|Year : 2016 | Volume
| Issue : 4 | Page : 209-214
Evaluation of seroprevalence of Hepatitis B virus infection among patients attending a hospital of semi-urban North India using rapid immunoassay test
Razia Khatoon1, Noor Jahan2
1 Department of Microbiology, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, Uttar Pradesh, India
2 Department of Microbiology, Integral Institute of Medical Sciences and Research, Integral University, Lucknow, Uttar Pradesh, India
|Date of Web Publication||20-Dec-2016|
Department of Microbiology, Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
Background: Viral hepatitis is a serious public health problem with hepatitis B virus (HBV) being one of its principle causes affecting billions of people globally. The laboratory diagnosis of HBV infection is made by detection of hepatitis B surface antigen (HBsAg) in serum.
Objective: The present study was done to evaluate the seroprevalence of hepatitis B infection among patients attending a hospital at a semi-urban North India using rapid immunoassay test kit.
Materials and Methods: A total of 1537 patients were included in the study whose venous blood samples were collected, and serum was tested for the presence of HBsAg using a rapid one-step immunoassay test kit.
Results: Out of 1537 patients whose blood samples were tested, 61 were found to be reactive to HBsAg giving the prevalence to be 3.9%, with 49 males and 12 females. Out of 61 reactive patient's majority belonged to inpatient (82.0%) as compared to outpatient department (18.0%). The majority of the reactive patients belonged to age group 28-37 years (37.7%), belonged to rural areas (86.9%), were illiterate (67.2%), were skilled workers (63.9%) and belonged to socioeconomic Class 4 (50.8%). Among the reactive patients, the most frequent suspected risk factor for hepatitis B infection was found to be visiting a community barber (19.7%).
Conclusion: HBV infection is a dreadful disease, and its accurate and timely diagnosis using rapid immunoassay test kit is useful as it gives an indication about its seroprevalence in a given geographical area even with limited resources.
Keywords: Hepatitis B surface antigen, rapid immunoassay kit, risk factors, seroprevalence
|How to cite this article:|
Khatoon R, Jahan N. Evaluation of seroprevalence of Hepatitis B virus infection among patients attending a hospital of semi-urban North India using rapid immunoassay test. Niger Postgrad Med J 2016;23:209-14
|How to cite this URL:|
Khatoon R, Jahan N. Evaluation of seroprevalence of Hepatitis B virus infection among patients attending a hospital of semi-urban North India using rapid immunoassay test. Niger Postgrad Med J [serial online] 2016 [cited 2019 Nov 15];23:209-14. Available from: http://www.npmj.org/text.asp?2016/23/4/209/196263
| Introduction|| |
Viral hepatitis is a significant public health problem affecting billions of people globally.  Hepatitis B virus (HBV) is one of the principle causes of severe liver disease, including 70% cases of chronic hepatitis, 80% cases of hepatocellular carcinoma and 80% cases of cirrhosis-related end-stage liver disease. It has been estimated that about 2 billion people worldwide have serological evidence of current or past HBV infection and approximately 350 million people are chronically infected with this virus. 
HBV is highly infectious and transmitted mainly through blood, body fluid contact and vertical transmission. It is the prototype member of the Hepadnaviridae (hepatotropic DNA virus) family and has a strong predilection for infecting liver cells. HBV virions are double-shelled particles, 40-42 nm in diameter, with an outer lipoprotein envelope that contains envelope glycoproteins (or surface antigens). The most abundant protein on the virion surface is the 24 kDa hepatitis B surface antigen (HBsAg) or S protein. The virus causes 60%-80% of all primary liver cancers, which is one of the top three causes of cancer deaths in the East and Southeast Asia Region, the Pacific Basin and Sub-Saharan Africa. ,,,
The diagnosis of HBV infection is based on clinical symptoms coupled with laboratory findings of serological markers. HBsAg acts as a hallmark of HBV infection as it is the first serological marker to appear in acute HBV infection and its persistence for more than 6 months suggest chronic HBV infection or development of a carrier state. ,
The prevalence of HBV infection varies from 0.1% to 20% in different countries. In areas of high endemicity, most people are infected early in life, and the prevalence of HBsAg carriage varies from 8% to 20%, whereas, in areas of low endemicity with the prevalence of HBsAg carriage varying from 0.1% to 2%, only a minority of people come in contact with the virus, usually as result of horizontal transmission among young adults. ,
India has intermediate endemicity (HBsAg carrier rate between 2% and 7%) with a burden of 40 million HBsAg carriers and deaths of around 1,000,000 people each year due to HBV infection-related illnesses.  Moreover, HBV is a silent killer causing liver disease with many carriers not realising that they are infected with the virus.  Currently, antiviral drugs are available for HBV-infected individuals that may prevent the critical consequences of chronic liver disease, this emphasises the significance of timely identification of infected individuals and monitoring the prevalence of the disease. ,
Keeping the above facts in mind the present study was undertaken with the aim to evaluate the seroprevalence of hepatitis B infection in the patients attending a hospital of semi-urban North India using the rapid and cost-effective immunochromatographic test and also to determine the risk factors of HBV infection in the study population.
