COVID-19 Biospecimen Guidelines
March 15, 2020
UCSF Guidelines for Research Biospecimens during the COVID-19 Outbreak
As the spread of COVID-19 continues, the UCSF community is encouraged to take precautions when working with biospecimens obtained for research. The BIOS Program under the Office of Research is providing the following guidance for all activities related to the handling, processing, and storage of biospecimens. The information below is based on the recommendations from global, federal, and state entities and input from our UCSF community. These guidelines will be updated as new details are provided. The recommendations below should be followed with all research biospecimens.
Biospecimen Handling
General guidance: No additional handling precautions are recommended for biospecimens collected during the COVID-19 outbreak from non-COVID-19 infected patients or from patients under investigation (PUIs). Universal Precautions remain the best practice for infection control from all biospecimens.
COVID-19 patients/PUI guidance: When handling and processing biospecimens from COVID-19 patients/PUIs, we strongly recommend adherence to the recently issued CDC guidelines ((cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html). Reiterated below are important guidelines aligned to those provided by the CDC and adapted for UCSF research laboratories:
- When collecting biospecimens from COVID-19 patients/PUIs, all personnel should follow current infection control precautions related to personal protective equipment (PPE) to minimize risk of transmission to self and others.
- All specimen containers (vacutainers, cups, test tubes, conical tubes, vials, etc.) that may contain SARS-CoV-2 should be opened and processed within a certified Class II Biological Safety Cabinet (i.e. tissue culture biosafety cabinet with HEPA filter).
- Following collections, biospecimens from COVID-19 patients/PUIs should be taken directly to a BSL-2 laboratory and not stored and/or opened at workstations (such as cubicles, desks, etc.). If the research project you are supporting does not have access to a BSL-2 space, please consider utilizing services provided by BIOS’ Acquisition and Processing Core, CTSI’s Clinical Research Services (CRS), or the AIDS Specimen Bank (ASB).
- All faculty and laboratory managers must ensure their personnel are using aseptic techniques when processing specimens. This includes disinfection of all surfaces and equipment using 10% bleach solutions (0.5% sodium hypochlorite), both inside and outside of the biosafety cabinet.
- All waste must be disposed of as biohazardous waste.
- Use of dedicated, HEPA-filtered incubators for tissue culture growth of any biospecimens from PUIs is recommended.
All biospecimen types procured from COVID-19 patients/PUIs are to be managed in only Biosafety Level 2 (BSL-2) or higher laboratories. This includes sampling of nasopharyngeal swabs, saliva, urine, blood, feces, and tissue. Early studies out of China, do indicate that COVID-19’s viral RNA has been found in saliva, feces, and blood.[1] [2] Please note: if working with live viral cultures of SARS-CoV-2, a BSL-3 laboratory facility is required and further consultation with UCSF’s EHS (refer to Exposure Control section). Recommendations from the UK (link) published March 13, 2020.
Biospecimen Storage
General guidance: No additional storage requirements are recommended for biospecimens collected during the COVID-19 outbreak from non-COVID-19 infected patients or from PUIs.
COVID-19 PUI/confirmed case guidance: Because the COVID-19 viral load may persist following archival and/or cryopreservation of biospecimens for future use, the BIOS program will maintain a list of confirmed UCSF COVID-19 cases. Researchers are encouraged to work with the BIOS personnel to reconcile any potential samples containing COVID-19 against the list of cases. If identified, those biospecimens may be submitted for laboratory testing to confirm the presence of COVID-19. Further guidance on the use of samples testing positive for COVID-19 will follow. Testing of solid tissue procured from suspected patients can be confirmed using CDC’s testing guidance for post-mortem tissue: https://www.cdc.gov/coronavirus/2019-ncov/hcp/guidance-postmortem-specimens.html
In the event of campus-wide shut-down, BIOS is working to establish a contract with a vendor for secure, offsite storage of biospecimens. There will be a negotiated cost associated with this service from the vendor. In addition, UCSF’s Supply Chain Management (SCM) is working diligently to ensure supply of power and gas to laboratories across UCSF are maintained despite any possible closure.
