Pre-Approval
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Prior approval is required to ship these samples for testing.
CDPH and CDC must approve testing before specimens are collected. VRDL will not test any unapproved suspect Ebola specimens. Contact your local public health department for pre-approval information. CDPH Ebola contacts are listed below.
Submitters must coordinate deliveries with CDPH before shipping. VRDL will not test any suspect Ebola specimens that are received without prior coordination and tracking information.
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āSupplemental Information Required
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Contact your local public health department for required supplemental information
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āSubmittal Forms
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āThe three following forms are required:
- VRDL General Purpose Specimen Submittal Form
- CDC Infectious Disease (CDC Form 50-34, VRDL version) provided by your local health department
- CDC Viral Special Pathogens Branch (VSPB) Specimen Submission Form (PDF)
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Methodology
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FilmArray NGDS
Warrior Panel (CDC/LRN/FDA 510(k) cleared) (Diagnostic)
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Reflex Testing
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Samples that test presumptive positive will be referred to the CDC for additional testing
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āAcceptable Specimen Type(s) and Collection Method
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Human Specimens:
- Whole blood: plastic (not glass) EDTA (lavender top tubes)
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āMinimum Volume Required
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Submitters should collect two (2) tubes of whole blood, each containing a minimum of 4 ml preserved with EDTA (lavender top tubes)
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āTransport Medium
| āNone
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āSpecimen Labeling
| āEach 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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āStorage & Preservation of Specimen / Shipping Conditions
| ā2Ā° - 8Ā°C / cold pack
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āShipping Instructions
| Work with your local public health department to ensure samples are packaged according to instructions for Biological Substance - Category A (UN 2814) shipment.
Ship speciments and a hard copy of the completed submittal forms to:
CDPH VRDL
ATTN: Specimen Receiving VRDL-X
850 Marina Bay Parkway
RIchmond, CA 94804
Phone: 510-307-8585
Submitters must coordinate deliveries with CDPH before shipping. VRDL will not test any suspect Ebola specimens that are received without prior coordination and tracking information.
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Turnaround Time
| ā48 hours
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āLimitations
| āThis is a presumptive assay. If a sample is positive the sample will be submitted to CDC for additional evaluation.
Negative results do not preclude infection with Ebola virus and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
If the patient's symptoms have been present for <3 days, a second sample collected 72 hours after onset of symptoms is required to definitively rule out Ebola.
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āAdditional Information
| āCDPH Ebola Virus Disease Information
CDC Guidance for Collection, Transport and Submission of Specimens for Ebola Virus Testing (https://www.cdc.gov/vhf/ebola/laboratory-personnel/specimens.html) |
āVRDL Points of Contact
| Medical and Epidemiology Liaisons: (510) 307-8585
Clinical Consultation: CDPH Infectious Disease Branch (510) 620-3434 (during business hours) or CDPH Duty Officer (916) 328-3605 (after hours)
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