The Lumipulse G HBsAg-Quant assay for screening and quantification of the hepatitis B surface antigen

Journal of Virological Methods

Volumn 228, Issue , 2016, Pages 39-47

  Yang, Ruifeng ^a   Song, Guangjun ^a   Guan, Wenli ^a   Wang, Qian ^a   Liu, Yan ^a   Wei, Lai ^a  

^a PEKING UNIVERSITY PEOPLE S HOSPITAL   (China)

Author keywords

Diagnosis; HBsAg; Hepatitis B virus; Performance evaluation; Quantitative

Indexed keywords

ANTIVIRUS AGENT; HEPATITIS B SURFACE ANTIGEN; DIAGNOSTIC KIT; HEPATITIS B ANTIBODY;

ADULT; AGED; ANTIGEN DETECTION; ARTICLE; BLOOD SAMPLING; CLINICAL ARTICLE; COMPARATIVE STUDY; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; FEMALE; GENE; GENE MUTATION; GENOTYPE; HEPATITIS B; HUMAN; IMMUNOASSAY; INFANT; LIMIT OF QUANTITATION; MALE; MIDDLE AGED; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; S GENE; SCREENING TEST; SENSITIVITY AND SPECIFICITY; VERY ELDERLY; YOUNG ADULT; BLOOD; DIAGNOSTIC KIT; EVALUATION STUDY; GENETICS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; IMMUNOLOGY; LIMIT OF DETECTION; LUMINESCENCE; MUTATION; PROCEDURES;

ADULT; AGED; AGED, 80 AND OVER; FEMALE; GENOTYPE; HEPATITIS B ANTIBODIES; HEPATITIS B SURFACE ANTIGENS; HEPATITIS B VIRUS; HEPATITIS B, CHRONIC; HUMANS; INFANT; LIMIT OF DETECTION; LUMINESCENT MEASUREMENTS; MALE; MIDDLE AGED; MUTATION; REAGENT KITS, DIAGNOSTIC; SENSITIVITY AND SPECIFICITY;

EID: 84949217211     PISSN: 01660934     EISSN: 18790984     Source Type: Journal    
DOI: 10.1016/j.jviromet.2015.11.016     Document Type: Article

References (37)