Exposure Control:
Refer to UCSF’s EHS website for complete information: https://ehs.ucsf.edu/biosafety-resources. Follow UCSF’s protocols for management of pathogen exposure for all individuals working with biospecimens.
In the event you are exposed (inhalation, ingestion, injury, or contact with mucosal surface) to any biospecimens, you must contact the UCSF Exposure Hotline at 415-353-7842 immediately and follow UCSF’s policy on seeking medical care and reporting.
In the event of a biospecimen spill or leak onto a surface, follow UCSF’s Bloodborne Pathogen’s Exposure Plan and immediately contact EH&S at 9-911.
Special thanks: UCSF’s Office of Research, Environmental Health & Safety, and Drs. Annie Luetemeyer, Chaz Langelier, and Carolyn Calfee.
Additional Resources (including references from CIDRAP, University of Minnesota):
Lab Guidance
- COVID-19: safe handling and processing for samples in laboratories(GOV.UK)
- Novel coronavirus (2019-nCoV) technical guidance: laboratory testing for 2019-nCoV in humans (WHO)
- Interim guidelines for collecting, handling, and testing clinical specimens from patients under investigation (PUIs) for coronavirus disease 2019 (COVID-19)(CDC)
- Interim laboratory biosafety guidelines for handling and processing specimens associated with coronavirus disease 2019 (COVID-19) (CDC)
- Laboratory guidelines for detection and diagnosis of the novel coronavirus (2019-nCoV) infection(PAHO)
- COVID-19: guidance for sampling and for diagnostic laboratories(PHE)
- Policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization for coronavirus disease-2019 during the Public Health Emergency(FDA)
- Information for laboratories COVID-19 requests for diagnostic panels and virus(CDC)
- Disease commodity package - novel coronavirus (nCoV)(WHO)
Diagnostics
- CDC tests for COVID-19(CDC)
- Real time RT-PCR panel for detection of 2019-novel coronavirus(CDC)
- 2019-novel coronavirus (2019-nCoV) real-time rRT-PCR panel primers and probes(CDC)
- Diagnostic testing for 2019-nCoV(Johns Hopkins fact sheet, Jan 28, 2020)
- Coronavirus (COVID-19) update: FDA issues new policy to help expedite availability of diagnostics(FDA news release, Feb 29, 2020)
- FDA’s actions in response to 2019 novel coronavirus at home and abroad(FDA statement, Feb 14, 2020)
- Shipping of CDC 2019 novel coronavirus diagnostic test kits begins(CDC news release, Feb 6, 2020)
- HHS seeks abstract submissions for 2019-nCoV diagnostics development(US HHS news release, Feb 5, 2020)
- Coronavirus disease (COVID-19) R&D(WHO)
- 2019 novel coronavirus Emergency Use Authorization/a>(FDA)
- FDA takes significant step in coronavirus response efforts, issues Emergency Use Authorization for the first 2019 novel coronavirus diagnostic(FDA news release, Feb 4, 2020)
- FDA announces key actions to advance development of novel coronavirus medical countermeasures(FDA news release, Jan 27, 2020)
[1] Wei Zhang, Rong-Hui Du, Bei Li, Xiao-Shuang Zheng, Xing-Lou Yang, Ben Hu, Yan-Yi Wang, Geng-Fu Xiao, Bing Yan, Zheng-Li Shi & Peng Zhou (2020) Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes, Emerging Microbes & Infections, 9:1, 386-389.
[2] Yong Zhang, Cao Chen, Shuangli Zhu, Chang Shu, Dongyan Wang, Jingdong Song, et al. Isolation of 2019-nCoV from a Stool Specimen of a Laboratory-Confirmed Case of the Coronavirus Disease 2019 (COVID-19)[J]. China CDC Weekly, 2020, 2(8): 123-124.