| Abstract|| |
Background and Objectives: Hepatitis C virus (HCV) is an important cause of blood-borne viral hepatitis throughout the world. Acute infection is usually silent and detected on the basis of raised liver enzymes and antihepatitis C antibody in patient's serum. Chronic infection may lead to hepatocellular carcinoma and liver cirrhosis. The present study was done to evaluate the seroprevalence of anti-HCV antibodies among patients using rapid qualitative in vitro diagnostic test. Materials and Methods: A total of 1,076 patients' blood samples were taken for testing antiHCV antibodies using rapid in vitro diagnostic test kit. Results: Out of 1,076 patients whose sera were tested, 18 were found to be reactive to antihepatitic C virus antibody giving the prevalence to be 1.7%. Out of 18 reactive patients majority belonged to inpatient department (88.9%) as compared with outpatient department (11.1%). Majority of the reactive patients belonged to age group 26-35 years (72.2%), were from rural areas (83.3%), were illiterate (77.7%), were skilled workers (66.7%), and belonged to socioeconomic class 3 (55.5%). Among the reactive patients, the most frequent risk factor for antihepatitis C antibody was found to be history of injecting drug abuse and tattooing and body piercing (22.2% each). Conclusion: Hepatitis C infection is usually a silent disease and therefore stringent screening for antihepatitis C antibody should be done in all patients using rapid in vitro diagnostic kits in order to timely diagnose the infection and initiation of treatment, thereby, preventing its adverse sequelae and also its spread to other patients.
Keywords: Antihepatitic C virus antibody, rapid diagnostic kit, risk factors, seroprevalence
|How to cite this article:|
Khatoon R, Jahan N. Assessment of seroprevalence of hepatitis C virus-specific antibodies among patients attending hospital of semi-urban North India using rapid qualitative in vitro diagnostic test. Ann Trop Med Public Health 2017;10:199-204
|How to cite this URL:|
Khatoon R, Jahan N. Assessment of seroprevalence of hepatitis C virus-specific antibodies among patients attending hospital of semi-urban North India using rapid qualitative in vitro diagnostic test. Ann Trop Med Public Health [serial online] 2017 [cited 2020 Aug 9];10:199-204. Available from: http://www.atmph.org/text.asp?2017/10/1/199/205586
| Introduction|| |
Hepatitis C virus (HCV), a small, enveloped, positive-stranded RNA virus belonging to genus Hepacivirus and family Flaviviridae, is one of the principle causative agents of blood-borne hepatitis. HCV causes both acute and chronic infection. The presence of anti-HCV antibody indicates previous exposure to HCV. This antibody is present in more than 95% of chronic infections, but in only 40% of acute infections. Acute infection is usually clinically silent, revealed only accidentally by abnormal liver function tests and /or anti-HCV antibody positivity, and is only very rarely associated with life-threatening disease. Spontaneous clearance of acute HCV infection occurs within 6 months of infection in 15-45% of infected individuals in the absence of treatment. Almost all the remaining 55-85% of persons harbour HCV for the rest of their lives (if not treated) and are considered to have chronic HCV infection. Left untreated, chronic HCV infection can cause hepatocellular carcinoma (HCC), liver cirrhosis, and liver failure., HCV-associated liver disease progression tends to be accelerated in patients who are elderly, alcoholics, and coinfected with human immunodeficiency virus.
Those at risk of acquiring HCV infection include recipients of unscreened infected blood or blood products, renal dialysis, reuse of syringes, catheters, needles, people who inject drugs using contaminated injections, people who have used intranasal drugs (cocaine etc) or undergone cosmetic procedures (such as tattooing, body piercing, dental procedures), and infants born to HCV-infected mothers. Sexual partners of HCV-infected people may become infected, although the risk is very low in heterosexual couples; however, the risk increases in those men who have coinfection with human immunodeficiency virus and have sex with other men.,,,
According to recent estimates, more than 185 million people around the world have been infected with HCV, of whom 350,000 die each year. The prevalence of HCV infection was found to vary substantially around the world ranging from 1.2% to 3.8%, with highest prevalence found in Central and East Asia (3.8%) and lowest prevalence was found in Tropical Latin America (1.2%).
