| Pre-Approval | Not Applicable |
Supplemental Information Requested
| Please include on the VRDL submittal form the following details: - Transmission route with dates
- If there is no known exposure history, please indicate that as well
- Date of illness onset
- Symptoms
- County of residence
- If initial testing performed, provide the following:
- Name and phone number of laboratory
- Test results, if available
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Submittal Form
| Specimens must be accompanied with a hard copy of the completed VRDL General Purpose Specimen Submittal Form (PDF) or a form generated in the VRDL Lab Web Portal.
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| Methodology (Commercial Test Name or Laboratory Developed Test (LDT)) | Real-time RT-PCR assay for Norovirus Genogroup I and Genogroup II, Astrovirus, Sapovirus, Rotavirus, and Adenovirus. LDT—Laboratory Developed Test, not for diagnostic use.
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| Reflex Testing | Specimens that test positive for Norovirus, Astrovirus, Sapovirus, and/or Adenovirus will be followed with Sanger sequencing for typing. Rotavirus positive specimens will be referred to the CDC for typing. Specimens may be further characterized by whole-genome sequencing.
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| Acceptable Specimen Type(s) and Collection Method | Human specimens
CDPH recommends collecting one stool specimen after symptom onset, if possible.
Whenever possible, stool specimens are preferred. However, in patients who are unable to produce stool specimens, vomitus specimen can be accepted.
Stool specimens should be collected as soon as possible, ideally within 7 days of symptom onset. However, if more than a week has passed since symptom onset and the patient is still symptomatic, stool specimens should still be collected. |
Minimum Volume Requested
| - Stool: 1 gram (solid or semi-solid) or 1 mL (liquid)
- Vomitus: 1 mL
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| Transport Medium (if using) | Use a clean, sterile, leak-proof plastic container with a screw-top lid. No transportation medium is needed. Cary-Blair or equivalent bacterial transport medium can be accepted. Do not use transport medium with preservatives such as formalin.
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| Specimen Labeling | Each specimen tube must be labeled with at least two unique patient identifiers, e.g., patient full name and date of birth. |
Storage & Preservation of Specimen / Shipping Conditions
| Specimen Storage: - Stool specimens can be stored refrigerated (2-8°C) for up to 72 hours after collection. If shipping cannot be completed within 72 hours, specimens should be stored frozen at -20°C or lower as soon as possible after collection. Specimens can be stored frozen (-70°C or lower) for up to 5 years.
- Stool specimens in Cary-Blair or bacterial liquid transport media should be refrigerated and not frozen.
Shipping: Ship specimens overnight for testing as soon as possible. - Refrigerated samples can be shipped on ice packs. If samples will arrive at CDPH within 72 hours of collection and temperature is maintained at 2-8°C. If there is concern that temperature cannot be maintained, submit frozen.
- If frozen, specimens should be shipped overnight on dry ice such that samples arrive at CDPH frozen at -70°C or lower.
Specimens received at temperatures above refrigerated or frozen, as noted above, will be tested for public health surveillance purposes only.
Maximum age of acceptable specimens: 5 years at -70°C or lower. |
Shipping Instructions | Work with your local public health department to ensure samples are packaged according to instructions for Biological Substance – Category B (UN 3373) shipment. Ship specimens and a hard copy of the completed submittal forms to: CDPH VRDL
ATTN: Specimen Receiving
850 Marina Bay Parkway Richmond, CA 94804 Phone: 510-307-8585
VRDL accepts sample deliveries 7 days/week, but for sample deliveries after business hours, or on weekends or holidays, specific consultation with VRDL is required and must be discussed on a case-by-case basis. For consultation, please contact VRDL via email at: VRDL.submittal@cdph.ca.gov.
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| Turnaround Time | - 10 Business days for Norovirus Grouping PCR
- 20 Business days for Rotavirus, Sapovirus, Astrovirus, and Adenovirus PCR
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| Limitations | Negative result does not preclude the possibility of infection.
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| Additional Information | This is a research-use-only assay for surveillance use only. Specimens should be collected as close to illness onset as possible.
For questions regarding Acute Flaccid Myelitis testing, please visit the CDPH Acute Flaccid Myelitis guidance page.
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| VRDL Points of Contact | Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.gov |