About the UCSC Molecular Diagnostic Lab
In response to the limited availability of testing to determine if someone is infected with the SARS-CoV-2 virus and unduly long wait times for results for those who are tested, a team of UC Santa Cruz researchers and staff established the Molecular Diagnostic Lab on the UC Santa Cruz campus.
UCSC opened its Molecular Diagnostic Lab on May 1, 2020, operating under CLIA certification of accreditation (CDF-00002057, CLIA # 05D0687329), to offer COVID-19 testing. We are a non-contiguous COVID-19 testing site operating under the UCSC Student Health Center CLIA License. Dr. Ralph Green is the Laboratory Director on the CLIA License. We are starting with two partnerships: UCSC Student Health Center and Santa Cruz Community Health.
The purpose of the UCSC Molecular Diagnostic Lab is to increase the capacity of COVID-19 diagnostic testing in Santa Cruz County with a goal of providing results within 48 hours. Guiding principles are high quality tests, rapid results, and provision of tests that are currently in short supply. Testing priorities will be informed by state and county guidance. Reporting of results will comply with state and county mandates.
This facility will operate within the guidance and regulations put forward by the State of California, the County of Santa Cruz. the California Department of Public Health (CDPH), and the FDA. The CDPH's complete interim guidance on prioritization for COVID-19 laboratory testing can be accessed here. The Centers for Disease Control and Prevention (CDC) and the World Health Organization offer additional guidelines and resources on COVID-19 testing.
Each individual’s eligibility for testing will be determined by the healthcare provider ordering the test. UCSC Molecular Diagnostic Lab’s UCSC qPCR SARS-CoV-2 Assay is a molecular-based test for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory specimens (nasopharyngeal swabs) collected from individuals suspected of COVID-19 by their healthcare provider. The performance characteristics of this Laboratory Developed Test were established by the UCSC Molecular Diagnostic Lab and test validation was performed according to the FDA’s “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” issued on the web on March 16, 2020. The assay is authorized for use only at the UCSC Molecular Diagnostic Lab, pursuant to the March 31, 2020 direction for “Laboratories Who Have Developed a Molecular-Based Test (LDTs) for Coronavirus Disease 2019 (COVID-19).” The necessary validation experiments required the collection of nasopharyngeal swabs from at least 60 volunteers. The response to help with test validation was overwhelming: The UCSC community came out in support with over 80 volunteers, including campus leadership and faculty.
Our authorization for testing is limited to persons identified for testing by their healthcare provider. Pursuant to County Health order No. C19-10, under all of the proposed phases, we will promptly report all positive, negative and inconclusive test results to the California Department of Public Health and follow all reporting guidelines established in the above listed County Health order.
All involved in bringing COVID-19 testing to the UC Santa Cruz campus are grateful for the opportunity to contribute in a positive way to the campus and to the local community.