Advertisement

VirusDisease

, Volume 30, Issue 3, pp 373–379 | Cite as

Comparative evaluation of three rapid immunochromatographic test assays with chemiluminescent microparticle immunoassay for the detection of hepatitis C virus antibody

  • Supriya Mahajan
  • Reshu Agarwal
  • Vaishali Rawat
  • Guresh Kumar
  • Manoj Kumar Sharma
  • Ekta GuptaEmail author
Original Article

Abstract

Rapid diagnostic tests (RDTs) can serve as good alternatives to standard serological assays for hepatitis C virus (HCV) detection in limited resource settings. Aim of this study was to evaluate performance of three Indian manufactured RDTs with chemiluminescent microparticle immunoassay (CLIA) for screening of HCV infection with further evaluation using HCV RNA. Serum samples tested for anti-HCV by CLIA (Architect i1000SR, Abbott Diagnostics, IL, USA) were retrieved from − 80 °C and retested for anti-HCV by three RDTs: Alere Trueline (SD Bioline; Haryana, India) (RDT 1), Benesphera HCV Rapid card test (Avantor Performance Materials India Limited; Uttarakhand, India) (RDT 2), AccuTest HCV (Accurex Biomedical Pvt. Ltd.; Mumbai, India) (RDT 3). HCV RNA results were obtained from hospital information system and anti-HCV reactive but RNA negative cases without treatment were considered as either ‘false positives’ or ‘spontaneous clearance of HCV RNA’. Among 86 samples, 75 (87.2%), 49 (57%), 58 (67.4%) and 51 (59.3%) were reactive by CLIA, RDT1, RDT2 and RDT3, respectively. Taking CLIA as reference standard, RDT 1, 2 and 3 demonstrated sensitivity of 65.30%, 77.33% and 68% respectively. Specificity of all three RDTs was 100% with sensitivity of 97.6–100% above signal/cut-off ratio (S/Co) of 6 by CLIA and 88–100% in all HCV RNA positive cases. Sensitivity of RDTs increased from 65.30–77.33 to 72–82.4% when RNA negative/anti-HCV reactive results were considered as non-reactive. The three RDTs have acceptable sensitivity and specificity in anti-HCV detection especially in RNA positive patients that would require treatment for HCV.

Keywords

Hepatitis C virus Rapid diagnostic tests Chemiluminescent microparticle immunoassay Anti-HCV HCV RNA 

Notes

Compliance with ethical standards

Ethical statement

Institutional Ethics Committee (IEC) of ILBS approved the study protocol.

Conflict of interest

The authors declare that they have no conflict of interest.

Supplementary material

13337_2019_542_MOESM1_ESM.pdf (193 kb)
Flowchart showing the overall evaluation and interpretation of results of the three RDTs and CLIA in relation to HCV RNA (n = 75) (PDF 194 kb)
13337_2019_542_MOESM2_ESM.pdf (274 kb)
Flowchart showing the evaluation of the results of the 3 RDTs in relation to HCV RNA results in cases with S/Co ratio of < 6 via CLIA (n = 34) (PDF 275 kb)
13337_2019_542_MOESM3_ESM.pdf (274 kb)
Flowchart showing the evaluation of the results of the 3 RDTs in relation to HCV RNA results in cases with S/Co ratio of > 6 via CLIA (n = 41) (PDF 275 kb)

