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.
|
| 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 assay (CDC Novel Coronavirus 2012 real-time RT-PCR Assay, Emergency Use Authorization Only)
Further information on the CDC Novel Coronavirus 2012 Real-Time RT-PCR Assay’s Emergency Use Authorization can be found at the links below.
|
| 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).
|
| Acceptable Specimen Type(s) and Collection Method | Human specimens: CDPH recommends collecting one or multiple specimens from each site after symptom onset, if possible. Specimen types include the following: - Lower respiratory (bronchoalveolar lavage, sputum and tracheal aspirates)
- Bronchoalveolar lavage, tracheal aspirate: Collect 2-3 mL into a sterile, leak-proof screw-cap sputum collection cup or sterile dry container
- Sputum: Expectorated deep cough sputum directly into a sterile, leak-proof, screw-cap sputum collection cup or sterile dry container. A minimum of 300 µL is required for testing.
- Upper respiratory (nasopharyngeal and oropharyngeal swabs)
- After collection, NP and OP specimens can be combined, placing both swabs in the same vial with appropriate viral transport medium.
Whenever possible, lower respiratory tract specimens are preferred. However, in patients who are unable to produce sputum or who are not severely ill, testing nasopharyngeal and oropharyngeal specimens is acceptable.
Respiratory specimens should be collected as soon as possible, ideally within 7 days of symptom onset. However, if more than a week has passed since symptom onset and the patient is still symptomatic, respiratory specimens should still be collected, especially lower respiratory tract 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.
|
Minimum Volume Requested
| - Respiratory swabs: 1mL of Universal or Viral Transport Medium
- Bronchoalveolar lavage, tracheal aspirate: 1 mL
- Sputum: minimum of 300 uL
|
| Transport Medium (if applicable) | Universal Transport Medium (UTM) or Viral Transport Medium (VTM)
|
| 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
| Specimen Storage: - Specimens can be stored refrigerated (2-8°C) for up to 72 hours after collection. If extraction cannot be completed within 72 hours, specimens should be stored frozen at -70°C or lower as soon as possible after collection. Specimens can be stored frozen (-70°C or lower) for up to 2 months.
Shipping: - Ship specimens overnight for testing as soon as possible.
- Refrigerated samples can be shipped on frozen cold packs if samples will arrive at CDPH within 72 hours of collection and temperature is maintained at 2-8°C. If there is concern that temperature cannot be maintained, submit frozen.
- If frozen, specimens should be shipped overnight on dry ice. 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.
Specimens received out of temperature ranges stipulated above will be tested for public health surveillance purposes only; no diagnostic results will be issued.
|
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
|
Limitations
| Negative result does not preclude the possibility of infection
|
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.
CDPH and CDC Resources |
VRDL Points of Contact
| VRDL Medical and Epidemiology Liaisons: (510) 307-8585 or VRDL.submittal@cdph.ca.gov
Coronavirus Control Branch at CDPH: |