The Enterovirus RNA Real-Time PCR kit coded ENTERORNA.CE is intended for the qualitative detection of Enterovirus RNA in human plasma and CSF samples (Cerebral Spinal Fluid) with a simultaneous control of the amplification reaction through an Internal Control (IC). 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™**).
NTRODUCTION
Human Enteroviruses ( until now there are 70 serotype known, belonging to the family of Picornaviridae) are ubiquitous pathogens with a high incidence worldwide. Although the majority of human enterovirus infections are asymptomatic, these viruses can cause a wide spectrum of clinical syndromes ranging from upper respiratory illness, febrile rash, aseptic meningitis, pleurodynia, encephalitis, acute flaccid paralysis, and neonatal sepsis-like disease. Human enterovirus may also be implicated in the pathogeneses of severe chronic diseases, including type 1 diabetes mellitus, myocarditis and congestive cardiomyopathy, and neuromuscular diseases. Furthermore, Enterovirus infections account for a substantial number of aseptic meningitis and encephalitis patients requiring hospitalization in summer and fall.
RINCIPLE OF THE TEST
The ENTERORNA.CE Kit is based on a Real Time chemistry which uses specific Primers and Probes.
Enterovirus RNA, recovered from the biological sample under investigation through an extraction step, is retrotrascribed to cDNA and amplified using Real Time amplification system. The amplified product is detected using a fluorescent reporter dye probe specific for an Enteroviruses unique genomic sequence.
An Heterologous Internal Control (IC) serves as an amplification control for each individually processed specimen aiming to the identification of reaction inhibitors.
An High Positive control (CTRL-H) and Low Positive control (CTRL-L) are supplied as controls for the PCR reaction.
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