scholarly journals Comparison of the Amplisure HBV Quantitative Kit with the Qiagen Artus HBV QS-RGQ Assay for Quantifying Viral DNA in Plasma Samples of Monitoring Cases

Intervirology ◽  
2021 ◽  
pp. 1-7
Author(s):  
Ganesan Praveenkumar ◽  
Chaitali Nikam ◽  
Ragoori Venkata Ramana ◽  
Sengupta Caesar ◽  
Velumani Amruta ◽  
...  
Keyword(s):  
Viral Load ◽  
Reference Method ◽  
Hbv Dna ◽  
Therapeutic Monitoring ◽  
Clinical Samples ◽  
Comparator Method ◽  
Dna Quantitation ◽  
B Virus ◽  
Comparable Performance ◽  
Overall Performance

<b><i>Background:</i></b> Monitoring of hepatitis B virus (HBV) viral load has become an essential phase in the treatment of HBV. There are many commercial assays available for HBV viral load quantification. In this study, we have evaluated the performance characteristics of Amplisure® HBV Kit in comparison with the Qiagen artus HBV QS-RGQ kit for HBV DNA quantitation. <b><i>Methods:</i></b> Comparison of 2 methods was carried out on 200 clinical samples, 150 HBV DNA positive and 50 HBV DNA negative, by a reference method. Results obtained with Amplisure® HBV Kit (Amplisure HBV) were compared using the Qiagen artus HBV QS-RGQ assay results as the comparator method. <b><i>Result:</i></b> The overall performance of the Amplisure HBV compared with the comparator method shows positive and negative clinical agreement of 100 and 76%, respectively. Among the 12 qualitative discrepant samples, all positive with Amplisure HBV were sequenced and 10 were below comparator method’s LOD. For 5 weak positives (−0.22 to 0.98 log IU/mL), the sequencing failed. The 7 other positives (0.48 to 1.89 log IU/mL) were confirmed positive by sequencing. Quantitative comparison gave an <i>r</i><sup>2</sup> of 0.967 with a mean log difference of 0.09 log<sub>10</sub> IU/mL. <b><i>Conclusion:</i></b> This study shows that Amplisure® HBV Quantitative Kit shows comparable performance with artus HBV QS-RGQ assays and can be useful in management and therapeutic monitoring of HBV in a clinical practice.

scholarly journals Development of a point-of-care test to detect hepatitis B virus DNA threshold relevant for treatment indication

2019 ◽  
Vol 12 (5) ◽  
pp. 201-209
Author(s):  
Saran Pankaew ◽  
Sittiporn Pataradilokrat ◽  
Jantana Kampeera ◽  
Wansika Kiatpathomchai ◽  
Kiat Ruxrungtham ◽  
...  
Keyword(s):  
Heat Treatment ◽  
Hepatitis B Virus ◽  
Hepatitis B ◽  
Quantitative Polymerase Chain Reaction ◽  
Antiviral Drug ◽  
Hbv Dna ◽  
Clinical Samples ◽  
Third Trimester ◽  
Assay Sensitivity ◽  
B Virus

Abstract Background Hepatitis B virus (HBV) has been the most prevalent blood-borne pathogen wherein utero transmission has still not been properly managed. Recent practice guidelines suggested that an antiviral drug should be administered to third-trimester pregnancies with significant viremia (>2 × 105 IU/mL). Objectives To develop a novel turbidity-based loop-mediated isothermal amplification (LAMP) coupled with heat treatment DNA extraction method that is a rapid, cost-effective, and feasible viral load assessment and could be applied to antenatal screening. Methods Primers and reagents were designed, turbidity-based platform and heat treatment method were added, and evaluated for optimal efficiency. Assay sensitivity was tested from serially diluted standard HBV DNA. Assay specificity was tested with six standard viral DNAs. Clinical samples were analyzed and the results were compared with those of quantitative polymerase chain reaction (qPCR) diagnostic records. Results The optimized condition was 60°C with no betaine, 1.4 mM deoxyribonucleotide triphosphates (dNTPs) and 6 mM of MgSO4 for 60 min. The assay accurately detected samples with standard HBV DNA at >2 × 105 IU/mL in both distilled water and spiked serum. Results can be interpreted within 31.48 ± 1.41 min in real-time turbidimeter. The amplification is exclusively specific to HBV, but not with the other six human-specific viruses. Moreover, the assay showed comparable performance within 95% confidence interval to the previously developed HBV LAMP toward clinical specimens. Conclusions This newly developed method was accurate, affordable, and flexible to further implementation to large-scale third-trimester pregnancy screening.

