LGC’s Immunogenicity Centre of Excellence has developed a COVID-19 antibody assay that is suitable for both serum and dried blood sampling. The assay can analyse up to 40,000 samples per day using serum or capillary blood collected remotely with Neoteryx’s Mitra microsampling device.
Individuals can be tested for SARS-CoV-2 antibodies by visiting a blood draw center to provide a serum sample via phlebotomy, or by collecting their own blood sample at home using the Mitra device and a simple fingerstick method.
Sample data are processed and reported using the company’s LIMS system.
The assay that LGC developed for SARS-CoV-2 antibody testing achieves specificity of (95% CI) 100% (98.7-100.0) and sensitivity of (95% CI) 98.0% (87.0-99.0) for samples taken 21 days post positive PCR test. Sample results can be reported within 24 hours of sample receipt.
Antibodies play a key role in the immune system’s defense against disease and reinfection. Unlike nasal/oral swab tests that detect an active viral infection, serology tests detect antibodies that develop after a person has recovered from an infection.
“A real value of remote blood sampling with the Mitra device for testing in LGC’s outstanding lab is that people don’t have to leave home to learn if they have developed SARS-CoV-2 antibodies,” said James Rudge, PhD, Technical Director, Neoteryx. “Our Mitra is designed with volumetric absorptive microsampling, or VAMS technology, which enables virtually anyone to collect a few drops of blood on the device with scientific precision.”
“Our assay is suitable for partnering with employers for back to work testing using the self-sampling Mitra device, and therefore does not require a phlebotomist to take the blood sample in a healthcare setting,” said LGC’s Commercial Director, Michael van der Merwe. “The assay can also support patient stratification for clinical trials and COVID-19 vaccine development. As well as qualitative data, we can also provide semi-quantitative data on the level of antibodies present indicating the magnitude of the immune response.”