Analytical and clinical validation of 3′ RACE RT-qPCR assay for detection and quantification of hepatitis B virus (HBV) serum RNA

Charre, 2019, Non-invasive biomarkers for chronic hepatitis B virus infection management, Antiviral Res, 169, 10.1016/j.antiviral.2019.104553 Ou, 2019, Insights for clinical diagnostic indicators of virus and host in chronic hepatitis B infection, J. Viral Hepat., 27, 224, 10.1111/jvh.13260 van Campenhout, 2020, Serum hepatitis B virus RNA predicts response to peginterferon treatment in HBeAg-positive chronic hepatitis B, J. Viral Hepat., 27, 610, 10.1111/jvh.13272 Tsuge, 2013, Serum HBV RNA and HBeAg are useful markers for the safe discontinuation of nucleotide analogue treatments in chronic hepatitis B patients, J. Gastroenterol., 48, 1188, 10.1007/s00535-012-0737-2 van Bömmel, 2015, Serum hepatitis B virus RNA levels as an early predictor of hepatitis B envelope antigen seroconversion during treatment with polymerase inhibitors, Hepatology, 61, 66, 10.1002/hep.27381 Vachon, 2021, Novel biomarkers of hepatitis B virus and their use in chronic hepatitis B patient management, Viruses, 13, 1, 10.3390/v13060951 Butler, 2018, Hepatitis B virus serum DNA and RNA levels in nucleos(t)ide analog-treated or untreated patients during chronic and acute infection, Hepatology, 68, 2106, 10.1002/hep.30082 Stadelmayer, 2020, Full-length 5’RACE identifies all major HBV transcripts in HBV-infected hepatocytes and patient serum, J. Hepatol., 10.1016/j.jhep.2020.01.028 Wang, 2016, Serum hepatitis B virus RNA is encapsidated pregenome RNA that may be associated with persistence of viral infection and rebound, J. Hepatol., 65, 700, 10.1016/j.jhep.2016.05.029 Wang, 2018, Relationship between serum HBV-RNA levels and intrahepatic viral as well as histologic activity markers in entecavir-treated patients, J. Hepatol., 68, 16, 10.1016/j.jhep.2017.08.021 Hilger, 1991, Diversity of hepatitis B virus X gene-related transcripts in hepatocellular carcinoma: a novel polyadenylation site on viral DNA, J. Virol., 65, 4284, 10.1128/jvi.65.8.4284-4291.1991 Limothai, 2020, Reverse transcriptase droplet digital PCR vs reverse transcriptase quantitative real-time PCR for serum HBV RNA quantification, J. Med. Virol., 92, 3365, 10.1002/jmv.25792 Scholtès, 2022, Performance of the cobas® HBV RNA automated investigational assay for the detection and quantification of circulating HBV RNA in chronic HBV patients, J. Clin. Virol., 150–151, 1 Yu, 2022, A standardized assay for the quantificative detection of serum HBV RNA in chronic hepatitis B patients, Emerg. Microbes Infect., 11, 1, 10.1080/22221751.2022.2045874 Tabernero, 2022, Letter to the editor: standardization of HBV-RNA assay for the different phases of chronic hepatitis B is essential, Hepatology, 75, 501, 10.1002/hep.32227 Tong, 2016, Overview of hepatitis B viral replication and genetic variability, J. Hepatol., 64, S4, 10.1016/j.jhep.2016.01.027 Nassal, 2008, Hepatitis B viruses: reverse transcription a different way, Virus Res., 134, 235, 10.1016/j.virusres.2007.12.024 Zhang, 2016, Characterization of novel hepadnaviral RNA species accumulated in hepatoma cells treated with viral DNA polymerase inhibitors, Antiviral Res., 131, 40, 10.1016/j.antiviral.2016.04.007 Bayliss, 2013, Hepatitis B virus splicing is enhanced prior to development of hepatocellular carcinoma, J. Hepatol., 59, 1022, 10.1016/j.jhep.2013.06.018 Lim, 2021, Quantitative analysis of the splice variants expressed by the major hepatitis B virus genotypes, Microb. Genom., 7, 1 Coffin, 2019, Epidemiologic and clinical features of chronic hepatitis B virus infection in 8 Canadian provinces: a descriptive study by the Canadian HBV Network, C. Open., 7, E610, 10.9778/cmajo.20190103 Vachon, 2021, An investigation of novel hepatitis B virus quantitative serum biomarkers in hepatitis B-hepatitis D virus co-infected patients enrolled in the Canadian hepatitis B virus network, P076 van Campenhout, 2018, Host and viral factors associated with serum hepatitis B virus RNA levels among patients in need for treatment, Hepatology, 68, 839, 10.1002/hep.29872 Chomczynski, 2006, The single-step method of RNA isolation by acid guanidinium thiocyanate-phenol-chloroform extraction: twenty-something years on, Nat. Protoc., 1, 581, 10.1038/nprot.2006.83 Tesena, 2017, Comparison of commercial RNA extraction kits and qPCR master mixes for studying gene expression in small biopsy tissue samples from the equine gastric epithelium, J. Equine Sci., 28, 135, 10.1294/jes.28.135 Laras, 2022, Serum hepatitis B virus RNA detectability, composition and clinical significance in patients with ab initio hepatitis B e antigen negative chronic hepatitis B, Virol. J., 19, 1, 10.1186/s12985-022-01749-7 Pan, 2022, Dynamics of hepatitis B virus pregenomic RNA in chronic hepatitis B patients with antiviral therapy over 9 years, Front. Med., 9, 1, 10.3389/fmed.2022.851717 Mak, 2021, Residual HBV DNA and pgRNA viraemia is associated with hepatocellular carcinoma in chronic hepatitis B patients on antiviral therapy, J. Gastroenterol., 56, 479, 10.1007/s00535-021-01780-5 Rodríguez-Cazorla, 2015, 3’ rapid amplification of cDNA ends (3’ RACE) using arabidopsis samples, Biol. Protoc., 5, e1604 Zhang, 2022, Complete genome sequence of GII.9 norovirus, Arch. Virol., 167, 249, 10.1007/s00705-021-05257-x Lin, 2020, Diagnostic value of detection of pregenomic RNA in sera of hepatitis B virus-infected patients with different clinical outcomes, J. Clin. Microbiol., 58, 1, 10.1128/JCM.01275-19 Seto, 2021, Role of serum HBV RNA and hepatitis B surface antigen levels in identifying Asian patients with chronic hepatitis B suitable for entecavir cessation, Gut, 70, 775, 10.1136/gutjnl-2020-321116