November 30, 2022

Efficacy of 4th Generation HCV testing: Avenues to explore.

HCV testing

Viral Hepatitis is a worldwide public health problem, and the growing burden of chronic hepatitis cases on the global healthcare system is a significant cause of concern.

There has been a constant increase in hepatitis C virus (HCV) infection. According to Institute of Liver and Biliary Sciences data, based in New Delhi, approximately 3% of the world’s population is infected with HCV, with a significantly higher percentage in the at-risk category.

Current Health Statistics project that 6-12 million people in India are infected with the  Hepatitis C virus. Chronic HCV infection accounts for 12-32% of Hepatocellular Carcinoma (HCC ) and 12-20% of cirrhosis in India based on regional-level studies. As per WHO data, in 2019, 58 million people lived with chronic hepatitis C infection. Hepatitis C results in upwards of 400,000 deaths each year. A real global issue.


There are no vaccines currently available for Hepatitis C. The best way to prevent & reduce the spread of hepatitis C is by getting tested for HCV regularly. Timely treatment is essential as the recovery time is  8 -12 weeks for current HCV infections.

There are gaps in Blood Transfusion safety due to Inadequate screening for HIV, Hepatitis B, Hepatitis C, and Syphilis as per the documented quality system requirements. In HCV infection, most patients are dormant carriers and do not exhibit visible symptoms. When these symptoms are developed and visible, it is in an advanced stage leading to HCC and, subsequently, death. Moreover, blood donors in either the asymptomatic phase or with mild symptoms are not always identifiable during the selection process.

The testing recommendation for HCV is screening for either a combination of HCV antigen-antibody or HCV antibodies. To ensure blood safety, the use of 4th generation HCV test based on simultaneous detection of Core Antigen and anti – HCV (core and non-structural) is the best alternative as a diagnostic method for the early detection of recent HCV infection. In addition, the 4th generation test reduces the window period by 5-7 weeks for HCV Acute infection compared to the 3rd generation HCV test based on only antibody detection.

HCV is primarily transmitted through parenteral exposures to body fluids or infectious blood, most commonly through injection drug use blood. In addition, an infected mother can transmit it to her infant during pregnancy or childbirth. Therefore 4th, generation HCV testing can help increase blood safety in  Blood Banks, Gulf testing centers, corporate labs, gynecologists, Dialysis centers, etc.

One of the most frequent causes of chronic viral liver disease in dialysis patients is Hepatitis C. It’s also associated with increased morbidity and mortality in them. More no. of blood transfusions, duration of the treatment & poor infection control measures are found to be the main risk factors for HCV infection in dialysis patients.

The safety and quality of Blood transfusions to dialysis patients can be improved by testing blood using the 4th generation HCV test, thereby reducing the risk of HCV infection among these patients.

HCV prevalence across the Middle Eastern nations is similar to global levels and is estimated to be around 1% among nationals compared to high prevalence in specific expatriate populations. Therefore, blood transfusion and hospital-associated practice are important risk factors for HCV in Arabian countries and can be overcome by safe and adequate blood screening and transfusion.

Due to the high prevalence in expatriate populations in gulf countries, it is mandatory to do HCV testing on the migrants going to these countries. Blood testing at Gulf centers using 4th generation tests will ensure effective blood screening in seronegative cases, thereby reducing transmission and the burden of disease.

There has been an increased incidence of HCV in reproductive-aged women. Hence, pregnancy represents an ideal opportunity to initially diagnose HCV in women, link them to care, and refer them for HCV treatment. Recently, the Infectious Disease Society of America( IDSA) and the American Association for the Study of Liver Diseases (AASLD)  have jointly recommended universal screening for HCV among women during pregnancy.

Considering the growing burden of managing HCV infections, CDC in Atlanta has recommended the following testing algorithm in the continental USA ;

Every pregnant woman during every pregnancy, including adults with ongoing risk factors, should be regularly tested.

J.Mitra has taken a lead role in improved diagnosis of HCV infection in India by providing HCV Gen4 Ag& Ab Microlisa, 4th generation ELISA test for detection of HCV Core antigen and anti-HCV(Core, NS3, NS4 & NS5) in serum/plasma.

The product is indigenously developed, has a user-friendly procedure, and has high precision and accuracy in test results concerning sensitivity and specificity. 4th generation  Elisa test based on the detection of Core antigen and anti-HCV is the best diagnostic screening method with higher sensitivity and specificity. Batch processing of Samples can result in a quick turnaround ( less than 3 hours) when working with the Elisa method.

Awareness of Hepatitis among the populace combined with an accurate diagnosis can reduce the impact of this deadly silent Killer Disease. 

It is treatable when diagnosed in a timely manner. Early diagnosis using 4th generation HCV Test kits and prompt treatment can significantly reduce life-threatening complications and mortality.