scholarly journals Diagnosis and Monitoring of Hepatitis B Virus Infection Using the Cobas® HBV Test for Use on the Cobas® 4800 System

2021 ◽  
Vol 9 (3) ◽  
pp. 573
Author(s):  
Valérie Ortonne ◽  
Mélanie Wlassow ◽  
Magali Bouvier-Alias ◽  
Giovana Melica ◽  
Jean-Dominique Poveda ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Limit Of Detection ◽  
Clinical Performance ◽  
Hbv Dna ◽  
Nucleic Acid Amplification ◽  
Hbv Genotypes ◽  
B Virus ◽  
System 2

(1) Background: Sensitive and accurate nucleic acid amplification technologies are now recommended for hepatitis B virus (HBV) DNA detection and quantification in clinical practice to diagnose and monitor hepatitis B infection. The aim of this study was to assess the analytical and clinical performance of the cobas® HBV Test on the cobas® 4800 System. (2) Methods: Standard panel and clinical specimens were tested in parallel with three different real-time commercial PCR assays including the cobas ® HBV Test, the Cobas® AmpliPrep/Cobas® TaqMan HBV Test v2.0 and Alinity™ m HBV assay. (3) Results: The specificity of the cobas® HBV Test was 97.9%. The limit of detection was estimated to be 2.1 IU/mL. Intra-assay and interassay coefficients of variation varied from 0.14% to 1.92% and 2.16% to 12.02%, respectively. HBV DNA levels in patients infected with different HBV genotypes strongly correlated with those measured by the two other commercial comparators assays. (4) Conclusions: The cobas® HBV Test can be confidently used to detect and accurately quantify HBV DNA in clinical practice as well as in clinical trials with the new anti-HBV drugs currently in development.

scholarly journals The New Aptima HBV Quant Real-Time TMA Assay Accurately Quantifies Hepatitis B Virus DNA from Genotypes A to F

2017 ◽  
Vol 55 (4) ◽  
pp. 1211-1219 ◽  
Author(s):  
Stéphane Chevaliez ◽  
Claude Dauvillier ◽  
Fabienne Dubernet ◽  
Jean-Dominique Poveda ◽  
Syria Laperche ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Real Time ◽  
Limit Of Detection ◽  
Antiviral Treatment ◽  
Hbv Dna ◽  
Hbv Genotypes ◽  
B Virus ◽  
Test Version ◽  
Related Liver Disease

ABSTRACT Sensitive and accurate hepatitis B virus (HBV) DNA detection and quantification are essential to diagnose HBV infection, establish the prognosis of HBV-related liver disease, and guide the decision to treat and monitor the virological response to antiviral treatment and the emergence of resistance. Currently available HBV DNA platforms and assays are generally designed for batching multiple specimens within an individual run and require at least one full day of work to complete the analyses. The aim of this study was to evaluate the ability of the newly developed, fully automated, one-step Aptima HBV Quant assay to accurately detect and quantify HBV DNA in a large series of patients infected with different HBV genotypes. The limit of detection of the assay was estimated to be 4.5 IU/ml. The specificity of the assay was 100%. Intra-assay and interassay coefficients of variation ranged from 0.29% to 5.07% and 4.90% to 6.85%, respectively. HBV DNA levels from patients infected with HBV genotypes A to F measured with the Aptima HBV Quant assay strongly correlated with those measured by two commercial real-time PCR comparators (Cobas AmpliPrep/Cobas TaqMan HBV test, version 2.0, and Abbott RealTi m e HBV test). In conclusion, the Aptima HBV Quant assay is sensitive, specific, and reproducible and accurately quantifies HBV DNA in plasma samples from patients with chronic HBV infections of all genotypes, including patients on antiviral treatment with nucleoside or nucleotide analogues. The Aptima HBV Quant assay can thus confidently be used to detect and quantify HBV DNA in both clinical trials with new anti-HBV drugs and clinical practice.

