Democratizing molecular diagnostics: the GeneXpert(®) enterovirus assay.

Background: Few clinical scenarios are as diagnostically demanding as the workup of acute meningitis in the emergency room setting. In humans, most cases of meningitis are due to enteroviral infection, which usually resolves with supportive care and does not generally require hospitalization. The difficulty in evaluating meningitis is often related to its nonspecific presentation; rapid identification of the underlying etiologic agent is critical to selection of the most appropriate course of therapy.

Objective: To develop a rapid, automated polymerase chain reaction-based test for enteroviral meningitis that can be run on demand, and to make the test easy enough to operate that most hospital laboratories can offer it on an immediate basis in order to provide maximum medical impact.

Methods: A sensitive and specific test on the GeneXpert was developed for detection of enteroviral RNA in cerebrospinal fluid. The automated test was carried out in a disposable GeneXpert cartridge, which conducts the steps of nucleic acid purification, amplification and detection of enteroviral genomic RNA in ∼ 2 h. Preclinical and clinical studies showed sensitivities of 97.1 and 98%, respectively, and specificities of 100 and 97.1%, respectively. In February 2006, the test received FDA clearance as an aid in the diagnosis of viral meningitis.

Conclusions: Rapid and accurate molecular diagnostic testing for enterovirus infection provides clinicians with information they need to make the best patient decisions in managing patients with meningitis. The GeneXpert enterovirus assay features on-demand availability and a level of simplicity that allows nearly any hospital laboratory to offer a sophisticated test that was once the exclusive domain of reference laboratories.