Mutation of the "a" Determinant of HBsAg with Discordant HBsAg Diagnostic Kits

Louisirirotchanakul, Suda; Kanoksinsombat, Chinda; Theamboonlert, Apiradee; Puthavatana, Pilaipan; Wasi, Chantapong; Poovorawan, Yong

doi:10.1089/0882824041857003

Cited by 7 publications

(13 citation statements)

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“…Based on the World Health Organization evaluation of the performance of HBsAg test kits, two commercial kits were tested to re-characterize for HBsAg status at the evaluation site (17). The first kit was based on a sandwich enzyme-linked immunoassay (ELISA) principle that used monoclonal detection with color format (Cobas Core HB-sAg, Roche, Mannheim, Germany) whereas the second one was a MEIA, using polyclonal determination with fluorochrome format (AxSYM HBsAg [V2], Abbott Diagnostic, Germany), as in our previous report (16). The negative result by both assays was considered to be negative.…”

Section: Methodsmentioning

confidence: 99%

“…Thus, the ability to detect HBV mutants in the blood transfusion setting is critical to the safety of blood products (14,15). We have previously demonstrated that a diagnostic kit, containing a monoclonal capture and color detection format, failed to detect the presence of HBsAg in a subject infected with HBV subtype adr containing a Gly145Arg substitution (16). The performance of HB-sAg commercial kits with Thai specimens especially from those infected with HBV subtypes adr and adw2 has not been done.…”

Section: Introductionmentioning

confidence: 99%

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HBsAg Diagnostic Kits in the Detection of Hepatitis B Virus Mutation within "a" Determinant

Louisirirotchanakul¹,

Kanoksinsombat²,

O-Charoen³

et al. 2006

Viral Immunology

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The performance of currently available hepatitis B surface antigen (HBsAg) commercial kits was analyzed by using a panel of 212 well-characterized plasma donors all over the country and a panel of nine recombinant HBsAg mutants containing single point or combinations of mutations between amino acid residues 124 and 147 of the "a" determinant. HBsAg commercial kits in this study were machine-based immunoassays with a one-step sandwich ELISA method using either an automatic closed system or manual system. The sensitivity of all machine-based assays evaluated with 105 HBsAg plasma panels was 100% (95% CL = 95.6-99.9%), whereas the specificity with 107 HBsAg negative plasma ranged from 99.07% to 100% (95% CL = 94.2-99.9%). The relative performance of these kits to detect the hepatitis B virus (HBV) mutant panel members of the "a" determinant was found to differ. Interestingly, any commercial kits with monoclonal antibody capture and polyclonal antibody detection (mono/poly), but not mono/mono Ab capture and detection, could pick up the common HBsAg Gly145Arg mutant either solely or in combination with other mutations within the "a" determinant. New versions of HBsAg test kits should recognize multiple HBsAg epitopes in order to detect mutant HBsAg, together with providing good analytical sensitivity and specificity, because of the importance of these assays in HBV diagnosis and in protecting the safety of the blood supply.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

HBsAg Diagnostic Kits in the Detection of Hepatitis B Virus Mutation within "a" Determinant

Louisirirotchanakul¹,

Kanoksinsombat²,

O-Charoen³

et al. 2006

Viral Immunology

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“…6 In a recent study it was shown that several HBsAg gene mutations either present alone (G145R) or in combination (IL110R, S117I, G119R, T123N, C124R, and P203R), in diluted (P120Q, T131K, and G145R) or undiluted form may lead to false negative results in several HBsAg assays including Monolisa Ultra and Vidas Ultra which are used in our setting for screening and confirmation, respectively. 7 Sensitivity performances for mutant HBV detection varied between 40% for Centaur, 86% for Liaison, 89% for Monolisa Ultra and Vidas Ultra to 91% for AxSYM assays.…”

Section: Case Reportmentioning

confidence: 98%

Hepatitis B virus reactivation in a large haemodialysis unit: Virological and infection control issues

Bhattacharya

Ijaz²,

Ratnaraja

et al. 2009

Journal of Clinical Virology

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“…The format of the HBsAg test kit from Abbott was based on polyclonal antibody detection whereas that from Roche was based on a monoclonal format. The HBsAg-reactive samples were confirmed, employing a neutralization assay by premixing the samples with anti-HBs at a given time before the addition of this mixture to the HBsAg assay (13). A positive result was based on a reaction decrease of at least 50% in the serum pretreated with antiHBs when compared with the same sample untreated.…”

Section: Immunoassays For Hepatitis B Markersmentioning

confidence: 99%

“…The presence of HBV infection and anti-HBs are thought to be mutually exclusive. Nevertheless, there have been studies reporting the simultaneous presence of HBV infection and anti-HBs in 3-26% of HBsAg carriers and in 24-36% of chronic hepatitis B patients (10)(11)(12)(13).…”

Section: Introductionmentioning

confidence: 99%

Hepatitis B Virus DNA in Unusual Serological Profiles of Hepatitis B Surface Antigen-Positive Sera

et al. 2006

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On the basis of a seroepidemiological survey of hepatitis B virus (HBV) infection conducted on 6208 random serum samples from four provinces of Thailand, we found 19 of 246 (7.7%) hepatitis B surface antigen (HBsAg)-positive samples with unusual serological constellations of HBV infection. Ten samples tested positive for HBsAg, anti-HBc (anti-hepatitis B core antibody), and anti-HBs (anti-hepatitis B surface antibody) markers (group I), 3 specimens were HBsAg and anti-HBs positive without detectable anti-HBc (group II), and the remaining 6 specimens showed only HBsAg (group III). In group I, 7 of 10 HBsAg-positive sera could be confirmed by HBsAg neutralization, yielding positive results for all samples. None of the group II sera were available in sufficient amounts for confirmation. In group III, five of six sera were confirmed by HBsAg neutralization, with four showing a positive reaction. HBV DNA was detected in 7 of 10 (70%) specimens in group I, in 1 of 3 (33.3%) specimens in group II, and in 3 of 6 (50%) specimens in group III. On the basis of HBsAg neutralization, HBV DNA was found in five of seven (71.4%) HBsAg-positive samples in group I and in three of four (75%) HBsAg-positive samples in group III, whereas the one confirmed HBsAg-negative sample in group III also remained negative for HBV DNA. Amino acid sequences were compared with those specifying the "a" determinant of the wild-type virus, particularly focusing on HBV-S protein variations between positions 110 and 160. Among 11 HBV DNA-positive sera, G145A was detected in 2 samples in group I, with the remaining samples identical to the wild-type virus. These unusual serological profiles may be due to the altered immune response of the host or to HBV variants.

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Mutation of the "a" Determinant of HBsAg with Discordant HBsAg Diagnostic Kits

Cited by 7 publications

References 0 publications

HBsAg Diagnostic Kits in the Detection of Hepatitis B Virus Mutation within "a" Determinant

HBsAg Diagnostic Kits in the Detection of Hepatitis B Virus Mutation within "a" Determinant

Hepatitis B virus reactivation in a large haemodialysis unit: Virological and infection control issues

Hepatitis B Virus DNA in Unusual Serological Profiles of Hepatitis B Surface Antigen-Positive Sera

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