Comparative Analysis of Electrochemiluminescence Assay and Chemiluminescent Microparticle Immunoassay for the Screening of Hepatitis C

  • Maeesa WadoodEmail author
  • Muhammad Usman
Original Article


The primary objective of the study was to identify a highly sensitive and specific screening technique for the detection of Hepatitis C infection in healthy blood donors in a low prevalence area for HCV. In this study, two of the most commonly used methods for Anti-HCV screening, i.e., Electrochemiluminescence Immunoassay (ECLIA) and Chemiluminescent Microparticle Immunoassay (CMIA) were performed among 517 selected healthy blood donors. The clinical performance of ECLIA and CMIA was compared on the basis of their operational variables, i.e., Sensitivity, Specificity, Accuracy, Youden’s J index, Positive and Negative predictive values and False discovery, False positive and False negative rate, etc., Both ECLIA and CMIA are highly sensitive (100%) and specific (98%) in terms of anti HCV detection among the blood donors. According to the clinical performance of ECLIA and CMIA, both are efficient in detecting anti-HCV antibodies among the asymptomatic population of healthy blood donors. But as both of them are associated with false positive results, it is recommended to have Polymerase chain reaction on the reactive samples to detect the HCV RNA.


Anti- HCV antibody screening Electro-chemiluminescence immunoassay Chemiluminescence immunoassay Healthy blood donor 



The supervision and support of Muhammad Usman during the research is highly appreciated.


This study is not funded by any institution or person.

Compliance with Ethical Standards

Conflict of interest

All the Authors declare that they have no conflict of interest.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Ethical approval

All procedures performed in the study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.


