Evaluation of an individual‐donation nucleic acid amplification testing algorithm for detecting hepatitis B virus infection in Chinese blood donors

Gou, Hongna; Pan, Yang; Ge, Hongwei; Zheng, Yourong; Wu, Yaling; Zeng, Jinfeng; Yang, Zhou; Tong, Pan; Wei, Cun; Zhou, Guoping; Gen, Fang; Zhang, Jiahong; Zhang, Kuo; Zhang, Rui; Sun, Yu; Xie, Jiehong; Li, Jinming; Wang, Lunan

doi:10.1111/trf.13135

Cited by 17 publications

(22 citation statements)

References 17 publications

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“…In Italy, highly sensitive HBV DNA detection methods showed that 6-MP HBV DNA screening failed to identify 14/28 (50%) viremic donations, which were released for transfusion (30). However, two studies (31, 32) from the Chinese national center for clinical laboratories (NCCL) demonstrated that despite the dilution factor, the MP6-TaqScreen system detected a significantly higher proportion of qPCR-confirmed HBV NAT yields than the Ultrio ID-NAT algorithm (1/1590 versus 1/2488; P < 0.01). Notably, the Ultrio assay detected genotype B and C strains in China with reduced analytical sensitivity.…”

Section: Discussionmentioning

confidence: 99%

Serological Patterns and Molecular Characterization of Occult Hepatitis B Virus Infection among Blood Donors

Lin

Tang

et al. 2016

Hepat Mon

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BackgroundHepatitis B infections, characterized by the presence of a viral genome without detectable hepatitis B surface antigen (HBsAg; Occult hepatitis B infection [OBI]), have been reported recently.ObjectivesWe performed serological and molecular characterization of OBI among blood donors at Jiangsu province blood center during years 2013 and 2014.MethodsAll donor samples were routinely screened by double enzyme-linked immunosorbent assay (ELISA) for hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV), Treponema pallidum (TP), and alanine aminotransferase (ALT). Single-reactive, nonreactive, and ALT-elevated samples were pooled or resolved by nucleic acid testing (NAT). Seromarkers were examined in HBsAg-/DNA+ samples. After 1 to 12 months of follow up, seromarkers were screened again to verify OBI samples.ResultsWe studied 157119 samples from blood donors. A total of 154397 ELISA nonreactive donor samples were identified, and HBV DNA was detected in 81 samples; no samples were positive for HIV or HCV RNA. Hepatitis B virus viral loads in most donors were less than 20 - 200 IU/mL. There was only one HBsAg-positive sample. Eighty HBsAg-/DNA+ samples were evaluated further. Of these samples, 85% (68/80) were reactive for anti-HBc and 36.2% (29/800) were reactive for anti-HBc and anti-HBs; 11.3% (9/80) did not have any detectable serological markers. Twenty-nine donors were followed up. One was HBsAg ELISA positive, and of six seronegative donors, all had anti-HBc and anti-HBs, but were negative for DNA. Samples were HBV genotypes B, C and D. Mutations in the S region of HBV DNA included S114T, G119R, P120S, T125M, C139Y, T140I, C147W, T148A, A159V/G, E164D, V168A, and R169C.ConclusionsOverall, we found that OBI was rare, but that the prevalence of OBI was slightly higher in Jiangsu than in other areas of China.

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Section: Discussionmentioning

confidence: 99%

Serological Patterns and Molecular Characterization of Occult Hepatitis B Virus Infection among Blood Donors

Lin

Tang

et al. 2016

Hepat Mon

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“…When NAT was performed in some blood centres, HCV RNA-positive blood donors did not exceed the expected levels in ELISA-negative blood donors [6]. The potential risk for HCV to spread from OCI subjects through blood transfusions [15] and haemodialysis units should thus be considered [16,17].…”

Section: Discussionmentioning

confidence: 99%

“…Only 1 HCV RNA-positive sample was detected in HBV-, HCV-, HIV- and syphilis seromarker-negative samples. NAT appeared not to have the expected effective role in the screening of HCV infection [6]. …”