Hepatitis B virus (HBV) DNA quantification and HBV genotypes detection in dried blood specimens

2003 ◽  
Vol 38 ◽  
pp. 112
Author(s):  
R. Jardi ◽  
F. Rodriguez-Frias ◽  
M. Buti ◽  
X. Costa ◽  
A. Valdes ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Dna ◽  
Dna Quantification ◽  
Hbv Genotypes ◽  
B Virus ◽  
Blood Specimens

scholarly journals Epidemiological and Clinical Features of Hepatitis B Virus Genotypes among Immigrants in Southern Italy

2010 ◽  
Vol 2010 ◽  
pp. 1-6 ◽  
Author(s):  
Gaetano Scotto ◽  
Domenico Martinelli ◽  
Rocco Di Tullio ◽  
Vincenzina Fazio
Keyword(s):  
Chronic Hepatitis ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Clinical Features ◽  
Hbv Dna ◽  
Hbv Infection ◽  
Hbv Genotypes ◽  
B Virus ◽  
Virus Genotypes ◽  
Severe Chronic Hepatitis

Background/aims. This study aims to determine the distribution and clinical features of HBV-genotypes in a population of immigrants affected by HBV-infection. Methods. Between 01/2003 and 03/2009, 1623 immigrants were tested for HBV-infection. Biochemical and virological activities were determined in HBsAg-positive patients; HBV-genotypes were determined, by the INNO-LiPA HBV Genotyping, in the subjects with HBV DNA detectable. In every patient we evaluated the stage and classified the infection as inactive carrier, mild or moderate/severe chronic hepatitis, cirrhosis, and/or HCC. Results. Among the tested subjects, 191 (11.7%) resulted HBsAg-positive, and in 144/191 (75.4%) serum HBV-DNA was detectable. The genotype distribution was as follows: 45,13% genotype E, 18,1% genotype D, 15,3% genotype B, 13,2% genotype C, 4,9% genotype A, 3,5% mixed genotypes (A–D). The evaluation of liver disease degree showed that 24.6% patients were inactive carriers of HBV infection, 19.4% presented a immunotolerance phase, 34.5% had mild chronic hepatitis, 13.6% had a moderate/severe chronic hepatitis, 6.3% had cirrhosis, and 1.6% presented HCC. Conclusions. Our study evidences a high prevalence of HBV-infection in immigrants, and the potentiality of migratory flow in the introduction of genotype non-D hepatitis B virus. The Hepatitis B virus genotypes presented significant differences in epidemiological and clinical characteristics.

scholarly journals Prevalence of hepatitis B virus genotypes among patients with liver disease in Eritrea

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mohammed Elfatih Hamida ◽  
Saud Mohammed Raja ◽  
Yodahi Petros ◽  
Munir Wahab ◽  
Yemane Seyoum ◽  
...  
Keyword(s):  
Viral Load ◽  
Liver Disease ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hepatitis B Surface Antigen ◽  
Hbv Dna ◽  
Hbv Genotype ◽  
Hbv Genotypes ◽  
B Virus ◽  
Intermediate Endemicity

AbstractEritrea is an East African multiethnic country with an intermediate endemicity for hepatitis B. Our aim was to establish the most prevalent genotypes of hepatitis B virus (HBV) among patients with liver disease. A total of 293 Eritrean patients with liver disease who were hepatitis B surface antigen (HBsAg) positive were enrolled. All sera were tested for liver transaminases, HBV DNA viral load, and hepatitis B seromarkers including HBsAg, anti-HBcAb (total), HBeAg, and anti-HBeAb. Those reactive for HBsAg and anti-HBc (total) were further tested for HBV genotyping. The median (interquartile range) of HBV DNA viral load and ALT levels were 3.47 (1.66) log IU/mL and 28 (15.3) IU/L, respectively. Using type-specific primer-based genotyping method, 122/293 (41.6%) could be genotyped. Irrespective of mode of occurrence, HBV genotype D (21.3%) was the predominant circulating genotype, followed by genotypes C (17.2%), E (15.6%), C/D (13.1%), and C/E (10.7%). Genotypes C/D/E (7.4%), A/D (4.9%), D/E (4.1%), A (2.5%), and B, A/E, B/E, and A/D/C (0.8%) were also present. HBV in Eritrea is comprised of a mixture of HBV genotypes. This is the first study of HBV genotyping among patients with liver disease in Eritrea.

scholarly journals DOCK11 and DENND2A play pivotal roles in the maintenance of hepatitis B virus in host cells

