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

Hepatitis b virus (hbv) infection is a leading cause of liver disease worldwide. it is estimatedthat approximately 350 million people worldwide have chronic hbv infection. in this study, immunochromatographicassays (icas) detection methods including rapid tests were compared with serum hbv-dna detecting by polymerasechain reaction (pcr) system.methods: 240 patients including 120 samples that were positive with quantitative pcr method and 120 that werenegative by either pcror 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 pcrmethod 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 indetecting hbsag in serum. also positive and negative predictive values of these two strips were higher compare to therest. in addition true negative value, specificity and positive predictive value of acon and dima strips were higher fordetecting 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 resultswith strips or device dose not exclude the presence of hbv dna and therefore one can be use rapid tests as a back upto standard testing methods. immunochromatographic results should be interpreted with caution, when the sample hasrelatively low reactivity by pcr method.