Hi‐PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit

Description

Hepatitis B is an infectious disease of liver caused by the Hepatitis B virus (HBV), which is a small DNA virus. It belongs to Hepadnaviridae family and is classified into 10 genotypes, A to J. Each genotype has a distinct geographic distribution. This virus can cause both acute and chronic infections of the liver. It is transmitted when blood or mucous membranes are exposed to infectious blood and body fluids. Other risk factors include working in healthcare, blood transfusions, dialysis, etc. Many people have no symptoms during the initial infection but some develop a rapid onset of sickness with vomiting, yellowish skin, tiredness, dark urine and abdominal pain. It may take 30 to 180 days for symptoms to begin. Early symptoms of the infection include appetite loss, vomiting and abdominal symptoms, with approximately 10‐20% of those patients developing fever as well as rheumatoid joint and muscle pain. Jaundice, which may be accompanied by itching, will then develop within 2‐14 days. Fulminant hepatitis then occurs in about 1% of all infected patients, which in severe cases may be fatal. Of those individuals infected by HBV, 5‐10% are likely to develop chronic liver inflammation which may progress to cirrhosis of the liver or, in the worst case, primary liver cell carcinoma. Chronic Hepatitis may progress to scarring of the liver, liver failure, or liver cancer. Hence, early diagnosis and treatment of Hepatitis is important which can also contribute to reducing Hepatitis transmission.

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

Intended Use

Hi‐PCR® Hepatitis B Virus (HBV) 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 HBV DNA in human plasma samples. The Hi‐PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit targets 100% of the known HBV genotypes (HBV genotype A‐J).

Product Description:

Hi‐PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit is based on real‐time PCR technology for the detection and quantitation of Hepatitis B Virus (HBV) specific DNA encompassing all major HBV genotypes (HBV genotype A‐J). The kit contains primer‐probe mixture specific for detection of HBV DNA. In addition, the kit can identify the DNA extraction efficiency and ensure successful PCR reaction with the help of an endogenous internal control. The quantitative standards (HBV quantitative standards QS1‐QS4) are supplied in the kit which allow the determination of viral DNA 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 DNA 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 that should amplify in all clinical samples which indicates the presence of sufficient DNA from human gene indicating the specimen is of acceptable quality. An internal control also allows to check for possible PCR inhibition or reagent failure.

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 DNA. In this reaction, Nuclease free water is used as the template. It is recommended to have a minimum of one reaction of negative template 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 DNA 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. HiMedia’s Hi‐PCR® Hepatitis B Virus (HBV) Detection and Quantitation Probe PCR Kit is designed to specifically detect HBV viral DNA from subtypes A to J in FAM channel with Internal Control (IC) in ROX channel.