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Date Published: 07/08/2021
Abstract Views: 298
Views PDF: 239
DOI: https://doi.org/10.51298/vmj.v504i1.841
Issue
Vol. 504 No. 1 (2021)
Section
Các bài báo
How to Cite
Như Bình, Đỗ . (2021). EVALUATE THE QUALITY OF ONE-STEP RT-qPCR HBV KIT TO DETECT THE SERUM pgRNA LEVEL IN CHRONIC HBV-INFECTED PATIENTS. Vietnam Medical Journal, 504(1). https://doi.org/10.51298/vmj.v504i1.841

EVALUATE THE QUALITY OF ONE-STEP RT-qPCR HBV KIT TO DETECT THE SERUM pgRNA LEVEL IN CHRONIC HBV-INFECTED PATIENTS

Đỗ Như Bình1,
1 Military Hospital 103, Vietnam Military Medical University

Main Article Content

Abstract

Objective:This study was to evaluate the quality of one-step RT-qPCR HBV kit to detect the serum pgRNA level in chronic HBV-infected patients. Materials and methods: The limit of detection, the limit of quantitation, linear range, repeatability, precision, and specificity of one-step R&D RT-qPCR HBV kit were included in the study, as well as compared the capability with two-step RT-qPCR method to detect serum pgRNA level. Results: The limit of detection and the limit of quantitation were 70 copies/ml and 140 copies/ml of serum, respectively. The linear range was from 102 to 108 copies/ml, R2 = 0,996. The repeatability and precision of  one-step R&D RT-qPCR HBV kit were in good performan with CV ≤ 0,03, deltaCt <0,5, and specificity of 100%. There was a high correlation in quantification of HBV-pgRNA between the two kits (R2= 0,9885). Conclusion: The one-step R&D RT-qPCR HBV kit could be useful for detection of serum pgRNA level and follow-up management of treated chronic HBV-infected patients.

Article Details

Keywords

Pregenomic RNA, one-step R&D RT-qPCR HBV kit, CHB

References

1. Burd EM. 2010. Validation of laboratory-developedmolecular assays for infectious diseases. Clin MicrobiolRev. 23(3):550-576.
2. CLSI/NCCLS. 2003. Evaluation of precision performance of quantitative measurement methods. Approved guideline. 2nd ed. CSLI document EP5-A2. Clinical and Laboratory Standards Institute, Wayne, PA.
3. F. van Bommel, A. Bartens, A. Mysickova et al., (2015), "Serum hepatitis B virus RNA levels as an early predictor of hepatitis B envelope antigen seroconversion during treatment with polymerase inhibitors", Hepatology. 61(1), 66-76.
4. K. Giersch, L. Allweiss, T. Volz et al., (2016), "Serum HBV pgRNA as a clinical marker for cccDNA activity", J Hepatol.
5. L. Jansen, N. A. Kootstra, K. A. van Dort et al., (2016), "Hepatitis B Virus Pregenomic RNA Is Present in Virions in Plasma and Is Associated With a Response to Pegylated Interferon Alfa-2a and Nucleos(t) ide Analogues", J Infect Dis. 213(2), 224-32.
6. M.J. van Campenhout, F. van Bömmel, M. Grossmann et al., (2017), "Serum hepatitis B virus RNA level is associated with hepatitis B virus genotype and BCP mutations in untreated patients with HBeAg positive chronic hepatitis B", Journal of hepatology. 66(1), S253–S254.
7. Jennings L, Van Deerlin VM, Gulley ML.2009.Recommended principles and practices for validatingclinical molecular pathology tests. Arch Pathol Lab Med.133(5):743-755.
8. J. Wang, T. Shen, X. Huang et al., (2016), "Serum hepatitis B virus RNA is encapsidated pregenome RNA that may be associated with persistence of viral infection and rebound", J Hepatol. 65(4), 700-10.