References

  1. 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.Google Scholar
  2. 2.
    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(28):9270–80.PubMedPubMedCentralGoogle Scholar
  3. 3.
    Shivkumar S, Peeling R, Jafari Y, Joseph L, Pant PN. Accuracy of rapid and point-of-care screening tests for hepatitis C. A systematic review and meta-analysis. Ann Intern Med. 2012;157(8):558–66.CrossRefGoogle Scholar
  4. 4.
    Guidelines on hepatitis B and C testing. World Health Organization February; 2017.Google Scholar
  5. 5.
    Dufour DR, Talastas M, Fernandez MDA, Harris B. Chemiluminescence assay improves specificity of hepatitis C antibody detection. Clin Chem. 2003;49:940–4.CrossRefGoogle Scholar
  6. 6.
    Kim S, Kim JH, Yoon S, Park YH, Kim HS. Clinical Performance evaluation of four automated chemiluminescenceimmunoassays for hepatitis C virus antibody detection. J Clin Microbiol. 2008;46(12):3919–23.CrossRefGoogle Scholar
  7. 7.
    John AS, Price CP. Economic evidence and point-of-care testing. Clin Biochem Rev. 2013;34:61–74.Google Scholar
  8. 8.
    Ward R, Willcox M, Price CP, Abangma G, Heneghan C, Thompson M, et al. Diagnostic technology: point-of-care testing for hepatitis C virus. Horizon scan report 0018 September 27th 2011.Google Scholar
  9. 9.
    Smith BD, Drobeniuc J, Jewett A, Branson BM, Garfein RS, Teshale E, et al. Evaluationof three rapid screening assays for detection of antibodies to hepatitis C virus. J Infect Dis. 2011;204:825–31.CrossRefGoogle Scholar
  10. 10.
    da Rosa L, Dantas-Correa EB, Narciso-Schiavon JL, de Lucca Schiavon L. Diagnostic performance of two point-of-care tests for anti-HCV detection. Hepat Mon. 2013;13(9):e12274.PubMedPubMedCentralGoogle Scholar
  11. 11.
    Kaur H, Dhanao J, Oberoi A. Evaluation of rapid kits for detection of HIV, HBsAg and HCV infections. Indian J Med Sci. 2000;54(10):432–4.PubMedGoogle Scholar
  12. 12.
    Gao F, Talbot EA, Loring CH, Power JJ, Dionne-Odom J, Alroy-Preis S, et al. Performance of the OraQuick HCV rapid antibody test for screening exposed patients in a hepatitis C outbreak investigation. J Clin Microbiol. 2014;52(7):2650–2.CrossRefGoogle Scholar
  13. 13.
    Hess KL, Fisher DG, Reynolds GL. Sensitivity and specificity of point-of-care rapid combination syphilis-HIV-HCV tests. PLoS ONE. 2014;9(11):e112190.CrossRefGoogle Scholar
  14. 14.
    Hui AY, Chan FK, Chan PK, Tam JS, Sung JJ. Evaluation of a new rapid whole-blood serological test for hepatitis C virus. Acta Virol. 2002;46(1):47–8.PubMedGoogle Scholar
  15. 15.
    Lee SR, Kardos KW, Schiff E, Berne CA, Mounzer K, Banks AT, et al. Evaluation of a new, rapid test for detecting HCV infection, suitable for use with blood or oral fluid. J Virol Methods. 2011;172(1–2):27–31.CrossRefGoogle Scholar
  16. 16.
    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(2):370–4.CrossRefGoogle Scholar
  17. 17.
    Buti M, Cotrina M, Chan H, Jardi R, Rodriguez F, Costa X, et al. Rapid method for the detection of anti-HCV antibodies in patients with chronic hepatitis C. Rev Esp Enferm Dig. 2000;92(3):140–6.PubMedGoogle Scholar
  18. 18.
    Cha YJ, Park Q, Kang ES, Yoo BC, Park KU, Kim JW, et al. Performance evaluation of the OraQuick hepatitis C virus rapid antibody test. Ann Lab Med. 2013;33(3):184–9.CrossRefGoogle Scholar
  19. 19.
    da Rosa L, Dantas-Correa EB, Narciso-Schiavon JL, de Lucca Schiavon L. Diagnostic performance of two point-of-care tests for anti-HCV detection. Hepat Mon. 2013;13(9):e12274.PubMedPubMedCentralGoogle Scholar
  20. 20.
    Ibrahim S, Al Attas SA, Mansour GA, Ouda S, Fallatah H. Accuracy of rapid oral HCV diagnostic test among a Saudi sample. Clin Oral Investig. 2015;19(2):475–80.CrossRefGoogle Scholar
