Kalita, S. J., None, B. S. & None, P. B. (2025). To Determine the Clinical, Serological and Molecular Parameters in the Diagnosis of Hepatitis C Infection in Clinically HCV Suspected Patients. Journal of Contemporary Clinical Practice, 11(11), 378-380.
MLA
Kalita, Smeet J., Babita S. and Pooja B. . "To Determine the Clinical, Serological and Molecular Parameters in the Diagnosis of Hepatitis C Infection in Clinically HCV Suspected Patients." Journal of Contemporary Clinical Practice 11.11 (2025): 378-380.
Chicago
Kalita, Smeet J., Babita S. and Pooja B. . "To Determine the Clinical, Serological and Molecular Parameters in the Diagnosis of Hepatitis C Infection in Clinically HCV Suspected Patients." Journal of Contemporary Clinical Practice 11, no. 11 (2025): 378-380.
Harvard
Kalita, S. J., None, B. S. and None, P. B. (2025) 'To Determine the Clinical, Serological and Molecular Parameters in the Diagnosis of Hepatitis C Infection in Clinically HCV Suspected Patients' Journal of Contemporary Clinical Practice 11(11), pp. 378-380.
Vancouver
Kalita SJ, Babita BS, Pooja PB. To Determine the Clinical, Serological and Molecular Parameters in the Diagnosis of Hepatitis C Infection in Clinically HCV Suspected Patients. Journal of Contemporary Clinical Practice. 2025 Nov;11(11):378-380.
Background: Hepatitis C virus (HCV) is the common cause of post transfusion hepatitis in developing countries. Hepatitis C virus infection occurs worldwide. Every year, 3-4 million people are infected with HCV with more than 3.5 lakhs deaths. Higher prevalence rates have been documented from Africa (up to 10%), followed by South America & Asia. In India, the prevalence is about 1 %. Various modes of transmission of HCV are Parenteral, Vertical transmission and sexual transmission. However, Hepatitis C virus doesnt spread through breast milk, food or casual contacts including hugging or kissing. Incubation period is about 15-160 days (average 50 days). About 20% of people develop acute hepatitis characterized by symptoms similar to that of other Hepatitis viruses. About 75-80% directly develops chronic disease out of which 60-70% develops chronic Hepatitis, 5-20% develops cirrhosis and 1-5% develops Hepatocellular carcinoma. The present study was done to determine the common clinical features, serological and molecular parameters in the diagnosis of Hepatitis C Virus infection in clinically suspected patients. Materials & Methods: This study was carried out in the department of Microbiology and Molecular Diagnostics in association with the Department of Pathology at Krsnaa Diagnostics Ltd, Guwahati, Assam over a period of 3 months from May, 2024 till July, 2024. This study was conducted among 687 patients, who were clinically suspected for HCV infection and screened for Hepatitis C ICT (HCV TRIDOT Card) serological test as well as HCV real time PCR molecular test with viral count quantification. The collected data was entered into MS excel followed by the analysis using SPSS version 21 (licensed to KDL). Results: In our study, we noted that, out of a total of 687 HCV suspected patients, 627(91%) patients were in the age group of 13-35 years, followed by 56 (8%) patients were in the age group of 36-59years, followed by 04(1%) patients were in the age group of >60 years. Number of intravenous drug users was 179, which signifies that 26% of study subjects were Intravenous drug users. Conclusion: Out of 687 samples, 627 were males & 60 were females. Out of total 687 patients, 446 came out to be reactive by rapid ICT card test and 241 came out to be HCV non reactive. 464 Came out to be reactive by real time PCR and 223 came out to be non reactive. Samples which came out to be HCV reactive by PCR but not reactive by ICT rapid card test were 18.
The PCR results average log value was 5.07548 & average CT value was 26.80.
Keywords
Hepatitis C Virus (HCV)
Clinical diagnosis
Molecular diagnostics
INTRODUCTION
Hepatitis C virus (HCV) is the common cause of post transfusion hepatitis in developing countries. It was discovered in 1989 and first labeled as non a, non B hepatitis virus while performing the experiments in Chimpanzees.
Hepatitis C virus infection occurs worldwide. Every year, 3-4 million people are infected with HCV with more than 3.5 lakhs deaths. Higher prevalence rates have been documented from Africa (up to 10%), followed by South America & Asia. In India, the prevalence is about 1 %.
Various modes of transmission of HCV are Parenteral (transmitted through exposure to infectious blood), Vertical transmission (from Mother to fetus) and sexual transmission (rare). However, Hepatitis C virus doesnt spread through breast milk, food or casual contacts including hugging or kissing.
Incubation period is about 15-160 days (average 50 days). About 20% of people develop acute hepatitis characterized by symptoms similar to that of other Hepatitis viruses. About 75-80% directly develops chronic disease out of which 60-70% develops chronic Hepatitis, 5-20% develops cirrhosis and 1-5% develops Hepatocellular carcinoma. Certain extrahepatic complications like mixed cryoglobulinemia, Glomerulonephritis, Arthritis and Joint pain are also seen.
MATERIALS AND METHODS
This prospective, cross sectional study was carried out in the Department of Molecular Diagnostics in association with Dept of Microbiology and Pathology, Krsnaa Diagnostics, Guwahati, Assam over a period of 3 months from May, 2024 till July, 2024. This study was conducted among 687 patients, who were clinically suspected for HCV infection and screened for Hepatitis C ICT (Hepatitis C TRIDOT) serological test as well as HCV real time PCR molecular test with viral count quantification.