A specific serologic diagnosis of hepatitis C infection can be made by demonstrating the presence of antibodies to HCV in serum of patients, which develop as part of acute infection and persist throughout life in chronic infection. Thus, HCV testing not only helps to increase the number of persons diagnosed with HCV, but it also improves the understanding of distribution of HCV infection in the general population of that geographical area. This helps in initiation of treatment of chronic HCV infection at the earliest, which has dual benefits, first is preventive benefit, as persons who are cured of HCV cannot transmit the virus to others, second, therapy reduces the risk of development of HCC among persons at all stages of fibrosis by >75%., This may ultimately help in reducing the burden of the disease to a significant extent.
Keeping in view the above facts, the present study was done to evaluate the seroprevalence of antibodies to HCV and the associated risk factors for hepatitis C infection among patients attending a hospital of semiurban area of North India using rapid qualitative in vitro diagnostic test kits.
| Materials and Methods|| |
A hospital-based cross-sectional study was done over a period of 4 months from November 2015 to February 2016 on patients admitted in various wards or attending outpatient department (OPD) of a hospital in a semiurban area of North India to determine the seroprevalence of HCV-specific antibodies and the association of hepatitis C infection with various risk factors among these patients. A predesigned questionnaire was used to extract the information regarding the demography, socioeconomic status, and risk factors for hepatitis C infection. Socioeconomic status was calculated using the Modified BG Prasad's Classification for 2014. An informed consent was taken from all patients.
Patients of all age group and both sexes who were registered at the OPDs or admitted in various wards (inpatient departments or IPDs) of this hospital and were advised to undergo anti-HCV antibody screening either as part of routine preoperative screening or for diagnostic purposes were included in the study.
Patients whose blood sample was not requested for screening for antihepatitis C antibody and those who refused to give consent were excluded from the study.
A total of 1,076 patients whose blood samples were taken for testing anti-HCV antibodies were included in the present study.
The anti-HCV antibodies in patient's serum was detected using rapid qualitative in vitro diagnostic 4th generation HCV TRI-DOT test kits (J. Mitra and Company Pvt. Ltd., India). The test device is composed of immunofiltration membrane. The kit is designed with a unique combination of modified HCV antigens from core (structural) and three nonstructural (NS) regions of the virus (NS3, NS4, and NS5) in the form of two test dots “T1” and “T2” to selectively identify anti-HCV antibodies in human serum or plasma with high degree of sensitivity and specificity. Under aseptic precautions from each patient around 5 mL of venous blood was withdrawn in a well-labelled plain vaccutainer 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 three drops of buffer solution was added to the center of the test device, followed by addition of one drop (50 µL) serum using separate sample dropper for each patient's sample. Then five drops of buffer solution was added, followed by addition of two drops of protein-A conjugate and finally five drops of buffer solution was added. The results were read immediately. In a reactive sample, pinkish purple dot against a white background appears at the test region (“T1” and /or “T2”) in addition to control “C” region, whereas in a nonreactive sample pinkish purple dot appears only at control “C” region.
