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Efficacy of Rapid Diagnostic Tests in Relation to ELISA in Hepatitis B and C Infection

Ghosh Tarapada, Panja Tanmay K., Satpathi Partha S., Sanghamitra Satpathi

Abstract


Background: Hepatitis B surface antigen and Hepatitis C antibodies in circulation are the common markers used for diagnosis of Hepatitis B and C infection. Though ELISA is the gold standard for detection of these markers, rapid diagnostic tests like immunochromatography is used in most of the centers for quick screening of cases. This study is undertaken to compare the result of both methods. Method: Both ICT and ELISA test were done for Hepatitis B in 275 cases and for Hepatitis C in 207 cases. Sensitivity, specificity, positive predictive value, negative predictive value and accuracy of rapid diagnostic test are evaluated keeping ELISA as gold standard. Results: Out of total 275 cases, 33 cases were found to be positive for Hepatitis B by ELISA and 109 by immunochromatography method having sensitivity, specificity, positive predictive value, negative predictive value and accuracy of rapid diagnostic test as 100%, 76.1%, 30.2%, 100% and 78.3% respectively. In Hepatitis C, out of 207, 17 were positive by ELISA and 22 by ICT method with sensitivity, Specificity, positive predictive value, negative predictive value and accuracy of rapid diagnostic test as 100%, 97.4%, 77.27%, 100% and 97.64% respectively. Conclusion: Rapid diagnostic tests for detection of Hepatitis B and C must be used very cautiously after evaluation in particular population and before terming a particular case to be positive. An alternative gold standard method must be used to confirm the case.

 


Keywords


Viral hepatitis; ELISA; Rapid diagnostic test

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References


Ananthanarayan R and Panicker JK. Ananthanarayan and Panicker's Textbook of Microbiology. 9th edition. India: Universities press India Pvt. Ltd; 1913. Chapter 58, pp. 540–551.

World Health Organization. Prevention and Control of Viral Hepatitis Infection: Framework for Global Action. 2012.

Hajarizadeh B, Grebely J, Dore GJ. Epidemiology and natural history of HCV infection. Nat Rev Gastroenterol Hepatol 2013; 10: 553–562 [PMID: 23817321 DOI: 10.1038/nrgastro.2013.107]

World Health Organization. Sixty Third World Health Assembly–Viral Hepatitis (WHA63.18).

Wiktor SZ, Hutin YJ. The global burden of viral hepatitis: better estimates to guide hepatitis elimination efforts. Lancet. 2016;338:1030–1031. [PMID: 27394646 DOI: 10.1016/S0140–6736(16)31018–2]

Roy L D. World Hepatitis Day 2019: Hepatitis Has Become One of The Pressing Public Health Concerns In India. Outlook Newsletter. 2019.

Perrillo R. Hepatitis B and D. Liver, In: Feldman M, Friedman LS, Brandt LJ (Ed.). Sleisenger and Fordtran’s gastrointestinal and liver disease: Pathophysiology, diagnosis, management, Vol. II, 9th Edn. Philadelphia: Saunders. 2010; 1287–311.

Narayan S. Microbes and blood transfusion. Ind. J. Med. Microbiology 2001; 19(3): 119–26.

Nanu A, Sharma SP, Chatterjee K, et al. Markers for transfusion-transmissible infection in north Indian voluntary and replacement donors: prevalence and trends 1989–1996. Vox Sanguinis. 1997;73:70–73.

World Health Organization. Status of blood safety in the WHO African Region. Report of the 2004 Survey WHO Regional Office for Africa, Brazzaville. Geneva: WHO; 2007.

Torane VP, Shastri JS. Comparison of ELISA HBSAg and HCV among healthy blood donors in a tertiary Care Hospital in Mumbai. India J Med. Microbiol. 2008;2:284–5p.

Adeyemi AA, Omolade OA, Raheem-Ademola RR. Immuno-chromatographic Testing Method for Hapatitis B, C in Blood Donors. Journal of Antiviral Antiretroviral. 2013; S (3) 005. DOI: 10.4172/jaa.S3–005.

Franco E, Bagnato B, Marino MG, et al. Hepatitis B: Epidemiology and prevention in developing countries. World J Hepatol. 2012;4: 74–80. [PMID: 22489259 DOI: 10.4254/wjh.v4.i3.74].

Jefferies M, Rauff B, Rashid H, et al. Update on global epidemiology of viral hepatitis and preventive strategies. World J Clin Cases 2018; 6(13): 589–599.

Reggiardo M V, Fay F, Tanno M, Camacho GG, et al. Natural history of hepatitis c virus infection in a cohort of asymptomatic post-transfused subjects. Annals of Hepatology. 2012; 11(5):658–666.

Maity S., Nandi S., Biswas S., et al. Performance and diagnostic usefulness of commercially available enzyme linked immunosorbent assay and rapid kits for detection of HIV, HBV and HCV in India. Virology Journal. 2012;9 (1, article 290) doi: 10.1186/1743–422x-9–290.

Shivkumar S, Peeling R, Jafari Y, et al. Rapid point-of-care first-line screening tests for hepatitis B infection: a metaanalysis of diagnostic accuracy (1980–2010). Am J Gastroenterol. 2012; 107: 1306–1313.

Njai HF, Shimakawa Y, Sanneh B, et al. Validation of rapid point-of-care (POC) tests for detection of hepatitis B surface antigen in field and laboratory settings in

the Gambia, western Africa. J Clin Microbiol. 2015; 53:1156–1163.

Devesh S, Singh V P, Dhanvijay A K, et al. A Study to Detect Hepatitis b and Hepatitis C infection by using Rapid Immuno Chromatographic Test and Elisa. International Journal of Current Medical and Pharmaceutical Research. 2018; 04(9): 3667–3670.

Mishra RK, Tiwari YK, Pundir S, et al. A Comparison of Rapid Card Test with Enzyme-Linked Immunosorbent Assay for the Detection of Hepatitis B Surface Antigen [HBsAg] in tertiary care hospital. Research & Reviews: A Journal of Microbiology and Virology. 2017; 7(3): 27–31p.

Farooqui M K. Comparison between rapid Immuno-Chromatographic Device Test and ELISA in detection of HBsAg and anti-HCV antibodies. International Journal of Recent Scientific Research. 2016;7:2:9129–2132.

Goswami P R and Padharia BB. A study on effectiveness of rapid diagnostic test as compared to ELISA for HBsAg Detection at Blood Bank in Tertiary Care Hospital. Sch. J. App. Med. Sci. 2016; 4(9D):3440–3441.

EWS Chameera, F Noordeen, H Pandithasundra, et al. Diagnostic efficacy of rapid assay for the detection of hepatitis B surface antigen. Srilankan Journal of Infectious Disease. 2013; 3(2): 21–27.

Kanaga Priya Muthiah and Susitha, T. Role of Rapid Test and ELISA in the Diagnosis of HCV in Haemodialysis Patients. Int. J. Curr. Microbiol. App. Sci. 2017; 6(1): 362–366.




DOI: https://doi.org/10.37591/rrjomv.v10i2.2092

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