Evaluation of the Roche AMPLICOR enterovirus PCR assay in the diagnosis ofenteroviral central nervous system infections

Background: Enteroviruses cause a substantial number of cases of aseptic me ningitis annually in the USA. While culture has been useful in the detectio n of patients with viral meningitis it is time-consuming and lacks sensitiv ity. Detection of vital nucleic acid in patient specimens has been demonstr ated to improve enteroviral detection. Objectives: A research use only comm ercial amplification assay, the Roche AMPLICOR EV test, was compared to cul ture for the diagnosis of enteroviral meningoencephalitis. Study Design: Fo ur-hundred and sixty-five consecutive CSF samples sent prospectively for su spicion of enteroviral infection were evaluated by PCR and shell-vial cultu re. Clinical information and CSF analysis were used to resolve PCR positive , culture negative samples. Sensitivity and specificity were calculated usi ng resolved data. Results: There were 138 samples which met the definition of a true positive. Of these culture detected 77 (sensitivity 55.8%) and PC R detected 136 (sensitivity 98.6%). PCR missed two culture positive samples . Upon repeat testing, these CSF samples were found to contain inhibitors. Conclusions: The Roche AMPLICOR EV-PCR test was statistically more sensitiv e than culture (P < 0.001) in the detection of enteroviruses in CSF in pati ents suspected of having enteroviral meningitis. This assay also has the ad vantage of a rapid turnaround time of 5-6 h compared to 3-5 days for cultur e. (C) 2000 Elsevier Science B.V. All rights reserved.