Comparative Evaluation of Immunochromatographic Rapid Diagnostic Tests (Strip and Device) and PCR Methods for Detection of Human Hepatitis B Surface Antigens

Background and Aims: Hepatitis B virus (HBV) infection is a leading cause of liver disease worldwide. It is estimated that approximately 350 million people worldwide have chronic HBV infection. In this study, immunochromatographic assays (ICAs) detection methods including rapid tests were compared with serum HBV-DNA detecting by polymerase chain reaction (PCR) system.
Methods: 240 patients including 120 samples that were positive with quantitative PCR method and 120 that were negative by either PCR or EIA methods were selected. Samples were examined by strip and device from Intec, Blue Cross, Acon, Atlas, DIMA and Cortez companies compare to the quantitative PCR method as gold standard for detecting HBsAg.
Results: Strip from Intec and Blue Cross, compare to the Acon, Atlas, DIMA and Cortez devices had higher sensitivity in detecting HBsAg in serum. Also positive and negative predictive values of these two strips were higher compare to the rest. In addition true negative value, specificity and positive predictive value of Acon and DIMA strips were higher for detecting HBsAg compare to the rest of the strips.
Conclusions: Rapid diagnostic tests are inexpensive, easy to complete, and impose the minimum discomfort to patients, as well as suitable for case-finding and epidemiological surveillance.  But it should be considered that negative results with strips or device dose not exclude the presence of HBV DNA and therefore one can be use rapid tests as a back up to standard testing methods. Immunochromatographic results should be interpreted with caution, when the sample has relatively low reactivity by PCR method.