Hi‐PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit

Description

Hepatitis C is a blood‐borne viral infection that is caused by Hepatitis C Virus (HCV), a hepatotropic RNA virus, with a propensity to affect the liver. It is responsible for chronic liver disease and a variety of extrahepatic manifestations, hence recognized as a major public health problem worldwide. HCV is primarily transmitted via the parenteral route which includes injection drug use, blood transfusion, unsafe injection practices, and other healthcare related procedures. HCV causes acute subclinical hepatitis which gradually evolves into chronic hepatitis in about 80% of the infected cases. For long, hepatitis C remained obscure to researchers due to its clinically silent nature. Most patients with acute infection are symptom free and only a small proportion develops jaundice. Chronic HCV infection may be associated with vague, non‐specific symptoms such as fatigue, joint pain, and discomfort in the right‐upper quadrant of the abdomen. Patients usually become symptomatic when complications of chronic liver disease or extra‐hepatic manifestations develop. Hence, early diagnosis and treatment of HCV is important which can also contribute to reducing Hepatitis transmission.

NOTE: HiMedia’s Hi‐PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit is for in vitro use only

Intended Use

Hi‐PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit is intended for use by qualified clinical laboratory personnel trained in the techniques of real‐time PCR and in vitro diagnostic procedures. The kit is recommended for sensitive and specific detection and quantitation of HCV RNA in human plasma samples. The Hi‐PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit targets 100% of the known HCV genotypes (HCV genotype 1‐7).

Product Description:

Hi‐PCR® Hepatitis C Virus (HCV) Detection and Quantitation Probe PCR Kit is based on real‐time PCR technology for the detection and quantitation of Hepatitis C Virus (HCV) specific RNA encompassing all major HCV genotypes (HCV genotype 1‐7). The kit contains primer‐probe mixture specific for detection of HCV RNA. In addition, the kit contains an internal control gene to identify the RNA extraction efficiency and to ensure successful PCR reaction. The quantitative standards (HCV quantitative standards QS1‐QS4) are supplied in the kit which allow the determination of viral RNA load. The assay principle is based on hydrolysis probe chemistry which confers higher specificity and sensitivity.

Positive control (or Quantitative standards)

This is a control reaction used to test for the presence of inhibitors in the sample or the efficiency of the polymerase chain reaction itself using a pre‐dispensed nucleic acid sequence and the primer set that detects it. It is usually used to ensure proper and intended functioning of all the reagents and is recommended to be used in every run to assess optimal performance.

Endogenous Internal control

This is a control sequence which is amplified in the same reaction tube along with the target sequence (target pathogen) but detected with a different primer (i.e. Multiplex PCR). An internal control is often used to detect the failure of amplification in cases where the target sequence is not amplified.

Negative Template Control

A negative template control is needed to ensure that the reagents, equipment, and environment used in the assay are not contaminated with target RNA. In this reaction, Nuclease free water is used as the template. It is recommended to have a minimum of one reaction of negative control per run.

Principle

Real‐time polymerase chain reaction, also called quantitative Polymerase Chain Reaction (qPCR) or kinetic Polymerase Chain Reaction, is a laboratory technique based on the principle of PCR. This technique is used to amplify a targeted cDNA sequence by use of hydrolysis probes that are short oligonucleotides that have a fluorescent reporter dye attached to the 5' end and a quencher dye to the 3' end. Hi‐PCR® Hepatitis C Virus (HCV) Quantification Kit (Probe PCR Kit) is designed to specifically detect HCV in the FAM channel with Internal Control (IC) in ROX channel.