GeneXpert Enterovirus Assay: One-Year Experience in a Routine Laboratory Setting and Evaluation on Three Proficiency Panels

ABSTRACT A prospective unblinded comparative evaluation of three assays for the detection of enteroviral RNA performed on 83 positive and 79 negative cerebrospinal fluid samples showed initial and resolved sensitivities of 90.4% and 98.8%, respectively, for the Cepheid GeneXpert enterovirus assay; 94.0% and 97.6%, respectively, for the Argene enterovirus consensus kit; and 100% and 100%, respectively, for an in-house real-time PCR. The initial and resolved specificities were 100% for all three assays.

[1]  H. Rotbart,et al.  Impact of rapid polymerase chain reaction results on management of pediatric patients with enteroviral meningitis , 2002, The Pediatric infectious disease journal.

[2]  Ellen Jo Baron,et al.  Manual of clinical microbiology , 1975 .

[3]  P. Hufnagl,et al.  Rapid diagnosis of enterovirus infections by real-time PCR on the LightCycler using the TaqMan format. , 2002, Diagnostic microbiology and infectious disease.

[4]  G. Rabalais,et al.  Potential cost savings through rapid diagnosis of enteroviral meningitis. , 1997, The Pediatric infectious disease journal.

[5]  R. Venezia,et al.  A one-step RT-PCR assay using an enzyme-linked detection system for the diagnosis of enterovirus meningitis. , 2000, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[6]  J. Motte,et al.  New Reverse Transcription-PCR Assay for Rapid and Sensitive Detection of Enterovirus Genomes in Cerebrospinal Fluid Specimens of Patients with Aseptic Meningitis , 2003, Journal of Clinical Microbiology.

[7]  H. Hyöty,et al.  Real-time PCR for rapid diagnosis of entero- and rhinovirus infections using LightCycler. , 2004, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[8]  H. Rotbart.  Diagnosis of enteroviral meningitis with the polymerase chain reaction. , 1990, The Journal of pediatrics.

[9]  M. Landry,et al.  Real-Time Nucleic Acid Sequence-Based Amplification Using Molecular Beacons for Detection of Enterovirus RNA in Clinical Specimens , 2005, Journal of Clinical Microbiology.

[10]  S. Lorch,et al.  Routine Cerebrospinal Fluid Enterovirus Polymerase Chain Reaction Testing Reduces Hospitalization and Antibiotic Use for Infants 90 Days of Age or Younger , 2007, Pediatrics.

[11]  F. Nolte,et al.  Multicenter Beta Trial of the GeneXpert Enterovirus Assay , 2007, Journal of Clinical Microbiology.

[12]  F. Nolte.  Case studies in cost effectiveness of molecular diagnostics for infectious diseases: pulmonary tuberculosis, enteroviral meningitis, and BK virus nephropathy. , 2006, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[13]  M. Beld,et al.  Highly Sensitive Assay for Detection of Enterovirus in Clinical Specimens by Reverse Transcription-PCR with an Armored RNA Internal Control , 2004, Journal of Clinical Microbiology.

[14]  M. Jackson,et al.  Clinical utility of polymerase chain reaction testing for enteroviral meningitis. , 1999, The Pediatric infectious disease journal.

[15]  M. Sawyer,et al.  Diagnosis of enteroviral meningitis by using PCR with a colorimetric microwell detection assay , 1994, Journal of clinical microbiology.

[16]  K. Korn,et al.  Nested PCR for specific detection and rapid identification of human picornaviruses , 1994, Journal of clinical microbiology.

[17]  R. Borrow,et al.  Development and evaluation of a ‘real‐time’ RT‐PCR for the detection of enterovirus and parechovirus RNA in CSF and throat swab samples , 2002, Journal of medical virology.

[18]  M. Abzug.  Presentation, Diagnosis, and Management of Enterovirus Infections in Neonates , 2004, Paediatric drugs.

[19]  A. V. van Loon,et al.  Rapid and Sensitive Routine Detection of All Members of the Genus Enterovirus in Different Clinical Specimens by Real-Time PCR , 2002, Journal of Clinical Microbiology.

[20]  C. Ginocchio,et al.  Development, Technical Performance, and Clinical Evaluation of a NucliSens Basic Kit Application for Detection of Enterovirus RNA in Cerebrospinal Fluid , 2005, Journal of Clinical Microbiology.

[21]  M. Pallansch,et al.  Outbreak of neurologic enterovirus type 71 disease: a diagnostic challenge. , 2007, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[22]  W. Verstrepen,et al.  Evaluation of a rapid real-time RT-PCR assay for detection of enterovirus RNA in cerebrospinal fluid specimens. , 2002, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[23]  M. Kockx,et al.  Rapid Detection of Enterovirus RNA in Cerebrospinal Fluid Specimens with a Novel Single-Tube Real-Time Reverse Transcription-PCR Assay , 2001, Journal of Clinical Microbiology.

[24]  P. Lebon,et al.  Detection of enteroviruses in cerebrospinal fluids: enzymatic amplification and hybridization with a biotinylated riboprobe. , 1994, Molecular and cellular probes.

[25]  H. Rotbart.  Enzymatic RNA amplification of the enteroviruses , 1990, Journal of clinical microbiology.