Sherly Purnamawaty, Irda Handayani, Asvin Nurulita, Uleng Bahrun


Hepatitis B surface antigen (HBsAg) is the earliest and most important serological marker for the diagnosis of HBV infection. The availability of new methods with a high sensitivity to detect HBsAg results in the increase of false reactive results so that a confirmatory test is needed,but this will increase the total test cost. A reactive cut-off value for a confirmatory test is needed to make the use of this test more efficient. This study was a cross-sectional. All the specimens with HBsAg >0.17 Cut-Off Index (COI) were confirmed with HBsAg confirmatory test. HBsAg test used a sandwich ELFA method while HBsAg confirmatory test used an antibody neutralization method. Analysis of the ROC curve obtained HBsAg cut-off value that need confirmatory test. Total samples were 80 with 51 (63.8%) confirmed reactive and 29 (36.2%) non-reactive. There was a statistically significant difference between HBsAg that confirmed reactive (median 2.76 COI) and non-reactive (median 0.32 COI) (p<0.001). ROC curve showed an AUC of 0.805 which meant a good diagnostic performance for HBsAg test based on a confirmatory test. The specificity of 89.66% and sensitivity 64.71% were obtained from the cut-off 1.08 COI and considered the best cut-off. Some possible causes of false reactive results were Hepatitis B vaccine, G-CSF therapy and limitation of the HBsAg methods. HBsAg cut-off with ELFA method that need HBsAg confirmatory test was <1.08 COI. The researchers suggests further studies with different sampling methods so a better data distribution can be obtained.


HBsAg, HBsAg confirmatory test, reactive cut-off

Full Text:



World Health Organization. Hepatitis B. [cited on October 4, 2016]. Available from:

Dienstag JL. Acute viral hepatitis. In: Longo DL, Fauci AS (eds). Harrison’s gastroenterology and hepatology. New York, The McGraw-Hill Companies, 2010; 349-55.

Fletcher GJ, Gnanamony M, David J, Ismail AM, Subramani T, Abraham P. Do we need an ‘in-house’ neutralization assay for confirmation of hepatitis b surface antigen? answers from a tertiary care hospital in India. J Gastroenterol and Hepatol, 2009; 25: 942-5.

Shao H, Li Y, Xu WZ, Zhou X. Increased need for testing to confirm initial weakly reactive results for hepatitis b virus surface antigen. Labmedicine, 2012; 43(4): 15-17.

Thio C, Hawkins C. Hepatitis B virus and hepatitis delta virus. In: Mandell, Douglas and Bennett’s principles and practices of infectious diseases. Philadephia, Elsevier, 2015; 1815-39.

Song J, Kim D. Diagnosis of hepatitis B. Ann Transl Med, 2016; 4(18):338-44.

Kaul R. Theory and applications of ligand binding, ELISA and related techniques. in: The Immunoassay handbook. 4th Ed., Philadelphia, Elsevier, 2013; 901-11.

Vidas® HBsAg Ultra Confirmation Insert Kit. France, Biomerieux, 2012.

Vidas® HBsAg Insert Kit. France, Biomerieux, 2011.

Aytac O, Toyran A, Aksoy A. The significance and place of HBsAg neutralization test in the diagnosis and algorithm of hepatitis B infection. Mikrobiyol bul, 2017; 51(2): 136-144.

Latuconsina VZ, Handayani I, Nurulita A, Bahrun U. Penentuan rentang nilai gray zone untuk tes HBsAg dan implikasinya untuk tes konfirmasi. Makassar, Departemen Ilmu Patologi Klinik Fakultas Kedokteran Universitas Hasanuddin, 2016 (Unpublished).

Muljono D. Epidemilogy of hepatitis B and C in Republic of Indonesia. Euroasian Journal of Hepato-Gastroenterology, 2017; 7(1): 55-59.

Cornberg M, Wong V, Locarnini S, Brunetto M, Janssen H, Chan H. The role of quantitative hepatitis B surface antigen revisited. Journal of Hepatology, 2017; 66: 398-411.

Dufour DR. Hepatitis B Surface Antigen (HBsAg) Assay-are they good enough for their current uses?. Clin Chem, 2006; 52(8):1457-59.

Rysgard C, Moris C, Drees D, Bebber T, Davis S, et al. Positive hepatitis B surface antigen test due to recent vaccination: a persistent problem. BMC Clin Pathol, 2012; 12(15):1-6.

Chen D, Kaplan LA. Performance of a new-generation chemiluminescent assay for hepatitis B surface antigen. Clin Chem, 2006; 52(8):1592-98.

Bigham M, Ponnampalam A. Neutralization positive but apparent false positive hepatitis B surface antigen in blood donor following influenza vaccination. Tranfus Apher Sci, 2015; 50(1): 92-4.



  • There are currently no refbacks.

Creative Commons License
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.