Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
This multicenter study aims to evaluate the performance of QIAstat-Dx Meningitis/Encephalitis (ME) Panel with another validated comparator method.
Study Type
OBSERVATIONAL
Enrollment
1,524
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.
Qiagen
Manchester, United Kingdom
PPA
positive percentage agreement
Time frame: 6 months
NPA
negative percentage agreement
Time frame: 6 months
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