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Performance of point of care assays for hepatitis B and C viruses in chronic kidney disease patients
  1. Jakeline Ribeiro Barbosa1,2,
  2. Vanessa Faria Cortes1,3,
  3. Moyra Machado Portilho1,
  4. Juliana Custódio Miguel1,
  5. Vanessa Alves Marques1,
  6. Cristianne Sousa Bezerra1,4,
  7. Natalia Vasconcelos de Souza5,
  8. Danielle Malta Lima2,6,
  9. Jeová Keny Baima Colares2,6,
  10. Lia Laura Lewis-Ximenez1,
  11. Elisabeth Lampe1,
  12. Livia Melo Villar1
  1. 1Viral Hepatitis Laboratory, Oswaldo Cruz Institute, Fiocruz, Rio de Janeiro, Brazil
  2. 2Postgraduate Program in Pathology, Federal University of Ceará, Ceará, Brazil
  3. 3Campus Divinopolis, Federal University of São João Del Rey, Minas Gerais, Brazil
  4. 4Federal Institute of Science, Education and Technology of Ceará, Ceará, Brazil
  5. 5Postgraduate Program of the Northeast Network of Biotechnology -RENORBIO, State University of Ceará and University of Fortaleza, Ceará, Brazil
  6. 6Postgraduate Program in Medical Sciences, University of Fortaleza, Ceará, Brazil
  1. Correspondence to Dr Livia Melo Villar, Viral Hepatitis Laboratory, Oswaldo Cruz Institute, Oswaldo Cruz Foundation, Rio de Janeiro 210360-040, Brazil; liviafiocruz{at}gmail.com

Abstract

Aims Point 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.

Methods A 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.

Results Using 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.

Conclusions This 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.

  • hepatitis
  • diagnosis
  • kidney

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Footnotes

  • Handling editor Tony Mazzulli.

  • Contributors JRB: Rapid tests performance, data collection, data analysis and interpretation and drafting the article. VFC, MMP, JCóM, VAM, CSB, NVdeS: Sample collection, execution of laboratory tests and manuscript revisions. DML, JáKBC, LLL-X and EL: participate in the concept of the study and Sample collection. LMV: Conception or design of the work, critical revision of the article and final approval of the version to be published.

  • Funding This research was supported by the Research Support Foundation of the State of Rio de Janeiro (FAPERJ), Brazilian National Council of Technological and Scientific Development (CNPq), Brazilian Ministry of Health, the Coordination of Improvement of Higher Education Personnel (CAPES) and Oswaldo Cruz Foundation (FIOCRUZ).

  • Competing interests None declared.

  • Patient consent Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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