Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings &amp; populations

Cruz, Helena Medina; Scalioni, Leticia de Paula; Paula, Vanessa Salete de; Silva, Elisangela Ferreira da; Ó, Kycia Maria Rodrigues do; Milagres, Flavio Augusto de Pádua; Cruz, Marcelo Santos; Bastos, Francisco I.; Pollo-Flores, Priscila; Leal, Erotildes Maria; Motta-Castro, Ana Rita Coimbra; Pilotto, José Henrique; Lewis-Ximenez, Lia Laura; Lampe, Elisabeth; Villar, Lívia Melo

doi:10.1186/s12879-015-1249-5

Cited by 19 publications

(28 citation statements)

References 15 publications

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“…On the other hand, the confidence intervals we found for sensitivity and positive predictive value (PPV) varied widely. Similar data were found by Cruz et al 14 in their study comparing groups of patients with low and high risk of HBV infection, without CKD.…”

Section: Discussionsupporting

confidence: 89%

Performance of point of care assays for hepatitis B and C viruses in chronic kidney disease patients

et al. 2018

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AimsPoint of care testing (POCT) has been used for hepatitis B and C diagnosis in general population, but little is known about the influence of clinical conditions in the accuracy of these assays. This study aims to evaluate the performance of POCTs for detection of hepatitis B virus surface antigen (HBsAg) and antibodies to Hepatitis C Virus (anti-HCV) in Chronic Kidney Disease (CKD) patients.MethodsA total of 286 subjects were included in this study. HBsAg and anti-HCV were detected using commercial EIAs and four POCTs: HBsAg (WAMA Imuno-Rápido HBsAg and VIKIA HBsAg) and anti-HCV (DOLES HCV teste rápido and WAMA Imuno-Rápido anti-HCV) in serum and whole blood.ResultsUsing EIA, HBsAg and anti-HCV prevalence was 4.5% and 16.1% in CKD patients. HBsAg and anti-HCV POCTs had sensitivities from 92.3% to 100% and 84.8% to 89.1% while specificities were 99.3% to 100% and 99.2% to 99.6%, respectively. POCT using serum samples performed well compared with whole blood samples and true positive samples of POCTs had high optical density to cut-off (OD/CO) values compared with EIA.ConclusionsThis study demonstrates good performance of HBsAg and anti-HCV POCTs in CKD patients, especially in serum samples indicating low interference of this disease in the performance of these assays. POCTs could be an important tool for HBV and HCV screening in high-risk populations.

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Section: Discussionsupporting

confidence: 89%

Performance of point of care assays for hepatitis B and C viruses in chronic kidney disease patients

et al. 2018

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“…While population prevalence should not alter sensitivity of a test, a study in Brazil demonstrated that the sensitivity of a rapid diagnostic HBsAg test was 93%‐96% in a group attending a hepatitis clinic, 60% in the general population including underserved and remote communities and 67% in a vulnerable population consisting of beauticians and those who used crack cocaine . This could reflect differences in concentration of HBsAg of the three groups and has implications for our study in that our sample population may have included more patients with higher HBsAg concentrations than our overall target population . Notably, the two false negatives in our study had very low corresponding HBsAg titres and this suggests a limit of detection (Figure ).…”

Section: Discussionmentioning

confidence: 69%

“…In addition, the influence of HTLV‐1 co‐infection, endemic in Central Australia, is not known. False negatives have also occurred with syphilis co‐infection and while there is a current outbreak of syphilis among Indigenous Australians in northern and central Australia, test performance remained acceptable . Low levels of HBsAg, alanine aminotransferase level and viral load, and differing genotypes can also hinder test performance .…”

Section: Discussionmentioning

confidence: 88%

“…Performing a venous blood POCT outside of the laboratory has been associated with reduced sensitivity compared to when the venous blood POCT is performed in the laboratory . Tests have also performed better in the developed compared to developing world . For instance, sensitivity was 100% when assays were performed in the United Kingdom and 56% when performed Malawi in two different groups of individuals co‐infected with HIV and hepatitis B .…”

