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Sunday, June 22, 2014

The new age of home lab tests

Despite your dread, a visit to your doctor should be an informative experience, and among the most valuable medical services provided are the lab tests. They furnish vital information about your health. Typically your doctor or nurse will draw a vial or two of your blood, and perhaps collect a small sample of urine.

There are countless blood tests for a variety of conditions and diagnostics; which ones you get depends on your health status. Some of the more common tests, e.g. for patients having a general checkup, include the complete blood count (CBC) which measures red blood cells, white blood cells, and platelets, and provides information about leukemia, anemia, and malaria; the basic metabolic panel which consists of measuring blood glucose, calcium, electrolytes, and kidney function tests; and the lipid panel which measures your cholesterol. Then there are diagnostics for specific disorders such as infections e.g. flu virus or HIV. You can also get tested for sexually-transmitted diseases (STDs). Then there are cancer diagnostics such as for prostate-specific antigen (PSA i.e. prostate cancer). The list goes on and on because your blood is a treasure trove of information.

From your urine, the rapid urine test can be performed which is a test strip that you dip in the urine. There are small square color fields that change color depending on the concentration of different chemicals. The strip tests pH, protein, sugar, blood which may indicate kidney stones (low pH) or bladder/kidney infections (blood in urine), etc.

These medical lab tests ordered by your doctor are the gold standard; however, there are home kits for some of these lab tests that can be used in conjunction or as alternatives to what the doctor may recommend. Two popular home lab tests are for measuring blood sugar which is crucial for diabetics and for determining pregnancy. There are a host of less well-known tests that measure among others: cholesterol, blood in stool, drugs (for drug testing), HIV, urinary infection, yeast infection, allergies, and so forth.

However, one can argue that the home lab test market probably is still in its infancy. Many people are not aware of the home kits, are uncertain of their accuracy and value, do not know how to properly interpret the results, and do not know how to keep track of the results or how to convey results to their doctors.

Times are a changin', however. As I mentioned in previous posts, Apple is making a big move into the fitness and health tracking arena. Two big new products are the Health App, which will serve as hub for all kinds of health information, and the HealthKit APIs which will allow non-Apple apps and devices to interface with Health App. Some of the data will come from Apple products, other data from third-party sources, which will include specialty devices for vital health information such as lab tests. The door is opened for a new wave of products. One such product is Cue which is described in an article from the Verge as well as on its home page.

Cue consists of a "universal reader" that reads cartridges. Each cartridge is used for an individual test with a different type of cartridge for the different types of lab tests. Cue initially plans to test five items: flu, fertility, testosterone, inflammation, and vitamin D levels. Depending on the test you take a swab of saliva, nasal fluid, or blood, insert it into the cartridge (see Figure 1, white stick protruding from red cartridge is the swab), and put the cartridge into the universal reader (white box). The data from the test measurement is fed to your iPhone via Bluetooth where presumably it can be stored in the Health App taking advantage of the HealthKit API.

What about the price? The universal readers costs $199, and each of the cartridges will sell for $20 per 5-pack. For comparison, a dipstick-based home pregnancy test kit costs about $2.50 per test. Pricing will be important in the consumer health market. Cue is hoping "to have both the unit and cartridges subsidized by insurance companies and government health-care programs like Medicare."

The makers of Cue claim that their device is "similar in performance" to their lab counterparts. That is a bold assertion that remains to be verified. Who determines this accuracy?  The FDA, which provides a list of approved laboratory tests offered to consumers. Many home lab test kits are FDA approved, but many others are not. In all likelihood Cue will apply for FDA approval.

I expect to see more of these home lab test machines appear that can interface with your mobile device, and store your personal medical information in the Cloud where you and your doctor (with proper authorization) can access it. If sufficiently accurate, that will be a valuable service to the health consumer.
Figure 1. The future of home lab testing?

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