scholarly journals Detection of HBV DNA by PCR and its application in clinical transfusion

2018 ◽  
Vol 1 (1) ◽  
pp. 22
Author(s):  
Shunqing Li
Keyword(s):  
Viral Load ◽  
Hepatitis B ◽  
Quantitative Polymerase Chain Reaction ◽  
Hbv Dna ◽  
Serological Markers ◽  
Serologic Test ◽  
Chain Reaction ◽  
Medical Disputes ◽  
B Virus ◽  
Polymerase Chain

<p><strong><em> </em></strong>This study was to detect the hepatitis B virus (HBV) DNA copies in patients through blood transfusions; recessive carriers with HBsAg negative but HBV DNA positive were further studied to see the content and distribution of HBV in patients, and provide evidence for the clinical treatment. A total of 532 blood samples collected from July 2014 to July 2015 were tested for HBV-DNA viral load and hepatitis B serological markers using quantitative Polymerase Chain Reaction (qPCR) and serologic test (five serological markers of hepatitis B). The results showed that, 3 cases were HBV serology negative and the HBV-DNA viral load was in the range of 250-500 whereas only 1 case was HBsAb positive and the HBV-DNA viral load was above 500. qPCR, for detecting HBV DNA, together with serological routine test can effectively reduce HBV infection during transfusion and prevent medical disputes.</p>

scholarly journals Performance Characteristics of a New Consensus Commercial Kit for Hepatitis D Virus RNA Viral Load Quantification

2016 ◽  
Vol 55 (2) ◽  
pp. 431-441 ◽  
Author(s):  
Frédéric Le Gal ◽  
Samira Dziri ◽  
Athenaïs Gerber ◽  
Chakib Alloui ◽  
Zahia Ben Abdesselam ◽  
...  
Keyword(s):  
Viral Load ◽  
High Performance ◽  
Clinical Samples ◽  
Reference Laboratory ◽  
Hepatitis D ◽  
Hepatitis D Virus ◽  
Virus Rna ◽  
B Virus ◽  
Term Administration

ABSTRACTHepatitis D virus (HDV) is responsible for fulminant hepatitis and liver failure and accelerates evolution toward cirrhosis and hepatocellular carcinoma in hepatitis B virus (HBV)-infected patients. To date, treatment relies upon long-term administration of pegylated alpha-interferon with a sustained virological response in 30% of the patients. Very recently, new, promising anti-HDV therapies have been developed and are already being used in clinical trials. HDV RNA viral load (HDVL) monitoring must be an integral part of the management of the infected patients. However, HDV genus is characterized by a high genetic variability into eight genotypes (HDV-1 to -8), and most available in-house or commercial assays are useful for only a limited subset of genotypes. Results of a comparison of the performance of a new kit for HDVL quantification with the consensus in-house assay of the French National Reference Laboratory for HDV developed in 2005 are reported here. A total of 611 clinical samples of all HDV genotypes with various HDVL values, including several consecutive samples over several years from 36 patients, were studied. A specificity, sensitivity, and reproducibility evaluation was conducted using HDV-positive clinical samples, hepatitis A, B, C and E (HAV, HBV, HCV, and HEV, respectively) and HIV mono-infected samples, and the WHO HDV RNA international standard. Overall results were strictly comparable between the two assays (median difference, 0.07 log IU/ml), with high diagnosis precision and capacity. In summary, this new kit showed high performance in detection/quantification of HDVL, regardless of the genotype of the infecting strain used, and seems to be a suitable tool for patient management.