  1. 1.
    Klein HG, Anstee DJ (2008) Mollison’s blood transfusion in clinical medicine. Wiley, New YorkGoogle Scholar
  2. 2.
    Rudmann SV (2005) Textbook of blood banking and transfusion medicine. Elsevier Health Sciences, LondonGoogle Scholar
  3. 3.
    Orton SL, Virvos VJ, Williams AE (2000) Validation of selected donor-screening questions: structure, content, and comprehension. Transfusion 40:1407–1413CrossRefGoogle Scholar
  4. 4.
    Busch MP, Kleinman SH, Nemo GJ (2003) Current and emerging infectious risks of blood transfusions. JAMA 289:959–962CrossRefGoogle Scholar
  5. 5.
    WHO (2006) Screening donated blood by Transfusion Transmissible Infections: RecommendationsGoogle Scholar
  6. 6.
    Sy T, Jamal MM (2006) Epidemiology of Hepatitis C Virus. Int J Med Sci 3:41–46CrossRefGoogle Scholar
  7. 7.
    Chen SL, Morgan TR (2006) The natural history of Hepatitis C virus (HCV) infection. Int J Med Sci 3:47–52CrossRefGoogle Scholar
  8. 8.
    Wang Y, Wang J, Wu S, Zhu H (2017) The unexpected structures of Hepatitis C Virus envelope proteins. Exp Ther Med 14:1859–1865CrossRefGoogle Scholar
  9. 9.
    Murphy DG, Sablon E, Chamberland J, Fournier E, Dandavino R, Tremblay CL (2015) Hepatitis C Virus Genotype 7, a new genotype originating from Central Africa. J Clin Microbiol 53:967–972CrossRefGoogle Scholar
  10. 10.
    Idrees M, Riazuddin S (2008) Frequency distribution of Hepatitis C Virus genotypes in different geographical regions of Pakistan and their possible routes of transmission. BMC Infect Dis 8:69CrossRefGoogle Scholar
  11. 11.
    Karim F, Nasar A, Alam I, Alam I, Hassam S, Gul R (2016) Incidence of active HCV infection amongst blood donors of Mardan District, Pakistan. Asian Pac J Cancer Prev 17(1):235–238CrossRefGoogle Scholar
  12. 12.
    Liu CH, Kao JH (2011) Treatment of Hepatitis C Virus infection in patients with end-stage renal disease. J Gastroenterol Hepatol 26:228–239CrossRefGoogle Scholar
  13. 13.
    Messina JP, Humphreys I, Flaxman A, Brown A, Cooke GS, Pybus OG, Barnes E (2015) Global distribution and prevalence of Hepatitis C Virus genotypes. Hepatology 61:77–87CrossRefGoogle Scholar
  14. 14.
    Ali SA, Donahue RM, Qureshi H, Vermund SH (2009) Hepatitis B and Hepatitis C in Pakistan: prevalence and risk factors. Int J Infect Dis. 13:9–19CrossRefGoogle Scholar
  15. 15.
    Khan NU, Ali I, Ahmad NU, Iqbal A, Rehman LU, Munir I, Rehman MU, Khan S, Ali S, Siddique L, Swati ZA (2011) Prevalence of active HCV infection among the blood donors of Khyber Pakhtunkwa and FATA region of Pakistan and evaluation of the screening tests for Anti-HCV. Virol J 8:154CrossRefGoogle Scholar
  16. 16.
    Swellam M, Mahmoud MS, Ali AA (2011) Diagnosis of Hepatitis C Virus infection by Enzyme-Linked Immunosorbent Assay and Reverse Transcriptase-nested polymerase chain reaction: a comparative evaluation. IUBMB Life 63:430–434CrossRefGoogle Scholar
  17. 17.
    Khan A, Tareen AM, Ikram A, Rahman H, Wadood A, Qasim M, Khan K (2013) Prevalence of HCV among the young male blood donors of Quetta region of Balochistan, Pakistan. Virol J 10(1):83CrossRefGoogle Scholar
  18. 18.
    Kim S, Kim JH, Yoon S, Park YH, Kim HS (2008) Clinical performance evaluation of four automated Chemiluminescence Immunoassays for Hepatitis C Virus antibody detection. J Clin Microbiol 46:3919–3923CrossRefGoogle Scholar
  19. 19.
    Kesli R, Ozdemir M, Kurtoglu MG, Baykan M, Baysal B (2009) Evaluation and comparison of three different Anti Hepatitis C Virus antibody test based on Chemiluminescence and Enzyme-Linked Immunosorbent Assay methods used in the diagnosis of Hepatitis C infections in Turkey. J Int Med Res 37:1420–1429CrossRefGoogle Scholar
  20. 20.
    Schmidt M, Jimenez A, Mühlbacher A, Oota S, Blanco L, Sakuldamrongpanich T, Schennach H, Seifried E (2015) Head-to-head comparison between two screening systems for HBsAG, anti-HBc, anti-HCV and HIV combination Immunoassays in an international, multicenter evaluation study. Vox Sang 109:114–121CrossRefGoogle Scholar
  21. 21.
    Sharma RK, Sharma PK, Talat G, Gautam P, Chhabra R, Singh S (2016) Brief overview on Hepatitis C Virus Immunoassays. Int J Res Granthaalayah 4:178–184Google Scholar
  22. 22.
    Busch MP, Kleinman SH, Jackson B, Stramer SL, Hewlett I, Preston S (2000) Nucleic acid amplification testing of blood donors for transfusion-transmitted infectious diseases. Transfusion 40:143–159CrossRefGoogle Scholar
  23. 23.
    Colin C, Lanoir D, Touzet S, Meyaud-Kraemer L, Bailly F, Trepo C (2001) Sensitivity and specificity of third-generation Hepatitis C Virus antibody detection assays: an analysis of the literature. J Viral Hepat. 8:87–95CrossRefGoogle Scholar
  24. 24.
    Shepard CW, Finelli L, Alter MJ (2005) Global epidemiology of Hepatitis C Virus infection. Lancet Infect Dis 5:558–567CrossRefGoogle Scholar
  25. 25.
    Madhava V, Burgess C, Drucker E (2002) Epidemiology of chronic Hepatitis C Virus infection in subSaharan Africa. Lancet Infect Dis 2:293–302CrossRefGoogle Scholar
  26. 26.
    Choo QL, Weiner AJ, Overby LR, Kuo G, Houghton M, Bradley DW (1990) Hepatitis C Virus: the major causative agent of viral non-A, non-B hepatitis. Br Med Bull 46:423–441CrossRefGoogle Scholar
  27. 27.
    Alter HJ (1992) New kit on the block: evaluation of second-generation assays for detection of antibody to the hepatitis C virus. Hepatology 15:350–353CrossRefGoogle Scholar
  28. 28.
    Yoo SJ, Wang LL, Ning HC, Tao CM, Hirankarn N, Kuakarn S, Yang R, Han TH, Chan RC, Hussain BM, Hussin H (2015) Evaluation of the Elecsys® Anti-HCV II assay for routine Hepatitis C Virus screening of different Asian Pacific populations and detection of early infection. J Clin Virol 64:20–27CrossRefGoogle Scholar
  29. 29.
    Carreño V, Bartolomé J, Castillo I, Quiroga JA (2012) New perspectives in Occult Hepatitis C Virus infection. World J Gastroenterol 18:2887–2894CrossRefGoogle Scholar
  30. 30.
    Manickam C, Martinot AJ, Jones RA, Varner V, Reeves RK (2017) Hepatic immunopathology during occult Hepacivirus re-infection. Virology 512:48–55CrossRefGoogle Scholar
  31. 31.
    Alter MJ, Kuhnert WL, Finelli L (2003) Centers for disease control and prevention. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR Recomm Rep 52:1–16Google Scholar

Copyright information

© Indian Society of Hematology and Blood Transfusion 2018

Authors and Affiliations

  1. 1.Department of Pathology and Hematology, Institute of HematologyBaqai Medical UniversityKarachiPakistan
  2. 2.Muhammadi Blood Bank and Thalassemia CentreKarachiPakistan

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