Push-button device collects 100 μL of blood from upper arm
• by Kristen Monaco
Contributing Writer, MedPage Today February 27, 2017
• This article is a collaboration between MedPage Today® and:
WASHINGTON — A push-button blood collection device billed as “virtually painless” received initial FDA 510(k) clearance late last week.
The device, called TAP and sold by Seventh Sense Biosystems, is cleared for use by healthcare workers for testing HbA1c levels in patients with diabetes and prediabetes. However, a company official said that, in practice, it could be used for other types of tests.
“It’s fairly common industry practice for labs to use products under CLIA guidelines as long as they do their own validation testing, i.e., for different tests. But that’s up to them,” said Stuart Blitz, Seventh Sense’s chief business officer, in an email to MedPage Today.
A notable feature of the device is that it collects only 100 μL of capillary blood, whereas 3-7 mL are typical of standard blood tubes.
Joana Velasquez, MS, RN, CNOR, of the Phillips School of Nursing at Mount Sinai in New York City, suggested that the TAP device would not be appropriate for at least some applications. “On the usual blood collection devices, we use multiple tubes for various tests. How will that work for this device?”
Donald R. Von Hagen, vice president of corporate communications for the giant diagnostic testing firm LabCorp told MedPage Today in an email, “Various testing platforms have different specimen volume requirements that can be explored for potential applications using TAP. We see promise for TAP in the appropriate setting and for certain tests.”
Attached to the upper arm through vacuum pressure, the single-use device draws blood through an array of fine needles concealed from the patient. The drawn blood is held internally within the device until laboratory analysis. The device uses lithium heparin as its anticoagulant, which may also limit the range of potential diagnostic testing.
The company hopes to widen the usage and clinical applicability of technology in the near future, looking to expand into the space of at-home collection and ability for other diagnostic testing.
“Now that we are cleared, we’re working on new versions which will expand the test menu, as well as add-on accessories to increase stability and transport. We also intend to go back and get an ‘at home’ claim to enable patients to use TAP on their own,” Blitz explained via email.
Although many technical questions regarding TAP remain, such as how to safeguard against spillage or contamination of the specimen, Velasquez did see the new device filling an unmet gap in the market.
“We do numerous phlebotomies in both inpatient and outpatient settings. I believe that it will be widely applicable. An in-service [training] to all endpoint users will be beneficial,” she told MedPage Today.