The collected data were transferred to a computer. The SPSS Data Editor Software version 20 was used for analysis of the data. Chi-square test was performed and P value ≤ 0.05 were considered statistically significant. To measure the strength of association between each risk factor and HCV infection, odds ratio (OR) with 95% confidence interval was calculated.
| Results|| |
A total of 1,076 patients were included in our study, of which 65.1% patients belonged to IPD and 34.9% patients belonged to OPD [Table 1]. The prevalence of anti-HCV antibodies depicting HCV infection among patients under study was found to be 1.7% (18 out of 1,076). Majority of anti-HCV antibody reactive patients belonged to IPD (88.9%) as compared to OPD (11.1%) and this difference was found to be statistically significant (P = 0.033). Among the indoor reactive patients, majority were found to be admitted in general medicine ward (37.5%), followed by orthopedic ward (31.2%) and general surgery ward (18.7%) as shown in [Table 2]. However, this difference was not found to be statistically significant (P = 0.810).
|Table 1: Distribution of the patients according to their registration at the hospital and their relation with hepatitis C infection (N = 1076)|
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|Table 2: Distribution of Inpatients and their relation with Hepatitis C infection (N = 701).|
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The socio-demographic profile of the patients included in our study and their relation to anti-HCV antibodies reactivity is shown in [Table 3]. Out of 1,076 patients, 72.7% were males and 27.3% were females. The mean age of patients was 35.6 ( ± 10.3) years which ranged from 16 to 65 years. Majority (68.5%) of the patients were married and only 31.5% patients were unmarried. Most of the patients were from rural areas (60.8%) as compared with patients from urban areas (39.2%). Majority of the patients belonged to social class 4 (37.4%), followed by class 5 (25.3%) and class 3 (20.0%). Most of the patients were illiterate (40.5%), followed by education up to primary school (22.5%). Majority of the male patients (80.8%) were skilled workers, whereas most of the female patients (63.3%) were housewife.
|Table 3: Sociodemographic characteristics of patients and their relation with hepatitis C infection (N = 1076)|
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As shown in [Table 3], out of 18 positive cases of anti-HCV antibodies, 17 (94.4%) were males and only 1 (5.6%) patient was female. This difference was found to be statistically significant (P = 0.037). Most of the anti-HCV antibody reactive patients belonged to age group 26-35 years (72.2%), followed by 36-45 years (16.7%) and this was also found to be statistically significant (P = 0.014). Out of 18 anti-HCV antibody reactive patients, 14 (77.8%) were married and 4 (22.2%) patients were unmarried, but this difference was not found to be statistically significant (P = 0.393). Majority of the anti-HCV antibody reactive patients belonged to rural areas (83.3%) were illiterate (77.7%) and skilled workers (66.7%) by profession. These findings were also found to be statistically significant (P = 0.048, P = 0.014, and P = 0.022, respectively). Also, majority of the reactive patients belonged to socioeconomic class 3 (55.5%), followed by class 4 (22.2%), which was found to be statistically significant (P = 0.005).
Among the reactive patients, the most frequent risk factors for hepatitis C infection were found to be injecting drug abuse and history of tattooing and body piercing (22.2% each), followed by history of haemodialysis and sexual promiscuity (16.7% each). As shown in [Table 4], the strength of association of various risk factors of HCV infection was estimated by using OR with 95% confidence interval, and it was found that the risk factors, such as injecting drug abuse (P < 0.001, OR = 29.943), history of hemodialysis (P = 0.020, OR = 4.032), tattooing, and body piercing (P = 0.046, OR = 3.000), history of sharing razors (P = 0.031, OR = 4.598) and sexual promiscuity (P = 0.039, OR = 3.512) were found to have significant association with anti-HCV antibody reactivity, whereas risk factors, such as history of blood transfusion (OR = 0.177) and previous surgery (OR = 0.053) did not show any significant association with anti-HCV antibody reactivity.
