Tasso+, The One Plus Product for At-Home Blood Collection

It’s a safe bet that most people prefer to keep their blood to themselves. The idea of getting pricked, lanced or otherwise disturbed to sacrifice a tube or two, on a regular or even irregular basis, usually doesn’t sit well. A Harvard newsletter that discussed fear of needles and blood said people will skip vaccinations because of them.¹

Blood draws usually have come from veins, as they carry more blood than a capillary, and more blood, at least until recently, has been needed for analytic purposes.² Moreover, capillary-drawn blood could become infected, either from multiple pricks because the first insertion wasn’t successful, or a piece of skin somehow got into the mix.³

The improvement of blood analysis technology and the dawn of decentralized trials have prompted development of at-home sampling products that draw from a capillary. Tasso, based in Seattle, has designed a relatively small, oval-shaped unit that can collect blood from the upper arm. A large red button on the unit, once pushed, releases a lancet into the user’s skin. The manufacturer has various models for different collection and analytic purposes. The lancet itself is FDA approved as a Class II device. The company has previously said that the FDA clearance “allows pharmaceutical companies to accelerate decentralized clinical trials.”⁴

The Tasso+ collects high volume, whole capillary blood samples. The One Plus product, now CE marked, is intended for high volume, clinical grade collection. The M20 device was created for patients in clinical trials. The blood sample gets divided into four, dried separate ones. These samples can be monitored for pharmacokinetic information and therapeutic drug levels. The M20 has CE clearance.⁴

Regarding the questions of ease of use and minimization of pain, one study looked at inflammation and autoantibodies in patients with rheumatoid arthritis. Some patients submitted to a finger prick test; others to an upper arm test. All submitted to a venous blood collection for comparison purposes. Virtually all of the 50 patients in the testing arm were able to collect their own blood, although some needed a second try and/or a little help. Pain scores results were “significantly lower” in the self-sampling group as compared to venous collection. Comparisons between capillary and venous blood draws for CCP IgG antibody (0.984) and rheumatoid factor IgM (0.994) were also good, according to the researchers.⁵

References

1. Robert H. Shmerling, MD. Terrified of needles? That can affect your health. Harvard Health blog. https://www.health.harvard.edu/blog/terrified-of-needles-that-can-affect-your-health-2021042722470
2. Wickremsinhe E, Fantana A, Berthier E, et al.Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of WHO Guidelines on Drawing Blood: Best Practices in Phlebotomy. Geneva: World Health Organization; 2010. 7, Capillary sampling. Available from: https://www.ncbi.nlm.nih.gov/books/NBK138654/
3. Andrea Park. Tasso lassos EU approval for at-home high-volume blood collection device. Feb 14, 2023 https://www.fiercebiotech.com/medtech/tasso-lassos-eu-approval-home-high-volume-blood-collection-device
4. Businesswire. Tasso+™ Device Earns FDA 510(k) Class II Medical Device Clearance. Sept. 14, 2022. https://www.businesswire.com/news/home/20220914005221/en/Tasso%E2%84%A2-Device-Earns-FDA-510-k-Class-II-Medical-Device-Clearance/?feedref=JjAwJuNHiystnCoBq_hl-ZuHAZxVRaQvQ0qaekuSK9f3_P53wLuJwyFVA4-mOrLx7fxFuNFTHSunhvli30RlBNXya2izy9YOgHlBiZQk2LP6oD-t3eB0qV-nJQ-WeFyCN1Simk7pbS0xXPOT069Puw==
5. Knitza J, Tascilar K, Vuillerme N, et al. Accuracy and tolerability of self-sampling of capillary blood for analysis of inflammation and autoantibodies in rheumatoid arthritis patients-results from a randomized controlled trial. Arthritis Res Ther. 2022 May 25;24(1):125. doi: 10.1186/s13075-022-02809-7. PMID: 35614488; PMCID: PMC9130452.