PLoS ONE ◽  
2021 ◽  
Vol 16 (2) ◽  
pp. e0246313
Author(s):  
Shinichi Hashimoto ◽  
Takayoshi Shirasaki ◽  
Taro Yamashita ◽  
Sadahiro Iwabuchi ◽  
Yutaka Suzuki ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Limit Of Detection ◽  
Low Frequency ◽  
Hbv Dna ◽  
Small Gtpase ◽  
Host Cells ◽  
Sequencing Analysis ◽  
Circular Dna ◽  
B Virus

Human hepatitis B virus (HBV) infection remains a serious health problem worldwide. However, the mechanism for the maintenance of HBV in a latent state within host cells remains unclear. Here, using single-cell RNA sequencing analysis, we identified four genes linked to the maintenance of HBV in a liver cell line expressing HBV RNA at a low frequency. These genes included DOCK11 and DENND2A, which encode small GTPase regulators. In primary human hepatocytes infected with HBV, knockdown of these two genes decreased the amount of both HBV DNA and covalently closed circular DNA to below the limit of detection. Our findings reveal a role for DOCK11 and DENND2A in the maintenance of HBV.

scholarly journals A Highly Prevalent Polymorphism in the Core Region Impairs Quantification of Hepatitis B Virus (HBV) by the cobas TaqMan HBV Assay

2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Laure Boizeau ◽  
Annabelle Servant-Delmas ◽  
Alexandra Ducancelle ◽  
Stéphane Chevaliez ◽  
Vincent Thibault ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Limit Of Detection ◽  
Hbv Dna ◽  
Cobas Taqman ◽  
The Core ◽  
B Virus ◽  
Reverse Primer ◽  
New Generation ◽  
Genotype A

ABSTRACT The high genetic variability of hepatitis B virus (HBV) can impair DNA quantification. Here, we investigate a major underquantification of HBV by the cobas TaqMan HBV assay (CTM; Roche). In France, between 2005 and 2017, HBV DNA was detected in 3,102 blood donations by use of the CTM (95% limit of detection [LOD95], 4.8 IU/ml). HBV strains were sequenced in the S region (LOD95, ∼30 IU/ml). Concordant (n = 120) and discordant (n = 45) samples were identified according to the agreement between the plasma viral load (pVL) determined by the CTM and sequencing; all samples were also quantified using the RealTime HBV assay (RTH; Abbott). The viral signature, cloning, and mutagenesis were used to characterize the polymorphism responsible for CTM misquantification. A CTM-RTH discordance (>1 log IU/ml) was found in 14/45 samples that had low pVLs and were successfully genotyped (pVLlow genoS+). PreC/C clones of concordant (C1, C2) and discordant (D1, D2) strains were used to challenge the CTM. Strains D1 and D2 were highly underquantified (42- and 368-fold). In clones, mutating the region corresponding to the CTM reverse primer from a discordant sequence to a concordant sequence restored the levels of quantification to 24% (D1→C1) and 59% (D2→C1) of theoretical levels, while mutating the sequence of a concordant strain to that of a discordant strain led to 78-fold (C1→D1) and 146-fold (C1→D2) decreases in quantification. Moreover, mutating positions 1961 and 1962 was enough to induce a 5-fold underquantification. We conclude that the CTM underestimates pVLs for HBV strains with mutations in the reverse primer target. Specifically, the polymorphism at nucleotides 1961 and 1962 is naturally present in 4.79 and 4.22% of genotype A and D strains, which are highly frequent in Europe, leading to a 5-fold decrease in quantification. Quantification using the new-generation Roche C4800 assay is not affected by this polymorphism.

Hepatitis B Virus Nucleic Acid Amplification Testing Assay in Detecting Window Period and Occult Hepatitis B Virus Infections in Blood Donors

2020 ◽  
Vol 13 (1) ◽  
pp. 48-53
Author(s):  
Mariya P. Georgieva-Sredkova ◽  
Neli S. Doseva ◽  
Vladislav M. Nankov ◽  
Pencho T. Tonchev ◽  
Aneta A. Surdzhyska
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Dna ◽  
Nucleic Acid Amplification ◽  
Fisher Exact Test ◽  
Exact Test ◽  
Negative Results ◽  
B Virus ◽  
Donated Blood ◽  
First Time

