Diagnostic validity of the chemiluminescent method compared to polymerase chain reaction for hepatitis B virus detection in the routine clinical diagnostic laboratory

Authors
Mohammad-Hassan Khadem-Ansari 1
Mir-Davood Omrani 2
Yousef Rasmi 3
Arsalan Ghavam 4
1 Department of Biochemistry, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran
2 Department of Genetics, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran
3 Department of Biochemistry, Faculty of Medicine; Cellular and Molecular Research Center, Urmia University of Medical Sciences, Urmi, Iran
4 Department of Biology, Faculty of Sciences, Hacettepe University, Ankara, Turkey
Abstract
Background: Hepatitis B virus (HBV) is the most common significant chronic viral infection world-wide. Hepatitis B surface antigen (HBsAg) has been the principal target for laboratory testing to identify active infection by HBV. We aimed to find out diagnostic validity of the Liaison chemiluminescent method compared to the polymerase chain reaction (PCR) method for HBV detection in the routine clinical diagnostic laboratory.
Materials and Methods: From 350 patients suspicious of having infection with HBV, serum samples were separated and used for testing HBsAg by two methods of Liaison chemiluminescent immunoassay, with HBsAg confirmatory test and PCR method.
Results: According to the PCR results as assumed as gold standard method with 100% sensitivity and specificity, detection rate sensitivity of chemiluminescent with confirmatory test was 96% and its specificity was 100%, and for chemiluminescent without confirmatory test sensitivity and specificity were 100% and 70%, respectively. Also for chemiluminescent with confirmatory test, positive predictive value (PPV) was 100% and its negative predictive value (NPV) was 97%, compared to chemiluminescent without confirmatory test with PPV and NPV equal to 71% and 100%, respectively.
Conclusions: It is possible to conclude that in the majority of the HBV cases, the diagnostic value of chemiluminescent method compared to the PCR method is acceptable, except in low indexes positive cases that need further investigation with the PCR method.

Keywords

1. Jahani MR, Motevalian SA, Mahmoodi M. Hepatitis B carriers in large vehicle drivers of Iran. Vaccine 2003;21:1948-51.  Back to cited text no. 1
    
2. Mohebbi SR, Amini-Bavil-Olyaee S, Zali N, Noorinayer B, Derakhshan F, Chiani M, et al. Molecular epidemiology of hepatitis B virus in Iran. Clin Microbiol Infect 2008 14:858-66.  Back to cited text no. 2
    
3. Belongia EA, Costa J, Gareen IF, Grem JL, Inadomi JM, Kern ER, et al. NIH consensus development statement on management of hepatitis B. NIH Consens State Sci Statements 2008;25:1-29.  Back to cited text no. 3
[PUBMED]    
4. Andre F. Hepatitis B epidemiology in Asia, the Middle East and Africa. Vaccine 2000;18 Suppl 1:S20-2.  Back to cited text no. 4
    
5. Bhattacharya S, O'Donnell K, Dudley T, Kennefick A, Osman H, Boxall E, et al. Ante-natal screening and post-natal follow-up of hepatitis B in the West Midlands of England. QJM 2008;101:307-12.  Back to cited text no. 5
    
6. Alavian SM, Bagheri-Lankarani K, Mahdavi-Mazdeh M, Nourozi S. Hepatitis B and C in dialysis units in Iran: changing the epidemiology. Hemodial Int 2008;12:378-82.  Back to cited text no. 6
    
7. Alavian SM, Fallahian F, Lankarani KB. The changing epidemiology of viral hepatitis B in Iran. J Gastrointestin Liver Dis 2007;16:403-6.  Back to cited text no. 7
    
8. Lai CL, Ratziu V, Yuen MF, Poynard T. Viral hepatitis B. Lancet 2003;362:2089-94.  Back to cited text no. 8
    
9. Lin HJ, Lai CL, Lau JY, Chung HT, Lauder IJ, Fong MW. Evidence for intrafamilial transmission of hepatitis B virus from sequence analysis of mutant HBV DNAs in two Chinese families. Lancet 1990;336:208-12.  Back to cited text no. 9
    
