With nearly half of all SARS-CoV-2 infections transmitted by people who are asymptomatic, our highly-automated lab is ideally suited to assist with mass, widespread assurance testing to reopen K-12 schools for in-school learning, to lift on-campus restrictions for universities, and to resume normal operations at workplaces.
To serve populations beyond the Twin Cities, the UMGC joined the Assurance Testing Alliance that connects employers, schools, and other organizations that need large-scale, low-cost testing with labs that have capacity available.
- Lab: The UMGC is a CLIA-certified, high-complexity lab with over 30 years of experience in high-throughput genomics automation.
- Test: The test -- from Perkin-Elmer -- is an EUA-approved real-time qPCR assay (qRT-PCR) that qualitatively detects SARS-CoV-2 viral nucleic acid, and has been assessed by the FDA as the most sensitive test on the market.
- Costs: Depending on the volume of samples and the commitment, the UMGC’s lab fee per test is $13, $19, $22, or $30. (Note that the final cost to a testing client will include additional costs assessed by our testing partners.)
- Turnaround: 95% of sample results are delivered within 24 hours of receiving at the lab and all samples are reported within 48 hours.
- Capacity: The UMGC has a current daily capacity of 15,000 samples with the ability to expand to 60,000 tests per day as demand increases.
- Type of samples: The workflow used at the lab is able to accommodate nasopharyngeal, oropharyngeal, and anterior nares swab specimens, as well as saliva specimens. Sample kits can be provided for anterior nares swabs and saliva.
- Reporting: Negative and positive test results are accurately reported to state health departments.
About our Test
The UMGC’s COVID-19 test uses the highly-sensitive PerkinElmer New Coronavirus Nucleic Acid Detection Kit that has been granted emergency use authorization by the FDA (11/2020). This qRT-PCR assay targets two specific genomic regions of SARS-CoV-2 (N and ORF1ab genes) and is not affected by mutations in the spike protein ("S" gene), as seen in the B.1.1.7 and B.1.351 lineages.
With the lowest Limit of Detection (LoD) among authorized COVID-19 molecular diagnostic assays reported (based on data released by the FDA), the PerkinElmer assay provides about 100X greater sensitivity, deeming it the most sensitive assay. As stated from the from PerkinElmer web-site:
Sensitive limits of detection (LoD) are of critical importance because each 10-fold increase in the LoD of a COVID-19 viral diagnostic test is expected to increase the false negative rate by 13% (Arnaout, R., 2020). In the recent Nature publication (Mackey, et al., 2020) report, PerkinElmer New Coronavirus Nucleic Acid Detection kit was stated to have the lowest limit of detection (LoD) described in the IFU for FDA EUA authorized tests reported in copies/μL.
Two benefits of the extraordinary sensitivity of the PerkinElmer assay:
- The FDA has approved this assay to include asymptomatic testing to make it an ideal assay for students, employees, and other predominantly asymptomatic groups.
- This test can be used with 5:1 sample pooling, in which multiple samples are combined, tested as a pool, and then positive pools are deconvoluted into individual tests. This increases throughput 5-fold and lowers cost, resulting in a low-cost test.
In addition to the PerkinElmer pooling assay, Yale University has authorized the UMGC to perform their EUA-approved SalivaDirectTM Test. This qualitative method uses saliva collected without preservatives to test for SARS-CoV-2 viral nucleic acid, instead of specimens from nasopharyngeal swabs. With its non-invasive sample collection, inexpensive reagents, and reagent and instrument validation from multiple vendors, SalivaDirectTM is an additional option for mass COVID-19 testing.
The UMGC does not provide COVID-19 testing directly to individuals. If you are an organization, like a school, university, or work-place, who needs to make rapid decisions about in-person interactions and would benefit from having self-collected testing at your site, please contact the Lab Director, Dr. Kenny Beckman, at email@example.com.
In addition to COVID-19 testing, the UMGC provides a SARS-CoV-2 strain sequencing service at cost recovery rates, in order to help accelerate the fight against the COVID-19 pandemic.