Summary To reduce the residual risk of transfusion-transmitted infections, nucleic acid amplification testing (NAT) of donated blood with higher sensitivity for HBV, HCV, and HIV 1/2 was implemented in Bulgaria at the end of 2019. This study aimed to assess the clinical sensitivity of HBsAg testing and NAT testing of donated blood to detect all forms of HBV infection. A total of 9498 consecutive blood donations collected for six months, from February 10 to July 17, 2020, from first-time and repeat donors at the Regional Center of Transfusion Hematology Pleven, Bulgaria, were screened for HBsAg and HBV DNA. The detection of HBsAg was performed by enzyme-linked immunoassay and chemiluminescent immunoassay. Detection of HBV DNA was performed using the HIV1/2 /HCV / HBV multiplex Procleix Ultrio Elite assay in a fully automated and integrated Procleix Panther System. The overall HBsAg prevalence was 0.05%. HBV DNA was detected in 25 blood units (0.26%), but only 12 (0.13%) were found positive after repeat testing and were confirmed by a discriminatory test. The other 13 units were false positive, with the initial reactive result and negative results after repeat testing. HBV DNA’s overall incidence was significantly higher in HBsAg-positive donors than the HBsAg- negative (Fisher exact p=0.0063). In our study, blood donations were not tested for anti-HBc and anti-HBs, so it is difficult to determine whether HBV DNA-positive/HBsAg-negative results were associated with the early phase of infection or persistent occult infection. There was no statistical difference in the incidence of HBV DNA between repeat-donors (0.16%) and first-time donors (0.06%) (Fisher exact test p=0.239 NS), and also between the incidence in female donors (0.12%) and male donors (0.13%) (Fisher exact test p=1.0 NS). The results of this study showed a low rate of detection of the hepatitis B virus in donated blood. NAT testing demonstrates higher sensitivity for the detection of HBV, as compare to HBsAg screening.

scholarly journals Reduced Expression of Human Chemokine Genes RANTES and IP-10 in Hepatitis B Virus Mediated Cirrhosis of Liver

2012 ◽  
Vol 3 (1) ◽  
Author(s):  
Gelli Veena Shravanti ◽  
Rathindra Mohan Mukherjee ◽  
Padaki Nagaraja Rao ◽  
Aparna Jakkampudi ◽  
Panyala balkumar Reddy ◽  
...  
Keyword(s):  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Mononuclear Cells ◽  
Hbv Dna ◽  
Immunocompetent Cells ◽  
Enzyme Linked Immunosorbent Assay ◽  
Peripheral Blood Mononuclear ◽  
Reverse Transcription Pcr ◽  
Hbv Genotypes ◽  
B Virus

Regulated upon Activation Normal T cell Expressed and Secreted (RANTES) and interferon gamma inducible protein 10 (IP-10), both chemokines are chemotactic for immunocompetent cells and play an important role in cell mediated antiviral defense. The objective of this work was to assess the expression pattern of RANTES and IP-10 genes in peripheral blood mononuclear cells (PBMCs) of hepatitis B virus (HBV) infected patients having various disease severity. The study was performed on 79 HBV infected patients grouped into acute, inactive carriers (IC), chronic (CHB), cirrhosis and hepatocellular carcinoma (HCC) plus 41 healthy voluntary blood donors as controls. Quantification of HBV surface antigen (HBsAg) was done by a sandwich enzyme linked immunosorbent assay (ELISA). Conventional and real time polymerase chain reaction (PCR) were used for genotyping and determination of HBV DNA load respectively. RANTES and IP-10 mRNA expressions were evaluated by reverse transcription PCR (RT-PCR) and densitometry. Results obtained show that RANTES expression reduced significantly (p<0.0001) in cirrhosis group in comparison to controls and remain unaltered in other disease categories. Reduction in IP-10 expression was significant (p=0.006) in patients of all disease categories than controls which was most evident in cirrhosis group (p<0.0001). No association was found between the expression level of chemokines with HBV genotypes, HBsAg and HBV DNA levels in sera.It could be concluded that reduced expression of both the chemokines might be associated with lesser infiltration of immunocompetent cells to liver to avert further damage in cirrhosis.Serum level of both RANTES and IP-10 can be considered as prognostic marker of liver cirrhosis by validation studies.