| Materials and Methods|| |
A hospital-based cross-sectional study was done over a period of 6 months from August 2015 to January 2016 on patients attending a teaching hospital of Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, Uttar Pradesh, India, to determine the seroprevalence of HBV infection and its association with various risk factors among these patients. A pre-designed questionnaire was used to extract the information regarding the demography, socioeconomic status and risk factors for hepatitis B infection. Socioeconomic status was calculated using the modified BG Prasad's Classification for 2014. Informed consent was taken from all patients.
The study was approved by Institutional Ethical Committee of Hind Institute of Medical Sciences, Mau, Ataria, Sitapur, Uttar Pradesh, India before commencing the study. The inclusion criteria of the study was to include patients of all age groups and both sexes coming with complaints of fever along with nausea, vomiting, joint pain, loss of appetite, jaundice and pain in abdomen, registered at the outpatient department (OPD) or were admitted to the wards of this hospital and advised to undergo hepatitis B screening. Patients whose blood sample was not requested for screening for HBsAg and those who refused to give consent were excluded from the study. A total of 1537 patients were included in the study whose blood samples were taken for testing HBsAg.
Under aseptic precautions from each patient 3 ml of venous blood was withdrawn in a labelled plain vacutainer tube. The blood was allowed to clot followed by centrifugation of the tube at 3000 rpm for 15 min to separate serum. Then, according to manufacturer's instruction two drops (70 μL) serum was tested for the presence of HBsAg using a rapid one-step immunoassay test kit HEPACARD (J. Mitra and Company Private Limited., India) based on antigen capture or sandwich principle and results were interpreted at 20 min. The appearance of pink coloured line, one each in the test "T" region and control "C" region indicated that the sample was reactive for HBsAg, whereas, appearance of only control "C" region denoted that the sample was non-reactive to HBsAg.
The collected data were transferred to a computer. The statistical package for social sciences (SPSS) data editor software version IBM SPSS-20, Inc., USA, was used for analysis of the data. Chi-square test was performed and P ≤ 0.05 was considered statistically significant. To measure the strength of association between each risk factor and hepatitis B infection odds ratio (OR) with 95% confidence interval was calculated.
| Results|| |
A total of 1537 patients were included in our study, with 987 (64.2%) males and 550 (35.8%) females. The mean age of the patients was 37.5 ± 13.8 years which ranged from 18 to 72 years. 61.1% of patients belonged to inpatient department (IPD), and 38.9% patients belonged to OPD. Out of 1537 patients, 72.5% were married and 27.5% patients were unmarried. Most of the patients were from rural areas (55.1%) as compared to patients from urban areas (44.9%). Majority of the patients belonged to social Class 3 (31.6%), followed by Class 4 (23.4%) and Class 5 (22.1%). The majority of the patients were illiterate (34.8%) followed by education up to primary school (29.5%). Majority (58.2%, 895 out of 1537) of the patients were skilled workers with 76.5% males and 23.5% females. The majority (61.8%, 340 out of 550) of female patients were homemaker. The sociodemographic profile of the patients included in our study and their relation to HBsAg reactivity is shown in [Table 1] and [Table 2].