Section: Discussionmentioning

confidence: 99%

“…Point of care (POCT) tests obviate the need for laboratory infrastructure at the site of testing, require minimal training, provide rapid diagnosis, and an opportunity to engage the patient in management . These tests are performed on serum or whole blood and are mostly immunochromatographic tests, also called lateral flow assays .…”

Section: Introductionmentioning

confidence: 99%

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Point of care and oral fluid hepatitis B testing in remote Indigenous communities of northern Australia

Sullivan

Davies

Binks

et al. 2019

Journal of Viral Hepatitis

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Many Indigenous Australians in northern Australia living with chronic hepatitis B are unaware of their diagnosis due to low screening rates. A venous blood point of care test (POCT) or oral fluid laboratory test could improve testing uptake in this region. The purpose of this study was to assess the field performance of venous blood POCT and laboratory performance of an oral fluid hepatitis B surface antigen (HBsAg) test in Indigenous individuals living in remote northern Australian communities. The study was conducted with four very remote communities in the tropical north of Australia's Northern Territory. Community research workers collected venous blood and oral fluid samples. We performed the venous blood POCT for HBsAg in the field. We assessed the venous blood and oral fluid specimens for the presence of HBsAg using standard laboratory assays. We calculated the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of the POCT and oral fluid test, using serum laboratory detection of HBsAg as the gold standard. From 215 enrolled participants, 155 POCT and 197 oral fluid tests had corresponding serum HBsAg results. The POCT had a sensitivity of 91.7% and specificity of 100%. Based on a population prevalence of 6%, the PPV was 100% and NPV was 99.5%. The oral fluid test had a sensitivity of 56.8%, specificity of 98.1%, PPV of 97.3% and NPV of 65.9%. The venous blood POCT has excellent test characteristics and could be used to identify individuals with chronic HBV infection in high prevalence communities with limited access to health care. Oral fluid performance was suboptimal.

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Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection

Avellón

Ala

Díaz

et al. 2020

Journal of Medical Virology

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Hepatitis B virus (HBV) infection is estimated to affect 292 million people worldwide, 90% of them are unaware of their HBV status. The Determine HBsAg 2 (Alere Medical Co, Ltd Chiba Japan [Now Abbott]) is a rapid test that meets European Union (EU) regulatory requirements for Hepatitis B surface antigen 2 (HBsAg) analytical sensitivity, detecting the 0.1 IU/mL World Health Organization (WHO) International HBsAg Standard. This prospective, multicentre study was conducted to establish its clinical performance. 351 evaluable subjects were enrolled, 145 HBsAg‐positive. The fingerstick whole blood sensitivity and specificity were 97.2% and 98.5% (15′ reading, reference assay cut‐off 0.05 IU/mL), sensitivity increasing to 97.9% with the prespecified cut‐off 0.13 IU/mL (EU regulations). The venous whole blood, serum and plasma sensitivity was 97.2%, 97.9%, and 98.6%, respectively (15′ reading); reaching 99%, 99.5% and 100% specificity. A testing algorithm following up an initial positive fingerstick test result with plasma/serum test demonstrates 100% specificity. The Determine HBsAg 2 test gives 15‐minute results with high sensitivity and specificity, making it an ideal tool for point‐of‐care testing, with the potential to enable large‐scale population‐wide screening to reach the WHO HBV diagnostic targets. The evaluated test improves the existing methods as most of the reviewed rapid tests do not meet the EU regulatory requirements of sensitivity.

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Evaluating HBsAg rapid test performance for different biological samples from low and high infection rate settings & populations

Cited by 19 publications

References 15 publications

Performance of point of care assays for hepatitis B and C viruses in chronic kidney disease patients

Performance of point of care assays for hepatitis B and C viruses in chronic kidney disease patients

Point of care and oral fluid hepatitis B testing in remote Indigenous communities of northern Australia

Clinical performance of Determine HBsAg 2 rapid test for Hepatitis B detection

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