Pre-Approval Required
| Prior approval is required to ship samples for MERS-CoV testing.
Pre-approval is required for any MERS-CoV test requests prior to specimens being sent to the VRDL for testing. Contact your local public health department and CDPH for pre-approval information (see Additional Information below).
Submitters must coordinate deliveries with VRDL ( VRDL.submittal@cdph.ca.gov) before shipping. VRDL will not test specimens for MERS-CoV that are received without prior approval, coordination, and tracking information. |
Supplemental Information Required
| Please include in with the request for pre-approval request and also on the VRDL submittal forms the following details: - Travel history with dates
- Any potential exposure to animals, and/or animal products
- If no known exposure history, please indicate that as well
- Date of illness onset
- Symptoms
- Date of illness onset
- County of residence
- Name(s) and phone number(s) of laboratory(-ies) where initial testing, if any, was conducted, with 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 (Novel Coronavirus 2012 real-time RT-PCR Assay, CDC, Emergency Use Authorization Only)
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| Reflex Testing | Specimens that test presumptive positive for MERS-CoV will be referred to the CDC for confirmatory testing. If negative for MERS-CoV, specimens may be reflexed for other respiratory viral pathogens (e.g., influenza).
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| Acceptable Specimen Type(s) and Collection Method | Human specimens: - Lower respiratory tract specimens have the highest yield for virus in patients with MERS-CoV pneumonia. Whenever possible collect one or more of: bronchoalveolar lavage fluid, tracheal aspirate, pleural fluid, or sputum.
- Upper respiratory tract specimens collected from the nasopharynx and oropharynx (throat) with swabs made of synthetic fiber* (NOT cotton) with plastic shafts may be submitted in viral or universal transport medium. Do not use calcium alginate or wooden shaft swabs. Nasal washes are not acceptable.
- Serum and/or stool may be submitted with respiratory specimens.
*Swabs must have a Dacron or synthetic tip with aluminum or plastic shaft. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and inhibit PCR testing.
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Minimum Volume Requested
| - Respiratory swabs: 2-3 mL of Universal or Viral Transport Medium
- Serum: 1 mL
- Stool: 1 gram
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| Transport Medium (if applicable) | 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. |
Storage & Preservation of Specimen / Shipping Conditions
| For respiratory specimens, serum, and stool, freeze or refrigerate specimens promptly after day of collection (DOC).
Delivery to VRDL: -70°C / Dry Ice
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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 VRDL-X
850 Marina Bay Parkway
Richmond, CA 94804
Phone: 510-307-8585
Submitters must coordinate deliveries with VRDL ( VRDL.submittal@cdph.ca.gov) before shipping. VRDL will not test specimens for MERS-CoV that are received without prior approval, coordination, and tracking information.
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 via email at VRDL.submittal@cdph.ca.gov. |
Turnaround Time
| 3 Business Days
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Limitations
| Negative result does not preclude the possibility of infection
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Additional Information
| This is a presumptive assay. Confirmation of MERS-CoV is performed at the CDC.
Specimens should be collected as close to illness onset as possible.
Prior approval is required to ship specimens for MERS-CoV testing.
Local health departments (LHD) should immediately notify CDPH of suspect MERS cases by first creating a MERS-CoV incident report in CalREDIE. LHDs should additionally notify the Coronavirus Control Branch at CDPH via email at ( CoronavirusClinical@cdph.ca.gov and COVIDEpi@cdph.ca.gov) and, if after hours, contact the CDPH Duty Officer (916) 328-3605. The CDPH MERS investigation team will work with LHDs to determine if testing is indicated, and if so, how to proceed.
If testing is approved, LHDs should contact the VRDL Medical and Epidemiology Liaisons at (510) 307-8585 to arrange shipping after the CDPH Clinical Consultant has been notified.
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VRDL Points of Contact
| VRDL Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.submittal@cdph.ca.gov
CDPH Clinical Consultant: Immunization Branch (510) 620-3737
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