title: Diagnostic validity of the chemiluminescent method compared to polymerase chain reaction for hepatitis B virus detection in the routine clinical diagnostic laboratory.
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.
  
  
  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.
authors.affiliation: Department of Biochemistry, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.
authors.forename: Mohammad-Hassan
authors.initials: MH
authors.lastname: Khadem-Ansari
authors.affiliation: Department of Genetics, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran.
authors.forename: Mir-Davood
authors.initials: MD
authors.lastname: Omrani
authors.affiliation: Department of Biochemistry, Faculty of Medicine, Urmia University of Medical Sciences, Urmia, Iran ; Department of Cellular and Molecular Research Center, Urmia University of Medical Sciences, Urmi, Iran.
authors.forename: Yousef
authors.initials: Y
authors.lastname: Rasmi
authors.affiliation: Department of Biology, Faculty of Sciences, Hacettepe University, Ankara, Turkey.
authors.forename: Arsalan
authors.initials: A
authors.lastname: Ghavam
keywords: Chemiluminescent; diagnostic value; hepatitis B virus; polymerase chain reaction