Multicenter Evaluation of the Amplicor Enterovirus PCR Test with Cerebrospinal Fluid from Patients with Aseptic Meningitis

Abstract

The Amplicor Enterovirus PCR test was compared with viral culture for the detection of enteroviruses in cerebrospinal fluid (CSF) specimens. In a multicenter study in which nine laboratories participated, a total of 476 CSF specimens were collected from patients with suspected aseptic meningitis. Sixty-eight samples were positive by PCR (14.4%), whereas 49 samples were positive by culture (10.4%), demonstrating that the Amplicor Enterovirus PCR test was significantly more sensitive than culture (P < 0.001). After discrepancy analysis the sensitivity and specificity of the Amplicor Enterovirus PCR test obtained by using viral culture as the “gold standard” were 85.7 and 93.9%, respectively. Our results with the CSF specimens collected in different countries demonstrate that the Amplicor test is capable of detecting a large variety of enterovirus serotypes and epidemiologically unrelated isolates in CSF specimens from patients with aseptic meningitis. The Amplicor Enterovirus PCR test is a rapid assay which can be routinely performed with CSF samples and is an important improvement for the rapid diagnosis of enteroviral meningitis.

Evaluation of a commercially available reverse transcription-PCR enzyme immunoassay (Enterovirus Consensus kit) for the diagnosis of enterovirus central nervous system infections

“…These figures were also similar to those reported for different amplification methods, such as the Roche Amplicor EV test [16], a real-time RT-PCR assay [21,35] and nucleic acid sequence-based amplification methodology [17,37]. As reported previously [16,30,36,38], there was a statistically significant improvement in the detection of enterovirus central nervous system disease with PCR compared to culture, and a very good correlation (80-85.9%) between the two assays [16,34]. Recently, Buck et al [39] compared a newly described shell vial assay, in which a mixture of human colon carcinoma and genetically engineered buffalo green monkey kidney cells (Super E-mix) was used, with two commercially available RT-PCR assays (one of which was the Enterovirus Consensus kit) and conventional cell culture for the diagnosis of enterovirus meningitis.…”

Acute flaccid myelitis: A clinical review of US cases 2012–2015

“…Poliovirus and enterovirus A71 are infrequently detected in CSF from acute flaccid paralysis cases and more readily identified in stool, which may parallel the inability to detect enterovirus D68 in CSF in AFM cases with the virus more readily identified in respiratory specimens. 54,55 Biological plausibility and a strong epidemiological association support that enterovirus D68 is a nonpolio enterovirus capable of causing AFM and may have contributed to the recent increase in AFM cases in the United States in 2014. Investigation of the association between enterovirus D68 and AFM, as well as the role of other nonpolio enteroviruses and rhinoviruses in the etiology of AFM is ongoing.…”

Multicenter Quality Assessment of PCR Methods for Detection of Enteroviruses

“…Our results indicate that this test has performance characteristics comparable to those of most in-house methods, and the time required to perform this test is less than that required to perform in-house methods. The Enterovirus Amplicor test has been validated for the detection of enteroviruses in CSF, where its superior sensitivity over cell culture methods has repeatedly been demonstrated (3,16,20,23,30,32,39,42). It has also been successfully used to detect enteroviruses in serum and throat swabs and, with somewhat reduced sensitivity compared to that of virus culture, in urine (2,3,28,34).…”