We run FDA-authorized tests to detect SARS-CoV-2, the virus that causes COVID-19, in patient samples. No collection of samples is taking place on-site. These tests are all requisitioned and collected by a clinician, tested by our CLIA-certified clinical laboratory, and test results are reported back to clinicians.

On the UC Berkeley campus, we work with University Health Services (UHS) to test students, faculty and staff who present with symptoms. We are expanding to offer the test to asymptomatic staff and students in the near future.

In the cities of Berkeley, Oakland, and Richmond, in partnership with LifeLong Medical Care, we test first responders (firefighters), nursing home residents, those experiencing homelessness, the uninsured, and the underserved. In Oakland, in partnership with Roots Community Health Center, we test disadvantaged populations served by the clinic, including unhoused individuals and the recently incarcerated. Across California, we testing essential workers at publicly owned electrical power plants and water management facilities.

The lab is CLIA certified to report results to physicians through a secure clinician portal, in compliance with all state and federal guidelines.

The IGI has developed a PCR-based test that detects genetic material from the SARS-CoV-2 virus and is based on the kit developed by ThermoFisher Scientific.

You can read more about the scientific development of this test in our medRxiv pre-print and view a diagram of the method here.

Our test can detect 1 copy of the virus per microliter of test solution, a sensitivity that is as good or better than other tests on the market. Additionally, we tested previously identified positive and negative clinical samples and observed 100% agreement with their known status. Clinical validation data can be viewed on medRxiv.

All health management decisions should be made in consultation with a healthcare professional. Because of the sensitivity and specificity of our test, positive results have a very high predictive power. Samples that return a positive result in our assay should be treated as indicating true cases of COVID-19 infection. Negative results should be interpreted in the clinical context of the patient and in consultation with the patient’s physician. Negative results should not be used as the sole determining factor to rule out SARS-CoV-2 infection.

Our current pipeline can run >900 specimens per week. Our robotic pipeline will comfortably run 1000 tests per day. Our turnaround time is 24-48 hours from the time we receive the specimen.

No, the virus is immediately inactivated at the point of sample collection. We use an inactivating solution in our sample collection tubes to maintain the virus genetic material in a stable but non-infectious state.

Yes, as long as the test is requisitioned by a clinician, and fits within our partnership agreements. Our goal is to meet all testing needs for our campus, and address the testing needs of high-risk and vulnerable populations in our community.

To date, our tests have been covered by generous philanthropic donations, and we are working on a tiered pricing strategy that will enable us to continue to provide access to testing for high-risk and vulnerable populations.

The entire team includes ~50 people made up of UC Berkeley faculty, LBNL staff, IGI staff, postdoctoral scholars, and graduate students. Two teams of 13 people each work in 5-hour shifts in the lab itself. Leading and supporting this team are a lab director, technical director, supply chain manager, clinical laboratory scientist, clinical testing site coordinator, software engineers, robotic engineers, and fundraisers.

We chose a test for which we could ensure a secure supply chain from the beginning, and we we plan carefully to ensure that orders and shipments can meet our demand. When we do have donation requests, they will appear in the “Supply Needs” section at the bottom of this page.