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 Clinical Features and Resistance to Entecavir Monotherapy of Patients with Hepatitis B

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Hideo Takayama ◽  
Takuya Komura ◽  
Takashi Kagaya ◽  
Saiho Sugimoto ◽  
Noriaki Orita ◽  
...  
Keyword(s):  
Viral Load ◽  
Hepatitis B ◽  
Clinical Features ◽  
High Viral Load ◽  
Hbv Dna ◽  
Health Concern ◽  
Naive Group ◽  
Rescue Treatment ◽  
Significant Difference ◽  
B Virus

Aim. Hepatitis B virus (HBV) infection is a major public health concern worldwide. Entecavir (ETV), a first-line nucleos(t)ide analogue (NA) for HBV, has a low risk of resistance. We evaluated the efficacy of ETV monotherapy, ratio of ETV-resistant, and the clinical features of patients with ETV resistance. Methods. A total of 130 patients (72 males, 58 females; mean age, 61 ± 15 years) were divided into a NA-naïve group (n = 108) and NA-experienced group (n = 22). We examined the clinical outcomes of ETV monotherapy and associated factors. We also assessed the clinical features of 15 patients with resistance to ETV (mean, 51.0 ± 27.4 weeks). Results. Among the 130 patients, 94.1% achieved ALT normalization and 63.6% achieved serum HBV DNA negativity after ETV monotherapy for 96 weeks. Of the patients in the NA-naïve group, 93.1% and 60.4% achieved ALT normalization and HBV DNA negativity, respectively. Of the patients in the NA-experienced group, 100% and 74.9% achieved ALT normalization and HBV DNA negativity, respectively. Compared to patients on ETV continuously, 15 ETV-resistant patients had a higher baseline HBV viral load. There was a significant difference in the time to HBV DNA negativity, but not ALT normalization after ETV monotherapy in these groups. Rescue treatment with other NAs led to ALT normalization in all of these patients, but not HBV DNA negativity. Conclusions. ETV monotherapy has a long-term clinical efficacy. While some patients especially with HBV DNA high viral load developed ETV resistance, rescue treatment led to ALT normalization in these patients.

scholarly journals Correlation of IP-10 gene expression with Serum alanine transaminase (ALT) levels and Hepatitis B viral load in cirrhosis and hepatocellular carcinoma (HCC) patients.

2016 ◽  
Vol 10 (2) ◽  
pp. 9-13
Author(s):  
Umme Shahera ◽  
Shahinul Alam ◽  
Munira Jahan ◽  
Afzalun Nessa ◽  
Saifullah Munshi ◽  
...  
Keyword(s):  
Gene Expression ◽  
Viral Load ◽  
Hepatitis B ◽  
Inflammatory Cells ◽  
Serum Levels ◽  
Study Groups ◽  
Hbv Dna ◽  
Hepatitis B Virus Infection ◽  
Gene Expressions ◽  
B Virus

Interferon-gamma induced protein 10 (IP-10), a chemokine is suggested to be involved in liver injury during Hepatitis B virus infection (HBV). The increase of IP-10 is a critical step for recruitment of inflammatory cells to the local focus of the liver and hepatopathology. This study was designed to assess the correlation of IP-10 gene expression with HBV-DNA and serumAlanine transaminase(ALT) in patients with cirrhosis and HCC.The study was conducted among 60 patients. The study populationwere divided into four groups (15 in each groups)-HBV positive cirrhosis, HBV negative cirrhosis, HBV positiveHCC and HBV negative HCC. Expression of IP-10 gene was observed using real time PCR.IP-10 gene expressions in the above mentioned groups were correlated with serum ALT level and HBV viral load.IP-10 gene was significantly higher in HBV-positive patients with HCC than HBVpositive cirrhosis. Similarly, the expression of IP-10 was significantly higher in HBV-positive HCC than HBVnegative HCC patients. However, the expression of IP-10 was reduced in HBV-positive cirrhosis in comparison with HBV-negative cirrhosis.IP-10 gene expression in liver was not correlated with the serum levels of ALT in any of the study groups. HBV- DNA load also did not correlated with IP-10 gene expression in HBV positive HCC and HBV positive cirrhosis patients.This study shows that there was no significant change with the expression of IP-10 gene in any of the study groups with ALT level or viral load, though differential expression of IP-10 gene were observed in cirrhosis and HCC patients. Bangladesh J Med Microbiol 2016; 10 (2): 9-13

