Smartphone Diagnoses HIV and Syphilis

I have written recently on the use of smart phones for various medical tests, but lingering doubts relate to their accuracy as compared to traditional laboratory testing. In addition, the F.D.A. has viewed such diagnostic Apps as ‘new medical devices’ and has required that they undergo extensive testing prior to their approval. Now, we hear about an amazing new technology that aims at addressing existing reservations.

A recently published study, by a team of researchers at Columbia University’s School of Engineering and Applied Science, reports on a smartphone accessory that claims to be as accurate as traditional medical laboratory testing, in detecting HIV and syphilis antibodies. The researchers claim that their device “replicates, for the first time, all mechanical, optical and electronic functions of a lab-based blood test.” This accessory, also known commonly as a “dongle”, is so small and lightweight, that it can be held in one hand and costs only about $34 to produce. This is in contrast to traditional and much larger diagnostic equipment used in medical laboratories which costs tens of thousands of dollars.

In their study, the device was tested in Rwanda among 96 pregnant women, in order to prevent them from passing these diseases to their offspring. With this test, all that’s required is that a drop of blood resulting from a finger prick be applied to a disposable plastic cassette which fits onto the device. The cassette houses chemical reagents that are mixed by simply applying digital pressure. Since the dongle does not contain its own electric current, it relies on the phone’s audio jack through which it receives power and through which it also transmits the results to the smartphone within 15 minutes, where they are then kept on file.

 

device

 

It’s anticipated that with time, this technology will be expanded to cover more diseases and be consumer oriented and user-friendly. Providing this level of accuracy in disease testing, especially in settings located far from the barest essentials, no doubt will have a major impact on the health and lives of millions who currently live in remote areas. Thanks to this new dongle and similar other developments, the smartphone has just become a little smarter, and all indications are that this trend will continue and bring with it novel applications that will result major changes in the delivery of healthcare.

by Jacob J Klausner

 

 

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Home Testing for Jewish Genetic Conditions

In the U.S., it’s estimated that about 1 in 4 Ashkenazic Jews is a carrier for genetic diseases more common in that population. Carriers typically have no symptoms of the disease and unless they undergo genetic testing, may remain unaware of their carrier status – this despite a 25% risk of producing offspring with the actual disease if their mate is also a carrier. When considering starting a family, most Jewish couples know that Tay-Sachs disease commonly runs among Ashkenazic Jews and they will often get tested. But what about testing for other genetic diseases, such as Cystic Fibrosis or Spinal Muscular Atrophy, which are also more commonly found in those of Jewish descent?

Despite also being a public health concern, until recently, there has been no readily accessible resource providing testing information for various Jewish genetic conditions. This is no longer the case. An effort by an Atlanta based non-profit group JScreen, in collaboration with Emory University School of Medicine, has taken on the task of making it much simpler for anyone of a Jewish genetic background to have a saliva home-test prior to starting a family. JScreen will also provide phone counseling to the couple regarding available options. Where results are more involved, JScreen will suggest a consultation with a local genetic counselor.

Participants are mailed a “spit kit” directly to their home. The saliva sample is returned to a certified lab in a pre-paid envelope and results are ready in a few short weeks. An analysis for more than 85 diseases is done, 40 of which are common in people with Jewish ancestry and over 45 of which are common in the general population. JScreen is currently available in the U.S. and its cost is often covered by commercial medical insurance policies as well as Obamacare plans purchased on government exchanges.

med jack

JScreen claims that depending on the medical insurance policy, the maximum out of pocket costs would be $99, even if the insurance plan does not cover genetic testing or has a high deductible. For those who have no health insurance or have Medicare or Medicaid coverage, the current cost for the test is $999. Couples who need help paying for the test, are required to fill out a financial application for assistance determination. JScreen’s Project Coordinator, Rachael Gates, says that due to the generosity of donors, they’re generally able to subsidize balances of over $99 that insurance does not pay. In addition, they have set up a gift certificate program called JGifts which allows friends or family members to offset the cost of testing for aloved one.

