Enhanced detection of hepatitis <scp>B</scp> virus in <scp>H</scp>ong <scp>K</scp>ong blood donors after introduction of a more sensitive transcription‐mediated amplification assay

Tsoi, W. C.; Lelie, Nico; Lin, Che-Kit

doi:10.1111/trf.12165

Cited by 41 publications

(84 citation statements)

References 30 publications

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“…However, in the light of the results obtained in this study, these recommendations should be revised in order to either exclude all anti-HBc-positive donors or to rescind the current NAT strategy and replace it with the most sensitive NAT applied to individual donation samples [9]. Notably, the prevalence of antiHBc antibodies among candidate donors is expected to decrease in the future as a result of vaccination and declining incidence of new infections.…”

Section: Discussionmentioning

confidence: 91%

“…However, HBV transfusion-transmission cannot be completely excluded since the pooling procedure reduces the assay's analytical sensitivity [9], and in fact a recent report indicated that the likelihood of detecting OBI donations by NAT increased when the size of the pool was decreased from 50 to 20 donations or when the test sensitivity was increased by a small margin [9][10][11]. As recently pointed out [5], studies on the safety of the current screening policies would require the testing of matched recipient specimens collected before and after transfusion.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Poor efficacy of nucleic acid testing in identifying occult HBV infection and consequences for safety of blood supply in Italy

Spreafico¹,

Berzuini²,

Foglieni³

et al. 2015

Journal of Hepatology

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Section: Discussionmentioning

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Poor efficacy of nucleic acid testing in identifying occult HBV infection and consequences for safety of blood supply in Italy

Spreafico¹,

Berzuini²,

Foglieni³

et al. 2015

Journal of Hepatology

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“…Additionally, the prevalence of OBI in Taiwan was 0.1% (from 10727 seronegative blood donors) (12), whereas in Hong Kong this was reported as 0.13% (4/3044) and 0.11% (11/9967) for two cohorts (13). However, in other studies, after introduction of a more sensitive transcription-mediated amplification assay, the HBV NAT-yield rates of OBI were 1:5120 and 1:2450 by ID-NAT using Ultrio and Ultrio Plus assays (Novartis Diagnostics), respectively (P < 0.0001) (14). …”

Section: Discussionmentioning

confidence: 96%

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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“…The dramatic increase in the proportion of reactive results in this subset of HBsAg‐yield samples indicates that there may be a subpopulation of HBV strains in South African donors that is poorly detected by the Ultrio assay and will be picked up with more than 10‐fold higher sensitivity by the addition of the TER in the Ultrio Plus assay. A similar hypothesis was formulated by Tsoi and coworkekrs who used mathematical modeling to explain a more than twofold higher WP NAT yield in Hong Kong blood donors after the Ultrio assay was replaced by the Ultrio Plus assay. Since similar results were found by us in South Africa our earlier reported residual risk estimates based on 95 and 50% LODs of the Ultrio assay on the Eurohep HBV Genotype A2 standard need to be reassessed.…”

Section: Discussionmentioning

confidence: 99%

Sensitivity of individual‐donation and minipool nucleic acid amplification test options in detecting window period and occult hepatitis B virus infections

et al. 2013

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BACKGROUND Several comparison studies showed that the Ultrio assay (Novartis Diagnostics) used in individual-donation nucleic acid amplification testing (ID-NAT) format was as sensitive as the TaqScreen assay (Roche) on minipools of six donations (MP6), but the sensitivity of HBV DNA detection has been improved in the new Ultrio Plus version of the assay. A head-to-head comparison study was designed to compare the clinical sensitivity of the Ultrio and Ultrio Plus assay in ID, MP4, and MP8 formats using TaqScreen MP6 as a reference assay. STUDY DESIGN AND METHODS Plasma samples of 107 hepatitis B surface antigen (HBsAg)-negative, HBV ID-NAT (Ultrio) positive-yield samples and 29 HBV DNA–negative, HBsAg-positive samples were used for comparison of NAT options in replicate testing of dilutions. Viral loads and relative sensitivities were determined by probit analysis against the Eurohep standard. RESULTS Ultrio Plus detected a significantly (p < 0.00001) higher proportion of replicate assays on HBV NAT yields (77%) than Ultrio ID (62%) and TaqScreen MP6 (47%), whereas Ultrio Plus MP4 and MP8 detected 53 and 41%, respectively. On HBsAg-yield samples missed by Ultrio screening, the reactivity rate increased significantly (p < 0.0001) from 23% in Ultrio to 65% in Ultrio Plus and further to 72% (p = 0.10) in the TaqScreen assay. The overall improvement factor of the analytical sensitivity offered by the target enhancer reagent in the Ultrio Plus assay was 2.5 (2.0–3.1)-fold on the Ultrio yield samples, but 43 (11–350)-fold on the HBsAg yields. In ID-NAT format the analytical sensitivity of TaqScreen relative to Ultrio Plus was 2.0 (1.0–4.2), 0.9 (0.7–1.3), and 1.6 (0.9–3.0) on the Eurohep standard, HBV NAT–, and HBsAg-yield samples respectively. CONCLUSION The clinical sensitivity of the currently available commercial NAT methods is mainly driven by the pool size.

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Enhanced detection of hepatitis B virus in Hong Kong blood donors after introduction of a more sensitive transcription‐mediated amplification assay

Cited by 41 publications

References 30 publications

Poor efficacy of nucleic acid testing in identifying occult HBV infection and consequences for safety of blood supply in Italy

Poor efficacy of nucleic acid testing in identifying occult HBV infection and consequences for safety of blood supply in Italy

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

Sensitivity of individual‐donation and minipool nucleic acid amplification test options in detecting window period and occult hepatitis B virus infections

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