Abstract
A novel multiplex real-time PCR assay for concurrent detection of hepatitis viruses was evaluated for its clinical performance in screening patients with acute hepatitis. A total of 648 serum samples were collected from patients with acute symptoms of hepatitis. Concurrent detection of nucleic acids of HAV, HBV and HCV was performed using the Magicplex™ HepaTrio Real-time Detection test. Serum nucleic acid levels of HBV and HCV were also quantified by the Cobas® AmpliPrep/Cobas® TaqMan® (CAP/CTM) HBV and HCV tests. Patients’ medical records were also reviewed. Concordance rates between the results from the HepaTrio and the CAP/CTM tests for the detection of HBV and HCV were 94.9% (k = 0.88) and 99.2% (k = 0.98), respectively. The cycle threshold values with the HepaTrio test were also correlated well with the levels of HBV DNA (r = −0.9230) and HCV RNA (r = −0.8458). The sensitivity and specificity of the HepaTrio test were 93.8% and 98.2%, respectively, for detecting HBV infection, and 99.1% and 100.0%, respectively, for HCV infection. For the HepaTrio test, 21 (3.2%) cases were positive for both HBV and HCV. Among the positive cases, 6 (0.9%) were true coinfections. This test also detected 18 (2.8%) HAV positives. The HepaTrio test demonstrated good clinical performance and produced results that agreed well with those of the CAP/CTM assays, especially for the detection of HCV. This assay was also able to detect HAV RNA from anti-HAV IgM-positive individuals. Therefore, this new multiplex PCR assay could be useful for the concurrent detection of the three hepatitis viruses.
Highlights
Hepatitis A, B, and C viruses (HAV, hepatitis B virus (HBV), and hepatitis C virus (HCV)) are common pathogens that cause hepatitis in humans
Obtaining informed consents from the enrolled subjects was exempted by the Institutional Review Board (IRB) because this study was retrospectively performed by analyzing medical records and assaying stored residual specimens that had been requested for hepatitis virus polymerase chain reaction (PCR) assays, and no additional specimen was collected from the subjects
Subject Characteristics The total of 648 patients suspected of having acute hepatitis included 340 males (52.5%) and 308 females (47.5%)
Summary
Hepatitis A, B, and C viruses (HAV, HBV, and HCV) are common pathogens that cause hepatitis in humans. Two billion people worldwide have been infected with HBV and about 350 million suffer from chronic hepatitis B (CHB). About 25% of adults who were infected with HBV during childhood die from hepatocellular carcinoma (HCC) or liver cirrhosis [1]. An estimated three to four million people worldwide are infected with HCV each year, and 130 to 170 million people are chronically infected with HCV. More than 350,000 people die from HCV-related liver diseases each year [2]. HAV infections, which occur sporadically and in epidemics, account for an estimated 1.4 million worldwide cases annually [3]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
