Molecular Panel Evaluation for Diagnosis of Infections of the Central Nervosous System

Infections involving the central nervous system (CNS), such as meningitis/encephalitis (ME), are serious clinical conditions associated with high morbidity and mortality rates, as well as significant long-term consequences. ME can be caused by a wide variety of pathogenic agents. Clinical symptoms may vary and it has been shown that early identification of the pathogens causing ME allows for timely and appropriate treatment, thus reducing permanent neurological damage. The multiparameter panel "QIAstat-Dx®Meningitis/Encephalitis" can detect in one hour on a sample of 15 bacterial, viral and fungal pathogens. In the diagnostic routine, Real-time PCR takes an average of 3 hours and culture examination 2 days. In addition, compared to other comparable rapid molecular systems, the "QIAstat-Dx" platform has the ability to generate a cycle-related threshold value (Ct) for the targets detected. This value may have a correlation with the viral load and thus provide in a short time not only the result of positivity, but also an indication of the amount of virus present. Other commercially available multiparameter molecular tests provide only qualitative data.

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Key information

Conditions

Infections Nervous System Bacterial Infections Bacterial Infections and Mycoses Brain Diseases Central Nervous System Diseases Central Nervous System Infections Encephalitis Infections Meningitis Nervous System Diseases Neuroinflammatory Diseases Virus Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

About this study

The study is on biological samples of cerebrospinal fluid, positive for viruses or bacteria of interest, retrospective, monocentric, non-pharmacological.

For each sample included in the study (170 total samples), the molecular/culture test result, provided by the normal diagnostic process at the Microbiology Unit, is available for comparison with those obtained with the multiparameter panel QIAstat-Dx® Meningitis/Encephalitis (ME) and QIAstat-Dx 1.0 analyzer.

The aim of the study is:

To evaluate the analytical sensitivity of the test by identifying positive samples for bacteria (culture comparison) and positive samples for viruses (qPCR comparison).
Compare the value of Ct obtained with the number of viral copies per ml of cerebrospinal fluid obtained by qPCR.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

170 samples of CSF positive for virus and/or bacteria;
Samples stored at -80°C, less than 5 years;
Samples with a volume of at least 800μL.

Exclusion criteria

Samples of a different matrix than CSF;
Samples stored at room temperature;
Samples for which diagnostic test results are not available;
Samples with a volume of less than 800μL;
Samples already thawed and refrozen.

Treatment and study plan

QIAstat-Dx®Meningitis/Encephalite Panel

Diagnostic Test

The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests.

For viruses only, the semi-quantitative value of Ct is also evaluated with the viral load provided by qPCR.

Primary outcomes

The analytical sensitivity of the multiparameter panel

Time frame: 6 months

The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests.

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Official study title

Multiparametric Molecular Panel Evaluation "QIAstatDxMeningitis/Encephalitis" for Diagnosis of Infections of the Central Nervosous System

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Dec 6, 2024
Registry last updated: Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed