Meningitis/Encephalitis
Conditions
Brief summary
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
Detailed description
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
Interventions
DEVICEQIAstat-Dx® Meningitis/Encephalitis (ME) Panel
The performance of QIAstat-Dx® Meningitis/Encephalitis Panel will be evaluated in comparison with another validated comparator method, followed by bidirectional sequencing using residual specimens of cerebrospinal fluid (CSF) obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis.
Sponsors
QIAGEN Gaithersburg, Inc
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Residual specimens (minimum 500μL) of CSF obtained by lumbar puncture from subjects with signs and symptoms of meningitis and/or encephalitis following completion of routine testing Specimen that have not undergone more than 3 freeze/thaw cycles.
Exclusion criteria
* Specimens not fitting criteria outlined above. * CSF obtained from an external ventricular drain or shunt source. * Lack of clear subject identification or label on residual banked CSF specimen. * Specimen has been centrifuged. * Obvious physical damage of banked residual specimen. * Repeat specimens from the same subject.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PPA | 6 months | positive percentage agreement |
| NPA | 6 months | negative percentage agreement |
Countries
United Kingdom
Outcome results
None listed