A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection
Recruitment status was Active, not recruiting
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||A Comparison Between a New Experimental Enzymatic Assay to Real Time PCR for the Diagnosing of Central Nervous System Enteroviral Infection|
|Study Start Date:||April 2009|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
any child undergoing a spinal tap due to suspected meningitis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00864903
|Shaare Zedek Medical Center|
|Jerusalem, Israel, 91031|
|Ness Ziona, Israel, 74036|
|Principal Investigator:||Yechiel Schlesinger, MD||Shaare Zedek Medical Center|