Hepatitis B viral load in dried blood spots: A validation study in Zambia
Graphical abstract
Section snippets
Background
Worldwide approximately 240 million individuals are chronically infected with hepatitis B virus (HBV), with the highest burden of cases in Asia and sub-Saharan Africa (SSA) [1]. Each year, 650,000 individuals die from complications of chronic HBV infection including decompensated cirrhosis and hepatocellular carcinoma [2]. For individuals with chronic HBV infection, several potent nucleoside/nucleotide analogues can durably suppress viral replication and reduce liver-related complications and
Objectives
Building on prior work in this area, we compared HBV viral loads in paired DBS and plasma samples using commercially available tests in a Zambian laboratory that had experience in HIV viral load and DBS testing.
Study population
HIV-infected adults (18+ years old) who were eligible for antiretroviral therapy, but had not yet initiated, were enrolled in a prospective cohort in two public sector clinics in Zambia’s capital Lusaka, funded through the International Epidemiologic Databases to Evaluate AIDS in Southern Africa [9]. The study’s aim was to evaluate the prevalence, risk factors, and outcomes of liver fibrosis. As part of the enrollment procedures, all participants were screened for hepatitis B virus (HBV)
Results
Of 798 patients screened for HBV infection, 98 (12.2%) were HBsAg-positive. Among HBsAg-positive patients, paired plasma and DBS samples from 68 patients with detectable plasma HBV DNA were included in this study. The median age of patients included in the study was 34 years (interquartile range [IQR], 29–37), 61.8% were men, median CD4+ count was 210 (IQR, 112–378), and 47.0% were hepatitis B e antigen positive. Original plasma samples had a median HBV viral load of 3.98 log IU/ml
Discussion
In a reference laboratory in Lusaka, Zambia, we used commercially available assays to demonstrate the feasibility and performance of HBV viral load testing of DBS samples that were collected by finger stick in field settings. There was a strong agreement between paired DBS and plasma samples over a dynamic range of viral loads for both HBV genotypes A1 and E viruses, the most common ones in Southern Africa. At recommended treatment thresholds, HBV DNA was detectable >98% of the time in DBS.
Funding
Data presented in this paper were supported by the International Epidemiological Databases to Evaluate AIDS in Southern Africa (IeDEA-SA) Collaboration with funding from the National Institute of Allergy and Infectious Diseases (grant number 4U01AI069924) of the National Institutes of Health (NIH). Additional NIH support was provided by the Fogarty International Center (grant number K01TW009998). We also received funding from the HIV Research Trust, Roche Molecular Systems Inc., and the Swiss
Competing interests
Roche Molecular Systems donated some of the laboratory reagents used in this study but did not participate in designing the study, collecting the data, analyzing the data, or writing the manuscript. All authors report no conflicts of interest.
Ethical approval
All participants provided written informed consent.
Acknowledgment
None
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2022, Journal of Clinical Virology PlusCitation Excerpt :Yet the overall accuracy was found to be 96% which was similar to the study by Jackson et al. [17]. Overall, a very good correlation between HBV DNA as detected by DBS was seen with the plasma sample as observed in other published studies [18]. Jardi et al. [19] in their study from Spain showed storage and stability of DBS for 7 days at room temperature (average temperature of 20–25 °C) with no significant effect on HBV DNA levels while Stene-Johansen et al. [16] from Norway demonstrated stability for up to 12 weeks at room temperate (average temperature of 20–25 °C).
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2020, Journal of Clinical VirologyCitation Excerpt :To estimate the impact of the genetic diversity for this assay, 59 HBV genotypes were described out of 266 samples included. This information was unfrequently evaluated in other studies [19,25]. The main genotypes observed were genotypes A, D and E and this distribution was similar to what was observed in France [19,26,27].
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2018, Journal of HepatologyCitation Excerpt :DBS pretreatment is crucial to retrieve the target serological marker or nucleic acid. Various nucleic acid extraction kits can be used prior to detection and quantification of viral genomes or genotype determination.60,62–64 DBSs provide an invaluable tool for large-scale viral hepatitis screening, diagnosis, treatment decision and monitoring in the developing world, because few laboratories have the capacity to perform virological tests and those who can are often distant from rural communities where a large proportion of the population lives.
Field performance of the Determine HBsAg point-of-care test for diagnosis of hepatitis B virus co-infection among HIV patients in Zambia
2018, Journal of Clinical VirologyCitation Excerpt :At enrollment, regardless of programmatic HBsAg test results, a research nurse or research assistant re-tested each participant with Determine HBsAg test by finger prick sampling. Among HBsAg-positives by either test (ELISA or Determine), we measured the HBV viral load (VL; Roche COBAS AmpliPrep/COBAS Taqman HBV test, V 2.0) and sequenced HBV for determination of genotype. [10] We also screened each patient for alcohol consumption using the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C)[11] and assessed liver fibrosis/cirrhosis using transient elastography (Fibroscan 402, Echosens, Paris, France).[12,13]
The role of dried blood spot tests in the detection of hepatitis B infection: A systematic review
2024, Journal of Viral Hepatitis
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