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.

Blood: 3 mL blood in EDTA (LAVENDER TOP) tube.

CSF: 1 mL in sterile container.

BAL/Washing/Body fluid/Swab: 1 mL in sterile container.

Stool: 3-5 gm (minimum 1 gm)

Tissue: Pea Size in sterile tube or universal transport media (UTM).

Also Acceptable: 3 mL blood in GOLD SST, RED, or PPT (PEARL TOP) tube.

Unacceptable samples: Plasma collected in sodium or lithium heparin.

Note: Separate specimens MUST be submitted when both Viral Culture/Serology and PCR testing are ordered.

Minimum sample requirement: 0.5 mL

Blood: Separate plasma from whole blood within 24 hours of collection. Freeze plasma at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Shipment time must not exceed 48 hours from collection. Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Clear non-cellular fluid (CSF or BAL or Washing): Freeze at -10°C or colder. Ship samples on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Shipment time must not exceed 48 hours from collection. Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Swabs: Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.

Stool: Ship immediately at 2-8°C (ice pack). Shipment time must not exceed 48 hours from collection. Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. If over 48 hours freeze at -10°C or colder and ship on dry ice.

Tissue Biopsy: Freeze at -10°C or colder and ship on dry ice. If freezer and/or dry ice is not available, ship immediately at 2-8°C (ice pack). Sample may be stored at 2-8°C (ice pack) for up to 48 hours of collection. Samples stored at 2-8°C greater than 48 hours old may be rejected. Do not freeze/thaw.