1. Allain J.P., Cox L. Challenges in hepatitis B detection among blood donors. Curr. Opin. Hematol. 2011, 18:461-466.
2. Anjum Q. False positive hepatitis B surface antigen due to recent vaccination. Int. J. Health Sci. 2014, 8:189-193.
3. Brunetto M.R. A new role for an old marker, HBsAg. J. Hepatol. 2010, 52:475-477.
4. Burdino E., Ruggiero T., Proietti A., Milia M.G., Olivero A., Caviglia G.P., Marietti M., Rizzetto M., Smedile A., Ghisetti V. Quantification of hepatitis B surface antigen with the novel DiaSorin LIAISON XL Murex HBsAg Quant: correlation with the ARCHITECT quantitative assays. J. Clin. Virol.: Off. Pub. Pan Am. Soc. Clin. Virol. 2014, 60:341-346.
5. Chen C.J., Wang L.Y., Yu M.W. Epidemiology of hepatitis B virus infection in the Asia-Pacific region. J. Gastroenterol. Hepatol. 2000, 15(Suppl.):E3-E6.
6. Choi S.J., Park Y., Lee E.Y., Kim S., Kim H.S. Performance evaluation of LUMIPULSE G1200 autoimmunoanalyzer for the detection of serum hepatitis B virus markers. J. Clin. Lab. Anal. 2013, 27:204-206.
7. Coleman P.F. Detecting hepatitis B surface antigen mutants. Emerg. Infect. Dis. 2006, 12:198-203.
8. EASL EASL clinical practice guidelines: management of chronic hepatitis B virus infection. J. Hepatol. 2012, 57:167-185.
9. Fattovich G., Bortolotti F., Donato F. Natural history of chronic hepatitis B: special emphasis on disease progression and prognostic factors. J. Hepatol. 2008, 48:335-352.
10. Ganji A., Esmaeilzadeh A., Ghafarzadegan K., Helalat H., Rafatpanah H., Mokhtarifar A. Correlation between HBsAg quantitative assay results and HBV DNA levels in chronic HBV. Hepat. Monthly 2011, 11:342-345.
11. Gotstein M.G., Aide P.M., Coleman P.F., Sanborn M.R. Rate of hepatitis B virus infection in pregnant women determined by a monoclonal hepatitis B surface antigen immunoassay. J. Clin. Microbiol. 2002, 40:3493-3496.
12. Hwang J.P., Lok A.S. Management of patients with hepatitis B who require immunosuppressive therapy. Nat. Rev. Gastroenterol. Hepatol. 2014, 11:209-219.
13. Lee H.J., Kim S.Y., Lee S.M., Heo J., Kim H.H., Chang C.L., Lee E.Y., Son H.C. Elecsys hepatitis B surface antigen quantitative assay: performance evaluation and correlation with hepatitis B virus DNA during 96 weeks of follow-up in chronic hepatitis B patients. Ann. Lab. Med. 2012, 32:420-425.
14. Lee M.H., Yang H.I., Liu J., Batrla-Utermann R., Jen C.L., Iloeje U.H., Lu S.N., You S.L., Wang L.Y., Chen C.J., Group R.E.V.E.A.L.H.S. Prediction models of long-term cirrhosis and hepatocellular carcinoma risk in chronic hepatitis B patients: risk scores integrating host and virus profiles. Hepatology 2013, 58:546-554.
15. Liang X., Bi S., Yang W., Wang L., Cui G., Cui F., Zhang Y., Liu J., Gong X., Chen Y., Wang F., Zheng H., Wang F., Guo J., Jia Z., Ma J., Wang H., Luo H., Li L., Jin S., Hadler S.C., Wang Y. Epidemiological serosurvey of hepatitis B in China - declining HBV prevalence due to hepatitis B vaccination. Vaccine 2009, 27:6550-6557.
16. Lok A.S., McMahon B.J. Chronic hepatitis B: update 2009. Hepatology 2009, 50:661-662.
17. Lu F.M., Zhuang H. Management of hepatitis B in China. Chin. Med. J. 2009, 122:3-4.
18. Ma H., Yang R.F., Wei L. Quantitative serum HBsAg and HBeAg are strong predictors of sustained HBeAg seroconversion to pegylated interferon alfa-2b in HBeAg-positive patients. J. Gastroenterol. Hepatol. 2010, 25:1498-1506.
19. Martinot-Peignoux M., Lapalus M., Laouenan C., Lada O., Netto-Cardoso A.C., Boyer N., Ripault M.P., Carvalho-Filho R., Asselah T., Marcellin P. Prediction of disease reactivation in asymptomatic hepatitis B e antigen-negative chronic hepatitis B patients using baseline serum measurements of HBsAg and HBV-DNA. J. Clin. Virol.: Off. Pub. Pan Am. Soc. Clin. Virol. 2013, 58:401-407.
20. Matsubara N., Kusano O., Sugamata Y., Itoh T., Mizuii M., Tanaka J., Yoshizawa H. A novel hepatitis B virus surface antigen immunoassay as sensitive as hepatitis B virus nucleic acid testing in detecting early infection. Transfusion 2009, 49:585-595.
21. Mizuochi T., Mizusawa S., Nojima K., Okada Y., Yamaguchi K. Single amino acid substitution in the hepatitis B virus surface antigen (HBsAg) "a" determinant affects the detection sensitivity of an HBsAg diagnostic kit. Clin. Chim. Acta: Int. J. Clin. Chem. 2010, 411:605-606.
