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

Mohammad Hassan Ansari; Mir Omrani; Vahid Movahedi

Hepatitis Monthly

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

Author(s):

Mohammad Hassan Khadem Ansari^1,*,

Mir Davood Omrani²,

Vahid Movahedi²

1Department of Clinical Biochemistry, Urmia School of Medicine, Urmia University of Medical Sciences, mhansari1@hotmail.com, IR-Iran

2Department of Cyto-Genetic, Urmia School of Medicine, Urmia University of Medical Sciences, IR-Irani

Hepatitis Monthly:Vol. 7, issue 2; 87-91

Published online:Jun 30, 2007

Article type:Research Article

Received:Jun 08, 2007

Accepted:Aug 18, 2007

How to Cite:Ansari M H K, Omrani M D, Movahedi V. Comparative Evaluation of Immunochromatographic Rapid Diagnostic Tests (Strip and Device) and PCR Methods for Detection of Human Hepatitis B Surface Antigens.Hepat Mon.2007;7(2):87-91.

Abstract

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.

Keywords

Hepatitis B Virus

PCR

Rapid Test

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Author(s):

Mohammad Hassan Ansari:[PubMed][Scholar]
Mir Omrani:[PubMed][Scholar]
Vahid Movahedi:[PubMed][Scholar]

Official Journal of Research Center for Gastroenterology and Liver Diseases

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

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