Multicenter evaluation of the ENTEROVIRUS R-gene real-time RT-PCR assay for the detection of enteroviruses in clinical specimens. Export

@article{citeulike:6072585, abstract = {BACKGROUND: The rapid molecular diagnosis of enteroviral meningitis has been shown important for an adequate management of the patients. OBJECTIVES: A new CE-marked real-time RT-PCR assay (ENTEROVIRUS R-gene, Argene) was evaluated in two university hospital virology laboratories. STUDY DESIGN: Reactivity, analytical sensitivity and specificity were evaluated using 54 prototype and 173 clinical human enterovirus (HEV) strains, a 12-sample HEV proficiency panel, and 30 non-HEV microorganisms. The clinical performance of the ENTEROVIRUS R-gene assay was evaluated by testing 197 cerebrospinal fluid (CSF) and 103 respiratory specimens, comparatively to the routinely used diagnostic techniques. RESULTS: Sixty-four out of the 65 HEV serotypes tested were detected. The analytical sensitivity ranged between 10(-2.64) and 10(2.39)TCID(50)/50mul. Cross-reactivity was observed with four human rhinoviruses. On 59 CSF specimens analyzed prospectively, the results of the ENTEROVIRUS R-gene assay showed a 94.8\% concordance with those of the Smart enterovirus (EV) assay (Cepheid). On 138 CSF specimens tested retrospectively, the results of the ENTEROVIRUS R-gene assay showed a 97.1\% concordance with those of either the GeneXpert EV assay (Cepheid) or the in-house RT-PCR HEV assays used at the time of specimen collection. On 103 respiratory specimens, the concordance between the results of the ENTEROVIRUS R-gene assay and those of the routine RT-PCRs or viral culture was 90.2\% and 96.1\% before and after retest, respectively. CONCLUSIONS: The new test was found able to detect a large panel of enterovirus serotypes; it was sensitive when used on clinical specimens; and, easy and rapid to perform on a routine basis.}, author = {Pillet, Sylvie and Billaud, Genevi\`{e}ve and Omar, Shabir and Lina, Bruno and Pozzetto, Bruno and Schuffenecker, Isabelle}, citeulike-article-id = {6072585}, citeulike-linkout-0 = {http://dx.doi.org/10.1016/j.jcv.2009.09.033}, citeulike-linkout-1 = {http://view.ncbi.nlm.nih.gov/pubmed/19879186}, citeulike-linkout-2 = {http://www.hubmed.org/display.cgi?uids=19879186}, day = {28}, doi = {10.1016/j.jcv.2009.09.033}, issn = {1873-5967}, journal = {Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology}, keywords = {enterovirus, rtpcr}, month = {October}, posted-at = {2009-11-05 07:37:01}, priority = {2}, title = {Multicenter evaluation of the ENTEROVIRUS R-gene real-time RT-PCR assay for the detection of enteroviruses in clinical specimens.}, url = {http://dx.doi.org/10.1016/j.jcv.2009.09.033}, year = {2009} }

TY - JOUR ID - citeulike:6072585 L3 - citeulike-article-id:6072585 N2 - BACKGROUND: The rapid molecular diagnosis of enteroviral meningitis has been shown important for an adequate management of the patients. OBJECTIVES: A new CE-marked real-time RT-PCR assay (ENTEROVIRUS R-gene, Argene) was evaluated in two university hospital virology laboratories. STUDY DESIGN: Reactivity, analytical sensitivity and specificity were evaluated using 54 prototype and 173 clinical human enterovirus (HEV) strains, a 12-sample HEV proficiency panel, and 30 non-HEV microorganisms. The clinical performance of the ENTEROVIRUS R-gene assay was evaluated by testing 197 cerebrospinal fluid (CSF) and 103 respiratory specimens, comparatively to the routinely used diagnostic techniques. RESULTS: Sixty-four out of the 65 HEV serotypes tested were detected. The analytical sensitivity ranged between 10(-2.64) and 10(2.39)TCID(50)/50mul. Cross-reactivity was observed with four human rhinoviruses. On 59 CSF specimens analyzed prospectively, the results of the ENTEROVIRUS R-gene assay showed a 94.8% concordance with those of the Smart enterovirus (EV) assay (Cepheid). On 138 CSF specimens tested retrospectively, the results of the ENTEROVIRUS R-gene assay showed a 97.1% concordance with those of either the GeneXpert EV assay (Cepheid) or the in-house RT-PCR HEV assays used at the time of specimen collection. On 103 respiratory specimens, the concordance between the results of the ENTEROVIRUS R-gene assay and those of the routine RT-PCRs or viral culture was 90.2% and 96.1% before and after retest, respectively. CONCLUSIONS: The new test was found able to detect a large panel of enterovirus serotypes; it was sensitive when used on clinical specimens; and, easy and rapid to perform on a routine basis. JF - Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology SN - 1873-5967 TI - Multicenter evaluation of the ENTEROVIRUS R-gene real-time RT-PCR assay for the detection of enteroviruses in clinical specimens. KW - enterovirus KW - rtpcr AU - Pillet, Sylvie AU - Billaud, Geneviève AU - Omar, Shabir AU - Lina, Bruno AU - Pozzetto, Bruno AU - Schuffenecker, Isabelle PY - 2009/10/28/ UR - http://dx.doi.org/10.1016/j.jcv.2009.09.033 ER -