22. Otag F. False positive HBsAg result in blood donors due to administration of three different recombinant DNA Hepatitis B vaccines. Vaccine 2003, 21:3734-3737.
23. Rijckborst V., Hansen B.E., Ferenci P., Brunetto M.R., Tabak F., Cakaloglu Y., Lanza A.G., Messina V., Iannacone C., Massetto B., Regep L., Colombo M., Janssen H.L., Lampertico P. Validation of a stopping rule at week 12 using HBsAg and HBV DNA for HBeAg-negative patients treated with peginterferon alfa-2a. J. Hepatol. 2012, 56:1006-1011.
24. Seto W.K., Tanaka Y., Wong D.K., Shinkai N., Cheung K.S., Liu K.S., Fung J., Lai C.L., Yuen M.F. Longitudinal profiles of highly-sensitive hepatitis B surface antigen levels: re-evaluation of HBsAg seroclearance. Liver Int.: Off. J. Int. Assoc. Study Liver 2015, 10.1111/liv.12980.
25. Seto W.K., Wong D.K., Fung J., Huang F.Y., Lai C.L., Yuen M.F. Reduction of hepatitis B surface antigen levels and hepatitis B surface antigen seroclearance in chronic hepatitis B patients receiving 10 years of nucleoside analogue therapy. Hepatology 2013, 58:923-931.
26. Shinkai N., Matsuura K., Sugauchi F., Watanabe T., Murakami S., Iio E., Ogawa S., Nojiri S., Joh T., Tanaka Y. Application of a newly developed high-sensitivity HBsAg chemiluminescent enzyme immunoassay for hepatitis B patients with HBsAg seroclearance. J. Clin. Microbiol. 2013, 51:3484-3491.
27. Song G., Rao H., Feng B., Wei L. Prediction of spontaneous HBeAg seroconversion in HBeAg-positive chronic hepatitis B patients during the immune clearance phase. J. Med. Virol. 2014, 86:1838-1844.
28. Sonneveld M.J., Rijckborst V., Boucher C.A., Zwang L., Beersma M.F., Hansen B.E., Janssen H.L. A comparison of two assays for quantification of hepatitis B surface antigen in patients with chronic hepatitis B. J. Clin. Virol.: Off. Pub. Pan Am. Soc. Clin. Virol. 2011, 51:175-178.
29. Stramer S.L., Zou S., Notari E.P., Foster G.A., Krysztof D.E., Musavi F., Dodd R.Y. Blood donation screening for hepatitis B virus markers in the era of nucleic acid testing: are all tests of value?. Transfusion 2012, 52:440-446.
30. Togashi H., Hashimoto C., Yokozawa J., Suzuki A., Sugahara K., Saito T., Yamaguchi I., Badawi H., Kainuma N., Aoyama M., Ohya H., Akatsuka T., Tanaka Y., Mizokami M., Kawata S. What can be revealed by extending the sensitivity of HBsAg detection to below the present limit?. J. Hepatol. 2008, 49:17-24.
31. Tseng T.C., Kao J.H. Clinical utility of quantitative HBsAg in natural history and nucleos(t)ide analogue treatment of chronic hepatitis B: new trick of old dog. J. Gastroenterol. 2013, 48:13-21.
32. Tuaillon E., Mondain A.M., Nagot N., Ottomani L., Kania D., Nogue E., Rubbo P.A., Pageaux G.P., Van de Perre P., Ducos J. Comparison of serum HBsAg quantitation by four immunoassays, and relationships of HBsAg level with HBV replication and HBV genotypes. PLoS ONE 2012, 7:e32143.
33. Veselsky S.L., Walker T.Y., Fenlon N., Teo C.G., Murphy T.V. Discrepant hepatitis B surface antigen results in pregnant women screened to identify hepatitis B virus infection. J. Pediatr. 2014, 165:773-778.
34. Weber B., Van der Taelem-Brule N., Berger A., Simon F., Geudin M., Ritter J. Evaluation of a new automated assay for hepatitis B surface antigen (HBsAg) detection VIDAS HBsAg Ultra. J. Virol. Methods 2006, 135:109-117.
35. Yang R., Cong X., Xu Z., Xu D., Huang W., Maertens R., Wei L. INNO-LiPA HBV genotyping is highly consistent with direct sequencing and sensitive in detecting B/C mixed genotype infection in Chinese chronic hepatitis B patients and asymptomatic HBV carriers. Clin. Chim. Acta: Int. J. Clin. Chem. 2010, 411:1951-1956.
36. Zhang J.M., Xu Y., Wang X.Y., Yin Y.K., Wu X.H., Weng X.H., Lu M. Coexistence of hepatitis B surface antigen (HBsAg) and heterologous subtype-specific antibodies to HBsAg among patients with chronic hepatitis B virus infection. Clin. Infect. Dis.: Off. Pub. Infect. Dis. Soc. Am. 2007, 44:1161-1169.
37. Zoulim F., Carosi G., Greenbloom S., Mazur W., Nguyen T., Jeffers L., Brunetto M., Yu S., Llamoso C. Quantification of HBsAg in nucleos(t)ide-naive patients treated for chronic hepatitis B with entecavir with or without tenofovir in the BE-LOW study. J. Hepatol. 2015, 62:56-63.