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SARS-CoV-2 Diagnostic Testing at UC Berkeley
The IGI has established a CLIA-certified and CAP-accredited diagnostic testing lab in the IGI building at UC Berkeley to meet the demand for fast-turnaround, high-quality COVID-19 diagnostic testing. Our robotic pipeline lets us test over 4,000 samples per day, providing results to patients in 24-48 hours.
As a UC Berkeley institution, we aim to satisfy our campus’s surveillance and medically indicated testing needs by working in close partnership with University Health Services. For non-UC Berkeley groups, we aim to maximize each test’s life-saving and preventative potential by working with healthcare organizations that serve high-risk or vulnerable populations, the underserved or disproportionately impacted, critical infrastructure essential workers, and first responders.
Please note that we are not collecting patient samples at IGI. If you feel sick, please follow guidance from the CDC, your local health department, and your healthcare provider. If you are a UC Berkeley student, faculty, or staff, are feeling sick and want to get tested, please visit the Tang Center’s page to learn how.
Hoping to establish a COVID-19 diagnostic testing laboratory at your institution? Check out our Nature Biotechnology paper “Blueprint for a pop-up SARS-CoV-2 testing lab.“
| April, 2022: The IGI Clinical Laboratory currently has additional capacity to take on more testing for a Bay Area provider. Please contact Carolyn Sherry at csherry@berkeley.edu for more information. |
We run CLIA-validated tests to detect SARS-CoV-2, the virus that causes COVID-19. We partner with external groups to test the samples that were requisitioned by their clinician(s) and report test results back to clinicians. No collection of samples is taking place on-site.
The IGI has validated and runs an improved SARS-CoV-2 laboratory-developed test (LDT) called LuNER. This test uses components from the CDC and Charite RT-qPCR tests to diagnose SARS-CoV-2 in respiratory swab specimens by detecting two viral genes (N gene and E gene) and a human RNA control (RNase P). You can read more about the development and performance of this test in our MedRxiv manuscript and on PubMed.
The experimentally determined detection limit of our LuNER test is 0.5 TCID50/mL, a sensitivity that is as good as or better than most other tests on the market. Additionally, when we directly compared LuNER performance to our previous test (based on the Thermo Fisher TaqPath COVID-19 Multiplex Diagnostic kit), we observed improved detection of known positives with the LuNER test.
PCR methods are highly sensitive — if there is viral RNA in the specimen, our test (like most PCR-based tests) is likely to detect it. However, the virus transfer from the patient to the specimen collection kit depends on both the specimen collection technique and the pathology of the disease (i.e., when the virus is shed during the progression of the disease and where it is present). The CDC and Charite components (on which we based our LDT) have also been assessed for cross-reactivity with other pathogens and show none, limiting the likelihood of false positives.
Once in the lab, we prioritize medically indicated tests to ensure timely results that are needed to inform contact tracing and follow-up care.
The majority of our community partner testing services are donated free of charge. We are very grateful for the generous philanthropic donations that enabled us to respond quickly to the COVID-19 testing crisis and continue providing these services for free.
We also may offer discounts on a sliding scale to nonprofits and government entities to meet our public mission. Additionally, we encourage groups to apply for funding through Alameda County or other State and Federal agencies to cover the cost of testing when not reimbursable by insurance.
Please note that partnering healthcare organizations administer our tests. All tests should be free to patients.
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