|Year : 2016 | Volume
| Issue : 1 | Page : 3-8
Special article on viral hepatitis 2015
Ranjani Shamsundar1, KL Sarada Devi2, Sara Chandy3, Reena John4, KA Sathiavathy5, J Lancy6, Anitha Madhavan7, Kavita Raja8, KV Susheela9, Shoba Kurian10, Lathi Nair11, Sheena Joe12, J Sudarsana13
1 Department of Microbiology, St. John's Medical College, Bengaluru, Karnataka, India
2 Department of Microbiology, Government Medical College, Kozhikode, Kerala, India
3 Department of Microbiology, Pushpagir Institute of Medical Sciences and Research Centre, Thiruvalla, Kerala, India
4 Department of Microbiology, Government Medical College, Thrissur, Kerala, India
5 Department of Microbiology, Jubilee Mission Hospital and Research Institute, Thrissur, Kerala, India
6 Department of Microbiology, Government Medical College, Thiruvananthapuram, Kerala, India
7 Department of Microbiology, Government T D Medical College, Alapuzha, Kerala, India
8 Department of Microbiology, SCTIMST, Thiruvananthapuram, Kerala, India
9 Department of Microbiology, Amala Institute of Medical Sciences, Thrissur, Kerala, India
10 Department of Microbiology, Government Medical College, Kottayam, Kerala, India
11 Department of Microbiology, KMCT Medical College, Kozhikode, Kerala, India
12 Department of Microbiology, Believers Church Medical College Hospital, Thiruvalla, Kerala, India
13 Department of Microbiology, Baby Memorial Hospital, Kozhikode, Kerala, India
|Date of Web Publication||28-Jun-2016|
Department of Microbiology, St. John's Medical College, Bengaluru, Karnataka
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Shamsundar R, Sarada Devi K L, Chandy S, John R, Sathiavathy K A, Lancy J, Madhavan A, Raja K, Susheela K V, Kurian S, Nair L, Joe S, Sudarsana J. Special article on viral hepatitis 2015. J Acad Clin Microbiol 2016;18:3-8
|How to cite this URL:|
Shamsundar R, Sarada Devi K L, Chandy S, John R, Sathiavathy K A, Lancy J, Madhavan A, Raja K, Susheela K V, Kurian S, Nair L, Joe S, Sudarsana J. Special article on viral hepatitis 2015. J Acad Clin Microbiol [serial online] 2016 [cited 2020 Feb 18];18:3-8. Available from: http://www.jacmjournal.org/text.asp?2016/18/1/3/184762
| Introduction|| |
Viral hepatitis caused by hepatitis viruses A through E remains a major public health problem in India. Hepatitis viruses B and C (HBV and HCV) have the potential to cause persistent infection in a subset of those infected, which may progress to cirrhosis or hepatocellular carcinoma. Hepatitis viruses A and E (HAV and HEV) are important causes of acute viral hepatitis and acute liver failure in India and have led to several outbreaks.
Diagnosis of HBV and HCV infections is a key tool to identify acute and chronic cases of infection to determine the severity of the disease, to define preventive measures and to initiate antiviral treatment. It is vital in monitoring the response to therapeutic interventions in HCV infection.
Detection of HBV and HCV infections and diagnosis is mainly based on immunological assays among which enzyme-linked immunosorbent assay (ELISA) and rapid tests are the most commonly used methods. For proper diagnosis of infection as well as disease management and prevention, identification of appropriate test kit is necessary. Hence, a need was felt to compile, share and analyse the data on viral hepatitis and the methods and kits used in the diagnosis.
Data for a special article on viral hepatitis for the year 2015 sent from 12 centres in Kerala were analysed [Table 1]. No data was received from centres outside Kerala for comparison and analysis.
The total number of samples tested for serodiagnosis of viral hepatitis (A, B, C and E) during the year 2015 in the different centres varied from 3695 to 70,970. In two centres, total number of samples was <10,000; three had samples from 10,000 to 20,000 and the remaining seven had samples above 20,000 [Table 2] and [Table 3].
|Table 2: Serodiagnosis of viral hepatitis and analysis of samples for diagnosis of Hepatitis B|
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The percentage of samples positive for viral hepatitis (A, B, C and E) ranged from 0.1% to 1.7% except for one centre (Centre no. 1), which had a positivity rate of 4.5% [Figure 1]. This could be because the sample load was less and the samples were all from clinically suspected cases of hepatitis [Figure 1].
|Figure 1: Percentage positivity of serum samples tested for hepatitis viruses (hepatitis B surface antigen, anti-hepatitis C virus antibody, hepatitis A virus, IgM, hepatitis E virus, IgM)|
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| Hepatitis B Virus|| |
The percentage of samples positive for hepatitis B surface antigen (HBsAg) ranged from 0.4% to 1.3% except for Centre no. 5 (2.7%) [Figure 2]. It could probably be due to larger percentage of patients on haemodialysis in this group. This compares well with point prevalence of 3.7% in India.
|Figure 2: Percentage positivity of serum samples tested for hepatitis B surface antigen and hepatitis C virus antibodies|
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HBsAg ELISA was done at all 12 centres. Different centres have utilised ELISA kits from varied manufacturers.
The various ELISA kits used to detect HBsAg included Hepalisa J. Mitra, ERBA Lisa Transasia and Microscreen Span Diagnostics (three centres); VIDAS ELFA Biomerieux, SD, Merilisa Meril Diagnostics (two centres); Qualisa, Monolisa HBsAg Ultra Bio-Rad, Ortho Clinical Diagnostics Vitros (one centre each) [Table 4].
