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CN 22-1108/R
Volume 38 Issue 5
May  2022
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Article Navigation >  Journal of Clinical Hepatology  > 2022  >  38(5): 1035-1040

Comparison of two quantitative real-time PCR methods for serum HBV RNA in patients with HBeAg-positive chronic hepatitis B: A propensity score matching study

DOI: 10.3969/j.issn.1001-5256.2022.05.012
  • 1.

    Difficult & Complicated Liver Diseases and Artificial Liver Center, Beijing YouAn Hospital, Capital Medical University, Beijing 100069, China

  • 2.

    Department of Microbiology and Infectious Disease Center, School of Basic Medical Sciences, Peking University Health Science Center, Beijing 100191, China

  • 3.

    Academy for Advanced Interdisciplinary Studies, Peking University, Beijing 100871, China

  • 4.

    Hunan Provincial Key Laboratory of Gene Diagnostic Technology, Changsha 410205, China

  • 5.

    Department of Infectious Diseases, Electric Power Teaching Hospital, Capital Medical University, Beijing 100073, China

Research funding:

National Science and Technology Key Project on "Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment" (2017ZX10302201-004);

National Science and Technology Key Project on "Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment" (2017ZX10202203-006);

National Science and Technology Key Project on "Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment" (2017ZX10201201);

National Science and Technology Key Project on "Major Infectious Diseases such as HIV/AIDS, Viral Hepatitis Prevention and Treatment" (2017ZX10203201-005)

More Information
  • Corresponding author: ZHENG Sujun, zhengsujun@ccmu.edu.cn(ORCID: 0000-0002-6367-5764)
  • Received Date: 2021-09-21
  • Accepted Date: 2021-10-29
  • Published Date: 2022-05-20
    Abstract
  •   Objective  To investigate the consistency between Shengxiang (S) and Xinbo (X) real-time PCR methods in the quantification of HBV RNA.  Methods  In the prospective follow-up cohort of 108 chronic hepatitis B (CHB) patients established from July 2007 to August 2008, 20 patients with HBeAg seroconversion were selected, and 20 patients without seroconversion were selected by propensity score matching at a ratio of 1∶ 1. The two quantification methods from S and X companies were used, and a retrospective analysis was performed for HBV RNA in serum samples at baseline and weeks 12, 24, and 48. The paired t-test was used for comparison of normally distributed continuous data between groups, and the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups; the chi-square test was used for comparison of categorical data. The Pearson correlation coefficient, intraclass correlation coefficient (ICC), and the Bland-Altman method were used to evaluate the consistency of the two quantification methods.  Results  A total of 132 serum samples were tested by S reagent, and 154 were tested by X reagent; the detection rate of HBV RNA was 100% by both reagents. A total of 131 serum samples were tested by both reagents, with 34 samples at baseline and 29, 35, and 33 samples, respectively, at weeks 12, 24, and 48 of follow-up; at these four time points, the HBV RNA quantification data detected by X reagent were significantly higher than those detected by S reagent (5.75±1.64/5.43±1.73/5.13±1.54/4.76±1.55 log10 copies/mL vs 4.80±1.48/4.52±1.53/4.10±1.50/3.92± 1.43 log10 copies/mL, t=8.348, t=5.341, Z=-5.086, Z=-4.762, all P < 0.001). The correlation analysis of the two methods showed a Pearson correlation coefficient of 0.915 (95% confidence interval [CI]: 0.836-0.957) and an ICC of 0.771(95%CI: -0.021 to 0.931) at baseline, a Pearson correlation coefficient of 0.849(95%CI: 0.701-0.927) and an ICC of 0.733(95%CI: 0.138-0.902) at week 12, a Pearson correlation coefficient of 0.951(95%CI: 0.905-0.975) and an ICC of 0.776(95%CI: -0.058 to 0.942) at week 24, and a Pearson correlation coefficient of 0.933(95%CI: 0.867-0.967) and an ICC of 0.804(95%CI: -0.014 to 0.944) at week 48 (all P < 0.05). The Bland-Altman analysis showed that the difference of 96.18%(126/131) samples tested by the two methods was within the mean difference±1.96 standard deviation.  Conclusion  HBV RNA quantification by X reagent is higher than that by S reagent, while the two real-time PCR quantification methods show a good consistency in CHB patients with HBeAg seroconversion and those without seroconversion.

     

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