| Pre-Approval | Not Applicable |
Supplemental Information Requested
| None
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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 (LDT) Assay (Diagnostic), for the detection of coronaviruses (229E, HKU1, NL63, and OC43), human metapneumovirus (hMPV), respiratory syncytial virus (RSV), parainfluenza virus 1-4 (PIV), adenovirus (ADV), enterovirus (EV), rhinovirus (RV), and Mycoplasma pneumoniae (Mp)
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| Reflex Testing | Specimens that test positive for enterovirus or adenovirus will be typed by Sanger sequencing for epidemiologic purposes only.
Specimens may be further characterized by whole-genome sequencing.
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| Acceptable Specimen Type(s) and Collection Method | Human specimens
Diagnostic Specimens:
- Upper Respiratory specimens:
- Nasopharyngeal swab (NPS), nasal swab (NS), throat swab (TS) and dual nasopharyngeal/throat swab (NPS/TS) specimen
- Nasal aspirates (NA), nasal wash (NW)
- Lower respiratory specimens
- Bronchoalveolar lavage (BAL)
- Bronchoalveolar wash (BW)
- Tracheal aspirate (TA)
- Sputum
- Cerebral Spinal fluid (CSF): enterovirus only
Non-Diagnostic (Surveillance Use Only) Specimens: Minimum volume for submission: - Respiratory swabs: 1 mL of Universal or Viral Transport Medium
- CSF: 300 µL
- Stool: 1 gram (solid or semi-solid) or 1 mL (liquid)
- Serum: 1mL
Swabs must have a Dacron or synthetic tip with aluminum or plastic shaft.
A nasopharyngeal swab (NPS) is the optimal upper respiratory tract specimen collection method for respiratory virus testing. In instances where an NPS cannot be collected, a combined nasal and throat swab specimen or aspirate specimen can provide good respiratory virus yield.
CSF: Use a clean, sterile leak-proof plastic container with a screw-top lid; do not add or use transport medium Stool: Use a clean, sterile leak-proof plastic container with a screw-top lid; do not add or use transport medium
Specimens should be collected as close to symptom onset as possible. For best results (i.e., highest respiratory virus yield), collect respiratory tract specimens within four days of illness onset. For more CSF, serum and stool specimen collection details, visit these CDC specimen collection instructions. |
| Minimum Volume Requested | - Respiratory swabs: 1 mL of Universal or Viral Transport Medium
- CSF: 300 µL
- Stool: 1 gram (solid or semi-solid) or 1 mL (liquid)
- Serum: 1 mL
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| Transport Medium (if using) | Respiratory swabs should be placed in sterile Universal Transport Medium (UTM) or Viral Transport Medium (VTM) Do not use transport medium for CSF, stool, or serum.
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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 | Specimens that will arrive at CDPH within 72 hours of collection may be shipped on frozen cold packs and must arrive at a temperature range of 2-8°C. If specimens cannot be sent within 72 hours of collection, they must be stored frozen at -70°C or lower* and should be shipped on dry ice to arrive at CDPH at temperature of < 0°C.
*Note: Respiratory specimens are stable when frozen at -70°C or lower for at least 1 year. Specimens received out of temperature ranges stipulated above will be tested for public health surveillance purposes only; no diagnostic results will be issued.
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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
If specimens will be delivered between 12 – 1 pm, after 5 pm, or on weekends, instruct the carrier to place specimens in the specimen delivery refrigerator. Please ensure packages arrive Monday – Friday. The 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 can be discussed on a case-by-case basis. For consultation, please contact VRDL at VRDL.submittal@cdph.ca.gov.
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| Turnaround Time | 10 Business Days |
| Limitations | Negative result does not preclude the possibility of infection. |
| Additional Information | For questions regarding Acute Flaccid Myelitis testing, please visit the CDPH Acute Flaccid Myelitis guidance page.
For information regarding Influenza or COVID-19 testing at VRDL please visit:
Other CDPH and CDC resources: |
| VRDL Points of Contact | Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.gov or CDPH Duty Officer (916) 328-3605 (after hours) |