10. Mast EE, Weinbaum CM, Fiore AE, Alter MJ, Bell BP, Finelli L, et al. Janssen RS, Ward JW: A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: Recommendations of the Advisory Committee on Immunization Practices Part II: immunization of adults. MMWR Recomm Rep 2006; 55(RR-16):1-33; quiz CE31-4.  Back to cited text no. 10
    
11. Krajden M, McNabb G, Petric M. The laboratory diagnosis of hepatitis B virus. Can J Infect Dis Med Microbiol 2005;16:65-72.  Back to cited text no. 11
    
12. Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2001;34:1225-41.  Back to cited text no. 12
    
13. Huzly D, Schenk T, Jilg W, Neumann-Haefelin D. Comparison of nine commercially available assays for quantification of antibody response to hepatitis B virus surface antigen. J Clin Microbiol 2008;46:1298-306.  Back to cited text no. 13
    
14. Ly TD, Servant-Delmas A, Bagot S, Gonzalo S, Ferey MP, Ebel A, et al. Sensitivities of four new commercial hepatitis B virus surface antigen assays in detection of HBsAg mutant forms. J Clin Microbiol 2006;44:2321-26.  Back to cited text no. 14
    
15. KhademAnsari MH, Omrani M, Movahedi V. Comparative evaluation of immunochromatographic rapid diagnostic tests (Strip and Device) and PCR methods for detection of human hepatitis B surface antigens. Hepatitis Mon 2007;7:373-7.  Back to cited text no. 15
    
16. Irwig L, Bossuyt P, Glasziou P, Gatsonis C, Lijmer J. Designing studies to ensure that estimates of test accuracy are transferable. BMJ 2002;324:669-71.  Back to cited text no. 16
    
17. Kramvis A, Kew M, Francois G. Hepatitis B virus genotypes. Vaccine 2005;23:2409-23.  Back to cited text no. 17
    
18. Lok AS, McMahon BJ. Chronic hepatitis B: update of recommendations. Hepatology 2004;39:857-61.  Back to cited text no. 18
    
19. Thomas HC. Best practice in the treatment of chronic hepatitis B: A summary of the European Viral Hepatitis Educational Initiative. J Hepatol 2007;47:588-97.  Back to cited text no. 19
[PUBMED]    
20. Chen D, Kaplan LA. Performance of a new-generation chemiluminescent assay for hepatitis B surface antigen. Clinical chemistry 2006;52:1592-8.  Back to cited text no. 20
    
21. Kessler HH. Comparison of currently available assays for detection of hepatitis B virus DNA in the routine diagnostic laboratory. Expert Rev Mol Diagn 2005;5:531-6.  Back to cited text no. 21
[PUBMED]    
22. Koyanagi T, Nakamuta M, Sakai H, Sugimoto R, Enjoji M, Koto K, Iet al. Analysis of HBs antigen negative variant of hepatitis B virus: Unique substitutions, Glu129 to Asp and Gly145 to Ala in the surface antigen gene. Med Sci Monit 2000;6:1165-9.  Back to cited text no. 22
    
23. O'Brien JE. Hepatitis B surface antigen: Decreased need for confirmation of reactive results. Clin Chem 2000;46:582.  Back to cited text no. 23
[PUBMED]    
24. Alter MJ, Kuhnert WL, Finelli L. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep 2003, 52(RR-3):1-13, 15; quiz CE11-14.  Back to cited text no. 24
    
25. Schwartz JS, Dans PE, Kinosian BP. Human immunodeficiency virus test evaluation, performance, and use. Proposals to make good tests better. JAMA 1988;259:2574-9.  Back to cited text no. 25
    
26. Dufour DR. Hepatitis B surface antigen assays: Are they good enough for their current uses? Clin Chem 2006;52:1457-9.  Back to cited text no. 26
[PUBMED]    
27. Carlson JR, Bryant ML, Hinrichs SH, Yamamoto JK, Levy NB, Yee J, et al. AIDS serology testing in low- and high-risk groups. JAMA 1985;253:3405-8.  Back to cited text no. 27
[PUBMED]    
Advanced Biomedical Research
Volume 2014, May
May 2014
Pages 1-5