|Table 1: Age, gender, marital status and residential distribution of patients and their relation with hepatitis B infection (n=1537) |
Click here to view
|Table 2: Educational, socioeconomic and employment status of patients and their relation with hepatitis B infection (n=1537) |
Click here to view
The prevalence of HBsAg among patients under study was found to be 3.9% (61 out of 1537). Out of 61 positive cases of HBsAg, 49 (80.3%) were males and 12 (19.7%) were females. This difference was found to be statistically significant (P = 0.007). Majority of the HBsAg reactive patients belonged to age group 28-37 years (37.7%), followed by 38-47 years (29.5%) and this was also found to be statistically significant (P = 0.012). Out of 61 HBsAg reactive patients 49 (80.3%) were married and 12 (19.7%) patients were unmarried, but this difference was not found to be statistically significant (P = 0.161). Majority of the HBsAg reactive patients belonged to rural areas (86.9%), were illiterate (67.2%) and were skilled workers (63.9%) by profession. Out of 61 HBsAg reactive patients, majority belonged to socioeconomic Class 4 (50.8%), followed by Class 3 (34.4%). All these findings were found to be statistically significant (P = 0.000). [Table 3] shows that majority of HBsAg reactive patients belonged to IPD (82.0%) as compared to OPD (18.0%). This difference was found to be statistically significant (P = 0.001). [Table 4] shows that among the reactive inpatients, majority were found to be admitted to orthopaedic ward (30.0%), followed by general medicine (28.0%) and general surgery ward (24.0%). However, this difference was not found to be statistically significant (P = 0.996). As shown in [Table 5], when the association of various risk factors of hepatitis B infection after calculation of OR was estimated among the 1537 patients included in our study, and it was found that risk factors such as injecting drug abuse (P = 0.000, OR = 84.98), dental procedure (P = 0.001, OR = 3.92), visiting a community barber (P = 0.000, OR = 3.96), multiple sexual partners (P = 0.000, OR = 43.83) and tattooing (P = 0.003, OR = 2.85) were found to be statistically significantly associated with HBsAg reactivity, whereas, risk factors such as blood transfusion (P = 0.406, OR = 0.713), previous surgery (P = 0.704, OR = 0.869) and previous hospitalisation (although P = 0.000, but OR = 0.046) did not show statistically significant association with HBsAg reactivity. Among the reactive patients, the most frequent risk factor for hepatitis B infection was found to be visiting a community barber (19.7%) followed by tattooing (16.4%) and injecting drug abuse (14.8%).
|Table 3: Distribution of the patients according to their registration at the hospital and their relation with hepatitis B infection (n=1537) |
Click here to view
|Table 4: Distribution of inpatients admitted in various wards and their relation with hepatitis B infection (n=939) |
Click here to view
|Table 5: Association of various risk factors of hepatitis B infection among patients under study (n=1537) |
Click here to view
| Discussion|| |
HBV infection is one of the most common viral infections known to humanity. Nearly, 350-400 million people suffer from this infection globally with 1 million deaths per year due to complications of this infection.  Prevalence of hepatitis B varies from country to country and depends on a complex interplay of behavioural, environmental and host factors. In general, it is lowest in countries with high standards of living (such as Australia, North America and North Europe) and highest in countries where socioeconomic level is lower (such as China, South East Asia, South America). 
India lies in intermediate zones of prevalence rates as set by the World Health Organization. There is a wide variation in HBsAg prevalence in different geographical regions in India. The overall rate of seropositivity for HBsAg varies from 2% to 4.7% with the highest prevalence recorded in natives of Andamans and Arunachal Pradesh. ,
The prevalence of HBsAg in our study was found to be 3.9%, with 80.3% males and 19.7% females. This finding of higher prevalence of HBsAg among males as compared to females is supported by various earlier done studies. ,,,, The possible reason for this higher male preponderance could be from a higher exposure of males to risk factors such as illicit drug use and multiple sexual partners due to their employment away from their homes. In addition as majority of the female patients were homemakers, they may have less exposure to various risk factors. In addition, it has been reported that females tend to clear HBsAg from their plasma more efficiently as compared to males. ,
In this study, the seroprevalence of HBsAg was highest among age groups 28-37 years (37.7%), followed by 38-47 years (29.5%) and as the age advanced the prevalence decreased being 13.1% among 48-57 years and 1.6% among 58-67 years age group. This finding is supported by a prior study.  The higher prevalence among 21-40 years age group could be due to higher exposure to occupational risk factors as well as high risky behaviour among young individuals. 
Our findings show that the prevalence of HBsAg was found to be higher in married patients as compared to unmarried patients. In another study, the prevalence of HBsAg was more in unmarried participants attributed to their high-risk behaviour of multiple sexual partners and injecting drug use.  This is in contrast to our finding. We show the prevalence of HBsAg was found to be higher among people from rural areas as compared to those coming from urban areas. This is supported by another study which also showed higher seroprevalence of HBsAg among rural populations. 
The reason behind this higher prevalence could be that the rural poor populations are still dependent on the untrained paramedics who often tend to use improperly sterilised syringes, needles and minor surgical instruments for their treatment. 
We discovered that most of the reactive patients belonged to socioeconomic Class 4 and were illiterate. This finding is supported by another study which also showed high prevalence among illiterates.  We also found that the majority of seropositives were skilled workers occupationally. This is supported by another study which also showed higher prevalence among skilled workers as they often engage unqualified medical practitioners for their treatment and most of them have got their body tattooed which itself is a major risk factor for hepatitis B infection.
In this study, regarding the various potential risk factors for hepatitis B infection, it was found that visiting a community barber, which might result in sharing of razors, was associated with seropositivity, followed by tattooing, injecting drug abuse, dental procedure and multiple sexual partners. This is similar to another study which also showed high association of tattooing and dental procedure done by unqualified medical practitioners using unsterilised instruments, injecting drug use and multiple sexual partners among seropositive cases as compared to seronegative cases. 
