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

Multiparametric Molecular Panel Evaluation "QIAstatDxMeningitis/Encephalitis" 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.

Study Overview

• Status: Completed
• Conditions: Infections Nervous System
• Intervention / Treatment: Diagnostic test: QIAstat-Dx®Meningitis/Encephalite Panel

Detailed Description

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:

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

• Study Type: Observational
• Enrollment (Actual): 170

Contacts and Locations

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Virus or bacterial positive samples from cerebrospinal fluid.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Positive Samples; Positive samples for viruses or bacteria typical of meningitis/encephalitis	Diagnostic test: QIAstat-Dx®Meningitis/Encephalite Panel; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The analytical sensitivity of the multiparameter panel	The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests.	6 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Liliana Gabrielli, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

General Publications

• Penata A, Mesa S, Leal A, Castano T, Bustamante J, Sigifredo O. Molecular diagnosis of meningitis and meningoencephalitis with an automated real-time multiplex polymerase chain reaction in a tertiary reference complex in Medellin, Colombia. Rev Inst Med Trop Sao Paulo. 2020 Oct 9;62:e77. doi: 10.1590/S1678-9946202062077. eCollection 2020.
• Shin SY, Kwon KC, Park JW, Kim JM, Shin SY, Koo SH. Evaluation of the Seeplex(R) Meningitis ACE Detection kit for the detection of 12 common bacterial and viral pathogens of acute meningitis. Ann Lab Med. 2012 Jan;32(1):44-9. doi: 10.3343/alm.2012.32.1.44. Epub 2011 Dec 20.
• Messacar K, Breazeale G, Robinson CC, Dominguez SR. Potential clinical impact of the film array meningitis encephalitis panel in children with suspected central nervous system infections. Diagn Microbiol Infect Dis. 2016 Sep;86(1):118-20. doi: 10.1016/j.diagmicrobio.2016.05.020. Epub 2016 Jun 2.
• Leber AL, Everhart K, Balada-Llasat JM, Cullison J, Daly J, Holt S, Lephart P, Salimnia H, Schreckenberger PC, DesJarlais S, Reed SL, Chapin KC, LeBlanc L, Johnson JK, Soliven NL, Carroll KC, Miller JA, Dien Bard J, Mestas J, Bankowski M, Enomoto T, Hemmert AC, Bourzac KM. Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens. J Clin Microbiol. 2016 Sep;54(9):2251-61. doi: 10.1128/JCM.00730-16. Epub 2016 Jun 22.
• de Crom SC, Obihara CC, van Loon AM, Argilagos-Alvarez AA, Peeters MF, van Furth AM, Rossen JW. Detection of enterovirus RNA in cerebrospinal fluid: comparison of two molecular assays. J Virol Methods. 2012 Jan;179(1):104-7. doi: 10.1016/j.jviromet.2011.10.007. Epub 2011 Oct 15.

Helpful Links

• Emergency management in bacterial meningitis and sepsis: application of real time-polymerase chain reaction and FilmArray technology performed directly on cerebrospinal fluid and blood samples Authors Loria Bianchi
• Role of computed tomography before lumbar puncture: a survey of clinical practice

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2024
• Primary Completion (Actual): October 17, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): December 18, 2025
• Last Update Submitted That Met QC Criteria: December 10, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Meningitis; Encephalitis; Viral Infection; Bacterial Infection; Central nervous system infections
• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infections; Bacterial Infections and Mycoses; Virus Diseases; Meningitis; Encephalitis; Bacterial Infections; Central Nervous System Infections
• Other Study ID Numbers: QIA-ME; 2024/67 QIAMA (Other Grant/Funding Number: QIAGEN STAT-Dx Life S.L)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No