On April 12, 2022, Daan's Diagnostic Kit for Quantification of Hepatitis C and Diagnostic Kit for Quantification of Hepatitis B obtained CE List A clearance.
Daan Gene is the first Chinese company that obtains the highest level of CE certification for hepatitis virus nucleic acid testing in the EU. Daan Gene is winning recognition from home and abroad, demonstrating a strong capability in hepatitis diagnosis and treatment testing solutions.
Hepatitis B and hepatitis C are viral infections that attack the liver and can cause both acute and chronic hepatitis, ranging in severity from a mild illness to a serious, lifelong illness including liver cirrhosis and cancer. Hepatitis B and hepatitis C can also be transmitted through unsafe injections, sexual contact and sharing equipment for injecting drug use, etc.
WHO estimates that 354 million people worldwide live with hepatitis B or hepatitis C, with about 3 million new infections occurring per year.
WHO’s Global hepatitis strategy aims to reduce new hepatitis infections by 90% and deaths by 65% between 2016 and 2030.
Symptoms of hepatitis B and hepatitis C may include fever, malaise, loss of appetite, diarrhea, nausea, abdominal discomfort, dark-colored urine, and jaundice (yellowing of the skin and whites of the eyes). In some cases, the virus can also cause a chronic liver infection that can later develop into cirrhosis (a scarring of the liver) or liver cancer. These patients are at risk of death.
In highly endemic areas, hepatitis B is most commonly spread from mother to child at birth (perinatal transmission) or through horizontal transmission (exposure to infected blood), especially from an infected child to an uninfected child during the first 5 years of life. The development of chronic infection is common in infants infected by their mothers or before the age of 5 years.
Hepatitis B is also spread by needlestick injury, tattooing, piercing, and exposure to infected blood and body fluids, such as saliva and menstrual, vaginal, and seminal fluids.
The hepatitis C virus is a bloodborne virus. It is most commonly transmitted through:
They reuse or inadequate sterilization of medical equipment;
The transfusion of unscreened blood and blood products;
Injecting drug use through the sharing of injection equipment.
Here is the clinical significance of the PCR kit for Hepatitis B and C:
1. Used in early diagnosis of at-risk individuals
2. Used to monitor response to therapy and as a marker of infectivity
3. The WHO “Guidelines on hepatitis B and C testing” made a strong recommendation for the use of a nucleic acid testing assay (e. g. PCR) as the preferred strategy for diagnosis of viraemic infection.
Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR-Fluorescence Probing)
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)
Internal control to monitor the whole NAT procedure.
Highly sensitive LoD: 10 IU/mL (HBV detection kit) and 20 IU/mL (HCV detection kit).
Shorter window period
Shorter window period (diagnostic period) owing to the adoption of PCR-based technology.
Wide linear range
Wide linear range from 20 to more than 1.0×10 9 IU/mL (HBV detection kit) and from 50 to more than 1.0×108 IU/mL (HCV detection kit).
Fully automatic nucleic acid extraction
Compatible with automated extraction platform for total nucleic acid purification.
Accuracy can be guaranteed as the kits are free of cross-reactivity with other viruses.
To meet our customer’s needs, Daan Gene's hepatitis products have covered the whole process of hepatitis diagnosis and treatment after years of development. As a leading company in the field of molecular diagnostics, Daan Gene has always been committed to promoting continuous progress in the diagnosis and treatment of infectious diseases, providing comprehensive molecular diagnostic solutions to facilitate a patient-centered care system, and working towards the elimination of viral hepatitis by 2030 as proposed by WHO.