Hepatitis Viruses - HCV RNA HBV DNA CE-IVD PCR kits
Hepatitis Viruses are a group of infectious liver diseases caused by hepatotropic viruses belonging to different families. There are 5 major viruses that cause hepatitis. They make up two groups of hepatitis: enteric (HAV and HEV) and parenteral (HBV, HCV and HDV) (see below table). Enteric hepatitis are characterized by a fecal-oral transmission way and these viruses cause only acute hepatitis. Viruses of enteric hepatitis possess high infectivity and stability. Viruses of hepatitis В, С and D are enveloped in a membrane, are transmitted by parenteral way and are able to promote not only acute but chronic virus hepatitis. Viruses of hepatitis В and С play an important role in the development of chronic virus liver diseases, they are responsible for development of 60-70 percent of hepatic cirrhosis and up to 70-80 percent of primary liver cancers. Due to a great incidence of hepatitis viruses one of the major task is the development of highly sensitive and reproducible methods of diagnostics allowing detection of the causative agent at all stages of the disease as well as monitoring of antiviral therapy effectiveness.
Products
Detection of HAV RNA by PCR method has significant advantages as related to ELISA and biochemical tests at detection of the virus in blood of contact persons as RNA of the hepatitis A virus manifests itself in the blood on the third week from the moment of contamination and is detected at the average within 20 days after appearance of the disease symptoms. Thus, RNA is the first diagnostic marker detected in the patient blood, occurs earlier than a HAV IgM and gives no falsely negative reactions.
Detection of HAV RNA with the help of PCR in feces is possible from the third week of the incubation period and up to three months after manifestation of the disease symptoms. Detection of RNA has more advantages (by 1000 times more at the least) as compared to detection of HAV-Ag in environmental entities (drinking or waste waters, waters from impounded surface waters and so on).
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Detection of HBV DNA is used for:
- Early diagnostics of acute viral hepatitis B;
- Detection of latent forms of viral hepatitis B;
- Detection of mutant strains of hepatitis B virus by HBsAg;
- Establishment of diagnosis of chronic viral hepatitis B;
- Monitoring of effectiveness of the antiviral therapy;
ADVANTAGES OF SACACE HBV REAL TIME QUANT KIT
- CE-IVD marked
- Use of the Quantitative Internal Control (concentration reported in Data Card) which represents recombinant DNA-containing-structure which carried through all steps of analysis from nucleic acid extraction to PCR amplification. The presence of quantitative HBV Rec IC allows not only to monitor the extraction procedure and to check possible PCR inhibition but also to verify possible losses of the DNA during extraction procedure thus enabling to calculate precisely the HBV viral load.
- Presence in the reagents supplied with the kit of two positive controls of the extraction: Pos1 HBV low viral load and Pos2 HBV medium viral load that are quantitatively described in Data Card which carried through all steps and allow quality control of the conducted analysis.
- High sensitivity: 20 copies/ml (value obtained using the Magno-Virus extraction kit (Sacace REF K-2-16)
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The leading position in laboratory diagnostics of HCV is taken by molecular-biological methods allowing: 1) early diagnostics of the acute viral infection; 2) establishment of indications to antiviral therapy; 3) choice of the optimum therapeutic regime.
ADVANTAGES OF SACACE HCV REAL TIME QUANT KIT
- CE-IVD marked
- Application of primers and probes in the most conservative area of the UTR region that allow effective detection of the majority of HCV genotypes (tested genotypes: 1a, 1b, 1c, 2a, 2b, 2c, 3a, 3b, 4a, 4c, 4d, 5a, 6a)
- Use of the Quantitative Internal Control (concentration reported in Data Card) which represents recombinant RNA-containing-structure which carried through all steps of analysis from nucleic acid extraction to PCR amplification. The presence of quantitative HCV Rec IC allows not only to monitor the extraction procedure and to check possible PCR inhibition but also to verify possible losses of the RNA during extraction procedure thus enabling to calculate precisely the HCV viral load.
- Presence in the reagents supplied with the kit of two positive controls of the extraction: Pos1 HCV low viral load and Pos2 HCV medium viral load that are quantitatively described in Data Card which carried through all steps and allow quality control of the conducted analysis
- Wide linear range of measurements (from 20 to 50.000.000 IU/ml).
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