Telehealth, Telemedicine’s Rapid Rise Requires Remote Specimen Collection
by Neoteryx, on December 14,2020
December 2020 — At-Home Specimen Collection Is Vital to Socially Distant Testing; Multiple Labs Pivot to Process Remote Blood Samples Using Neoteryx’s Mitra® Microsampling Devices & Kits.
The Coronavirus Pandemic has driven a surge in demand for remote specimen collection solutions that keep people safe at home during a viral pandemic that shows no signs of abating. Requests are high for remote devices that enable accurate testing of blood samples for SARS-CoV-2 antibodies—the presence of which could indicate an individual’s immunity against the novel coronavirus. Since the onset of the pandemic in early March 2020, Neoteryx has provided Mitra® devices with VAMS® technology to numerous organizations that are working on COVID-19 research studies and public health projects. The Mitra microsampler is considered the gold-standard device for remote sample collection.
Mitra samples are analyzed as dried blood, and can be mailed directly to designated labs that leverage microsampling methods for measuring antibody levels. Though many other specimen collection devices deployed during the early weeks of the pandemic encountered problems, the Mitra and its volumetric absorptive microsampling (VAMS) technology have enabled labs to consistently deliver accurate data, contributing to successful serology studies and antibody testing programs at multiple medical and scientific institutions.
The National Institutes of Health (NIH), a premier research organization in the United States, has been using the Mitra device with VAMS technology since early April 2020 to enable US citizens isolating at home to participate in remote specimen collection for a nationwide “Sero Survey.” The NIH study, aimed at tracking the number of undetected COVID-19 cases across the country, led to the successful development of a highly accurate analytical method for testing blood samples to identify SARS-CoV-2 antibodies. The NIH serology testing assay is outlined in a pre-print manuscript, now slated for publication in a top peer-reviewed journal, which can be replicated by other labs pursuing antibody studies.
Biotech company Quanterix is using its Ultrasensitive Simoa® HD-X platform to offset the impact of dilution when using small volume samples for detecting antibodies and biomarkers. The company reported that its Simoa platform improves sensitivity and specificity for measuring immune response and seroconversion earlier and with higher resolution than other COVID-19 assays. Self-collected capillary blood samples, such as those collected with the Mitra device and its volumetric absorptive microsampling, can be used with Quanterix’s implementation of Simoa for remote testing for COVID-19. Mitra samples can be tested in the lab with Simoa, which detects SARS-CoV-2 antibodies in the first week of infection, and also detects sub-types of antibodies with a specificity that Quanterix CEO, Kevin Hrusovsky, has compared to high-definition, high-fidelity TV.
In the United Kingdom, LGC’s Immunogenicity Centre of Excellence developed a COVID-19 antibody assay that can analyze up to 40,000 samples per day using serum or capillary blood collected remotely by British citizens using the Mitra® microsampling device. The Mitra blood samples can be sent through the regular mail to the Centre’s 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.
Other organizations using Mitra devices with VAMS technology for COVID-19 and SARS-CoV-2 studies include the University of California San Diego School of Medicine, University of Rochester’s Clinical and Translational Science Institute (CTSI), and Massachusetts General Hospital, which is working with Harvard University to apply a high-throughput electrochemiluminescence-based SARS-CoV-2 total antibody immunoassay from Roche Elecsys®, Roche Diagnostics Inc. The team at Mass General found that the Roche Elecsys assay has a high dynamic range that allows for accurate detection of SARS-CoV-2 antibodies in serum samples diluted 1:20 as well as dried blood extracts from Mitra samples collected at home.
To help organizations and providers locate laboratories that can process remotely collected specimen samples at this critical time, Neoteryx has launched a Microsampling Lab Directory on its website, featuring labs with experience and expertise in analyzing Mitra microsamples.
“A real value of remote blood collection with the Mitra® device for testing in any of these outstanding labs 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. “The pandemic has given rise to many research studies that rely on the Citizen Scientist, who can use our Mitra microsampler at home to easily collect a few drops of blood on the device’s absorptive tip with scientific precision.”
Neoteryx LLC, based in Southern California, is a medical device company that delivers simple, quantitative and automatable microsampling solutions. Its Mitra® Microsampler, an FDA-listed 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 telemedicine, personalized medicine, pharmaceutical development, biotechnology research and clinical diagnostics.
Image Credits: UC San Diego; Neoteryx