All the patients with clinical HCV suspected symptoms like jaundice, intravenous drug abusers, pregnant women, HCV reactive individuals were included in the current study group. Patients without clinical signs/symptoms of HCV infection, patients with fever and related symptoms but due to some other diagnosed etiology like typhoid fever, malaria, ITP, etc were excluded from the study.
Under aseptic precautions, a minimum of 5 ml of blood sample was collected from patients having clinical suspicion of HCV infection. By the process of centrifugation, the plasma was separated from blood and stored at -20 degree celcius. All the plasma samples were tested using rapid ICT card test and real time PCR with quantification (viral load). The collected data was entered into MS excel followed by the analysis using SPSS version 21 (licensed to KDL). The demographic variables were represented using arithmetic mean, standard deviation, percentages and pie diagrams. The clinico-serological parameters were depicted in the form of a multiple bar diagram.
RESULTS
In our study, we noted that, out of a total of 687 HCV suspected patients, 627(91%) patients were in the age group of 13-35 years, followed by 56 (8%) patients were in the age group of 36-59years, followed by 04(1%) patients were in the age group of >60 years. Number of intravenous drug users was 179, which signifies that 26% of study subjects were Intravenous drug users. Out of 687 samples, 627 were males & 60 were females.
Out of total 687 patients, 446 came out to be reactive by rapid ICT card test and 241 came out to be HCV negative. 464 Came out to be reactive by real time PCR and 223 came out to be negative. Samples which came out to be HCV reactive by PCR but not reactive by ICT rapid card test were 18.
The PCR results average log value was 5.07548 & average CT value was 26.80.
DISCUSSION
Early detection of severe cases, case confirmation and differential diagnosis is of primary importance for clinical care in effective and accurate diagnosis of Hepatitis C Infection. Virus isolation, molecular diagnosis using real time polymerase chain reaction (PCR) and serological methods have been used for laboratory confirmation of HCV infection. Although PCR is a useful tool for identification of HCV virus infection, its widespread use for diagnosis of HCV infection is limited due to high cost, especially in developing countries.
out of a total of 687 HCV suspected patients, 627(91%) patients were in the age group of 13-35 years, followed by 56 (8%) patients were in the age group of 36-59years, followed by 04(1%) patients were in the age group of >60 years. Number of intravenous drug users was 179, which signifies that 26% of study subjects were Intravenous drug users. Out of 687 samples, 627 were males & 60 were females.
Out of total 687 patients, 446 came out to be reactive by rapid ICT card test and 241 came out to be HBV negative. 464 Came out to be reactive by real time PCR and 223 came out to be negative. Samples which came out to be HCV reactive by PCR but not reactive by ICT rapid card test were 18.The PCR results average log value was 5.07548 & average CT value was 26.80.
However, it is to be noted that the HCV TRIDOT (rapid ICT card test) is a screening test only with high sensitivity and specificity but false positive results can be obtained due to the presence of other antigens or elevated level of RF factor as per kit literature of HCV TRIDOT. It should be noted that false reactive results may occur due to non specific binding of the sample to the membrane. Patients with auto immune liver diseases may show falsely reactive results.
In our study, we noted that, out of a total of 687 HCV suspected patients, 627(91%) patients were in the age group of 13-35 years, followed by 56 (8%) patients were in the age group of 36-59years, followed by 04(1%) patients were in the age group of >60 years. Number of intravenous drug users was 179, which signifies that 26% of study subjects were Intravenous drug users. Out of 687 samples, 627 were males & 60 were females.
Out of total 687 patients, 446 came out to be reactive by rapid ICT card test and 241 came out to be HCV non-reactive. 464 Came out to be reactive by real time PCR and 223 came out to be non-reactive. Samples which came out to be HCV reactive by PCR but not reactive by ICT rapid card test were 18.
CONCLUSION
The present study concluded that maximum patients were in the age group from 20-30 years and HCV infection was prevalent in males more than females.
Out of a total of 687 HCV suspected patients, 627(91%) patients were in the age group of 13-35 years, followed by 56 (8%) patients were in the age group of 36-59years, followed by 04(1%) patients were in the age group of >60 years. Number of intravenous drug users was 179, which signifies that 26% of study subjects were Intravenous drug users. Out of 687 samples, 627 were males & 60 were females.
Out of total 687 patients, 446 came out to be reactive by rapid ICT card test and 241 came out to be HCV non reactive. 464 Came out to be reactive by real time PCR and 223 came out to be non reactive. Samples which came out to be HCV reactive by PCR but not reactive by ICT rapid card test were 18.
The PCR results average log value was 5.07548 & average CT value was 26.80.
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6. Prevalence of hepatitis C among haemodialysis patients in a tertiary care hospital in south India. Madhavan A, Sachu A, Balakrishnan AK, Vasudevan A, Balakrishnan S, Vasudevapanicker J. Iran J Microbiol. 2020 Dec; 12(6):644-649. doi: 10.18502/ijm.v12i6.5041.
7. Qualitative detection of hepatitis C virus RNA: comparison of analytical sensitivity, clinical performance, and workflow of the Cobas Amplicor HCV test version 2.0 and the HCV RNA transcription-mediated amplification qualitative assay. Krajden M, Ziermann R, Khan A, Mak A, Leung K, Hendricks D, Comanor L. J Clin Microbiol. 2002 Aug;40(8):2903-7. doi: 10.1128/JCM.40.8.2903-2907.2002.
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