ZA Approval of Mitra® Devices for Remote Specimen Collection at Home Gives Citizens Living in Rural Areas Greater Access to Critical Lab Services
Los Angeles, USA & South Africa — October 2021 — The Mitra® microsampling device from US-based Neoteryx is now approved as a Class B in vitro diagnostic (IVD) medical device by the South African Health Products Regulatory Authority (SAHPRA) in South Africa (ZA). Separations, a South Africa-based distributor of devices and products for research scientists and labs, was instrumental in helping to get the Mitra device approved for broad use in ZA. Class B registration allows lay people to use the Mitra to self-sample at home for participating in a study or monitoring non-critical conditions.
The Mitra is a portable specimen collection device ideal for remote use by both professionals and laypersons to collect a small blood sample using a simple finger-stick method. The Mitra device is based on volumetric absorptive microsampling technology, made possible by its absorbent VAMS® tip, which allows even untrained users to collect a precise microsample for analysis in a lab. Mitra devices can be used at home, in the field or lab, and many scientists around the world are using them for remote research studies, clinical trials, and public health surveys.
“In South Africa, it is estimated that 15% of poor rural households live more than an hour away from the closest clinic and 20% live more than an hour away from the closest hospital,” said Nicolas Queisser, Managing Director, Separations. “While the Government is addressing the access to health care in rural areas, the availability of Mitra devices for remote sampling can limit the negative impact of resource constraints.”
South Africa covers a vast region, and many citizens live in remote areas with limited access to transport. Mitra devices can be shipped from Separations on behalf of researchers and service providers via regular mail to research volunteers living in distant areas. With the availability of Mitra devices, more ZA citizens will be able to provide specimen samples without having to travel to labs or facilities in city centers. With the help of online video demonstrations and illustrated instructions in Mitra Collection Kits, the Mitra devices allow people to collect high-quality blood samples for validated lab testing. The data gathered from Mitra microsamples can be used for both scientific research and clinical diagnostics.
“The SAHPRA registration confirms that Mitra® devices from Neoteryx have met all regulatory and quality standards in South Africa and can be imported for application in research and clinical settings,” said Loc Huynh, MS, RAC, Regulatory Affairs and Quality Director, Neoteryx.
Mitra microsamples are intended to be analyzed in labs as dried specimen samples, a method that keeps bio-specimens stable and eliminates the need for cold shipping and storage. Remote collection and microsampling of dried specimens are ideal for remote monitoring or studies in low-resource areas and for virtual clinical trials or public health studies where people can easily participate from home. The benefits of Mitra devices versus other microsampling tools include ease of use, a minimally invasive collection experience, quantitative accuracy, and compatibility with automated laboratory instruments for high-throughput processing.
“Before COVID-19 hit our shores, Sub-Saharan Africa was already home to a large immunocompromised population living with HIV/AIDS, heart disease, diabetes, lung disease and cancer, as well as those who take medication that treats lupus, rheumatoid arthritis, cystic fibrosis, and Crohn's disease,” stated Mr. Quiesser. “One fact remains clear: those with persistent health conditions are more susceptible to viruses, may have more severe symptoms, and may have a more difficult recovery. For these patients, the SAHPRA registration of Mitra permits at-home sample collection both for convenience and to avoid potential exposure.”
About Neoteryx Neoteryx LLC, a medical device company in Southern California, delivers simple, quantitative and automatable microsampling solutions. Its Mitra device facilitates remote specimen collection and transportation of blood and other biological fluids to improve human health, reduce laboratory costs and enable new models of care. Neoteryx’s customers include scientific researchers, laboratories and health providers working to advance telemedicine, pharmaceutical development, biotechnology research and clinical diagnostics. For more information, visit www.neoteryx.com.
Mitra devices are intended as a specimen collector and for the storage and transport of biological fluids. They are CE-IVD self-certified in the UK and EU, a Class 1 IVD in Australia & China, a Class B in South Africa, and registered with health agencies in Canada, Thailand, and Ukraine. In the United States, Mitra devices are for Research Use Only (RUO). In some countries, Mitra devices may be used in clinical diagnostic laboratory systems after the laboratory has validated their complete system in compliance with relevant rules and regulations. Neoteryx operates a Quality Management System (QMS) that is based on FDA good manufacturing practices, 21 CFR 820 regulations, and ISO-13485.
About Separations Separations is a product distributor and service provider serving South African scientists and laboratory technicians. With offices in Cape Town and Johannesburg, their mission is to supply spectacular products, technical support, and commercial services. The Applications Support Team at Separations provides specialized services in techniques scripting, assay development, experimental optimization, tailored training sessions, method troubleshooting, and support for general scientific queries. The company follows the highest standards of ethics, and works to build mutually beneficial relationships between customers, employees, suppliers and shareholders. For more information, visit www.separations.co.za.