While saliva genetic testing can accurately detect up to 99% of carriers for some conditions, they typically average 94% accuracy, which is comparable to blood testing. Anyone over age 18
with at least one Jewish grandparent and planning on having children, should request a genetic screening kit by going to their website, www.JScreen.org. They are also encouraged to view a brief video explaining the screening process as well as sign a consent form. The test request is normally coordinated with a physician. Test results are sent to the couple in approximately four weeks and a followup consultation with a genetic counselor is arranged to review results.

Jacob J. Klausner

 

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Saliva Fertility Monitors

Women traditionally track their fertility on a calendar. Those experiencing difficulty conceiving have used other means, including urine-based ovulation monitoring strips – despite their messiness and cost, to improve their chances of conceiving. More information about these kits can be found on: http://www.hometest4.com/pregnancy-test/female-fertility-test.

Less widely known, are saliva-based monitoring kits, which we report on here. Although such kits have been around many years, they have gained little market share despite their lower cost, reduced messiness and earlier notification of estrogen surge – correlating with ovulation. Utilization stands to increase due to recent European research findings reporting high efficacy and renewed marketing efforts by manufacturers.

Interestingly, both type tests rely on the same biology. As ovulation approaches, estrogen levels surge, leading to higher sodium levels in saliva and cervical fluids. Increased salinity leads to microscopic crystal formation in dry saliva — fern-like patterns (ferning) detected with a handheld microscope and a light. The units have a lipstick case design and testing takes about five minutes.

Currently two companies produce multiple-use, saliva-based kits; Hilin Life Products of Newark, N.J., and Fairhaven Health of Bellingham, Wash. It’s reported that German firm, Geratherm Medical AG, plans to enter the U.S. market with OvuControl. While the companies advocate the kits for conception purposes, they advise against their use for birth-control.

CompanyWebsiteProductMagnificationCost
Hilin Life ProductsHilin Life ProductsKnoWhen60X$59.99
Fairhaven Healthwww.fertile-focus.comFertile-Focus55X$27.95
Geartherm Medical AGTBDOvuControl50XTBD

While the major benefits to these tests relate to convenience and cost, there are some reservations. They include research findings that fail to demonstrate any link between ferning and ovulation, variability in ferning timing which compromises its utility, and ferning is completely absent in some women. In addition, there is a learning curve in being able to recognize ferning. Apparently, women with difficulty conceiving should still rely on more than a single ovulation monitoring system in order to improve their chances.

Jacob J. Klausner

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Google Video Chats With Doctors

If you’re one of millions of people who has done a Google search of your symptoms to try to figure out why you’re not feeling well, Google now hopes to be more helpful in getting you an answer. In an attempt to benefit from the extensive searches being done to self diagnose, Google is testing a new program that allows you to video chat with a physician and supposedly receive better information. It is widely claimed that researching symptoms on the web, frequently leads to misdiagnosis. If the false diagnosis is a serious condition, it can elicit unfounded anxiety, a condition that’s been termed “cyberchondria.”

At the present time, only individuals in Massachusetts and California have access to this trial service where Google will pick up the tab for the chat. To help in the launch, Google has teamed up with licensed physicians from Scripps Medical and One Medical. Though similar services exist, Google believes it’s got an edge by allowing the physician to view the individual. If they’re correct, its official launch will likely impact this field.

Although several headwinds to this platform may be cited, my main concern relates to tremendous reliance on sophisticated technology in current medical practice. It’s common today for a physician, despite being fully aware of the medical history and the patient standing before them, to request a series of laboratory tests and/or radio-graphic imaging before proposing a diagnosis.
With this practice playing a part in Google platform’s, aside from the straight forward case, the best a clinician could provide is a list of several possible diagnoses. Will individuals be inclined to open their Google Wallet for a list of conditions? Time will tell.

The way the Google platform now works is fairly straight forward. When doing a search of symptoms, a pop-up icon appears with the message:“Based upon your search query, we think you are trying to understand a medical condition. Here you can find healthcare providers who you can visit with over video chat. All visit costs are covered by Google during this limited trial. Talk with a doctor now.”

