Performance of the GeneXpert® enterovirus assay for detection of enteroviral RNA in cerebrospinal fluid

Marlowe, Elizabeth M.; Novak, Susan; Dunn, James J.; Smith, Amy; Cumpio, Joven; Makalintal, Edna; Barnes, Darryl E.; Burchette, Raoul J.

doi:10.1016/j.jcv.2008.04.006

Cited by 28 publications

(11 citation statements)

References 17 publications

(21 reference statements)

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“…Invalid results occurred at a rate of 8.2% when original, untreated CSF specimens were used. These results were in the range of the results of other published studies, which have ranged from 6.7% to 16% (7,12), and show that the internal control is functioning correctly to detect inhibition. We found that invalid results were highly correlated to the level of RBC cellularity, i.e., "bloody tap."…”

supporting

confidence: 81%

“…Nucleic acid amplification-based procedures for the detection of EnV RNA in CSF have replaced cell culture as the test of choice (10,11,14). The GeneXpert enterovirus assay (GXEA; Cepheid, Sunnyvale, CA) is designed as an integrated system combining specimen processing, EnV amplification, and detection in a disposable cartridge which takes 2.5 h to detect EnV from CSF (6,7,12). It is designed for on-demand testing, such that "stat" PCR results can be returned to the emergency room physicians in time for patient management decisions to be made in real time.…”

mentioning

confidence: 99%

“…The information from each kit lot was recorded. CSF samples were tested using the GXEA as previously described (6,7). In brief, 140 l of CSF was added to the GeneXpert cartridge and then processed automatically for the different steps of sample preparation and amplification.…”

mentioning

confidence: 99%

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Prevalence and Management of Invalid GeneXpert Enterovirus Results Obtained with Cerebrospinal Fluid Samples: a 2-Year Study

Sefers¹,

Raymer²,

Kilby³

et al. 2009

J Clin Microbiol

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A total of 525 cerebrospinal fluid (CSF) samples submitted during the 2007 and 2008 enteroviral seasons were included in a study to determine the prevalence of and potential risk factors for invalid Cepheid GeneXpert enterovirus assay (GXEA) results, as well as possible solutions for the problem. The invalid GXEA results were reported for 43 (8.2%) specimens and correlated with increased visibility of red blood cells (P < 0.0001) but not with CSF xanthochromia and clotting. Invalid GXEA result rates were markedly diminished by 82.1% and 96.0% and test sensitivities were minimally decreased by 1.7% and 3.6% when these specimens were tested at a 1:5 dilution and after a freeze-thaw cycle, respectively.Enterovirus (EnV) meningitis can be difficult to distinguish from disease caused by other etiologic agents when patients present with nonspecific pathogenic symptoms and signs, such as fever, headache and stiff neck, and pleocytosis in cerebrospinal fluid (CSF) (4,8,9). Nucleic acid amplification-based procedures for the detection of EnV RNA in CSF have replaced cell culture as the test of choice (10,11,14). The GeneXpert enterovirus assay (GXEA; Cepheid, Sunnyvale, CA) is designed as an integrated system combining specimen processing, EnV amplification, and detection in a disposable cartridge which takes 2.5 h to detect EnV from CSF (6,7,12). It is designed for on-demand testing, such that "stat" PCR results can be returned to the emergency room physicians in time for patient management decisions to be made in real time. The system includes an internal control that provides a means to detect amplification inhibitors. When the internal control does not amplify, the presence of an amplification inhibitor is assumed and the result is reported as "invalid." Invalid results, if and when they occur, could delay patient management in the emergency setting.We performed a 2-year prospective study to determine the prevalence of invalid GXEA results and explore the potential risk factors related to the occurrence of invalid results. We also validated two alternative procedures to minimize the occurrence of these invalid results for EnV detection in CSF.(This study was presented in part at the 25th Annual Meeting of the Pan American Society for Clinical Virology, Daytona Beach, FL, 19 to 22 April, 2009.) Clinical samples. CSF specimens submitted to Vanderbilt University Medical Center between 1 April 2007 and 20 September 2008 for detection of EnV by PCR were collected consecutively. Specimens with enough leftover volume and still unfrozen after the completion of diagnostic testing were included in the study.Determination of CSF characteristics. Each CSF sample was visually examined for visible red blood cells (RBCs), clotting, and the presence of xanthochromia. RBC visibility was graded semiquantatively on a scale using rankings of clear, 1ϩ, 2ϩ, 3ϩ, and 4ϩ. These grades were based on specimen colors and turbidities which roughly correspond to CSF RBC counts of Ͻ200/l (clear), 200 to 5,000/l (1ϩ), 5,000 to 75,000/l (2ϩ), 75...