|Table 4: Association of various risk factors of hepatitis C virus infection and reactivity of anti-HCV antibodies among patients under study (N = 1076)|
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| Discussion|| |
HCV is an important cause of viral hepatitis throughout the world. World Health Organization estimates that in India, there are around 10-24 million HCV-infected persons with its seroprevalence in apparently healthy people ranging from 1.5% to 4.0% and that in suspected acute hepatitis patients ranging from 3% to 12%.,,
In our study, the prevalence of HCV specific antibodies among patients was found to be 1.7%. This finding is comparable with another study done in Kolkata which showed the prevalence of HCV infection among patients to be 1.5%, whereas another study done in Delhi showed prevalence of HCV infection to be 5.5%.,
In our study, majority of anti-HCV antibody reactive patients belonged to IPD (88.9%) as compared with OPD (11.1%) and this difference was found to be statistically significant. Also, in the present study, the prevalence of anti-HCV antibody was found to be more in males (94.4%) as compared with females (5.6%), which is comparable to another study showing higher prevalence of HCV in male patients (71.6%) as compared with female patients (28.4%). In our study, maximum seropositivity was found in age group of 26-35 years (72.2%), followed by 36-45 years (16.7%). This is in agreement to the finding of another study that has reported maximum seroprevalence (46.6%) of anti-HCV antibodies in the age group of 30-40 years. The high prevalence rate seen in young adults (15-40 years) may be due to cumulative risk of exposure to various HCV risk factors in these age groups.
In the present study, majority of the seropositive patients belonged to rural areas (83.3%) were illiterate (77.7%), skilled workers (66.7%) by profession, and belonged to socioeconomic class 3 (55.5%). These findings are comparable with another study done in Yemen, which also reported highest seroprevalence of HCV antibodies among 14 illiterate subjects (0.59%) and those with poor socioeconomic condition belonging to rural areas.
Among the various risk factors for HCV infection, blood transfusions and unsafe therapeutic injections used to be the predominant modalities of HCV transmission in India. However, after HCV screening of blood and blood products was made mandatory in India, injectible drug use (IDU) is gradually becoming the major route of HCV infection. Also, in our study, 16.7% seropositive patients gave history of hemodialysis. Patients on hemodialysis are at an increased risk for acquiring hepatitis C infection as a result of cross-contamination from the dialysis circuits. Various Indian studies have reported HCV seropositivity in IDUs to be in the range of 20-90%. This is the reason behind the detection of statistically insignificant seropositive patients having history of blood transfusion and quite high prevalence (22.2%) of seropositive patients giving history of injectible drug abuse as seen in the present study. The reason for such high prevalence of HCV infections in IDUs could be due to presence of high-risk behaviors in IDUs, such as needle sharing, unsafe disposal of needles as well as unsafe sex with limited condom use.
Some people acquire HCV infection through sexual transmission and tattooing could be an added risk factor., In our study, 22.2% seropositive patients had history of tattooing and body piercing and 16.7% seropositive patients gave history of sexual promiscuity.
| Conclusion|| |
Since hepatitis C infection mostly remains silent due to its asymptomatic nature, the infected persons remain unaware of their clinical status and may unknowingly transmit the disease to others. Hepatitis C infection can be easily diagnosed by detection of HCV antibodies in patient's sera using rapid qualitative in vitro diagnostic test kit even in health-care facilities with limited resources. Therefore, it is recommended that stringent screening for anti-HCV antibodies should be done in all patients seeking medical advice in order to find out all those who are infected with HCV and therefore initiating the treatment of chronic cases at the earliest, thereby preventing the disease transmission and progression to end-stage liver disease. As there is no vaccine available for HCV, the prevention of HCV infection can be achieved by proper blood screening for HCV before donation, avoiding sharing needles or any injecting equipment and following safe sexual practices. Also, it is suggested that there should be active governmental educational and media campaign to increase the public awareness about the risk factors of HCV infection, its routes of transmission, and methods of prevention among the general population covering even the less literate people and high risk groups, thereby reducing the disease burden. A continuous surveillance would further provide a better insight of this silent disease in a particular geographical area and also in understanding the impact of preventive measures in the population at risk.
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Conflicts of interest
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Dr. Razia Khatoon
Department of Microbiology, Hind Institute of Medical Sciences, Sitapur, Uttar Pradesh
Source of Support: None, Conflict of Interest: None
[Table 1], [Table 2], [Table 3], [Table 4]