ROCKVILLE, Md. — 20/20 GeneSystems announced that it has received its first allotment of the new Elecsys Anti-SARS-CoV-2 S lab-based blood test that quantitatively measures antibodies against the virus’ spike protein which received an emergency use authorization from FDA earlier this month. Both the Pfizer and Moderna vaccines are designed to induce an antibody response against the spike protein.  The test manufacturer Roche Diagnostics announced last week that their product will be used in ongoing clinical trials of the Moderna vaccine. “Measuring the quantitative levels of anti-[spike] SARS-CoV-2 antibodies using Roche’s test will help Moderna to gain valuable insights into the correlation between protection from vaccination and antibody levels. This could play a role in assessing if, or when, an individual needs revaccination” Roche said in a Dec. 9 release. Quantitative tests permit individuals to monitor changes in their antibody levels over time and may help assess susceptibility to future infections.

To help determine the minimum antibody levels needed to maintain a safe “return to normal” 20/20 plans to urge its antibody test consumers to complete and update cloud accessible health questionnaires and will deploy machine learning to calculate individualized antibody thresholds based on age, race, BMI and other clinical factors. The company has already successfully used this approach to markedly improve the accuracy of blood-based tumor markers based on real-world data gleaned from over 230,000 tested individuals.

“With vaccines rapidly being rolled out there should be increasing demand by individuals and their healthcare providers for antibody tests,” said Michael Lebowitz, 20/20’s chief scientific officer. “The presence of serum antibodies against an infectious agent may be an indicator of immunity against said agent. Until such time as the durability of the immune response is established, it will be important for both those who have had a prior infection, as well as those who have received a vaccine, to be monitored on a regular basis for the presence of antibodies. Such information can be used to suggest that an individual may benefit from a boost with the vaccine.”

Access to these tests is expected to significantly increase early in the new year after 20/20 completes clinical studies demonstrating that small volumes of capillary blood collected via fingerstick produces equivalent results as traditional venipuncture blood draws. These fingerstick collection kits will be especially useful at pharmacies administering vaccines that do not employ phlebotomists. The company is also planning to develop a home collection kit for the Elecsys Anti-SARS-CoV-2 S likely utilizing a novel capillary blood collection device.

20/20 currently provides an array of COVID-19 testing solutions including viral tests based on PCR, rapid antibody tests authorized for use at the point-of-care, and rapid antigen tests. Please refer to www.CoronaCheckTests.com for product details, updates, and ordering information.