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This assay is intended to be used as an aid in the diagnosis of enteroviral infections.
Weak cross-reactivity was observed with some strains of rhinovirus that could be present in respiratory samples, and a false-positive result is possible if samples contain these viruses.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary. Test results should be interpreted in conjunction with clinical observations and other laboratory data and not used as the sole basis for diagnosis.
