A clinical consensus study of HBsAg quantitative results by two methods

doi:10.3969/j.issn.1673-8640.2013.09.023

Abstract

Abstract:

Objective To evaluate the clinical application feasibility of hepatitis B surface antigen (HBsAg) quantitative determination by Roche and Abbott. Methods A total of 423 serum and plasma samples were collected and determined by Abbott ARCHITECT HBsAg and Roche HBsAg quantitative Elecsys, and the results were analyzed comparatively. The correlation was analyzed statistically. Performance evaluation on Roche and Abbott was also conducted. Results The intra-analysis and inter-analysis coefficients of variation (CV) were low. The HBsAg results of serum and plasma samples from the same patient correlated well (r=0.988, P<0.05). The correlation between Roche and Abbott was good (r=0.965,P<0.05). The 2 assays were not influenced by potential interferences such as lipemia, icterus and hemolysis. The limit of the 2 assays was 0.05 IU/mL. Through dilution, the 2 assays could report the common clinical high-value HBsAg results. The recoveries of the 2 assays were consistent. Conclusions Results from Roche and Abbott HBsAg quantitative results are consistent and have a good correlation, and they are suitable for the clinical application. HBsAg results are consensus for each other.

Key words: Hepatitis B surface antigen, Correlation, Result consensus

CLC Number:

R446.61

SHENG Huan,HU Xiaobo,XU Jie. A clinical consensus study of HBsAg quantitative results by two methods[J]. , 2013, 28(9): 828-834.

References

[1] European Association for the Study of the Liver. EASL clinical practice guidelines: management of chronic hepatitis B[J] . J Hepatol, 2012,57(1):167-185.
[2] Moucari R,Mackiewicz V,Lada O,et al. Early serum HBsAg drop: a strong predictor of sustained virological response to pegylated interferon alfa-2a in HBeAg-negative patients[J] . Hepatology, 2009,49(4):1151-1157.
[3] 〖JP+3〗Marcellin P,Bonino F,Lau GK,et al. Sustained response of hepatitis B e antigen-negative patients 3 years after treatment with peginterferon alpha-2a[J] . Gastroenterology, 2009,136(7):2169-2179.
[4] Perrillo RP. Hepatitis B surface antigen quantification as a current-day paradox: obtaining the gold in the face of diminishing returns[J] . Hepatology, 2009,49(4): 1063-1065.
[5] Brunetto MR,Moriconi F,Bonino F,et al. Hepatitis B virus surface antigen levels: a guide to sustained response to peginterferon alfa-2a in HBeAg-negative chronic hepatitis B[J] . Hepatology, 2009,49(4): 1141-1150.
[6] Chan HL,Wong VW,Tse AM,et al. Serum hepatitis B surface antigen quantitation can reflect hepatitis B virus in the liver and predict treatment response[J] . Clin Gastroenterol Hepatol, 2007,5(12):1462-1468.
[7] Gish RG,Lau DT,Schmid P,et al. A pilot study of extended duration peginterferon alfa-2a for patients with hepatitis B e antigen-negative chronic hepatitis B[J] . Am J Gastroenterolistry, 2007,102(12): 2718-2723.
[8] Engvall E,Perlmann P. Enzyme-linked immunosorbent assay (ELISA). Quantitative assay of immunoglobulin G[J] . Immunochemistry, 1971,8(9):871-874.
[9] Engvall E,Perlmann P. Enzyme-linked immunosorbent assay (ELISA). Protides of the Biological Fluids[M] . Oxford: Pergamon Press,1971: 553-556.
[10] Wisdom GB. Enzyme-immunoassay[J] . Clin Chem, 1976,22(8):1243-1255.
[11] Goodall AH,Miescher G,Meek FM,et al. Monoclonal antibodies in a solid-phase radiometric assay for HBsAg[J] . Med Lab Sci, 1981,38(4):349-354.
[12] Kennedy RC,Ionescu-Matiu I,Adler-Storthz K,et al. Characterization of anti-hepatitis B surface antigen monoclonal antibodies[J] . Intervirology, 1983,19(3):176-180.
[13] Brunetto MR,Mocriconi F,Bonino F,et al. Hepatitis B virus surface antigen levels a guide to sustained response to peginterferon alfa-2a in HBeAg-negative chronic hepatitis B[J] . Hepatology, 2009,49(4): 1141-1150.

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