A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
This trial is active, not recruiting.
|Sponsor||Shaare Zedek Medical Center|
|Start date||April 2009|
|End date||October 2009|
|Trial size||200 participants|
|Trial identifier||NCT00864903, SZMC|
A new enzymatic assay was developed by NMD Diagnostics for rapid diagnosis of Enteroviral CNS infection. This study will compare this assay to RT-PCR, by testing human CSF samples taken from children at the ER who are undergoing a spinal tap due to suspicion of meningitis.
any child undergoing a spinal tap due to suspected meningitis
Male or female participants up to 16 years old.
Inclusion Criteria: - any child undergoing a spinal tap - parents agreed on participation Exclusion Criteria: - refusal to participate in the study
|Official title||A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection|
|Principal investigator||Yechiel Schlesinger, MD|
|Description||MND's new enzymatic assay is based on the detection of a specific viral enzyme through the detection of its enzymatic reaction. The detection of a specific enzymatic reaction is indicative to the presence of the specific virus in a biological specimen. This study will compare this diagnostic assay to RT-PCR for diagnosis of enteroviral infection in cerebrospinal fluid. CSF samples will be taken from children undergoing a spinal tap at the pediatric ER due to a suspicion of meningitis. A total of 100 samples will be collected, from children 0-16 years old who's parents agreed on participation in the study. A comparison of the enzymatic assay to RT-PCR as well as calibration and validation of the new assay will be done with the harvested samples, for a rapid and accurate identification of Enterovirus in human cerebrospinal fluid.|
Call for more information