Hepatitis C virus

Hepatitis C virus is a small, enveloped, single-stranded, positive-sense RNA virus. It is the only known member of the hepacivirus genus in the family Flaviviridae. There are six major genotypes of the hepatitis C virus, which are indicated numerically - genotype 1 etc.). Based on the NS5 gene there are three major and eleven minor genotypes. HCV genotype matters because it can affect how successful a person's hepatitis C treatment will likely be and how long the hepatitis C medication will need to be taken.

Hepatitis C is an infectious disease primarily affecting the liver, caused by the HCV. HCV is transmitted by blood-to-blood contact. In developed countries, it is estimated that 90% of persons with chronic HCV infection were infected through transfusion of unscreened blood or blood products or via injecting drug use or sexual exposure. The infection is often asymptomatic, but chronic infection can lead to scarring of the liver and ultimately to cirrhosis, which is generally apparent after many years. In some cases, those with cirrhosis will go on to develop liver failure or other complications, including liver cancer or life-threatening esophageal varices and gastric varices. During the first 12 weeks after infection with HCV, most people suffer no symptoms. For those who do, the main manifestations of acute infection are generally mild and vague and rarely point to a specific diagnosis of hepatitis C. Symptoms of acute HCV infection include decreased appetite, fatigue, abdominal pain, jaundice, itching and flulike symptoms.

HCV is usually detectable in the blood by PCR within one to three weeks after infection and antibodies to the virus are generally detectable within 3 to 15 weeks. Liver enzyme tests show variable ALT/ALS elevation. Periodically, they might show normal results. Usually, prothrombin and albumin results are normal, but may become abnormal, once cirrhosis has developed. The levels of elevation of liver tests do not correlate well with the amount of liver injury on biopsy. Viral genotype and viral load also do not correlate with the amount of liver injury. Liver biopsy is the best test to determine the amount of scarring and inflammation. The natural course of chronic hepatitis C varies considerably from one person to another. Although almost all people infected with HCV have evidence of inflammation on liver biopsy, the rate of progression of liver scarring (fibrosis) shows significant variability among individuals. Once chronic hepatitis C has progressed to cirrhosis, signs and symptoms may appear that are generally caused by either decreased liver function or increased pressure in the liver circulation, a condition known as portal hypertension. Possible signs and symptoms of liver cirrhosis include accumulation of fluid in the abdomen, bruising and bleeding tendency, varices (especially in the stomach and esophagus), jaundice and syndrome of cognitive impairment known as hepatic encephalo pathy (HE). HE is due to the accumulation of ammonia and other substances normally cleared by a healthy liver.

AmpliSens® HCV-FRT PCR kit is a qualitative One-Step RTPCR test for detection of HCV RNA in the clinical material (blood plasma). Internal Control allows to determine the RNA extraction efficiency, reverse transcription and cDNA amplification steps. The analytical sensitivity depends on the clinical sample volume and is 100 IU/ml (if the sample volume is 100 ul) or 10 IU/ml (if the sample volume is 1 ml). Detection channels: FAM/Green and JOE/Yellow/HEX.

AmpliSens® HCV Monitor FRT PCR kit is quantitative OneStep RT-PCR test for detection of HCV RNA. The linear range depends on the clinical sample volume and is 300-100,000,000 IU/ml (100 ul sample) or 150-100,000,000 IU/ml (200 ųl sample) or 30-100,000,000 IU/ml (1 ml sample).

AmpliSens® HCV-1/2/3-FRT PCR kit allows detection and differentiation of HCV genotypes 1, 2, and 3 in one tube. The analytical sensitivity depends on the clinical sample volume and is 500 IU/ml (100 ul sample) or 50 IU/ml (1 ml sample). FAM/Green (genotype 1), JOE/Yellow/HEX (genotype 2), ROX/ Orange (genotype 3), Red/Cy5 (IC) channels are needed.

AmpliSens® HCV-genotype-FRT (R-V1-G(1-4)-2x) PCR kit allows detection and differentiation of HCV genotypes 1a, 1b, 2, 3a and 4. Analytical sensitivity is not less than 2.5 x 10³ copies/ml. Detection channels: FAM/Green and JOE/HEX/ Yellow.

AmpliSens® HCV-genotype-FRT R-V1-G(1-6)-2x PCR kit allows detection and differentiation of HCV genotypes 1a, 1b, 2, 3a, 4, 5a and 6. Detection channels: FAM/Green and JOE/HEX/Yellow/Cy3.
A reverse transcription kit in AmpliSens® HCV-genotype-FRT kits is not included.

Catalog   number	Description	Detection	Format	# of reactions	Certifi- cation	Assay detail	Shelf life	Fluorescent channels	Availa- bility
R-V1-MC (RG,iQ,Mx,Dt)-CE	AmpliSens® HCV-Monitor-FRT			80		quantitative	12  months
R-V1-Mod (RG,iQ,Mx,Dt)-CE	AmpliSens® HCV-FRT			112		qualitative	12  months
R-V1-G-4x (RG,iQ,Mx)-CE	AmpliSens® HCV-1/2/3-FRT			55		genotyping	9  months
R-V1-G(1-4)-2х (RG,iQ,Mx,Dt,SC)-CE	AmpliSens® HCV-genotype-FRT			55		genotyping	12 months
H-4001-1-14-CE	AmpliSens® HCV-Monitor-L PCR kit variant FRT-L			480		quantitative	12 months
H-4002-1-14-CE	AmpliSens® HCV-Monitor-L PCR kit variant FRT-L			96		quantitative	12 months
NEW CE IVD  H-0256-1-3-CE	AmpliSens® HCV-genotype-FRT PCR kit (REVERTA-L included)			55		genotyping	12 months

  Real-Time     Reverse transcription    Fluorescent End-Point     Reagents in stock tubes    Ready-to-use PCR tubes   
 on request     available