Summary:
Babson Diagnostics has validated capillary blood as a reliable alternative to venous blood for routine diagnostic testing, paving the way for less-invasive, more accessible healthcare through innovative assay miniaturization and collection technologies.

Takeaways:

  1. Validated Accuracy: Two landmark studies showed that capillary blood performs equivalently to venous blood across 39 analytes, confirming its suitability for routine testing.
  2. Assay Miniaturization Breakthrough: Miniaturized assays enable reliable diagnostics from small capillary samples without compromising precision or requiring dilution.
  3. Enhanced Accessibility: Babson’s BetterWay system simplifies fingertip blood collection, reducing the need for phlebotomy and expanding access to diagnostic testing.

Babson Diagnostics, a science-first healthcare technology company transforming diagnostic blood testing, today announced the results of landmark studies confirming that capillary blood is a reliable alternative to traditional venous blood for routine diagnostic testing. The results, published in the Journal of Applied Laboratory Medicine, demonstrate that through assay miniaturization and novel collection technologies, Babson has successfully addressed longstanding barriers of sample volume and quality. This paves the way for broader access to testing by enabling blood testing without phlebotomy, resulting in a less-invasive patient experience and expanded access to care.

Assay Miniaturization Key to Capillary Blood Testing Viability

This peer-reviewed publication is the first to validate capillary blood as a viable option for routine testing. In it, researchers described the methods and results of two major studies. The first study verified performance of 20 miniaturized assays by comparing them to their unmodified versions using venous blood. The second study used these assays in addition to 19 other assays (39 in total) that did not require miniaturization, to compare conventional venous samples to capillary samples collected with novel technologies. Together, these studies demonstrate both that assay miniaturization can significantly increase the number of reliable tests that can be performed from small sample volumes and that capillary blood performs equivalently to venous blood across a broad range of tests. This advancement is critical to enabling the use of capillary specimens for routine diagnostic testing.

“This study went above and beyond to evaluate accuracy and precision across the entire testing process,” says Robert H. Christenson, PhD, DABCC, FAACC, FACC, former President of the American Association for Clinical Chemistry and a member of Babson’s Scientific Advisory Board. “It shows that challenges with limited sample volume can be circumvented by assay miniaturization without compromising analytical performance, enabling broad test panels.”

39 Analytes Tested

The 39 analytes tested—and their associated 16 calculations and ratios—comprise 90% of Babson’s current BetterWay blood testing menu. BetterWay integrates enabling technologies including the BD MiniDraw Capillary Collection System, the Babson Sample Preparation Device, and the Babson Hand Warmer.

“Together, these innovations enable high-quality blood collection from a fingertip in decentralized settings, reducing the need for phlebotomy.“BetterWay’s patented reverse centrifugation and optimized, miniaturized assays reduce dead volume and maximize test utilization from small capillary samples without requiring workarounds such as sample predilution, making routine diagnostics possible from a simple fingertip collection,” says Chris DiPasquale, vice president of Assay Development at Babson Diagnostics. “The evidence from this study gives both clinicians and patients greater confidence in the quality and reliability of low-volume blood samples.”

Alan Wu, PhD, professor of Laboratory Medicine at UCSF and member of Babson’s Scientific Advisory Board, added: “The team’s transparency in methodology and rigor in validation are exemplary. By benchmarking against venous samples, they not only demonstrated equivalence but, in some cases, even superior performance.”

Diagnostic testing informs 70% of clinical decisions, yet one in three people delay or avoid testing due to inconvenient locations and pain and anxiety in the blood collection process. With BetterWay blood testing, any healthcare worker can collect capillary samples from a fingertip. This approach helps overcome barriers to necessary testing, including fear of needles, logistical challenges, and shortages of trained phlebotomists. By improving access and patient experience, BetterWay supports earlier detection, better chronic disease management, and stronger community health outcomes.

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