Correlation of improved hepatitis B surface antigen detection limits with hepatitis B virus DNA nucleic acid test yield in blood donations

Martin, Lynn A.; Stramer, Susan L.; Kuhns, Mary C.; Schlauder, George G.

doi:10.1111/j.1537-2995.2011.03553.x

Cited by 7 publications

(5 citation statements)

References 21 publications

(61 reference statements)

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“…The HBV DNA concentration in all OBI donors was 40 IU/mL or lower. Higher HBsAg assay sensitivity would be required to detect possible HBsAg in infected individuals having such low viral loads (e.g., 0.02 ng/mL vs. 0.08–0.10 ng/mL of current assays) . OBI donors who are HBV DNA positive provide ongoing evidence that they may be “currently” infected and therefore potentially infectious.…”

Section: Discussionmentioning

confidence: 99%

Recent and occult hepatitis B virus infections among blood donors in the United States

et al. 2018

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BACKGROUND: Characteristics of US blood donors with recent (RBI) or occult (OBI) hepatitis B virus (HBV) infection are not well defined. METHODS: Donors with RBI and OBI were identified by nucleic acid and serologic testing among 34.4 million donations during 2009-2015. Consenting donors were interviewed and their HBV S-gene sequenced. RESULTS:The overall rate of HBV-infected donors was 7.95 per 100,000; of these, 0.35 per 100,000 and 1.70 per 100,000 were RBI and OBI, respectively. RBI (n = 120) and OBI (n = 583) donors constituted 26% of all HBV-infected (n = 2735) donors. Detection of HBV DNA in 92% of OBI donors required individual donation nucleic acid testing. Donors with OBI compared to RBI were older (mean age, 48 vs 39 years; p < 0.0001) with lower median viral loads (9 vs. 529 IU/mL; p < 0.0001). A higher proportion of OBI than RBI donors were born or resided in an endemic country (39% vs. 5%; p = 0.0078). Seventy-seven percent of all RBI and OBI donors had multiple sex partners, an HBV-risk factor. Of 40 RBI and 10 OBI donors whose S gene was sequenced, 33 (83%) and 6 (60%), respectively, carried HBV subgenotype A2; 18 (55%) and 2 (33%), respectively, shared an identical sequence. Infection with 1 or more putative HBVimmune-escape mutants was identified in 5 (50%) of OBI but no RBI donors. CONCLUSION: RBI and OBI continue to be identified at low rates, confirming the importance of comprehensive HBV DNA screening of US blood donations. HBV-infected donors require referral for care and evaluation and contact tracing; their HBV strains may provide important information on emergent genotypes. ABBREVIATIONS: ARC = American Red Cross; CI = confidence interval; HBcAb = hepatitis B core antibody; HBsAb = antibody to hepatitis B surface antigen; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; ID = individual; MPs = minipools; NAT = nucleic acid testing; OBI = occult HBV infection; OR = odds ratio; PCR = polymerase chain reaction; RBI = recent HBV-infected; TMA = transcription-mediated amplification From the

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Section: Discussionmentioning

confidence: 99%

Recent and occult hepatitis B virus infections among blood donors in the United States

et al. 2018

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“…Testing for HBsAg was initiated in the early 1970s with, at that time, assays detecting HBs concentrations higher than 1000 ng/ml. Current available assays achieve a limit of detection lower than 0·1 ng/ml with an estimated viral load at assay cut‐off under 300 copies/ml, that is equivalent to the threshold of NAT methods when performed in mini‐pools . It should be noted, however, that in spite of a very high level of sensitivity, HBsAg assays may be affected by HBV variants bearing substitutions in the amino acids sequence of HBs protein, which prevent binding to anti‐HBs monoclonal antibodies (Ab) that are used in immunoassays .…”

