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DIAGNOSTIC TESTING

At this time, diagnostic testing for COVID-19 is available to licensed Health Care Providers through the California Department of Public Health Viral and Rickettsial Disease Laboratory (CDPH-VRDL), many local Public Health Laboratories, and increasing numbers of private clinical laboratories (Map of Public Health Labs Testing for COVID-19). If your Local Health Department or Public Health Laboratory for your jurisdiction does not currently have the capacity to test for COVID-19 virus, we encourage them to work with their catchment area Public Health Laboratory or CDPH-VRDL as needed for testing.  Please contact your Local Health Department if you have any questions about COVID-19 testing. 

SPECIMEN TESTING APPROVAL

Please note that at this time, a Person Under Investigation (PUI) number derived from the CDPH generator is still required for Public Health Laboratory testing.  Health care providers that identify patients for COVID-19 Public Health Laboratory testing must contact their Local Health Department for COVID-19 testing approval and guidance on specimen submissions for testing. A PUI number is not required for private laboratory testing.

For previous laboratory-confirmed cases or patients who may not meet the CDC PUI criteria, please contact your Local Health Department for guidance.

SPECIMEN TYPES AND LABELING

The CDC COVID-19 EUA diagnostic test is approved for upper and lower respiratory tract specimens.  A nasopharyngeal (NP) swab in viral/universal transport medium is the recommended upper respiratory tract specimen. A sputum specimen (in a sterile container) should also be sent if a productive cough is present, but sputum should NOT be induced. An oropharyngeal (OP) swab is no longer required for CDC COVID-19 EUA testing, but if collected may be placed together in the same vial with the NP swab. Serum, urine, and stool specimens are not approved for EUA testing and are not requested at this time.

Please see this link for more details:

CDC Coronavirus Disease 2019 Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens

Required Paperwork

Specimens for Public Health Laboratory testing must be submitted with the following information:

• Disease Suspected: Coronavirus Disease 2019 (COVID-19)
• Test Requested: 2019-nCoV PCR
• Case ID#: PUI number (please also include CalREDIE number if available) - for questions about the PUI generator website call the CDPH Coronavirus Hotline (510) 255-8922
  
• Laboratory data: Any relevant laboratory data, such as respiratory test results
  
• Clinical information: Symptoms, hospitalization status, hospital name and location if applicable
• Travel Information:  Location of travel, current location, exposure history (e.g., if contact to a known case), repatriation flight information (if applicable)
  

SAFETY

Health care providers and laboratories should be familiar with CDC biosafety guidelines for handling and processing potential COVID-19 specimens. Manipulation of open containers of potentially infected specimens should only be performed in a certified Class II biological safety cabinet.

Safety guidelines for handling potentially infected specimens can be found here:

CDC Coronavirus Disease 2019 Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens

PACKAGING AND SHIPPING

Specimens for COVID-19 Public Health Laboratory testing must be packaged and shipped according to US Department of Transportation and International Air Transport Association (IATA) regulations for Category B, Diagnostic Specimens UN 3373. For the purpose of private courier transport between the collecting facility and the Public Health Laboratory, a small volume of Category B Diagnostic Specimens may be transported by employees of the facility or lab under the 49 CFR § 173.6 Materials of trade exceptions: Code of Federal Regulations Title 49. If you do not already have a method for submitting specimens to your local Public Health Laboratory, please contact your Local Health Department for additional instructions.

Weekday Deliveries to Public Health Laboratories

High priority specimens should be clearly labeled on the outside to expedite processing.

Weekend Deliveries to Public Health Laboratories

Please notify the Public Health Laboratory as soon as possible if any submissions are scheduled to arrive on Saturdays or Sundays (such as an overnight shipment sent on Friday or Saturday) to ensure that adequate staff will be available to test and receive the specimens. Weekend specimens should preferably be delivered by courier, not commercial shipping company, and a weekend point of contact must be provided to the laboratory in advance in order to facilitate successful weekend deliveries.

RESULTS

Positive and negative COVID-19 Public Health Laboratory test results will be reported through the local Public Health Laboratory. Laboratory test turn-around time from specimen receipt to result is approximately 48 hours.

PUBLIC HEALTH REPORTING

The CDPH Coronavirus Hotline (510) 255-8922 is attended 24 hours a day, 7 days a week.  When calling, please be prepared to provide the following information (which should not delay reporting if not known): PUI number, name, date of birth, county of residence, county of testing, name of person reporting, and a callback number. 

LHDs currently entering all COVID-19 cases into CalREDIE by 3 pm the following day only need to call the Hotline to report a positive test result if the patient falls into one of these four urgent categories:

1. Death in a patient with a positive COVID-19 test result
2. First patient with a positive test result in your LHD
   
3. Positive test result in a pregnant woman
4. Positive test result in a long-term care setting, including in a skilled nursing facility
   

LHDs not entering cases into CalREDIE are requested to continue to call the Hotline to report all positive results, but may batch positive test results together as long as reports are received within 24 hours.