direct to consumer testing

Microfluidics + Consumer Electronics = The Future of Point of Care Testing?

In a paper published yesterday in Science Translational Medicine, researchers tested a low-cost smartphone attachment (a “dongle”) that detects the presence of HIV and syphilis antibodies using ELIZA technology. While the research took place in Rwanda and highlights the usefulness of such technology in low-resource settings, the implications are potentially far-reaching in terms of point-of-care and direct-to-consumer testing.

What do you think? Do you think using smartphone attachments could replace full laboratories in the not-so-distant future?

–Kelly Swails, MT(ASCP), is a laboratory professional, recovering microbiologist, and web editor for Lab Medicine.

Mobile Technology and Health Care

I just stumbled upon this BBC article about a TED talk from about a year ago that discusses an app called Ucheck that can be used to test urine samples for a variety of elements, including glucose, proteins and nitrites. Instead of having to go to a lab to get these urine tests, an individual can use this app—the purchase of which includes the dipsticks and supplies needed to utilize the app—to run initial urinalysis screening tests.

I imagine the Ucheck folks have thought about and researched the pros and cons and possible issues with a system like this. Process issues, user error, contamination (although supposedly one of the elements in the test helps to gauge contamination), among others come to my mind immediately. My biggest question, however, is what does the Ucheck app-user do next after they receive their results? How does the patient proceed if they do need additional medical attention?

The internet can make mini doctors of all of us—there is enough information to make many self-diagnoses, but not necessarily accurate ones. My doctor recently told me they have stopped giving patients full reports from various tests because they found the patients would go home and Google everything on the report and come back to them scared and with inaccurate information. She said this Google-ing gives everyone access to enough information to be dangerous. Would this app give people just enough information to be dangerous?

The TED talk mentions that the app is being put to the test in a laboratory in India—if effective that certainly could be very useful in terms of providing mobile health care, particularly in remote regions of the world. Use of the app in a controlled medical setting where there are trained laboratory and medical personnel available to interpret results is a different story than an individual using it at home.

The TED talk and related articles I found were from 2013 so I did some sleuthing to see if I could find more recent information. I found an article noting that the FDA sent the Ucheck developers a note that the app needs to meet FDA guidelines in order to be in use. I didn’t find follow-up information on what happened after the FDA note, but I haven’t been able to find the app through my iPhone’s app store. Perhaps it’s been put on hold?

Regardless of whether this particular app moves forward, however, medical advances using mobile technology such as these are certainly on the horizon. Which makes for an interesting conversation. Mobile technology could be revolutionary in some parts of the developing world where access to medical resources is scarce. But do they provide what is needed? Are they being used in a setting where if a diagnosis is made there are resources to treat that diagnosis?

What do you think? Are these positive developments? Could they be helpful and harmful? How will regulation work?

-Marie Levy spent over five years working at American Society for Clinical Pathology in the Global Outreach department.

Direct To Consumer Testing: Wave of the Future?

Direct to consumer (DTC) testing is one of the fastest growing industries on the internet, and if laboratories are not careful, we’re going to be blind-sided by it. I wanted to know how this works because in general the websites for this testing have nothing whatsoever on them about the lab. I searched for lab information – accreditation, etc – and found nothing. What I found was that most of these sites are essentially online middlemen between the consumer and the labs – allowing access to lab testing and bypassing the doctor. I decided to do an experiment and see just how easy it was.

I went online and found a DTC company and ordered tests. I skipped their specials, “test of the month” was a complete thyroid panel, and settled for their most popular, most ordered test. It is actually a group of tests which includes a CBC with differential and a chemistry panel for a total of 27 tests plus six calculated values (eGFR, HDL/total cholesterol ratio, etc). The complete test cost me $97.00 plus tax. I can tell you that those tests run at my institution would cost well over $2500.00, and even at a big reference lab, the best price I could get was about $425.00.

It was when I placed my order that any mention of a lab came into the process. Before I could place the order, I had to make sure there was a LabCorp near me. I then went back to the website and printed the company’s requisition for the test and took it with me to a LabCorp draw station. They took the requisition, checked it against a photo ID, collected the appropriate blood samples and sent me on my way. Three days later I received an email from the online company that my results were available. I logged on, and it was just that easy. There were all my test results with appropriate reference intervals and flags. If I want my physician to have a copy, I can have them sent or print them and take them with me.

Amazingly, this is incredibly easy to do, although I suppose you would have to know enough to know what tests to order, or be told what to order by your physician. But I now have the ability to order my own tests, and at significantly less cost than the average hospital or reference lab. If doctors begin telling their patients just what tests to get run and then to bring them the results, this DTC testing will put hospital labs out of business, at least out of the outpatient lab business. There’s no way for a hospital lab to compete with this cost structure. Now all you need is a LabCorp interface to your hospital system and the test results go right back into the chart where the doctor ordered them and the hospital lab is totally outside the loop.

Of course, you will also have people just running tests on themselves after doing some online research, but they will still have to hook up with a doctor somewhere to explain abnormal lab results. I’ve already seen some of that – calls or emails from people off the street looking for explanations of results of metabolic testing. DTC is going to open many, many cans of worms, but it’s coming, nonetheless. I suppose there might be a role for the laboratory professional here, to help the consumer understand their lab results when they do them directly. And hospital labs will always be necessary for STAT and critical tests for inpatients. But the world is changing. We need to be ready for it.

-Patti Jones PhD, DABCC, FACB, is the Clinical Director of the Chemistry and Metabolic Disease Laboratories at Children’s Medical Center in Dallas, TX and a Professor of Pathology at University of Texas Southwestern Medical Center in Dallas.