scholarly journals DEPENDENCE OF GRAVITY OF LIVER DISEASE FROM REPLICATIVE ACTIVITY OF VIRUS HEPATITIS B AND D

2018 ◽  
Vol 23 (5) ◽  
pp. 234-238
Author(s):  
M. A. Abdukadirova ◽  
A. A. Khikmatullaeva ◽  
M. E. Hodjaeva ◽  
N. G. Kan
Keyword(s):  
Chronic Hepatitis ◽  
Viral Load ◽  
Hepatitis B ◽  
Clinical Stage ◽  
Hbv Dna ◽  
B Virus ◽  
Viral Nature ◽  
Severity Of The Disease ◽  
High Level ◽  
Biochemical Indices

The article is devoted to the study of the connection between the replicative activity of HBV DNA and HDV RNA with the formation of CP at all stages of development of chronic hepatitis of viral nature, evidence that a high level of HBV DNA is a pronounced predictor of liver cirrhosis (LC) progression. The purpose of the study is to study the dependence of the severity of liver damage on the replicative activity of the hepatitis B virus and D. Materials and methods. The study included 67 patients with cirrhosis of the liver in the outcome of viral hepatitis B and 140 patients with an outcome of cirrhosis against the background of chronic hepatitis B + D. The clinical stage of LC was determined according to the Child-Puy classification. Results. A direct link has been established between the increase in the viral load of HBV DNA and HDV RNA with the duration of the disease. A tendency was revealed to increase the severity of the disease in patients with LC of viral etiology with an increase in viral load. The biochemical indices of blood showed a tendency to an increase in the level of cytolytic enzymes against the background of high replicative activity of HBV DNA and HDV RNA. The conclusion. Thus, a high level of HBV DNA is a pronounced predictor of the progression of LC at all stages of the pathological proces

scholarly journals DEPENDENCE OF GRAVITY OF LIVER DISEASE FROM REPLICATIVE ACTIVITY OF VIRUS HEPATITIS B AND D

2018 ◽  
Vol 23 (5) ◽  
pp. 234-238
Author(s):  
M. A. Abdukadirova ◽  
A. A. Khikmatullaeva ◽  
M. E. Hodjaeva ◽  
N. G. Kan
Keyword(s):  
Chronic Hepatitis ◽  
Viral Load ◽  
Hepatitis B ◽  
Clinical Stage ◽  
Hbv Dna ◽  
B Virus ◽  
Viral Nature ◽  
Severity Of The Disease ◽  
High Level ◽  
Biochemical Indices

The article is devoted to the study of the connection between the replicative activity of HBV DNA and HDV RNA with the formation of CP at all stages of development of chronic hepatitis of viral nature, evidence that a high level of HBV DNA is a pronounced predictor of liver cirrhosis (LC) progression. The purpose of the study is to study the dependence of the severity of liver damage on the replicative activity of the hepatitis B virus and D. Materials and methods. The study included 67 patients with cirrhosis of the liver in the outcome of viral hepatitis B and 140 patients with an outcome of cirrhosis against the background of chronic hepatitis B + D. The clinical stage of LC was determined according to the Child-Puy classification. Results. A direct link has been established between the increase in the viral load of HBV DNA and HDV RNA with the duration of the disease. A tendency was revealed to increase the severity of the disease in patients with LC of viral etiology with an increase in viral load. The biochemical indices of blood showed a tendency to an increase in the level of cytolytic enzymes against the background of high replicative activity of HBV DNA and HDV RNA. The conclusion. Thus, a high level of HBV DNA is a pronounced predictor of the progression of LC at all stages of the pathological proces

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