Since last year, Google has employed some health video chats in its Google Helpouts platform. Here “providers” schedule a time to teach or offer advise for a predetermined fee. In the US, the health care industry is over $3 trillion in size and in developed economies it regularly makes up 10% of the GNP. If Google is able to succeed with the platform, then even tapping into a fraction of the health care market, could be very beneficial for the company and hopefully patients as well.

Jacob J. Klausner

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Anemia Home Test Shows Promise

 The hemoglobin of our red blood cells carries oxygen to tissues throughout the body and is normally taken for granted until the level drops and anemia results. This may cause mild symptoms such as dizziness, tiredness and weakness or far more serious cardiac symptoms and even permanent cognitive deficits in children.

 It is estimated that as much as one third of the world’s population are at risk of developing anemia. In the U.S., this translates to 85 million people being at risk while 5 million actually are affected. Managing anemia, requires the drawing of blood by a skilled phlebotomist, followed by analysis by a trained laboratory technician. Since all this requires specialized equipment, testing until now has been limited to hospitals, medical offices or laboratories. Further negatives may include the need for blood drawing on a periodic basis, which can sometimes be painful.

 A just published study out of Georgia Institute of Technology and Emory University, reports on an at home, self-administered, inexpensive, disposable, simple plastic device that measures hemoglobin without even needing electricity. The study involved 238 adults and children with various levels of anemia who also underwent standard blood testing for comparison.

 The device draws up a small drop of blood by capillary action, similar to the way a diabetic performs a finger stick. Exactly 5 micro liters of blood is mixed with a precise amount of a reagent solution to produce a characteristic color that is determined by the hemoglobin level. In less than a minute, test results are achieved by matching colors ranging from blue to red. For those who are color-blind or simply color-challenged, an optional smart phone app has been developed which estimates the hemoglobin level and can then transmit the information.

 Individuals who will benefit most from hemoglobin home testing are those who require ongoing management of blood anemias, including sick-cell anemia, aplastic anemia and thalassemia. In addition, cancer patients receiving chemotherapy, individuals with kidney failure and those with chronic inflammatory-immunologic disorders will also benefit.

 The results of the FDA supported study demonstrated that the device has sensitivity levels greater than 90% in individuals with mild and severe anemia. While the device currently costs only half a dollar to produce, it still requires FDA approval and is expected not to make it to market shelves until 2016.

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Photo shows the two parts of the anemia test device assembled.

Jacob J. Klausner

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FDA Approves New Colon Cancer Screening Home Test

We first reported this past April on a large scale study of Cologuard, a new multiple target home test for colon cancer. The DNA and blood-based test was shown to be more accurate than any screening test currently on the market. Last week, Exact Sciences, the company behind Cologuard, announced FDA’s decision to approve the test.

 In an unprecedented move, the Centers for Medicare and Medicaid Services (CMS) concurrently proposed that Cologuard be covered nationally by these programs. Normally, CMS begins its evaluation for coverage of new technology, only after the FDA submits their approval. It is anticipated that by November, Cologuard will receive final approval for coverage by other medical insurance programs. Cologuard will be available to patients without insurance at a cost of $599.

 The CMS has proposed that medical insurance companies cover the test for individuals aged 50 to 85 who are of average risk and have no signs or symptoms of colon disease. It still remains to be determined how often the test should be performed, how to deal with false positives or how to correlate it with a colonoscopy procedure.

 Exact Sciences has created the website www.CologuardTest.com and is planning to make the test available in select European markets once it receives CE Mark approval. The test which is conveniently performed at home, will be available to patients through their medical providers who will also receive the results. More information about the importance of colon cancer screening can be found on the company’s website, www.beseengetscreened.com. According to the U.S. National Cancer Institute, almost 50,000 people died of colon cancer in the U.S. last year and although it is considered the most preventable cancer, it is also the least prevented due failure in following screening guidelines.

