Evidence map›Paper›PMID 34696483›Full record

ArticleViruses2021

Molecular and Serological Characterization of Hepatitis B Virus (HBV)-Positive Samples with Very Low or Undetectable Levels of HBV Surface Antigen.

Mary C Kuhns, Vera Holzmayer, Mark Anderson, Anne L McNamara, Silvia Sauleda, Dora Mbanya, Pham T Duong, Nguyen T T Dung, Gavin A Cloherty

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Viruses, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.0field-weighted citation impact, top 8% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 31 citations in OpenAlex.

  1. Occult hepatitis B virus infection.Nature reviews. Gastroenterology & hepatology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 4 countries.

Mary C KuhnsAbbott Laboratories, Infectious Diseases Research, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Vera HolzmayerAbbott Laboratories, Infectious Diseases Research, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Mark AndersonAbbott Laboratories, Infectious Diseases Research, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Anne L McNamaraAbbott Laboratories, Infectious Diseases Research, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Silvia SauledaLaboratori de Seguretat Transfusional BST, Banc de Sang I Teixits Passeig Taulat, 08005 Barcelona, Spain.
Dora MbanyaDepartment of Hematology, University of Yaounde, Yaounde BP 8046, Cameroon.
Pham T DuongMinistry of Health-National Institute of Hematology and Blood Transfusion, Pham Van Bach St., Yen Hoa, Cau Giay, Ha Noi 122000, Vietnam.
Nguyen T T DungMinistry of Health-National Institute of Hematology and Blood Transfusion, Pham Van Bach St., Yen Hoa, Cau Giay, Ha Noi 122000, Vietnam.
Gavin A ClohertyAbbott Laboratories, Infectious Diseases Research, Diagnostics Division, 100 Abbott Park Road, Abbott Park, IL 60064, USA.
Abbott Fund · USMinistry of Health · VNBanc de Sang i Teixits · ESUniversité de Yaoundé I · CM

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGaps remain in the detection of nucleic acid test (NAT) yield and occult hepatitis B virus (HBV) infection (OBI) by current HBV surface antigen (HBsAg) assays. The lack of detection may be due to HBsAg levels below current assay detection limits, mutations affecting HBsAg assays or HBsAg levels, or the masking of HBsAg by antibody to HBsAg (anti-HBs). In this study, we evaluate the incremental detection of NAT yield and OBI from five diverse geographic areas by an improved sensitivity HBsAg assay and characterize the samples relative to the viral load, anti-HBs status, and PreS1-S2-S mutations. Included is a comparison population with HBV DNA levels comparable to OBI, but with readily detectable HBsAg (High Surface-Low DNA, HSLD).

methodsA total of 347 samples collected from the USA, South Africa, Spain, Cameroon, Vietnam, and Cote D'Ivoire representing NAT yield (HBsAg(-), antibody to HBV core antigen (anti-HBc)(-), HBV DNA(+), N = 131), OBI (HBsAg(-), anti-HBc(+), HBV DNA(+), N = 188), and HSLD (HBsAg(+), anti-HBc(+), HBV DNA(+), N = 28) were tested with ARCHITECT HBsAg NEXT (HBsAgNx) (sensitivity 0.005 IU/mL). The sequencing of the PreS1-S2-S genes from a subset of 177 samples was performed to determine the genotype and assess amino acid variability, particularly in anti-HBs(+) samples.

resultsHBsAgNx detected 44/131 (33.6%) NAT yield and 42/188 (22.3%) OBI samples. Mean HBV DNA levels for NAT yield and OBI samples were lower in HBsAgNx(-) (50.3 and 25.9 IU/mL) than in HBsAgNx(+) samples (384.1 and 139.5 IU/mL). Anti-HBs ≥ 10 mIU/mL was present in 28.6% HBsAgNx(+) and 45.2% HBsAgNx(-) OBI, and in 3.6% HSLD samples. The genotypes were A1, A2, B, C, D, E, F, and H. There was no significant difference between HBsAgNx(-) and HBsAgNx(+) in the proportion of samples harboring substitutions or in the mean number of substitutions per sample in PreS1, PreS2, or S for the NAT yield or OBI (

conclusionsHBsAgNx provides the improved detection of NAT yield and OBI samples. Samples that remain undetected by HBsAgNx have exceptionally low HBsAg levels below the assay detection limit, likely due to low viremia or the suppression of HBsAg expression by host and viral factors.

Indexed as

Antigens, SurfaceCameroonCote d'IvoireDiagnostic Tests, RoutineDNA, ViralGenotypeHepatitis BHepatitis B AntibodiesHepatitis B Core AntigensHepatitis B Surface AntigensHepatitis B virusHumansLimit of DetectionMutationProtein PrecursorsSensitivity and SpecificityAntigens, SurfaceDNA, ViralHepatitis B AntibodiesHepatitis B Core AntigensHepatitis B Surface Antigenspresurface protein 1, hepatitis B surface antigenpresurface protein 2, hepatitis B surface antigenProtein PrecursorsHBV biomarkershepatitis B surface antigenhepatitis B virusoccult hepatitis B

Identifiers

PMID34696483
PMCPMC8537069
OpenAlexW3205530543

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.