LOS ANGELES and CAMBRIDGE, England, Sept. 23, 2020 /PRNewswire/ -- LGC's Immunogenicity Centre of Excellence has successfully developed a COVID-19 antibody assay that is suitable for both serum and dried blood sampling. LGC's new assay can analyze 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. The Mitra blood samples can be posted through the regular mail to LGC's Centre of Excellence laboratory for testing, where sample data are processed and reported using the company's custom 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.
Why is precise detection of SARS-CoV-2 antibodies so important? Antibody tests are critical to understanding how widely the novel coronavirus has spread and how immunity against COVID-19 illness develops. 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," commented 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."
About LGC's Centre of Excellence LGC is an international life sciences measurement and testing company, building leading positions in sustainably growing markets, with expertise in regulation, accreditation and standard setting. We provide reference materials, genomics solutions and analytical testing products and services, based on our innovations and our own intellectual property.
LGC's Immunogenicity Centre of Excellence has 20+ years' experience working to GLP and GCP on a wide range of species and matrices. Based in Cambridge (Fordham), UK, the collaborative Centre operates to the highest scientific and quality standards. We have the capacity, rapid turnaround and logistics needed to support the largest, most complex protocols.
About Neoteryx Neoteryx LLC, based in Southern California, is a medical device company that delivers simple, quantitative and automatable microsampling solutions. Its Mitra® Microsampler, an FDA-approved class 1 exempt medical device, facilitates convenient specimen collection and transportation of blood and other biological fluids to improve human welfare, reduce laboratory costs and enable new models of care. Neoteryx's customers include scientific researchers, laboratories and healthcare providers working to advance personalized medicine, pharmaceutical development, biotechnology research and clinical diagnostics. For more information, visit the website at www.neoteryx.com.