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.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.

Diagnostic accuracy of tests to detect hepatitis B surface antigen: a systematic review of the literature and meta-analysis

“…The use of different reference standards makes pooling across studies difficult; this is further complicated by rapid changes in technology and analytical sensitivity combined with suboptimal reporting of LOD in both index tests and reference standards. For studies using NAT as a reference, assays were not standardized, with poor reporting of testing, albeit all were according to the manufacturer’s instructions; some used pooled NAT of HBsAg negative sample [ 55 , 57 ], while others described inadequate detail for qPCR methodology [ 51 , 54 ]. Finally, the natural history of diagnostic markers in chronic hepatitis B is more complex than most viral infections, with transient low level asynchronous quantitative fluctuations of HBsAg and DNA recognised in uncomplicated chronic HBV [ 73 ].…”

Profile Quantitative Hepatitis B Surface Antigen (qHBsAg) of Chronic Nai?ve Hepatitis B Patients in Dr. Soetomo Hospital, Surabaya, Indonesia

“…HBV patients are approximately 4.0-20.3% of the healthy population of Indonesia. However, The java island proportion is lower than the other islands 1,2 . The risk of developing chronic HBV infection based on the age of infection was as much as 90% if infection occurred from perinatal to 6 months and 20%-60% if infection occurred between the age 6 of the month-5 years 3 .…”

“…HBs Ag is a seromarker used routinely to diagnose acute or chronic viral hepatitis B, screening blood donors or organ donors, surveillance persons at risk of acquiring or transmitting (HBV) 1 . Quantitative HBs Ag has been proposed to be used as monitoring the course of chronic hepatitis B infection including the immune tolerance, immune clearance, immune control/inactive carrier phase as well as reactivated negative HBe phase 4 .…”