Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2024/67 QIAMA | Other Grant/Funding Number | QIAGEN STAT-Dx Life S.L |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive Samples | Positive samples for viruses or bacteria typical of meningitis/encephalitis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Virus or bacterial positive samples from cerebrospinal fluid.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liliana Gabrielli, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Bologna | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33053146 | Background | 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. | |
| 22259778 |
| Label | URL |
|---|---|
| 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 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002494 | Central Nervous System Infections |
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| D008581 | Meningitis |
| D004660 | Encephalitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
cerebrospinal fluid
|
| 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. |
| 27342782 | Background | 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. |
| 27335149 | Background | 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. |
| 22024398 | Background | 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. |
| Role of computed tomography before lumbar puncture: a survey of clinical practice | View source |
| D000090862 | Neuroinflammatory Diseases |
| D001927 | Brain Diseases |