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Multicenter beta trial of the GeneXpert enterovirus assay.
J Clin Microbiol. 2007 Apr; 45(4):1081-6.JC

Abstract

The GeneXpert Dx system (Cepheid, Sunnyvale, CA) is a fully integrated and automated nucleic acid sample preparation, amplification, and real-time detection system. It consists of an instrument, a personal computer, and disposable fluidic cartridges. The analytical sensitivity and specificity of the GeneXpert enterovirus assay (GXEA) were determined with a panel of 63 different enterovirus serotypes and 24 other microorganisms, respectively. The potential for blood, hemoglobin, white blood cells, and excess protein to interfere with the assay was also assessed. The performance parameters of the GXEA were determined at three sites with 102 cerebrospinal fluid (CSF) samples obtained from patients with suspected meningitis. All samples were tested for enterovirus RNA with locally developed reverse transcription-PCR (RT-PCR) assays at the trial sites and with a seminested RT-PCR and an analyte-specific reagent (Cepheid) at a reference laboratory. The 5' nontranslated region was the target for all of the PCR assays except the seminested RT-PCR, which amplified a VP1 sequence. The VP1 amplicon was sequenced to identify the enterovirus types. Consensus reference laboratory RT-PCR results were used to classify cases of enteroviral meningitis. The GXEA detected all of the enterovirus serotypes and none of the other microorganisms tested except rhinovirus 16. The assay was unaffected by moderate amounts of blood or blood components. Thirty-six (35%) of the CSF samples tested had at least one positive PCR result. Eleven different enterovirus serotypes were identified in the positive samples. The GXEA had a sensitivity of 97.1% (95% confidence interval [CI], 84.7 to 99.9%) and a specificity of 100% (95% CI, 94.6 to 100%) for the diagnosis of enteroviral meningitis.

Authors+Show Affiliations

Emory University Hospital, 1365 Clifton Road N.E., Atlanta, GA 30322, USA.No 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

17251395

Citation

Kost, Christine B., et al. "Multicenter Beta Trial of the GeneXpert Enterovirus Assay." Journal of Clinical Microbiology, vol. 45, no. 4, 2007, pp. 1081-6.
Kost CB, Rogers B, Oberste MS, et al. Multicenter beta trial of the GeneXpert enterovirus assay. J Clin Microbiol. 2007;45(4):1081-6.
Kost, C. B., Rogers, B., Oberste, M. S., Robinson, C., Eaves, B. L., Leos, K., Danielson, S., Satya, M., Weir, F., & Nolte, F. S. (2007). Multicenter beta trial of the GeneXpert enterovirus assay. Journal of Clinical Microbiology, 45(4), 1081-6.
Kost CB, et al. Multicenter Beta Trial of the GeneXpert Enterovirus Assay. J Clin Microbiol. 2007;45(4):1081-6. PubMed PMID: 17251395.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Multicenter beta trial of the GeneXpert enterovirus assay. AU - Kost,Christine B, AU - Rogers,Beverly, AU - Oberste,M Steven, AU - Robinson,Christine, AU - Eaves,Brenda L, AU - Leos,Kristi, AU - Danielson,Susan, AU - Satya,Malini, AU - Weir,Fred, AU - Nolte,Frederick S, Y1 - 2007/01/24/ PY - 2007/1/26/pubmed PY - 2007/10/12/medline PY - 2007/1/26/entrez SP - 1081 EP - 6 JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 45 IS - 4 N2 - The GeneXpert Dx system (Cepheid, Sunnyvale, CA) is a fully integrated and automated nucleic acid sample preparation, amplification, and real-time detection system. It consists of an instrument, a personal computer, and disposable fluidic cartridges. The analytical sensitivity and specificity of the GeneXpert enterovirus assay (GXEA) were determined with a panel of 63 different enterovirus serotypes and 24 other microorganisms, respectively. The potential for blood, hemoglobin, white blood cells, and excess protein to interfere with the assay was also assessed. The performance parameters of the GXEA were determined at three sites with 102 cerebrospinal fluid (CSF) samples obtained from patients with suspected meningitis. All samples were tested for enterovirus RNA with locally developed reverse transcription-PCR (RT-PCR) assays at the trial sites and with a seminested RT-PCR and an analyte-specific reagent (Cepheid) at a reference laboratory. The 5' nontranslated region was the target for all of the PCR assays except the seminested RT-PCR, which amplified a VP1 sequence. The VP1 amplicon was sequenced to identify the enterovirus types. Consensus reference laboratory RT-PCR results were used to classify cases of enteroviral meningitis. The GXEA detected all of the enterovirus serotypes and none of the other microorganisms tested except rhinovirus 16. The assay was unaffected by moderate amounts of blood or blood components. Thirty-six (35%) of the CSF samples tested had at least one positive PCR result. Eleven different enterovirus serotypes were identified in the positive samples. The GXEA had a sensitivity of 97.1% (95% confidence interval [CI], 84.7 to 99.9%) and a specificity of 100% (95% CI, 94.6 to 100%) for the diagnosis of enteroviral meningitis. SN - 0095-1137 UR - https://www.unboundmedicine.com/medline/citation/17251395/Multicenter_beta_trial_of_the_GeneXpert_enterovirus_assay_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=17251395 DB - PRIME DP - Unbound Medicine ER -