āPre-Approval
| āPRIOR 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 Requested
| āContact your local public health department for requested supplemental informationā
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āSubmittal Forms
| āThe three following forms are required: |
āMethodology
| āFilmArray NGDS Warrior Panel (CDC/LRN/FDA 510(k) cleared) (Diagnostic)
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āReflex Testing
| āSamples that test presumptive positive will be referred to the CDC for additional testing
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āAcceptable Specimen Type(s) and Collection Method
| āHuman Specimens:- āWhole blood: plastic (not glass) EDTA (lavender top) tubesā
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āMinimum Volume Required
| āSubmitters 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
| - āWhole blood: refrigerate specimens promptly after collection. Do not freeze whole blood.
Ship refrigerated specimens to VRDL on cold packs.
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āShipping Instructions
| āWork with your local public health department to ensure samples are packaged according to instructions for Biological Substance ā Category A (UN 2814) shipment.
Ship specimens 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
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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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āāTurnaround 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 patientās 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
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āVRDL Points of Contact
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| āMedical 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)ā
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