Entero/parechovirus by PCR Qualitative

This assay tests for the qualitative presence of parechovirus and enterovirus by RT-PCR detection of viral RNA. This assay detects Enterovirus D68. It does not distinguish which serotype of enterovirus or parechovirus is present. The enterovirus primers and probes target a 116 base fragment of the viral 5’ untranslated region. This region is the most conserved among >100 enterovirus genotypes. The parechovirus primers and probe target a 64 base fragment of the viral polyprotein. The amount of enterovirus/parechovirus required for detection in 95% of replicates is 500 viral copies/mL (2.70 log copies/mL). Results are reported out as “positive” (if cycle threshold is 40 or less) or “not detected”.

This test was developed and its performance characteristics determined by the University of Washington Department of Laboratory Medicine and Pathology. It has not been cleared or approved by the US Food and Drug Administration.