for donation release did not increase and algorithm 2 allowed for accelerated release of most donations.
J. Transf. Med. 2010; 2: 55-61
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Keywords

blood donors; donation; pooled plasma samples; serological markers; nucleic acid testing (NAT); RNA HCV; RNA HIV; DNA HBV

About this article
Title

Molecular biology techniques for testing hepatitis B virus, hepatitis C virus and human immunodeficiency virus in 6-donation pools regardless of serological test results and alanine aminotransferase values

Journal

Journal of Transfusion Medicine

Issue

Vol 3, No 2 (2010)

Article type

Research paper

Pages

55-61

Published online

2010-06-02

Bibliographic record

Journal of Transfusion Medicine 2010;3(2):55-61.

Keywords

blood donors
donation
pooled plasma samples
serological markers
nucleic acid testing (NAT)
RNA HCV
RNA HIV
DNA HBV

Authors

Elżbieta Ćwikowska
Izabela Michalczak
Karolina Stasik-Pierechod
Danuta Pruszkowska
Barbara Wyrwińska
Małgorzata Szafran

References (10)
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  2. Grabarczyk P, Medyńska J, Liszewski G, et al. HCV RNA and HIV RNA detection by PROCLEIX HIV1/HCV ASSAY in blood donors with various results of anti-HCV and anti-HIV EIA. Journal of Transfusion Medicine. 2009; 1(1): 26–33.
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  6. Grabarczyk P, Seyfried H, Brojer E, et al. Regionalne Centra Krwiodawstwa i Krwiolecznictwa. Wykrywanie HBsAg u polskich dawców krwi w latach 1995–2004. Journal of Transfusion Medicine. 2009; 2(1): 20–25.
  7. Mikulska M, Sułkowska E, Grabarczyk P, et al. Częstość zakażeń wirusem HIV w populacji krwiodawców w Polsce w latach 1988–2007. Journal of Transfusion Medicine. 2008.
  8. Instrukcja wykonania testu cobas® TaqScreen MPX do użytku z systemem cobas s 201.
  9. Phikulsod S, Oota S, Tirawatnapong T, et al. Working Group for NAT Study in Thai Blood Donations. One-year experience of nucleic acid technology testing for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus in Thai blood donations. Transfusion. 2009; 49(6): 1126–1135.
  10. Schmidt M, Pichl L, Jork C, et al. Blood donor screening with cobas s 201/cobas TaqScreen MPX under routine conditions at German Red Cross institutes. Vox Sang. 2010; 98(1): 37–46.

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