- New molecular diagnostic test has been developed that can accurately detect hepatitis B virus
- This test is much more superior than conventional testing methods for hepatitis B
- It could lead to quicker diagnosis and treatment of hepatitis B, thereby saving many lives
Hepatitis B can now
be diagnosed using a powerful new molecular diagnostic technique that is much
more superior to currently available testing methods. This new, highly
sensitive technique is advantageous as it is capable of simultaneously
evaluating several parameters that are crucial for the optimal management of
The new molecular diagnostic technique, known as COLD-PCR (co-amplification at lower denaturation temperature-polymerase chain reaction), is coupled with FMCA (fluorescence melting curve analysis), which allows highly accurate diagnosis of chronic hepatitis B patients.
The study, published in the Journal of Molecular Diagnostics, was led by Dr. Qishui Ou, Ph.D., who is attached to the Department of Laboratory Medicine at the First Affiliated Hospital of Fujian Medical University. He also has joint appointments at the Gene Diagnostic Laboratory of Fujian Medical University and the Fujian Key Laboratory of Laboratory Medicine, Fuzhou, China.
Hepatitis B: Facts & FiguresHepatitis B is caused by the hepatitis B virus (HBV), which can cause serious, potentially life-threatening infections of the liver. It is a major global public health problem. Chronic infections can cause death from cirrhosis and liver cancer. HBV can be transmitted from mother-to-child during pregnancy or through infected blood and other body fluids. A safe and effective vaccine is available that can prevent chronic infections and liver cancer.
- 257 million people suffer from hepatitis B worldwide
- 887,000 deaths occur due to cirrhosis and liver cancer worldwide
- 27 million (10.5%) HBV-infected patients are aware of their infection
- 4.5 million (16.7%) HBV-infected patients have access to treatment
- Hepatitis B vaccine confers 98-100 percent protection against HBV
Disadvantages of Current Molecular Diagnostic TestsSeveral molecular diagnostic tests are currently available for detecting HBV. However, they suffer from several limitations, including the following:
- Poor sensitivity
- Inability to simultaneously detect multiple mutations
- Time-consuming and cumbersome
Advantages of the New Molecular Diagnostic TestThe major advantages of the new COLD-PCR/FMCA diagnostic technique include the following:
- High Sensitivity: COLD-PCR/FMCA has very high sensitivity and can detect HBV mutations at much lower concentrations than conventional techniques such as PCR/FMCA and PCR Sanger DNA Sequencing (Sensitivity: 1% vs 10% vs 20% respectively)
- High Differentiation Power: It can differentiate between different phases of HBV infection based on proportion and type of mutations as well as by detection of HBV DNA
- High Predictive Power: It exhibits a high capacity to predict whether a patient will respond to antiviral therapy or not
- Other Advantages: The technique is simple, stable, practical, inexpensive, and convenient and can be used routinely in standard hospital laboratories
Concluding RemarksExisting guidelines have clearly indicated that dynamic monitoring of HBV DNA, genotypes, and RT mutations are vital for determining infection status, predicting disease progression, and assessing treatment efficacy in HBV-infected patients. In this regard, the new COLD-PCR/FMCA technique is an ideal molecular tool for the accurate diagnosis and treatment of HBV-infected patients.
Dr. Qishui Ou concludes: "Until now there have not been high-throughput approaches to detect HBV DNA, genotype, and RT mutations simultaneously. Therefore, it was necessary to establish a more practical and inexpensive method with high sensitivity to detect genotype and RT mutations while detecting HBV DNA. COLD-PCR/FMCA has that potential."
- Establishment of Co-amplification at Lower Denaturation Temperature PCR/Fluorescence Melting Curve Analysis for Quantitative Detection of Hepatitis B Virus DNA, Genotype, and Reverse Transcriptase Mutation and its Application in Diagnosis of Chronic Hepatitis B - (https://jmd.amjpathol.org/article/S1525-1578(19)30356-3/fulltext)