High Viral Load and Hepatitis B Virus Subgenotype Ce Are Associated With Increased Risk of Hepatocellular Carcinoma

2008 ◽  
Vol 26 (2) ◽  
pp. 177-182 ◽  
Author(s):  
Henry Lik-Yuen Chan ◽  
Chi-Hang Tse ◽  
Frankie Mo ◽  
Jane Koh ◽  
Vincent Wai-Sun Wong ◽  
...  
Keyword(s):  
Risk Factors ◽  
Hepatocellular Carcinoma ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Hbv Dna ◽  
Hazard Ratio ◽  
Hbv Genotype ◽  
Hbv Genotypes ◽  
B Virus ◽  
Genotype C

Purpose We aimed to investigate the impact of hepatitis B virus (HBV) DNA and HBV genotypes/subgenotypes on the risk of hepatocellular carcinoma (HCC). Patients and Methods A prospective cohort of patients infected with chronic HBV in a surveillance program for HCC since 1997 was studied. Ultrasound and alpha-fetoprotein evaluation were regularly performed to detect HCC. Risk factors for HCC and the relationship between HBV DNA and HBV genotypes were determined. Results Among 1,006 patients with a median follow-up of 7.7 years, 86 patients (8.5%) developed HCC. With reference to the low HBV DNA stratum (log HBV DNA ≤ 4.5 copies/mL), the hazard ratio for HCC of the intermediate HBV DNA stratum (log HBV DNA > 4.5 to 6.5 copies/mL) was 1.62 (95% CI, 1.05 to 2.48; P = .027) and that of the high HBV DNA stratum (log HBV DNA > 6.5 copies/mL) was 2.73 (95% CI, 1.76 to 4.25; P < .001). Among patients with genotyping results, 330 patients had HBV genotype B and 439 patients had HBV genotype C (94 subgenotype Ce and 345 subgenotype Cs). With reference to HBV genotype B, HBV subgenotype Ce has the highest risk of HCC (hazard ratio = 2.75; 95% CI, 1.66 to 4.56; P < .0001) and HBV subgenotype Cs has intermediate risk (hazard ratio = 1.70; 95% CI, 1.09 to 2.64; P = .020). On multivariate analysis, HBV DNA, HBV genotypes, liver cirrhosis, male sex, older age, and lower serum albumin were independent risk factors of HCC. Conclusion High HBV DNA level and HBV genotype C, particularly subgenotype Ce, increased the risk of HCC in chronic hepatitis B.

scholarly journals Genotypes of the hepatitis B virus within the area of Terni, Italy: our experience

2016 ◽  
Vol 31 (3) ◽  
Author(s):  
Michela Piermarini ◽  
Maria Chiara Medori ◽  
Alessandra Pagnani ◽  
Monica Proietti ◽  
Augusto Scaccetti
Keyword(s):  
Hepatitis B Virus ◽  
Nucleotide Sequence ◽  
Hepatitis B ◽  
Geographical Location ◽  
Hbv Dna ◽  
Native Population ◽  
Hbv Genotype ◽  
Hbv Genotypes ◽  
B Virus ◽  
The World

<em>Background and aims</em>: The presence of hepatitis B varies depending on the different areas of the world; 10 genotypes of hepatitis B virus (HBV) (A to J) have been identified, and they differ from one another in the nucleotide sequence and geographical location. The various genotypes are associated with a different evolution of the disease and with distinct responses to treatment. <br /><em>Materials and Methods:</em> From January 2010 to March 2014 we assessed the genotype of the HBV virus on 35 specimens with HBVDNA&gt;1000 IU/mL. The HBV genotype has been determined through sequencing. <br /><em>Results</em>: The 35 specimens belonged to individuals with a mean and median age of 42.8 and 40 years respectively: 17 of them were Italian and 18 from other countries. In total there were 19 males: 12 Italians and 7 foreigners. Females were 16: 5 Italians and 11 foreigners. The subjects with HBV-DNA≥10<sup>6</sup> IU/mL were prevailing, followed by subjects with HBV-DNA between 1000 IU/mL and 10.000 IU/mL. Out of 35 patients analysed by genotype, we found 20 genotypes D and 15 non-D genotypes. <br /><em>Conclusions</em>: The analyses carried out on results suggest that Italy, land of immigration, has become a multi-ethnic country with people coming from high and medium endemic disease areas in terms of HBV. Most patients show D genotype, however the migratory flows lead to the introduction of patients with non-D HBV genotypes in the native population as highlighted in Terni.

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