A New Enzymatic Assay for Rapid Diagnosing of Central Nervous System Enteroviral Infection

Shaare Zedek Medical Center

Status: Withdrawn

Conditions: Viral Meningitis

Study type: Observational

Funder types: Other

Identifiers

NCT00864903

SZMC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• any child undergoing a spinal tap
• parents agreed on participation

Exclusion criteria

• refusal to participate in the study

Trial design

0 participants in 1 patient group

pediatric ER

Description:

any child undergoing a spinal tap due to suspected meningitis