Comparative evaluation of immunochromatographic card tests with enzyme-linked immune sorbent assay for the detection of hepatitis C virus antibody

Rajeev Kumar Jain; Rakesh Shrivastava; Deepti Chaurasia; Anamika Jain; Nagaraj Perumal

doi:10.18203/2320-6012.ijrms20230874

Authors

Rajeev Kumar Jain Scientist C, State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh
Rakesh Shrivastava Associate Professor, Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh
Deepti Chaurasia Professor, Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh
Anamika Jain Techinical Officer, State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh
Nagaraj Perumal Scientist B, State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh

DOI:

https://doi.org/10.18203/2320-6012.ijrms20230874

Keywords:

Hepatitis C, Anti-HCV, Rapid test, HCV disease, ELISA

Abstract

Background: Hepatitis C virus (HCV) is a global prevalent pathogen causes both acute and chronic hepatitis and leading to serious liver damage. Correct and rapid diagnosis is pivotal for the management of HCV disease. Rapid card tests are superior alternatives for the large-scale screening of HCV infection.

Methods: The present observational study evaluates analytical performance of four different anti-HCV rapid tests. A total of 200 ELISA confirmed, HCV positive (n=100) and HCV negative (n=100) clinical specimens were selected and re-tested for anti-HCV antibodies by using commercially available four different immunochromatography cards (Meriscreen, Accurate, Oscar and Biolab).

Results: Among all, Biolab rapid card test shown highest (98%) sensitivity. On the other hand, all rapid card test kits showed identical 100% specificity.

Conclusions: Overall BioLab anti-HCV rapid card tests found to be superior in the present study and strongly suggest in house validation of rapid card tests before their diagnostics use on clinical specimens.

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References

Cooke GS, Lemoine M, Thursz M, Gore C, Swan T, Kamarulzaman A, et al. Viral hepatitis and the Global Burden of Disease: a need to regroup. J Viral Hepat. 2013;20:600-1.

Hanafiah KM, Groeger J, Flaxman AD, Wiersma ST. Global epidemiology of hepatitis virus C infection: new estimates of age specific antibody to HCV sero-prevalence. Hepatology. 2013;57:1330-42.

Lee MH, Yang HI, Yuan Y, L'Italien G, Chen CJ. Epidemiology and natural history of hepatitis C virus infection. World J Gastroenterol. 2014;20:9270-80.

WHO. Available at: https://www.who.int/news/ item/25-06-2021-who-releases-first-ever-global-guidance-for-country-validation-of-viral-hepatitis-b-and-c-elimination. Accessed on 29 October 2022.

Chevaliez S, Roudot-Thoraval F, Hézode C, et al. Performance of rapid diagnostic tests for HCV infection in serum or plasma. Future Microbiol. 2021;16:713-9.

Chevaliez S. Strategies for the improvement of HCV testing and diagnosis. Expert Rev Anti Infect Ther. 2019;17:341-347.

WHO. Available at: https://www.who.int/ publications/i/item/978924154998. Guidelines on hepatitis B and C testing. World Health Organization February;2017. Accessed on 29 October 2022.

Smith BD, Drobeniuc J, Jewett A, Branson BM, Garfein RS, Teshale E, et al. Evaluation of three rapid screening assays for detection of antibodies to hepatitis C virus. J Infect Dis. 2011;204:825-31.

da Rosa L, Dantas-Corrêa EB, Narciso-Schiavon JL, de Lucca Schiavon L. Diagnostic Performance of Two Point-of-Care Tests for Anti-HCV Detection. Hepat. 2013;13:e12274.

Al-Tahish G, El-Barrawy MA, Hashish MH, Heddaya Z. Effectiveness of three types of rapid tests for the detection of hepatitis C virus antibodies among blood donors in Alexandria, Egypt. J Virol Methods. 2013;189:370-4.

Kosack CS, Nick S, Shanks L. Diagnostic accuracy evaluation of the immunoflow HCV rapid immunochromatographic test for the detection of hepatitis C antibodies. J Virol Methods. 2014;204:6-10.

ScalioniLde P, Cruz HM, de Paula VS, Miguel JC, Marques VA, Villela-Nogueira CA, et al. Performance of rapid hepatitis C virus antibody assays among high- and low-risk populations. J Clin Virol. 2014;60:200-5.

Daniel HD, Abraham P, Raghuraman S, Vivekanandan P, Subramaniam T, Sridharan G. Evaluation of a rapid assay as an alternative to conventional enzyme immunoassays for detection of hepatitis C virus-specific antibodies. J Clin Microbiol. 2005;43:1977-8.

Maity S, Nandi S, Biswas S, Sadhukhan SK, Saha MK. Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of HIV, HBV and HCV in India. Virol. J 2012;26:290.

Mane A, Sacks J, Sharma S. 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. PLoS One. 2019;17;14:e0210556.

Mahajan S, Agarwal R, Rawat V. Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody. Virus Disease. 2019;30:373-9.

Available at: https://cdsco.gov.in/opencms/ export/sites/CDSCO_WEB/Pdf-documents/IVD/ FAQs/Final-FAQS-IVDnew3.pdf. Accessed on 29 October 2022.

Puri P, Anand AC, Saraswat VA. Consensus Statement of HCV Task Force of the Indian National Association for Study of the Liver (INASL). Part I:Status Report of HCV Infection in India. J Clin Exp Hepatol. 2014;4:106-16.

Dhiman RK. Future of therapy for hepatitis C in India:a matter of accessibility and affordability? J Clin Exp Hepatol 2014;4:85-6.

Sood A, Sarin SK, Midha V. Prevalence of hepatitis C in a selected geographical area of northern India:a population based survey. Ind J Gastroenterol. 2012;31:132-6.

Chadha MS, Tungatkar SP, Arankelle VA. Insignificant prevalence of antibodies to hepatitis C in a rural western area of western Maharashtra. Indian J Gastroenterol. 1999;18:22-23.

National Viral Hepatitis Control Program- Operational guidelines. Available at: https://main.mohfw.gov.in/sites/default/files/National%20Viral%20Hepatitis%20Control%20Program_Reference%20file_0.pdf Accessed on 29 October 2022.