A history of previous blood transfusion, previous hospitalisation and previous surgery were not found to be significantly associated with hepatitis B infection in our patient pool. This is supported by earlier done studies which also showed that history of blood transfusion and previous surgery was not significantly associated with HBsAg seropositivity. This could be because of optimum HBsAg screening before blood transfusion and strict aseptic precautions being taken during surgical procedures and good patient care being provided during the previous hospitalisation. ,
| Conclusion|| |
The HBV is a silent disease and spreads with even minute traces of infected blood; therefore, accurate and rapid diagnosis of even asymptomatic individuals should be properly done using rapid immunoassay tests. In resource-poor health facilities, these rapid immunoassay kits may be the only way to diagnose this dreadful disease. Furthermore, there should be active governmental educational and media campaign about the risk factors of HBV infection, its routes of transmission and methods of prevention by improving screening facilities of blood and blood products before transfusion and controlling infection by giving proper immunisation of hepatitis B vaccine to the general population and particularly to high-risk groups. A continuous surveillance would further provide better insight of this infection in our geographical area and also the impact of preventive measures in the population at risk.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Baha W, Foullous A, Dersi N, They-they TP, El alaoui K, Nourichafi N, et al.
Prevalence and risk factors of hepatitis B and C virus infections among the general population and blood donors in Morocco. BMC Public Health 2013;13:50.
Kanodia V, Yadav M, Bittu R, Maheshwari RK, Singh SK. Seroprevalence of hepatitis B surface antigen in hospital based population of Jaipur, Rajasthan. MedPulse Int Med J 2015;2:123-5.
Lok AS, McMahon BJ. Chronic hepatitis B. Hepatology 2007;45:507-39.
Rukadikar A, Agarwal SG, Jain S, Teja V. Seropositivity of hepatitis B surface antigen in tertiary care hospital, central India. Int J Curr Microbiol Appl Sci 2015;4:714-7.
Ganem D, Prince AM. Hepatitis B virus infection - Natural history and clinical consequences. N Engl J Med 2004;350:1118-29.
WHO. Life in the 21 st
century, a vision for all. Geneva: WHO; 1998.
Kao JH. Diagnosis of hepatitis B virus infection through serological and virological markers. Expert Rev Gastroenterol Hepatol 2008;2:553-62.
Naqshbandi I, Qadri SY, Yasmeen N, Bashir N. Seroprevalence and risk factors of hepatitis B virus infection among general population of Srinagar Kashmir. Int J Contem Med Res 2016;3:1050-4.
Lavanchy D. Public health measures in the control of viral hepatitis: A World Health Organization perspective for the next millennium. J Gastroenterol Hepatol 2002;17:452-9.
Samuel D, Muller R, Alexander G. Educational research, national hepatitis B virus programme. Infect Dis 2004;234:221-32.
Weinbaum CM, Mast EE, Ward JW. Recommendations for identification and public health management of persons with chronic hepatitis B virus infection. Hepatology 2009;49 5 Suppl:S35-44.
Janahi EM. Prevalence and risk factors of hepatitis B virus infection in Bahrain, 2000 through 2010. PLoS One 2014;9:e87599.
Dienstag JL, Isselbacher KJ. Acute viral hepatitis. In: Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, Kasper DL, et al.
, editors. Harrisons Principles of Internal Medicine. New York: McGraw Hill; 1998. p. 1677-92.
Mittal G, Gupta P, Gupta R, Ahuja V, Mittal M, Dhar M. Seroprevalence and risk factors of hepatitis B and hepatitis C virus infections in uttarakhand, India. J Clin Exp Hepatol 2013;3:296-300.
Chowdhury A. Epidemiology of hepatitis B virus infection in India. Hepat B Annu 2004;1:17-24.
Dutta S, Shivananda PG, Chatterjee A. Prevalence of hepatitis B surface antigen and antibody among hospital admitted patients in Manipal. Indian J Public Health 1994;38:108-12.
Vazhavandal G, Ganesh Bharadwaj BV, Uma A, Chitra Rajalakshmi PC. Seroprevalence of hepatitis B virus among patients at a rural tertiary health care centre in South India; a four year study. Int J Res Med Sci 2014;2:310-3.
Thursz MR. Host genetic factors influencing the outcome of hepatitis. J Viral Hepat 1997;4:215-20.
Chu CJ, Hussain M, Lok AS. Hepatitis B virus genotype B is associated with earlier HBeAg seroconversion compared with hepatitis B virus genotype C. Gastroenterology 2002;122:1756-62.
Ghadir MR, Belbasi M, Heidari A, Jandagh M, Ahmadi I, Habibinejad H, et al.
Distribution and risk factors of hepatitis B virus infection in the general population of central Iran. Hepat Mon 2012;12:112-7.
[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]