Innovative Capitainer®SEP10 Revolutionizes Blood Plasma Sampling
Capitainer, a leading Swedish MedTech company specializing in advanced self-sampling solutions, has announced the launch of a new sampling card designed for collecting separated blood from a finger prick. Capitainer®SEP10 generates a plasma-like sample without the need for a centrifuge, providing at-home sampling capabilities to areas previously not feasible, making it ideal for testing substances that cannot be measured from a whole blood sample.
Capitainer's innovative sampling card Capitainer®SEP10 is developed for collection of blood where the cells are separated from the plasma at the site of collection without centrifugation. The cell-separated blood matrix is measured to an exact volume and dried for best shipping stability in ambient temperature, ready to be sent to a laboratory by regular mail.
Capitainer®SEP10 has obtained its CE marking in accordance with the IVD regulation in the EU and is registered as a product for In Vitro Diagnostics. The product has also received registration approval as a Medical Device Class 1 by the U.S. Food and Drug Administration (FDA).
The product is now ready for sale and use in healthcare diagnostics throughout the USA and countries within the EU, and has already attracted interest in the research community. Professor Henrik Zetterberg, world-leading researcher on biomarkers for neurodegenerative dementias, such as Alzheimer’s disease, is conducting ongoing studies and has already successfully used the cards. Zetterberg sees this new technology as a game-changer for AD diagnostics, read more.
“With our new product, Capitainer is meeting a since long existed demand on the market, by providing a solution to enable at-home collection of plasma,” says Christopher Aulin, CEO at Capitainer. “Our unique technology has already been granted 4 of the 9 patent applications in the US.”
”The new sampling card automates the entire collection process, making it the ultimate at-home sampling product for dried plasma-like material," says Anna Ohlander, R&D Manager at Capitainer. “The cells are separated from the blood at the site of collection without centrifugation and with minimal user requirements making the microfluidic technology we have developed unique and outstanding in the microsampling segment.”
The patient simply pricks the finger, applies the blood and puts the card in the mailbox. Everything else is handled by the Capitainer®SEP10; measurement of exact blood volume, separation of blood cells from the liquid, indication of sample success. Since no trained phlebotomist, test tubes, disposable gloves, syringes, centrifuge etc. are needed, resources and costs are saved for the healthcare system.
“Although dried whole blood gives a good performance for several classic plasma analyses, it is still sometimes required to separate away the cells in the blood” says Mathias Karlsson, Chief Medical Officer at Capitainer. "The new Capitainer®SEP10 card is an important addition to our product portfolio to fulfill our mission to offer alternative sampling for large patient groups and thereby make their lives easier."
For more information, please contact:
Christopher Aulin, CEO
Phone: +46 (0)708 977 577
Email: christopher.aulin@capitainer.com
About Capitainer
Capitainer AB is a Swedish MedTech company that develops and sells patient-centric solutions for self-sampling of blood, plasma, and urine. Founded in 2016, Capitainer has developed unique technologies for collecting and drying exact volumes of fluid within easy-to-use sampling cards. These cards may be sent as standard post to relevant testing laboratories, thus bypassing the need for cold chain logistics and specialised packaging. Capitainer’s products are market-leading with respect to precision and accuracy, with demonstrated equal performance to established pipetting methods. The products are applicable within several market segments, including but not limited to, clinical biomarkers, therapeutic drug monitoring, genomics, drug abuse and doping testing, and R&D and clinical studies.
