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

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 Coba...

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Bibliographic Details
Published in:Hepatology (Baltimore, Md.) Md.), 2006-12, Vol.44 (6), p.1666-1674
Main Authors: Brojer, Ewa, Grabarczyk, Piotr, Liszewski, Grzegorz, Mikulska, Maria, Allain, Jean‐Pierre, Letowska, Magdalena
Format: Article
Language:English
Subjects:
Biological and medical sciences
Blood Donors
Blood Transfusion - standards
DNA, Viral - blood
Gastroenterology. Liver. Pancreas. Abdomen
Hepatitis B - epidemiology
Hepatitis B Antibodies - blood
Hepatitis B Surface Antigens - blood
Hepatitis B virus - immunology
Human viral diseases
Infectious diseases
Medical sciences
Poland - epidemiology
Serologic Tests - methods
Viral diseases
Viral hepatitis
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Summary: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 × 104 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. (HEPATOLOGY 2006;44:1666–1674.)
ISSN:0270-9139
1527-3350
DOI:10.1002/hep.21413