The HDV Quantitation Real-Time PCR kit coded DRNA.CE is intended for the quantitative detection of Hepatitis D Virus RNA in human sample (plasma, serum) with a simultaneous control of the amplification reaction through an Internal Control (IC).
DRNA.CE assay was standardised against the 1st WHO International Standard for Hepatitis D Virus RNA (PEI code 7657/12) to express samples concentration also in International Unit (IU/ml).
The kit has been adapted for the use on the Real-Time Thermacyclers ABI 7500 Sequence Detection System® (Software SDS version 1.3.1, Applied Biosystems™*) or MX3000P® (Software MxPro version 4.01, Stratagene™***) and CFX96 (Software CFX manager version 1.7, Biorad™**).
NTRODUCTION
Hepatits delta virus (HDV) is a defective RNA virus which can only infected patient with acute or chronic hepatitis B virus. For this reason virion assembly and propagation depends on the hepatits B virus.
The HDV genome is a circular, single stranded RNA molecule of about 1700 bp and is strongly base-paired. The genome encodes two different ribonucloproteins, referred to as the small hepatits delta antigen (sHDAg) and the large hepatits delta antigen (LHDAg). This production is related to the use different termination codons. The two form of protein have different functions: the sHDAg is required for HDV replication, whereas LHDAg inhibit HDV replication and is required for virion formation. HDV infection can cause severe liver diseases, with fulminant hepatitis occurring more often than for HBV alone and with a higher chronicity rate in case of superinfection. In many case, chronic delta hepatits evolves to cirrhosis and hepatocellular carcinoma.
RINCIPLE OF THE TEST
The DNA.CE Kit is based on a Real Time chemistry which uses specific Primers and Probes.
HDV RNA, recovered from the biological sample under investigation through an extraction step, is retrotrascripted to cDNA and amplified using Real Time amplification system. The amplified product is detected and quantified, against the standard curve using a fluorescent reporter dye probe specific for a HDV unique genomic sequence.
Internal Control (IC) serves as an amplification control for each individually processed specimen aiming to the identification of reaction inhibitors.
An external standard curve is supplied allowing the determination of the viral load.
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