  21. 21.
    Jewett A, Smith BD, Garfein RS, Cuevas-Mota J, Teshale EH, Weinbaum CM. Field-based performance of three pre-market rapid hepatitis C virus antibody assays in STAHR (study to assess hepatitis C risk) among young adults who inject drugs in San Diego, CA. J Clin Virol. 2012;54(3):213–7.CrossRefGoogle Scholar
  22. 22.
    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.CrossRefGoogle Scholar
  23. 23.
    Kim MH, Kang SY, Lee WI. Evaluation of a new rapid test kit to detect hepatitis C virus infection. J Virol Methods. 2013;193(2):379–82.CrossRefGoogle Scholar
  24. 24.
    Montebugnoli L, Borea G, Miniero R, Sprovieri G. A rapid test for the visual detection of anti-hepatitis C virus antibodies in whole blood. Clin Chim Acta. 1999;288(1–2):91–6.CrossRefGoogle Scholar
  25. 25.
    Poovorawan Y, Theamboonlers A, Chumdermpadetsuk S, Thong CP. Comparative results in detection of HCV antibodies by using a rapid HCV test, ELISA and immunoblot. Southeast Asian J Trop Med Public Health. 1994;25(4):647–9.PubMedGoogle Scholar
  26. 26.
    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(3):200–5.CrossRefGoogle Scholar
  27. 27.
    Yaari A, Tovbin D, Zlotnick M, Mostoslavsky M, Shemer-Avni Y, Hanuka N, et al. Detection of HCV salivary antibodies by a simple and rapid test. J Virol Methods. 2006;133(1):1–5.CrossRefGoogle Scholar
  28. 28.
    Smith BD, Teshale E, Jewett A, Weinbaum CM, Neaigus A, Hagan H, et al. Performance of premarket rapid hepatitis C virus antibody assays in 4 national human immunodeficiency virus behavioral surveillance system sites. Clin Infect Dis. 2011;53(8):780–6.CrossRefGoogle Scholar
  29. 29.
    Majumder P, Shetty AK. Comparison between ELISA and chemiluminescence immunoassay for the detection of hepatitis C virus antibody. Indian J Microbiol Res. 2017;4(4):353–7.Google Scholar
  30. 30.
    Kesli R. Evaluation of assay methods and false positive results in the laboratory diagnosis of hepatitis C virus infection. Arch Clin Microbiol. 2011;2(4):1–4.Google Scholar
  31. 31.
    Sharma UK, Stramer SL, Wright DJ, Glynn SA, Hermansen S, Schreiber GB, et al. Retrovirus epidemiology donor study. Impact of changes in viral marker screening assays. Transfusion. 2003;43:202–14.CrossRefGoogle Scholar
  32. 32.
    Rahman M, Khan SA, Lodhi Y. Unconfirmed reactive screening tests and their impact on donor management. Pak J Med Sci. 2008;24:517–9.Google Scholar
  33. 33.
    Fei K, Pan Yu, Xiumei C, Xiaomei W, Linjiao C, Juan L, et al. Factors associated with spontaneous clearance of hepatitis C virus in Chinese population. Biomed Res Int. 2014;2014:527030.Google Scholar
  34. 34.
    Gupta E, Ballani N. Low signal-to-cutoff ratio (S/Co) in the diagnosis of hepatitis C: A diagnostic dilemma? Indian J Gastroenterol. 2015;34(5):413–4.CrossRefGoogle Scholar
  35. 35.
    Kesli R, Ozdemir M, Kurtoglu MG, Baykan M, Baysal B. Evaluation and comparison of three different anti-hepatitis C virus antibody tests based on chemiluminescence and enzyme-linked immunosorbent assay methods used in the diagnosis of hepatitis C infections in Turkey. J Int Med Res. 2009;37:1420–9.CrossRefGoogle Scholar

Copyright information

© Indian Virological Society 2019

Authors and Affiliations

  • Supriya Mahajan
    • 1
  • Reshu Agarwal
    • 1
  • Vaishali Rawat
    • 1
  • Guresh Kumar
    • 2
  • Manoj Kumar Sharma
    • 3
  • Ekta Gupta
    • 1
    Email author
  1. 1.Department of Clinical VirologyInstitute of Liver and Biliary SciencesNew DelhiIndia
  2. 2.Department of Clinical ResearchInstitute of Liver and Biliary SciencesNew DelhiIndia
  3. 3.Department of HepatologyInstitute of Liver and Biliary SciencesNew DelhiIndia

Personalised recommendations