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supporting

confidence: 81%

mentioning

confidence: 99%

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Prevalence and Management of Invalid GeneXpert Enterovirus Results Obtained with Cerebrospinal Fluid Samples: a 2-Year Study

Sefers¹,

Raymer²,

Kilby³

et al. 2009

J Clin Microbiol

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“…It appears that the FilmArray may have provided a more definitive diagnosis in these 22 patients (16 with EV and 6 with HPeV). Of impor-tance, the FilmArray has the significant advantage over the one currently available, FDA-cleared molecular test (33) for detection of enterovirus in CSF, in that the FilmArray can also detect HPeV in addition to the other 12 pathogens.…”

Section: Discussionmentioning

confidence: 99%

Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens

et al. 2016

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Rapid diagnosis and treatment of infectious meningitis and encephalitis are critical to minimize morbidity and mortality. Comprehensive testing of cerebrospinal fluid (CSF) often includes Gram stain, culture, antigen detection, and molecular methods, paired with chemical and cellular analyses. These methods may lack sensitivity or specificity, can take several days, and require significant volume for complete analysis. The FilmArray Meningitis/Encephalitis (ME) Panel is a multiplexed in vitro diagnostic test for the simultaneous, rapid (ϳ1-h) detection of 14 pathogens directly from CSF specimens: Escherichia coli K1, Haemophilus influenzae, Listeria monocytogenes, Neisseria meningitidis, Streptococcus pneumoniae, Streptococcus agalactiae, cytomegalovirus, enterovirus, herpes simplex virus 1 and 2, human herpesvirus 6, human parechovirus, varicella-zoster virus, and Cryptococcus neoformans/Cryptococcus gattii. We describe a multicenter evaluation of 1,560 prospectively collected CSF specimens with performance compared to culture (bacterial analytes) and PCR (all other analytes). The FilmArray ME Panel demonstrated a sensitivity or positive percentage of agreement of 100% for 9 of 14 analytes. Enterovirus and human herpesvirus type 6 had agreements of 95.7% and 85.7%, and L. monocytogenes and N. meningitidis were not observed in the study. For S. agalactiae, there was a single false-positive and false-negative result each, for a sensitivity and specificity of 0 and 99.9%, respectively. The specificity or negative percentage of agreement was 99.2% or greater for all other analytes. The FilmArray ME Panel is a sensitive and specific test to aid in diagnosis of ME. With use of this comprehensive and rapid test, improved patient outcomes and antimicrobial stewardship are anticipated.

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“…The analytical sensitivity and specificity of the Xpert EV assay relative to other NAATs for detection of enterovirus RNA in CSF have been previously published (4,5,18). The sensitivity ranged from 97.1 to 100%, and the specificity was 100% in these studies.…”

Section: Discussionmentioning

confidence: 95%

Evaluation of a Rapid and Completely Automated Real-Time Reverse Transcriptase PCR Assay for Diagnosis of Enteroviral Meningitis

et al. 2011

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Performance of the GeneXpert® enterovirus assay for detection of enteroviral RNA in cerebrospinal fluid

Cited by 28 publications

References 17 publications

Prevalence and Management of Invalid GeneXpert Enterovirus Results Obtained with Cerebrospinal Fluid Samples: a 2-Year Study

Prevalence and Management of Invalid GeneXpert Enterovirus Results Obtained with Cerebrospinal Fluid Samples: a 2-Year Study

Multicenter Evaluation of BioFire FilmArray Meningitis/Encephalitis Panel for Detection of Bacteria, Viruses, and Yeast in Cerebrospinal Fluid Specimens

Evaluation of a Rapid and Completely Automated Real-Time Reverse Transcriptase PCR Assay for Diagnosis of Enteroviral Meningitis

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