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. 2019 Jan 17;14(1):e0210556.
doi: 10.1371/journal.pone.0210556. eCollection 2019.

Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India

Arati Mane  1 , Jilian Sacks  2 , Sadhya Sharma  2 , Harpreet Singh  3 , Alexandra Tejada-Strop  4 , Saleem Kamili  4 , Kartik Kacholia  2 , Ritubhan Gautam  2 , Madhuri Thakar  1 , Radhey Shyam Gupta  5 , Raman Gangakhedkar  6
Affiliations

Evaluation of five rapid diagnostic tests for detection of antibodies to hepatitis C virus (HCV): A step towards scale-up of HCV screening efforts in India

Arati Mane et al. PLoS One. .

Abstract

Objectives: Hepatitis C virus (HCV) infection is a major contributor to morbidity and mortality worldwide. Early detection and curative treatment of HCV can reduce the risk of liver-related mortality and serve to prevent transmission of new infections. India is estimated to have about six million HCV infected individuals, most of whom are unaware of their infection status. Rapid diagnostic test kits (RDTs) could help identify HCV infected persons more expeditiously and thus availability of high performing, quality-assured RDTs is essential to scale-up HCV screening efforts. The present study was thus undertaken to evaluate the performance characteristics of five anti-HCV RDTs.

Methods: Five anti-HCV RDTs (Alere Truline, Flaviscreen, Advanced Quality, SD Bioline and OraQuick) were evaluated using two panels of known anti-HCV positive and negative samples; one characterized from Indian patient samples (n = 360) and other obtained from the US Centers for Disease Control and Prevention (CDC), Atlanta (n = 100). Sensitivity, specificity, inter-observer agreement, test validity and operational characteristics of RDTs were assessed.

Results: The combined sensitivities across both panels for Alere Truline, Flaviscreen, Advanced Quality, SD Bioline and OraQuick RDTs were 99.4% (95%CI-96.6%-99.9%), 86.2% (95%CI-79.8%-91.1%), 96.2% (95%CI-91.9%-98.6%), 99.4% (95%CI-96.6%-99.9%) and 99.4% (95%CI-96.6%-99.9%) respectively. The overall specificities across both panels for all RDTs were 99.7%. The inter-observer agreement was 100% for Alere Truline, SD Bioline and OraQuick, while it was 99.5% and 98.6% with Advanced Quality and Flavicheck respectively. Discordant results were significantly associated with human immunodeficiency virus (HIV) positivity for both Advanced Quality and Flavicheck (p<0.001).

Conclusion: The present evaluation demonstrated that Alere Truline, SD Bioline and OraQuick RDTs had sensitivity and specificity in accordance with the acceptance criteria of the Drug Controller General, India, the national regulatory authority, had excellent inter-observer agreement and superior operational characteristics. Our findings suggest that certain HCV RDTs perform well and can be a useful tool in screening of HCV infections expeditiously.

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Conflict of interest statement

Authors ATS and SK are affiliated with the Centers for Disease Control and Prevention. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials. The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Use of trade names and commercial sources is for identification only and does not constitute endorsement by the US Department of Health and Human Services, or the US Centers for Disease Control and Prevention.

Figures

Fig 1
Fig 1. Sensitivities of anti-HCV rapid diagnostic test kits by HIV sero-status.
See this image and copyright information in PMC

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References

    1. World Health Organization Global hepatitis report, 2017. [Internet] 2017. Available from: http://www.who.int/hepatitis/publications/global-hepatitis-report2017/en/.
    1. Doan T. Chapter 3.5—Hepatitis C in Developing Countries in Southeast Asia, Editor(s): Kamal Sanaa M., Hepatitis C in Developing Countries, Academic Press, 2018, Pages 97–104, ISBN 9780128032336, 10.1016/B978-0-12-803233-6.00009-6. - DOI
    1. Shekhar S. Chapter 3.4—Hepatitis C Virus Infection in the Indian Sub-Continent, Editor(s): Kamal Sanaa M., Hepatitis C in Developing Countries, Academic Press, 2018, Pages 83–95, ISBN 9780128032336, 10.1016/B978-0-12-803233-6.00008-4. - DOI
    1. Ringehan M, McKeating JA, Protzer U. Viral hepatitis and liver cancer. Phil Trans R Soc B. 2017; 372:20160274 10.1098/rstb.2016.0274 - DOI - PMC - PubMed
    1. Martin NK, Vickerman P, Dore G, Hickman M. The HCV epidemics in key populations (including PWID, prisoners, and MSM): the use of DAAs as treatment for prevention. Curr Opin HIV AIDS. 2015; 10: 374–380. 10.1097/COH.0000000000000179 - DOI - PMC - PubMed

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