 Jacob J. Klausner

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Lab Tests by Mail

Those who have followed this blog, know that many recent advances in home medical testing have involved developments in the information technology field. But what if you don’t own a smart phone or you’re not especially enamored by medical apps but you’re still interested in basic home laboratory screening.

In most states, you can now receive an assortment of laboratory tests you can perform anytime in the privacy of your own home. For some routine lab tests, there is no longer a need to drive to a medical laboratory and wait in the early morning hours to have your blood drawn. A test requiring that you fast or abstain from your morning coffee will likely further irritate you.

A Chicago medical company, Insight Echo Inc, now provides a service which will allow you to avoid these hassles. When you order an Insight Screenings kit, you will be sent everything required to perform the test. Included are detailed instructions on how to produce blood or saliva samples to ship for complete analysis. The company claims that their results are as accurate as those attained by traditional laboratory testing. Furthermore, if you know what you want and do not reside in New York, Maryland or California, you don’t need a physician’s prescription.

As of now, lab. kits are offered for four common tests as listed.

 

Home Tests Available

CardioMetabolic ProfileInsulin
Hemoglobin A1C
C-Reactive Protein
Triglycerides
Total Cholesterol
HDL
LDL
VLDL
Blood $154.95
Male/ Female Hormones Progesterone
Testosterone
Estradiol
Cortisol
DHEA-S
Saliva $149.95
Prostate Specific Antigen PSA Blood $35.89
Thyroid Stimulating Hormone TSH Blood $59.95
Vitamin D D2, D3 Blood $64.95

 

The lab. results with explanations are sent to you within 7-10 days to any address that you’ve requested. You can then choose to share or not share these findings with as many physicians as you wish. If you don’t know physician, Insight Screenings can provide you with some names of those who’ve utilized their services.

Rapid developments in information technology have impacted numerous industries, including the medical laboratory industry. As a result, consumers are being provided with a greater number and more convenient testing options. You need to wonder why such a straight forward and direct service had not arrived on the market sooner.

 

Jacob J. Klausner

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New App for Pain

Studies have reported that almost 50% of the population suffers from various types of chronic pain conditions. Although most patients get relief with use of over the counter analgesics, there are those who need ongoing professional help to cope with the pain.

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The American Pain Society last month met in Tampa, where initial research findings were presented on a newly developed pain app. What this app does is allow for the patient to input their level of pain, mood, physical activity, medication side effects and compliance with management suggestions. Pain experts have recognized for some time that regular monitoring of patients is of benefit in managing their chronic pain. Furthermore, electronic record keeping has been shown to be more effective than paper diaries.

The pain app was developed by Robert Jameson PhD, a pain psychologist at the Brigham & Women’s Hospital in Boston and professor of anesthesia and psychiatry at Harvard Medical School. In addition to monitoring, the app also provides cognitive behavioral therapy and encourages the patient to remain active and to continue developing pain coping skills.

The app requires that patients are asked five questions and answer them on a sliding scale of 1 through 10. Their responses are analyzed relative to baseline measures. When reports are found to be significantly elevated, the patient is advised that their provider will immediately be contacted and will call them. Monitored information is transmitted and becomes part of the patient’s permanent medical record. It’s anticipated that the app will allow pain specialists to more efficiently and economically monitor patients and reduce visits to hospital emergency services by up to half.

The app comes at a time when we are facing an apparent shortage of pain specialists, due mainly to the newness of the speciality. It is estimated that there is only one pain specialist for every 10,000 patients. A major benefit of this app is that it will make it easier for overburdened practitioners to more easily manage their patients. This is especially important with chronic pain patients since they often experience breakthrough pain and significant adverse effects from medications they’ve been prescribed, and then require costly urgent care.

Bottom line. The app should allow pain practitioners to provide their patients better care more easily.

 

Jacob J Klausner

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Home Sleep Apnea Testing Revisited

The FDA last week approved what is probably the most convenient device currently on the market for sleep apnea testing at home.

