| Pre-Approval |
None |
Supplemental Information Requested
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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. |
| Methodology (Commercial Test Name or Laboratory Developed Test (LDT)) |
Real-time RT-PCR (CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay, For in Vitro Diagnostic use; for Emergency Use Only)
Further information on the CDC Influenza SARS-CoV-2 Real-Time RT-PCR Assay's Emergency Use Authorization can be found in:
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| Reflex Testing |
Specimens that test positive for influenza A will be subtyped as follows:
- Seasonal Influenza A subtyping: A(H1)pdm09 and A(H3)
- Novel Influenza subtyping: A(H5) and A(H7)
Specimens that test positive for influenza B will be further tested as follows:
Specimens that test positive for SARS-CoV-2 may be further characterized by whole-genome sequencing.
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| Acceptable Specimen Type(s) and Collection Method |
Human specimens:
Swabs must have a Dacron or synthetic tip with aluminum or plastic shaft.
A nasopharyngeal (NP) swab is the optimal upper respiratory tract specimen collection method for influenza testing. However, such specimens cannot be collected from infants and many older patients may not allow an NP specimen to be collected. Alternatively, a combined nasal and throat swab specimen or aspirate specimens can provide good influenza virus yield.
Specimens should be collected as close to symptom onset as possible. For best results (i.e., highest influenza virus yield), collect respiratory tract specimens within four days of illness onset.
For more collection details, please visit:
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| Minimum Volume Requested |
Respiratory swabs: 1 mL of Universal or Viral Transport Medium
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| Transport Medium (if using) |
Swabs should be placed in sterile Universal Transport Medium (UTM) or Viral Transport Medium (VTM)
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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.
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Storage & Preservation of Specimen / Shipping Conditions
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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
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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
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
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CDPH and CDC resources:
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VRDL Points of Contact
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VRDL Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.Submittal@cdph.ca.gov
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