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Clinical Laboratories and Pathology Groups

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University of Washington Researchers Develop Home Blood Clotting Clinical Laboratory Test That Uses a Smartphone and a Single Drop of Blood

UW scientists believe their at-home test could help more people on anticoagulants monitor their clotting levels and avoid blood clots

In a proof-of-concept study,researchers at the University of Washington (UW) are developing a new smartphone-based technology/application designed to enable people on anticoagulants such as warfarin to monitor their clotting levels from the comfort of their homes. Should this new test methodology prove successful, clinical laboratories may have yet one more source of competition from this at-home PT/INR test solution.

PT/INR (prothrombin time with an international normalized ratio) is one of the most frequently performed clinical laboratory blood tests. This well-proven assay helps physicians monitor clotting in patients taking certain anticoagulation medications.

However, the process can be onerous for those on anticoagulation drugs. Users of this type of medication must have their blood tested regularly—typically by a clinical laboratory—to ensure the medication is working effectively. When not, a doctor visit is required to adjust the amount of the medication in the bloodstream.

Alternatively, where a state’s scope of practice law permits, pharmacists can perform a point-of-care test for the patient, thus allowing the pharmacist to appropriately adjust the patient’s prescription.

Though in the early stages of its development, were the UW’s new smartphone-based blood clotting test to be cleared by the federal Food and Drug Administration (FDA), then users would only need to see a doctor when their readings went and stayed out of range, according to Clinical Lab Products (CLP).

The UW researchers published their findings in the journal Nature Communications, titled, “Micro-Mechanical Blood Clot Testing Using Smartphones.”

Enabling Patients to Test Their Blood More Frequently

More than eight million Americans with mechanical heart valves or other cardiac conditions take anticoagulants, and 55% of people taking those medication say they fear experiencing life-threatening bleeding, according to the National Blood Clot Alliance.

They have reason to be worried. Even when taking an anticoagulation drug, its level may not stay within therapeutic range due to the effects of food and other medications, experts say. 

“In the US, most people are only in what we call the ‘desirable range’ of PT/INR levels about 64% of the time. This number is even lower—only about 40% of the time—in countries such as India or Uganda, where there is less frequent testing. We need to make it easier for people to test more frequently,” said anesthesiologist and co-author of the study Kelly Michaelsen, MD, PhD, UW Assistant Professor of Anesthesiology and Pain Medicine, in a UW news release.

Shyam Gollakota, PhD
“Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form. This, however, requires a lot of blood, making it infeasible to use in home settings,” said senior study author Shyam Gollakota, PhD (above), professor and head of the Networks and Mobile Systems Lab at UW’s Paul G. Allen School of Computer Science and Engineering, in the UW news release. “The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood. And we get accuracy similar to the best commercially available techniques [used by clinical laboratories].” (Photo copyright: University of Washington.)

How UW’s Smartphone-based Blood Clotting Test Works

The UW researchers were motived by the success of home continuous glucose monitors, which enable diabetics to continually track their blood glucose levels.

According to the Nature Communications paper, here’s how UW’s “smartphone-based micro-mechanical clot detection system” works:

  • Samples of blood plasma and whole blood are placed into a thimble-size plastic cup.
  • The cup includes a small copper particle and thromboplastin activator.
  • When the smartphone is turned on and vibrating, the cup (which is mounted on an attachment) moves beneath the phone’s camera.
  • Video analytic algorithms running on the smartphone track the motion of the copper particle.
  • If blood clots, the “viscous mixture” slows and stops.
  • PT/INR values can be determined in less than a minute.  

“Our system visually tracks the micro-mechanical movements of a small copper particle in a cup with either a single drop of whole blood or plasma and the addition of activators,” the researchers wrote in Nature Communications. “As the blood clots, it forms a network that tightens. And in that process, the particle goes from happily bouncing around to no longer moving,” Michaelsen explained.

The system produced these results:

  • 140 de-identified plasma samples: PT/INR with inter-class correlation coefficients of 0.963 and 0.966.
  • 79 de-identified whole blood samples: 0.974 for both PT/INR.

Another At-home Test That Could Impact Clinical Laboratories

The UW scientists intend to test the system with patients in their homes, and in areas and countries with limited testing resources, Medical Device Network reported.

Should UW’s smartphone-based blood-clotting test be cleared by the FDA, there could be a ready market for it. But it will need to be offered it at a price competitive with current clinical laboratory assays for blood clotting, as well as with the current point-of-care tests in use today.

