Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections
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<sup>®</sup&g...
Main Authors: | , , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
MDPI AG
2023-03-01
|
Series: | Diagnostics |
Subjects: | |
Online Access: | https://www.mdpi.com/2075-4418/13/6/1110 |
_version_ | 1797612389312495616 |
---|---|
author | Hervé Le Bars Neil Madany Claudie Lamoureux Clémence Beauruelle Sophie Vallet Christopher Payan Léa Pilorgé |
author_facet | Hervé Le Bars Neil Madany Claudie Lamoureux Clémence Beauruelle Sophie Vallet Christopher Payan Léa Pilorgé |
author_sort | Hervé Le Bars |
collection | DOAJ |
description | 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<sup>®</sup> Meningitis/Encephalitis panel (QS) compared to the laboratory reference methods and the POC SPCR Biofire<sup>®</sup> FilmArray<sup>®</sup> Meningitis Encephalitis Panel (FA). Viral (Enterovirus, Parechovirus, HSV-1, HSV-2, HHV-6, VZV) and bacterial (<i>E. coli</i> K1, <i>H. influenzae</i>, <i>L. monocytogenes</i>, encapsulated <i>N. meningitidis</i>, <i>M. pneumoniae</i>, <i>S. agalactiae</i>, <i>S. pneumoniae</i>, <i>S. pyogenes</i>) 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 <i>S. agalactiae</i> 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. |
first_indexed | 2024-03-11T06:41:30Z |
format | Article |
id | doaj.art-16b1a033b5484e4b8fe092c7f02c41ec |
institution | Directory Open Access Journal |
issn | 2075-4418 |
language | English |
last_indexed | 2024-03-11T06:41:30Z |
publishDate | 2023-03-01 |
publisher | MDPI AG |
record_format | Article |
series | Diagnostics |
spelling | doaj.art-16b1a033b5484e4b8fe092c7f02c41ec2023-11-17T10:34:28ZengMDPI AGDiagnostics2075-44182023-03-01136111010.3390/diagnostics13061110Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal InfectionsHervé Le Bars0Neil Madany1Claudie Lamoureux2Clémence Beauruelle3Sophie Vallet4Christopher Payan5Léa Pilorgé6Unity of Bacteriology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Virology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Bacteriology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Bacteriology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Virology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Virology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FranceUnity of Virology, Department of Bacteriology-Virology-Parasitology-Mycology-Hygiene, Pole of Biology-Pathology, University Hospital of Brest, F-29200 Brest, FrancePoint-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<sup>®</sup> Meningitis/Encephalitis panel (QS) compared to the laboratory reference methods and the POC SPCR Biofire<sup>®</sup> FilmArray<sup>®</sup> Meningitis Encephalitis Panel (FA). Viral (Enterovirus, Parechovirus, HSV-1, HSV-2, HHV-6, VZV) and bacterial (<i>E. coli</i> K1, <i>H. influenzae</i>, <i>L. monocytogenes</i>, encapsulated <i>N. meningitidis</i>, <i>M. pneumoniae</i>, <i>S. agalactiae</i>, <i>S. pneumoniae</i>, <i>S. pyogenes</i>) 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 <i>S. agalactiae</i> 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.https://www.mdpi.com/2075-4418/13/6/1110point of caresyndromicPCRcerebrospinal fluidmeningitisencephalitis |
spellingShingle | Hervé Le Bars Neil Madany Claudie Lamoureux Clémence Beauruelle Sophie Vallet Christopher Payan Léa Pilorgé Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections Diagnostics point of care syndromic PCR cerebrospinal fluid meningitis encephalitis |
title | Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections |
title_full | Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections |
title_fullStr | Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections |
title_full_unstemmed | Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections |
title_short | Evaluation of the Performance Characteristics of a New POC Multiplex PCR Assay for the Diagnosis of Viral and Bacterial Neuromeningeal Infections |
title_sort | evaluation of the performance characteristics of a new poc multiplex pcr assay for the diagnosis of viral and bacterial neuromeningeal infections |
topic | point of care syndromic PCR cerebrospinal fluid meningitis encephalitis |
url | https://www.mdpi.com/2075-4418/13/6/1110 |
work_keys_str_mv | AT hervelebars evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT neilmadany evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT claudielamoureux evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT clemencebeauruelle evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT sophievallet evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT christopherpayan evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections AT leapilorge evaluationoftheperformancecharacteristicsofanewpocmultiplexpcrassayforthediagnosisofviralandbacterialneuromeningealinfections |