Immunochromatographic (ICT) kits were used by eight centres.
Card/ICT kits used to detect HBsAg were Hepacard, J. Mitra (four centres), Hepaview and QualPro (four centres) and SD Bioline, ECI ES card and Crystal Span Diagnostics (one centre each) [Table 4].
Three centres have used ICT kits from two different manufacturers during this period.
Polymerase chain reaction for hepatitis B virus DNA
Quantitative HBV polymerase chain reaction (PCR) was carried out on samples from chronic HBsAg-positive patients in two centres. Out of 32 tested, two (37.5%) were positive in Centre no. 5 and out of 415, 232 (56%) were positive in Centre no. 8. Geno-sense HBV quantitative PCR kit (Genome Diagnostics, New Delhi, India) was used in Centre No. 8. Centre No. 5 and No. 8 seem to be specialised for viral hepatitis diagnosis [Table 2].
| Hepatitis C Virus|| |
The percentage of samples detected positive for anti-HCV antibody ranged from 0.1% to 1.3% [Figure 2]. This is in keeping with Indian data of 1% population prevalence.
ELISAs were used by all centres.
The various ELISA kits used to detect ant HCV antibody:
Microlisa, J. Mitra, ERBA Transasia and SD (three centres); Monolisa plus version 2 Bio-Rad, Ortho Clinical diagnostics Vitros by one centre each [Table 4].
ICT kits were used by eight centres. For anti-HCV antibody detection, some of the centres have utilised enzyme-linked fluorescent (ELFA) kits from different manufacturers. VIDAS ELFA Biomerieux and Architect ELFA were the most common [Table 4].
Card/Immunochromatographic kits that were used to detect anti-hepatitis C virus antibody
HCV Tridot, J. Mitra and Signal Immunodot Span Diagnostics (two centres).
The other kits were used by only one centre each were SD Bioline, ECI OCD card and Flav Screen Rapid QualPro Tulip [Table 4].
Polymerase chain reaction for hepatitis C virus RNA
Quantitative HCV PCR was carried out only in two centres to differentiate recent/past infection, to decide on initiation of treatment and to evaluate response to treatment. Positivity in Centre no. 5 was 4 of 15 (26.6%) and 41 out of 82 (50%) in Centre No. 8 [Table 3].
| Hepatitis E Virus|| |
The percentage of samples positive for anti-HEV IgM ranged from 3% to 14.2% in various centres. As per the available data, HEV IgM positivity varies from 10.54% in Mangalore  to 41.8% in Kolkata [Figure 3].
|Figure 3: Percentage positivity of serum samples tested for hepatitis A virus IgM and hepatitis E virus IgM|
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The ELISA kits used to detect anti-HEV IgM antibody were Wanta Bio-pharm ELISA, DiaPro ELISA, DSI ELISA, Amar Immunodiagnostics ELISA [Table 4].
Card/ICT kit used was INSIGHT Rapid Tulip [Table 4].
| Hepatitis A Virus|| |
The percentage of samples positive for anti-HAV IgM ranged from 22% to 39% in most centres. However, it was 61% at one centre (No. 9); and 4.5% and 5.7% at two centres (Centre no. 4 and no. 6, respectively) [Figure 3].
The high percentage of positivity in some of these centres was probably due to the occurrence of an outbreak during this period. HAV IgM positivity varies from 12.76% in Puducherry  to 19.31% in Mangalore.
Card/ICT kits used were Rapid CTK Biotech Recombilisa, Insight Rapid HAV IgM [Table 4].
The ELISA kits used were Wantai, Insight, ELFA VIDAS Biomerieux, DSI, Recombilisa, CTK (each by two centres), ECI Beckman Coulter and DS EIA (one centre each) [Table 4].
In some centres, the serum samples which tested positive by ELISA kits were further confirmed by Card/ICT kits for the same parameter. This explains the high rate of positivity with card tests in these centres. However, in other centres, those tested by ELISA kits are probably different from those tested by the card/ICT kits for the respective parameter; in some centres, they are a subset. Hence, analysis could not be done whether there was agreement between the ELISA and card results for a particular parameter.
| Conclusion|| |
Rapid card/ICTs are simple without much instrumentation requiring minimum training and can be carried out at room temperature. The latest rapid tests using synthetic antigens have increased specificity, a high positive predictive value and less false negatives. Although ELISA kits have a high degree of sensitivity, they are expensive and time-consuming. Therefore, commercially available ELISA kits are good for screening but rapid tests may be used for further confirmation. Improvement of sensitivity of the rapid kit will help laboratories without an ELISA/CLIA set-up.
An evaluation of some HBsAg and HCV rapid and ELISA kits was carried out by the National Reference Laboratory at National Institute of Cholera and Enteric Diseases, Indian Council of Medical research, Kolkata. The HBsAg rapid kits evaluated were Hepacard, J. Mitra, Crystal Span and SD Bioline, all of which were recommended. The HCV rapid kits evaluated included HCV Comb, J Mitra, Signal Ver 2.0 Span, and SD Bioline, of which only the latter two were recommended. The HBsAg ELISA kits evaluated were Microscreen Span, Hepalisa J Mitra and ERBA Lisa Transasia, of which the latter two were recommended. The HCV kits tested were HCV Microlisa J Mitra, Innova Span and ERBA Lisa Transasia. However, only ERBA Lisa Transasia has been recommended.
Evaluation of kits used on a regular basis will help ensure availability of quality commercial kits and reliable reporting.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3]
[Table 1], [Table 2], [Table 3], [Table 4]