Serology for COVID-19
Babson Diagnostics is developing COVID-19 serology assays designed for high throughput.
Accurate, scalable serology testing
Clinical performance evaluation for Babson’s IgG assay resulted in 100% sensitivity and 100% specificity.
High-throughput analysis enables processing up to tens of thousands of tests per week.
Babson Diagnostics has a pipeline of COVID-19 serology assays in development, both qualitative and quantitative, that span IgG, IgM, and IgA antibodies. The company’s first serology assay, Babson Diagnostics aC19G1, is a qualitative IgG assay. The test was validated at Babson’s high-complexity CLIA laboratory in Austin, TX and has received Emergency Use Authorization from the FDA.
Babson is providing its test for free to Austin-area COVID-19 patients, front-line employees such as health care, grocery, and social service workers, and researchers working to understand COVID-19 immunity.
Serology vs. PCR
Babson Diagnostics is focused on COVID-19 serology, but both serology and PCR tests are important for managing COVID-19.
PCR testing uses a nasopharyngeal swab to detect SARS-CoV-2 viral RNA in the respiratory tract. It is the preferred method for determining whether a patient currently has an active SARS-CoV-2 infection.
Serology testing is used to detect antibodies to SARS-CoV-2 in the bloodstream. It is the preferred method for evaluating whether a person has had a SARS-CoV-2 infection in the past and whether they may have developed immunity to SARS-CoV-2 infections in the future. Babson’s first serology assay detects IgG antibodies, which generally become detectable 10-14 days after infection, but may occur later. Further research is needed to understand how long IgG antibodies persist.
Babson Diagnostics aC19G1
Our qualitative IgG assay has received Emergency Use Authorization from the FDA
Babson Diagnostics aC19G1 is a COVID-19 serology test for the qualitative detection of IgG antibodies to SARS-CoV-2. Babson Diagnostics launched the test on April 30, 2020 and received FDA Emergency Use Authorization on June 23, 2020. The following disclaimers apply:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA only for use by the authorized laboratory, Babson Diagnostics, Inc.
- This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Free testing for front-line employees
Babson Diagnostics is offering free serology testing to Austin-area grocery, health care, and social service employees.
Organizations and businesses employing front-line workers may request free serology testing from Babson Diagnostics.
Business serology testing service
Babson Diagnostics is now accepting business service agreements for employee serology testing.
Austin-area companies may hire Babson to provide COVID-19 serology testing to their employees.
Babson Diagnostics is sponsoring a clinical study about COVID-19 serology blood testing.
Austin-area adults who suspect they have had COVID-19 are invited to participate
- Participants must be 18 years of age or older and willing to have a small amount of blood taken from their inner elbow.
- Participants who have documentation of having had COVID-19 will be compensated $50 and, if they agree to return on a monthly basis for up to 24 months, will be compensated an additional $50 at each return visit.
- Participants without documentation of having had COVID-19 will not be compensated initially, but if their sample is of research interest and they agree to return on a monthly basis for up to 24 months, they will be compensated $50 at each return visit.
- Participants may withdraw at any time and are not obligated to agree to return visits.
- A combination of commercially available and investigational test methods will be used. Participants will receive test results from commercially available test methods, but will not receive test results from investigational test methods.
- It will take about 30 minutes to participate per visit.
Guidance on lateral flow kits
Babson has received numerous requests for advice on implementing COVID-19 lateral flow serology kits, which are often from unconventional suppliers and have sparse or vague performance data. Babson and its Scientific Advisory Board have assembled five recommendations to support those who implement lateral flow serology test kits in optimizing accuracy.