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Molecular diagnostics: Redefining hepatitis diagnosis & treatment

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Dr V Ravi, Virologist and Head of Research and Development, Tata Medical and Diagnostics highlights that molecular diagnostics significantly advances detection, treatment, and response monitoring of Hepatitis B and Hepatitis C infection. This technology accurately identifies minute traces of viral DNA, enabling earlier and more precise diagnosis, which improves intervention timelines

Viral hepatitis is a systemic infection that predominantly affects the liver, causing inflammation. It may be acute (recent infection, relatively rapid onset) or chronic. Among the types of hepatitis that form a public health concern, Hepatitis B (HBV) and Hepatitis C (HCV) have the potential to lead to persistent infection with the attendant risk of chronic liver disease, cirrhosis, and even liver cancer.

The population prevalence of chronic HBV infection in India is around 3-4 per cent with an estimated 40 million chronic HBV infected people. Chronic HBV infection accounts for 40-50 per cent of liver cancer (hepatocellular carcinoma) and 10-20 per cent cases of cirrhosis in India. For HCV, the population prevalence of chronic HCV infection is around 1 per cent with a higher occurrence in high-risk groups such as injecting drug users, truckers, individuals suffering from sexually transmitted infections, and persons suffering from thalassemia, haemophilia and other conditions that require blood products transfusion.

Early detection and treatment of the Hepatitis B and C Virus infections is crucial to reducing the burden of this disease and improving patient outcomes. Enter molecular diagnostics, a cutting-edge technology with the potential to transform the diagnosis and management of hepatitis. Molecular diagnostics, specifically open system kits for qPCR platforms, are poised to revolutionise hepatitis detection, treatment and patient care.

Early diagnosis can improve outcomes and prevent complications.

Alarmingly, a considerable number of individuals with chronic hepatitis infections remain undiagnosed due to the asymptomatic nature of the disease in its early stages. As a result, many patients only receive a diagnosis when liver damage has already occurred, making treatment more challenging and less effective. Early detection and treatment of hepatitis is essential to mitigate these risks, reduce the overall burden of hepatitis and improve patient outcomes. With innovative diagnostic tools such as molecular diagnostics, we can significantly impact the course of hepatitis.

The promise of molecular diagnostics

Molecular diagnostics significantly advances detection, treatment, and response monitoring of Hepatitis B and Hepatitis C infection. This technology accurately identifies minute traces of viral DNA, enabling earlier and more precise diagnosis, which improves intervention timelines. It also detects viral mutations and drug resistance markers, allowing for personalised, data-driven treatment strategies tailored to individual patients.

Revolutionising hepatitis treatment, molecular diagnostics provides precise, actionable information, monitoring viral load and treatment efficacy. This shortens the time required for informed decisions, enabling quicker intervention and reducing complications.

Molecular diagnostics empowers healthcare providers to make informed decisions, adjust therapy as needed, and predict treatment outcomes, ultimately reducing the overall burden of hepatitis.

Advantages of open system kit for qPCR platforms and its advantages

In the detection of HBV and HCV, antibody testing does not establish whether the patient is currently infected, since many people spontaneously clear hepatitis infection. It is here that molecular diagnostics play an important role in detecting viral DNA.  The open system kits detect and quantify HBV and HCV-specific DNA for observing therapy efficacy. Today, the need of the hour is to have HBV testing kits that can validate genotypes A, B, C, D & H while the HCV kits that can validate genotypes 1-6. Both viral load qPCR kits must have 100 per cent clinical sensitivity and specificity with proprietary primers and probes that target highly conserved gene regions that are unaffected by a mutation in the virus. The HCV kit must give a reliable performance with EDTA plasma samples.

Open system kits for qPCR platforms offer numerous advantages that make them an attractive choice for healthcare providers and diagnostic laboratories. One of the most significant benefits of an open system kit is its compatibility with a wide range of commonly used qPCR platforms. This broad compatibility allows laboratories to leverage their existing equipment, reducing the need for additional investments in specialised instruments.

Furthermore, open system kits provide increased flexibility in diagnostic testing, enabling the customization of assays to suit specific needs or research interests. This adaptability is particularly valuable when dealing with emerging viral strains or mutations, as it allows for the rapid development and implementation of updated diagnostic protocols. Additionally, open system kits allow for simultaneous testing of multiple targets, streamlining the diagnostic process and potentially reducing turnaround time.

By offering greater compatibility, flexibility, and accessibility, open system kits for qPCR platforms contribute to the growing potential of molecular diagnostics in the early detection and treatment of hepatitis, enabling healthcare providers to monitor treatment efficacy and viral load more effectively for improved patient outcomes and more efficient healthcare systems.

The future of molecular diagnostics

By offering precise, actionable information, molecular diagnostics is revolutionising the way we approach HBV treatment. The future holds even more promise, with advancements that will further enhance the diagnosis and treatment of this disease. More sensitive and specific diagnostic tests will improve early detection and new technologies in patient management will allow healthcare providers to monitor patients more effectively. The molecular diagnostics revolution will help us win the battle against Hepatitis B, C and ensure the health and well-being of millions worldwide.

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