We run CLIA-validated 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 as well as asymptotic surveillance testing.

In the cities of Berkeley, Oakland, and Richmond, in partnership with LifeLong Medical Care, we test 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. In the Bay Area, we test first responders (firefighters and police), and across California, we test essential workers at publicly owned electrical power plants and water management facilities.

Our CLIA-certified lab reports 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 using Luna(R) Probe One-Step 4x Mix from New England BioLabs Inc. and primers & probes developed by the CDC and Charité-Berlin available from Integrated DNA Technologies.

You can read more about the development of IGI-LuNER in our pre-print manuscript and view a diagram of the method here.

Our test can detect one 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 in our Nature Biotechnology paper.

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 robotic pipeline can run >10,000 specimens 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.

Please note that our tests are administered through partnering healthcare organizations and are not supplied directly to consumers. All our tests are free to patients. 

Our standard charge is $80 per specimen. This charge is inclusive of the supplied specimen collection kits, the laboratory processing of those specimens, and the cost of Provider Portal access and maintenance.

We may offer discounts on a sliding scale to nonprofits and government entities to meet our public mission. Additionally, we encourage potential partnering organizations to apply for funding through Alameda County or other State and Federal agencies to cover the cost of testing when not reimbursable by insurance.

The entire team includes ~40 people made up of IGI staff, postdoctoral scholars, and graduate and undergraduate students. Two teams of 13 people each work in 5-hour shifts in the lab itself and a team of 25 undergraduates work between classes to make the testing kits. 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.