Section: Screening Testingmentioning

confidence: 99%

Testing for established viruses: from the screening to the confirmation

Laperche

2013

ISBT Science Series

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Enzyme Immunoassays (EIAs) detecting antibodies (Ab) or antigen (Ag) used to avoid viral transmissions by transfusion, are the most suitable methods for blood screening because they are economical and adaptable to high‐throughput testing. The continuing need to improve screening for HIV and HCV, led to develop Ag/Ab combination assays. The benefit of such assays has been widely demonstrated, since they are able to detect infected individuals in viremic pre‐seroconversion phase, making them particularly attractive for ensuring blood safety when nucleic acid testing (NAT) cannot be implemented. In resource‐limited countries, especially in remote‐areas, blood safety is often based upon rapid tests (RT) which are easy to handle and can be used with whole blood. Nevertheless, the poor sensitivity of RT compared to EIAs could significantly impair blood safety. Because NAT could efficiently detect serologically negative donors, many developed countries have implemented this method in blood screening. NAT yields vary depending on epidemiological situations. NAT is subjected to false‐negative results due to viral diversity or to extremely low viral loads, but also to false‐positive due to sample cross‐contamination. A repeatedly NAT reactive sample with multiplexed NAT is submitted to a virus‐specific amplification testing to discriminate between the viruses, creating some problematic situations consisting of samples reactive with the screening assay but non‐reactive with the discriminatory assay. Although the primary purpose of viral screening testing is to prevent pathogen transmission to recipients, confirmatory testing intends to manage donors with adverse test results and to guarantee an optimal blood supply. As EIAs show a low positive predictive value in low‐prevalence countries due to frequent non‐specific reactions, the use of confirmatory assays is justified. Nevertheless confirmatory tests are known to be less sensitive than EIAs in the early phase of infection and show also nonspecific reactivity leading to indeterminate results which create difficulties in managing donors. As in limited‐resource countries, specific confirmatory assay cannot be used, alternate strategies for confirmatory testing have been proposed, as to simultaneously test blood with two assays and to exclude donors reactive with both, or to use screening test signal values to support confirmation. Although the direct detection of the virus through its genome might be considered as the best solution to ensure blood safety, the choice of blood screening strategy should be adapted to local epidemiology and organization constraints.

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“…Besides approximately 40% of individuals with this pro le of results, this serological marker has low speci city and high rates of false-positives, requiring additional con rmatory tests such as molecular tests to retain the result (25)(26). In contrast, several studies have shown that Anti-HBc is the only serological marker found in occult infection with NAT negative HBV, being considered an important complement to transfusion safety (20,(27)(28)(29)(30).…”

Section: Introductionmentioning

confidence: 99%

Accuracy of screening for HBV (NAT, HBSAg, anti-HBC) in blood donors from the Brazilian Amazon from 2105 to 2018

Belota

Silva

Nascimento

et al. 2023

Preprint

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Background Hepatitis B (HBV) is an infectious disease of worldwide importance and of great interest to transfusion medicine. The Amazon region has areas of high endemicity, outlining a worrying scenario for local transfusion safety, and it is necessary to investigate its impact on public health and blood component stocks. Objective To investigate the accuracy of HBV screening (NAT, HBSAg, anti-HBC) in blood donors from the Hemocentro do Amazonas, Brazil, from 2105 to 2018. Methods Blood donors reactive in serological and molecular screening for HBV were tested for viral load detection using the qPCR method at the reference center for liver diseases in the State of Amazonas to verify the accuracy of the screening established in Brazilian blood centers. Results A total of 230,591 blood donations were analyzed, with detection of 3,932 inaptitudes by serological and molecular tests, of which 3,104 samples were reactive for some marker for HBV (78.94%). Among the results found, no detection of viral load was observed in 100% of donors reactive to HBsAg alone, while 100% of donors with the NAT-/HBsAg+/Anti-HBc + profile had a detectable viral load. Conclusion The positivity for some HBV marker in blood donors was the biggest reason for discarding blood bags in the period; Serological and molecular screening proved to be safe and reliable; The evasion of individuals from continuing the investigation at the referral center can impact the epidemiological control of hepatitis B.

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Correlation of improved hepatitis B surface antigen detection limits with hepatitis B virus DNA nucleic acid test yield in blood donations

Cited by 7 publications

References 21 publications

Recent and occult hepatitis B virus infections among blood donors in the United States

Recent and occult hepatitis B virus infections among blood donors in the United States

Testing for established viruses: from the screening to the confirmation

Accuracy of screening for HBV (NAT, HBSAg, anti-HBC) in blood donors from the Brazilian Amazon from 2105 to 2018

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