Key result
The QIAstat-Dx Meningitis/Encephalitis panel demonstrated similar performance to the Biofire FilmArray panel, yielding 6.25% false positive results (3/48) versus 2.7% (1/37) for Biofire.
Why the study?
Point-of-care syndromic PCR assays are useful for rapid detection of meningitis and encephalitis pathogens, prompting evaluation of the performance characteristics of the new QIAstat-Dx Meningitis/Encephalitis panel.
Does the QIAstat-Dx Meningitis/Encephalitis panel perform comparably to the Biofire FilmArray panel for detecting neuromeningeal pathogens?
Does the QIAstat-Dx Meningitis/Encephalitis panel perform comparably to the Biofire FilmArray panel for detecting neuromeningeal pathogens?
Absolute Event Rate: 6.25% vs 2.7%
The QIAstat-Dx Meningitis/Encephalitis panel demonstrates performance characteristics comparable to the Biofire FilmArray panel for the rapid detection of neuromeningeal pathogens.
Comparable performance is hypothesis-generating; larger prospective studies needed before clinical adoption.
Point-of-care syndromic PCR (POC SPCR) assays are useful tools for the rapid detection of the most common causative agents of community-acquired infections responsible for meningitis and encephalitis infections. We evaluated the performance characteristics of the new QIAstat-Dx® Meningitis/Encephalitis panel (QS) compared to the laboratory reference methods and the POC SPCR Biofire® FilmArray® Meningitis Encephalitis Panel (FA). Viral (Enterovirus, Parechovirus, HSV-1, HSV-2, HHV-6, VZV) and bacterial (E. coli K1, H. influenzae, L. monocytogenes, encapsulated N. meningitidis, M. pneumoniae, S. agalactiae, S. pneumoniae, S. pyogenes) pathogens were suspended at low concentrations and tested with the POC SPCR systems. The reproducibility, analytical specificity, carryover contamination, interferences and clinical samples were evaluated. All samples tested positive with both QS and FA except for those containing the lowest concentrations of Enterovirus-D68-B3, Echovirus-30 and S. agalactiae which were only detected by FA. In terms of analytical specificity, we observed 3 false positive results out of 48 QS tests versus 1 out of 37 FA tests. For the other studied criteria, both QS and FA performed as expected. Our results suggest that the performance characteristics of QS are close to those of FA. A prospective multicenter study would be useful to complete the performances evaluation of QS.
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Bars et al. (2023) studied Viral and Bacterial Neuromeningeal Infections. QIAstat-Dx Meningitis/Encephalitis panel (QS) vs. Biofire FilmArray Meningitis Encephalitis Panel (FA) and laboratory reference methods was evaluated on False positive results (analytical specificity). The QIAstat-Dx Meningitis/Encephalitis panel demonstrated similar performance to the Biofire FilmArray panel, yielding 6.25% false positive results (3/48) versus 2.7% (1/37) for Biofire.
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