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Evaluation of a rapid and completely automated real-time reverse transcriptase PCR assay for diagnosis of enteroviral meningitis.
J Clin Microbiol. 2011 Feb; 49(2):528-33.JC

Abstract

Nucleic acid amplification tests (NAATs) for enterovirus RNA in cerebrospinal fluid (CSF) have emerged as the new gold standard for diagnosis of enteroviral meningitis, and their use can improve the management and decrease the costs for caring for children with enteroviral meningitis. The Xpert EV assay (Cepheid, Sunnyvale, CA) is a rapid, fully automated real-time PCR test for the detection of enterovirus RNA that was approved by the U.S. Food and Drug Administration for in vitro diagnostic use in March 2007. In this multicenter trial we established the clinical performance characteristics of the Xpert EV assay in patients presenting with meningitis symptoms relative to clinical truth. Clinical truth for enteroviral meningitis was defined as clinical evidence of meningitis, the absence of another detectable pathogen in CSF, and detection of enterovirus in CSF either by two reference NAATs or by viral culture. A total of 199 prospectively and 235 retrospectively collected specimens were eligible for inclusion in this study. The overall prevalence of enteroviral meningitis was 26.04%. The Xpert EV assay had a sensitivity of 94.69% (90% confidence interval [CI] = 89.79 to 97.66%), specificity of 100% (90% CI = 99.07 to 100%), positive predictive value of 100%, negative predictive value of 98.17, and an accuracy of 98.62% relative to clinical truth. The Xpert EV assay demonstrated a high degree of accuracy for diagnosis of enteroviral meningitis. The simplicity and on-demand capability of the Xpert EV assay should prove to be a valuable adjunct to the evaluation of suspected meningitis cases.

Authors+Show Affiliations

Emory University School of Medicine, Atlanta, Georgia, USA. nolte@musc.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

21159942

Citation

Nolte, Frederick S., et al. "Evaluation of a Rapid and Completely Automated Real-time Reverse Transcriptase PCR Assay for Diagnosis of Enteroviral Meningitis." Journal of Clinical Microbiology, vol. 49, no. 2, 2011, pp. 528-33.
Nolte FS, Rogers BB, Tang YW, et al. Evaluation of a rapid and completely automated real-time reverse transcriptase PCR assay for diagnosis of enteroviral meningitis. J Clin Microbiol. 2011;49(2):528-33.
Nolte, F. S., Rogers, B. B., Tang, Y. W., Oberste, M. S., Robinson, C. C., Kehl, K. S., Rand, K. A., Rotbart, H. A., Romero, J. R., Nyquist, A. C., & Persing, D. H. (2011). Evaluation of a rapid and completely automated real-time reverse transcriptase PCR assay for diagnosis of enteroviral meningitis. Journal of Clinical Microbiology, 49(2), 528-33. https://doi.org/10.1128/JCM.01570-10
Nolte FS, et al. Evaluation of a Rapid and Completely Automated Real-time Reverse Transcriptase PCR Assay for Diagnosis of Enteroviral Meningitis. J Clin Microbiol. 2011;49(2):528-33. PubMed PMID: 21159942.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of a rapid and completely automated real-time reverse transcriptase PCR assay for diagnosis of enteroviral meningitis. AU - Nolte,Frederick S, AU - Rogers,Beverly B, AU - Tang,Yi-Wei, AU - Oberste,M Steven, AU - Robinson,Christine C, AU - Kehl,K Sue, AU - Rand,Kenneth A, AU - Rotbart,Harley A, AU - Romero,Jose R, AU - Nyquist,Ann-Christine, AU - Persing,David H, Y1 - 2010/12/15/ PY - 2010/12/17/entrez PY - 2010/12/17/pubmed PY - 2011/5/14/medline SP - 528 EP - 33 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 49 IS - 2 N2 - Nucleic acid amplification tests (NAATs) for enterovirus RNA in cerebrospinal fluid (CSF) have emerged as the new gold standard for diagnosis of enteroviral meningitis, and their use can improve the management and decrease the costs for caring for children with enteroviral meningitis. The Xpert EV assay (Cepheid, Sunnyvale, CA) is a rapid, fully automated real-time PCR test for the detection of enterovirus RNA that was approved by the U.S. Food and Drug Administration for in vitro diagnostic use in March 2007. In this multicenter trial we established the clinical performance characteristics of the Xpert EV assay in patients presenting with meningitis symptoms relative to clinical truth. Clinical truth for enteroviral meningitis was defined as clinical evidence of meningitis, the absence of another detectable pathogen in CSF, and detection of enterovirus in CSF either by two reference NAATs or by viral culture. A total of 199 prospectively and 235 retrospectively collected specimens were eligible for inclusion in this study. The overall prevalence of enteroviral meningitis was 26.04%. The Xpert EV assay had a sensitivity of 94.69% (90% confidence interval [CI] = 89.79 to 97.66%), specificity of 100% (90% CI = 99.07 to 100%), positive predictive value of 100%, negative predictive value of 98.17, and an accuracy of 98.62% relative to clinical truth. The Xpert EV assay demonstrated a high degree of accuracy for diagnosis of enteroviral meningitis. The simplicity and on-demand capability of the Xpert EV assay should prove to be a valuable adjunct to the evaluation of suspected meningitis cases. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/21159942/Evaluation_of_a_rapid_and_completely_automated_real_time_reverse_transcriptase_PCR_assay_for_diagnosis_of_enteroviral_meningitis_ L2 - https://journals.asm.org/doi/10.1128/JCM.01570-10?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -