AffiPCR® HDV Quantitative Real Time PCR

Target Disease Type: HDV Associated Kits

Specific Application: Hepatitis D (HDV)

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HDV RT-PCR Quant V3-100/2FRT DataSheet

INTRODUCTION

Hepatitis D, also referred to as Hepatitis D virus (HDV) and classified as Hepatitis delta virus, is a disease caused by a small circular RNA virus. HDV is considered to be a subviral satellite because it can propagate only in the presence of the Hepatitis B virus (HBV) . Transmission of HDV can occur either via simultaneous infection with HBV (coinfection) or via infection of an individual previously infected with HBV (superinfection) .

Both superinfection and coinfection with HDV results in more severe complications compared to infection with HBV alone. These complications include a greater likelihood of experiencing liver failure in acute infections and a rapid progression to liver cirrhosis, with an increased chance of developing liver cancer in chronic infections. In combination with hepatitis B virus, hepatitis D has the highest mortality rate of all the hepatitis infections of 20%.

INTENDED USE

HDV Real-TM Quant is a Real-Time test for the Quantitative detection of Hepatitis D Virus in human plasma and the simultaneous detection of a HDV-specific Internal Control (IC) by dual color detection.

HDV Real-TM Quant assay is proposed for management of chronically infected patients to specify their evolutionary profiles before, during, and after treatment, and to study the natural history of HDV infection. It could also be used in large-scale prospective studies to define treatment guidelines and to evaluate the efficacy of new drugs.

PRINCIPLE OF ASSAY

HDV Real-TM Quant Test is based on three major processes: isolation of virus RNA from specimens, one-step reverse transcription of the RNA and Real Time amplification of the cDNA. HDV detection by the polymerase chain reaction (PCR) is based on the amplification of pathogen genome specific region using specific primers and detection via fluorescent dyes.

These dyes are linked with probes of oligonucleotides which bind specifically to the amplified product. The real-time PCR monitoring of fluorescence intensities allows the accumulating product detection without reopening of reaction tubes after the PCR run. HDV Real-TM Quant-PCR kit is a quantitative test which contain the Internal Control (IC) . It must be used in the isolation procedure in order to control the process of each individual sample extraction and serves also to identify possible reaction inhibition.