 Itamar Medical’s approval of its upgraded WatchPAT technology requires only one finger sensor to measure levels of blood oxygen saturation as well as the integrity of peripheral blood flow. The updated device, called the WatchPAT Unified, greatly simplifies home testing for sleep apnea as it requires the wearing of a single finger sensor which attaches by a short cable to a wristwatch style device. A second optional sensor may be used to assess snoring and body position during sleep.

WatchPAT

Itamar Medical, a medical technology firm based in Israel, claims to have centers in all fifty states where the data from the WatchPAT Unified can be assessed and results sent to the physician. Itamar Medical received it’s FDA clearance earlier than was expected and chose to announce it to over 4500 sleep expert physicians, dentists and psychologists gathered at the Annual Meeting of the Associated Professional Sleep Societies in Minneapolis. There reportedly was much enthusiasm among conference attendees for the monitor’s simplicity and comfort.

It was just over two years ago that we first reported on home sleep apnea monitors coming to market and providing a cost-efficient alternative to studies conducted at sleep centers. Although the first generation sleep disorder monitors such as the SleepView Monitor may have been small, they nevertheless took more getting used to as they required wearing a nasal cannula and finger sensors that would attach by cables to a monitor strapped across the chest.

By now, most insurance companies have realized the cost benefits of such devices and usually require home testing before authorizing a sleep center study for milder and more difficult to detect sleep apnea cases. There is the hope that with such technical advances in sleep monitors for the home and simplified dental therapy for sleep apnea, the potential consequences of undiagnosed or untreated sleep breathing disorders will be greatly reduced.

 

Jacob J Klausner

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Developments in Home Thermometers

Parents generally tend to be somewhat anxious when recording their squirming babies’ rectal temperature. But todays parents can breath a sigh of relief, as recent technical advances have come up with quick, accurate and noninvasive solutions. In fact, as a result of the possibility of injury, many pediatricians no longer suggest that parents record rectal temperature on infants.

Infrared based professional thermometers have been around for several years in hospital and medical settings but only more recently has such technology been made available home use. Although there are many versions on the market, let’s review three of the major brands.

Exergen of Watertown, MA  was one of the the first to incorporate such advanced technology in thermometers for the consumer market. The Exergen Temporal Artery Thermometer requires lightly swiping the forehead and measures the blood temperature of the temporal artery. It has been demonstrated in one study to be accurate to within a fraction of a degree. The thermometer is reported to make 1,000 measurements per second and on instant analysis, displays the most accurate reading. The measurements equate with rectal temperature readings which are considered more precise than oral readings. Selling at local pharmacies and on the internet, the Exergen Temporal Artery Thermometer generally range between $30-50.

 

By sarang (Own work) [Public domain], via Wikimedia Commons

By sarang (Own work) [Public domain], via Wikimedia Commons

The Italian manufacturer, Tecnimed, has produced the Thermofocus which measures forehead temperature while hovering about an inch above the forehead. It claims to be the first non-contact forehead thermometer in the world, but can also be used at the neck or navel if these areas are more convenient. The readings that result equate in accuracy with rectal temperature measurements. The Thermofocus thermometer is especially effective is mass screenings since no covers or disinfectants are required.

A more recent model on the market, is the Braun Forehead Thermometer put out last spring by Kaz USA Inc. of Southborough, MA. Braun also produces an ear version which measures the heat of the ear drums. Ear temperature readings are generally considered to be more accurate than forehead readings, especially if the child is sweating. But the accuracy of measurements in small and tortuous ear canals is questionable and therefore it is not recommended for use in infants below six months of age. The Braun forehead version is somewhat different in that it equates with oral temperature readings which generally run almost a full degree lower than rectal measurements.

Despite the focus on infants in this piece, realizing the convenience and practicality that an infrared thermometer provides, its purchase should be considered in households of any age group.

 

NEW TECHNOLOGY THERMOMETERS

  • Readings take only a couple of seconds and can quickly be repeated
  • Measurements do not require a babies’ cooperation.
  • Can be used to measure temperature at various parts of the body
  • Some models do not require disinfection
  • Requires fully charged batteries
  • More costly than traditional digital thermometers

 

Jacob J Klausner

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