Nevertheless, UW’s work is the latest example of a self-testing methodology that could become a new competitor for clinical laboratories. This may motivate medical laboratories to keep PT/INR testing costs low, while also reporting quick and accurate results to physicians and patients on anticoagulants.

Alternatively, innovative clinical laboratories could develop a patient management service to oversee a patient’s self-testing at home and coordinate delivery of the results with the patient’s physician and pharmacist. This approach would enable the lab to add value for which it could be reimbursed. 

Donna Marie Pocius

Related Information:

Smartphone App Can Vibrate a Single Drop of Blood to Determine How Well It Clots

Blood Coagulation Testing Using Smartphones

Micro-Mechanical Blood Clot Testing Using Smartphones

55% of Americans Taking Blood Thinners Indicate They Fear Suffering from Major Blooding, 73% More Cautious with Routine Activities to Avoid Risk

University of Washington Develops New Blood Clotting Test

Cleveland Clinic and Microsoft Team up to Use Point-of-Care Testing in EMR Network

New care delivery model might emerge from collaboration between two partners

Guess which famous health provider is partnering with Microsoft (NASDAQ:MSFT) to encourage patients using home self-testing devices to regularly upload those data into an electronic medical record? It’s the Cleveland Clinic Health System. This project may point to a disruptive new model for laboratory testing.

It’s a pioneering arrangement. Microsoft’s HealthVault is interfaced with the eCleveland Clinic MyChart patient portal to create an interactive feature that collects data on from in-home medical devices used by patients with chronic conditions. The pilot project includes 460 patients with diabetes, congestive heart failure and hypertension. These patients use home blood pressure monitors, glucometers, and weight scales which are linked to the HealthVault platform personal health record (PHR) system.

Mayo Clinic Considers Implementing Genetic Tests Enable Personalized Medicine

It may be that the hospital industry’s first implementation of genetic testing will be to support improved use of the prescription drug warfarin in anti-clotting therapy. Healthcare companies and hospitals are banking on the fact that genetics can answer questions about which drugs are safe for individuals to use. Medco Health Solutions and the Mayo Clinic are currently collaborating on a study on personalized medicine to confirm whether genetic testing can help eliminate the life-threatening and costly complications that many patients develop after starting a prescription of the anti-clotting drug warfarin.

This is the latest study in the realm of “personalized medicine,” in which physicians use genetic or other molecular tests to tailor a patient’s treatment. Promoters of personalized medicine say the science boils down to delivering the right treatment at the right dose to the right patient at the right time. Doctors use genetic testing to customize the dosage of a drug, determine which treatment will work and which may pose safety problems, and determine a patient’s susceptibility to disease. These customized therapies have already been put to some clinical use and drug makers, biotech companies, medical institutions, testing laboratories, and government agencies such as the Food and Drug Administration and National Institutes of Health all appear eager to advance the practice.

Each of the types of companies listed above have a different incentive to support personalized medicine. Drug makers and biotech companies can increase their profit by developing drugs tailored to people with specific genetic make-ups. Medical institutions can provide better and safer care to their patients. Government agencies can look forward to a reduction in side effects and health-care spending to treat those side effects (A study by the American Enterprise Institute and the Brookings Institute estimates that the use of genetic testing to personalize dosages of warfarin alone could reduce health care spending by $1.1 billion a year).

For clinical laboratories, the widespread use of genetic testing to tailor drugs and drug dosages has long been expected to increase utilization of genetic assays. Should health insurers discover that the inclusion of these tests in treatment protocols can save billions of dollars now spent in treating life-threatening side effects, then it is likely that payers will offer adequate reimbursement for genetic testing that contribute to a reduction in negative side affects. The FDA has already approved personalized medicine drugs from Genentech, Novartis, and Roche Holding.

Ongoing advances in the knowledge of how genetics can affect specific diseases are being combined with new technologies in molecular diagnostics to create assays which have improved levels of sensitivity and specificity. Should healthcare leaders like the Mayo Clinic introduce clinical protocols such as genetic testing linked to warfarin prescriptions, then the day is not far off when most of the nation’s community hospitals will similarly embrace this type of genetic testing for their patient population. Progressive pathologists and laboratory directors should be developing strategies that prepare their laboratories to support this next generation of molecular diagnostics.

Related Articles:

New genetic tests boost impact of drugs

Medco Launches Collaboration To Study Emerging Field of Personalized Medicine (press release)

Personalizing medicine: Researchers study how genes affect proper dosages