Section: Introductionmentioning

confidence: 99%

Prevalence of Occult Hepatitis C Virus Infection among Blood Donors in Jiangsu, China

Lin

Chen²,

Zhu³

et al. 2016

Intervirology

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Objective: In 2010, only 1 donor blood sample was found to be anti-hepatitis C virus (HCV) negative and HCV RNA positive, as detected by nucleic acid testing. In occult HCV infection (OCI), HCV RNA is found in peripheral blood mononuclear cells (PBMCs). We investigated the prevalence of OCI among blood donors. Methods: We collected 513 samples from 334 eligible and 179 deferred donors, including 55 anti-HCV-positive, 113 alanine aminotransferase (ALT)-elevated, and 11 hepatitis B virus surface antigen (HBsAg)-positive blood donors. PBMCs were isolated, the 5′-untranslated region of HCV RNA was amplified by reverse transcription nested PCR, and the genotype of the core region was determined. Results: No HCV RNA was detected among the eligible samples. Among the deferred donors, 15 (27.2%) had detectable HCV RNA in 55 anti-HCV PBMC specimens. HCV RNA was detected in 1 (9.1%) HBsAg-positive and 9 (8%) ALT-elevated samples. The prevalence of OCI in the blood donors was 2.2% (10/458). HCV genotypes were determined in 10 subjects, indicating that 2 (20.0%) were subtype 2a, 7 (70.0%) were 1b, and 1 (10%) was 6a. Conclusions: This study showed that OCI does exist among Chinese blood donors. However, to determine the epidemiology and outcome of this HCV infection, further follow-up with more participants and patients receiving blood components with OCI is needed.

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“…At least two lines of evidence indicate that a proportion of NDR results with concomitant anti‐HBc reactivity may represent OBI. Firstly, donors with NDR results have a higher prevalence of anti‐HBc reactivity than those who are NAT non‐reactive . Additionally, one study has reported that the anti‐HBc prevalence in donors who test NDR is higher for those who are reactive when retested on the multiplex assay compared to those who are non‐reactive .…”

Section: The Interpretative Challenges Of Nucleic Acid Testing (Nat)mentioning

confidence: 99%

False positive viral marker results in blood donors and their unintended consequences

2018

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False positive (FP) viral marker results in blood donors continue to pose many challenges. Informing donors of FP results and subsequent deferral can result in stress and anxiety for donors and additional complexity and workload for blood services. Donor management strategies need to balance the requirement to minimise donor anxiety and inconvenience while maintaining sufficiency of supply. Decisions about how and when to inform donors of FP results and determine deferral periods can be difficult as FP results, while often transitory, can take up to several years to resolve. Additional complexities include the interpretation of indeterminate serological confirmatory testing without detectable viral RNA or non-discriminated NAT results with concomitant anti-HBc reactivity - both may be due to FP results, but the former may also represent past infection and the later may represent occult hepatitis B infection. In this review we discuss strategies to minimise indeterminate serological confirmatory results, possible donor deferral policies and the impact on donors when notified of FP results. We also provide some new data from Australia that address the challenge of interpreting non-discriminated NAT results with concomitant anti-HBc reactivity. Ultimately, the challenge is for each blood service to develop appropriate strategies for donor management, taking into account local information and requirements.

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Evaluation of an individual‐donation nucleic acid amplification testing algorithm for detecting hepatitis B virus infection in Chinese blood donors

Cited by 17 publications

References 17 publications

Serological Patterns and Molecular Characterization of Occult Hepatitis B Virus Infection among Blood Donors

Serological Patterns and Molecular Characterization of Occult Hepatitis B Virus Infection among Blood Donors

Prevalence of Occult Hepatitis C Virus Infection among Blood Donors in Jiangsu, China

False positive viral marker results in blood donors and their unintended consequences

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