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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.


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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