Search Results

The NucliSens EasyQ® Enterovirus v1.1 Assay is an in vitro nucleic acid amplification assay to be used in conjunction with the NucliSens EasyQ® System for the qualitative detection of Enterovirus RNA in cerebral spinal fluid (CSF) specimens in patients with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the presumptive laboratory diagnosis of enterovirus infection in pediatric patients with a clinical suspicion of aseptic meningitis or aseptic meningioencephalitis. Negative results should be confirmed by cell culture. Assay performance characteristics have not been established for adults, or for immunocompromised or immunosuppressed patients. Caution: The results obtained with the NucliSens EasyQ Enterovirus v1.1 Assay should be used only as an adjunct to clinical observation and other information available to the physician. Positive results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g. herpes family viruses, arboviruses, mumps virus, etc) and fungi).

NucliSENS EasyQ® Enterovirus v1.1 is an in-vitro diagnostic assay which uses nucleic acid amplification combined with a simultaneous detection step to detect the presence of enteroviral RNA in eluates derived from cerebrospinal fluid or appropriate control material. The assay requires extracted nucleic acid as input material, and has been validated using nucleic acid eluates extracted from clinical specimens with NucliSENS® miniMAG™. The amplification step is performed using the NucliSENS EasyQ System. NucliSENS® miniMAG™ utilizes NucliSENS® Lysis Buffer and magnetized silica beads to extract nucleic acids from lysed biological specimens. The end product of a NucliSENS® miniMAG™ extraction is an eluate containing total nucleic acid (DNA+RNA) from the specimen. The NucliSENS® easyQ™ System utilizes Nucleic Acid Sequence-Based Amplification (NASBA) and detection of fluorescence from specific molecular beacons to signal the presence of target nucleic acid sequences. The NASBA reaction requires the use of specific reagents, including the enzymes, primers and probes which are components of the NucliSENS EasyQ" Enterovirus v1.1 assay. Reactions are performed in closed tubes in a NucliSENS EasyQ® Analyzer in which fluorescence is measured in real-time. NucliSENS EasyQ® Director Software, in combination with NucliSENS EasyQ® Enterovirus v1.1 assav software, provides automated analysis of the resulting fluorescence signal curves and reporting of assay results. The NucliSENS® easyQ™ System utilizes 3 types of controls: Internal Control RNA, Negative and Positive Controls, and Lysis and Viral Extraction Controls.

The Cepheid® Xpert EV assay is a reverse transcription polymerase chain reaction (RT-PCR) using the GeneXpert® Dx System for the presumptive qualitative detection of enterovirus (EV) RNA in cerebrospinal fluid (CSF) specimens from individuals with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis or meningoencephalitis. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. CAUTION: The results obtained with the Xpert EV assay should be used only as an adjunct to clinical observation and other information available to the physician. Positive Xpert EV results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g. herpes family viruses, arboviruses, mumps virus, etc) and fungi.

The Xpert EV assay is designed to detect enterovirus (EV) RNA (enterovirus genome 5' untranslated region (UTR) between nucleotide 452 and 596) in CSF samples from patients exhibiting meningitis like symptoms. The assay includes reagents, primers, and probes for the simultaneous detection of nucleic acid from the target EV and the sample-processing control/internal control (SPC/IC). The assay includes the SPC/IC to verify adequate processing of the target virus and monitors the presence of inhibitors in the RT-PCR assay to avoid a false negative result. The assay also includes a probe check control to verify reagent rehydration, probe integrity, and reaction-tube filling in the cartridge. The assay is run on the GeneXpert Dx System. The GeneXpert Dx System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence using real-time PCR and RT-PCR assays. The system consists of an instrument, personal computer, and preloaded software for running tests on collected samples and viewing the results. The system requires the use of single-use disposable GeneXpert cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained, cross-contamination between samples is eliminated. The above described sample-processing control/internal control (SPC/IC) is named CIC in the GeneXpert Dx System software. To run a test, the CSF sample and four reagents are transferred into designated chambers of the Xpert EV cartridge. The GeneXpert Dx System performs sample preparation by lysing the virus and SPC (armored pseudovirus RNA), binding the RNA to the capture matrix, and eluting the RNA. The RNA is mixed with dry RT reagents and transferred into the reaction tube for preparation of cDNA. The cDNA is then mixed with dry PCR reagents and transferred into the reaction tube for real-time PCR and detection. The EV primers and probe amplify and detect a consensus region of the enterovirus 5' untranslated region (UTR). The test takes approximately 2.5 hours.