Should You Trust At-Home Health Tests?

Feb. 4, 2008 — -- At-home health screening has moved way beyond the pregnancy test. People can now determine if they have a yeast infection or UTI, measure cholesterol levels, assess fertility, and even check for colon cancer in the privacy of their own homes.

So why wait for a doctor's appointment when you can buy a test at the drugstore and screen yourself?

While there are many reliable home tests you can take, not every condition is so easy to diagnose.

Internist Dr. Marie Savard says that taking charge of your health and having the information to work with a doctor is important, but she cautions that some tests are better than others and that some raise more concerns than they're worth.

Yeast Infection and Urinary Tract Infection Tests

These over-the-counter products rely on a simple pH test. The pH test, which measures acidity, is no different than what a doctor does in his office to diagnose infection. If the pH level is high, it's not normal and you may need to see a doctor.

The at-home tests are affordable and let you find out if you can treat yourself with over-the-counter medication for a yeast infection or call a doctor to get antibiotics for a UTI.

Symptoms like itching do not necessarily mean you have a yeast infection, though, so in many cases you would have to see a doctor to diagnose and treat other infections.

Cholesterol Tests

Kits such as CholesTrak or Home Access, which are both under $15 a test, use a drop of blood to determine total cholesterol level. CardioChek, which costs over $100, measures high-density lipoprotein ("good") cholesterol and triglycerides (bad fat in your blood).

Experts say the more affordable tests don't provide enough information to be truly useful, while the more expensive tests can be performed incorrectly and give unreliable results.

Savard says that home cholesterol tests worry her. If you're concerned about high cholesterol, it's important to see a doctor for a professional evaluation and treatment plan. She says you can't make an informed choice on a cholesterol reading at one point in time. Cholesterol level is just one aspect of heart health, and the numbers might not provide the whole health picture.

* See a response from CardioChek below.

At-Home Fertility Tests

Fertell offers at-home pregnancy testing for both men and women. The screening for men measures their concentration of motile sperm. For women, a urine test measures her level of follicle stimulating hormone (FSH), which can be an indication of egg quality.

Savard says home fertility testing can be great, especially for men. Typically, a woman goes through testing first, even though fertility problems are just as likely to stem from the man.

The men's at-home fertility test is good for the "shy guy," so he can do it quickly and privately, says Savard. The results may convince him to see a doctor for an evaluation. It's not a perfect test, she says, but may encourage men to take their possible fertility problems more seriously.

Women who are worried about fertility are, in many cases, already being checked out by a gynecologist. Like the cholesterol test, the at-home fertility test only gives one piece of the puzzle.

Colon Cancer Tests

An at-home colon cancer test is essentially the same test a doctor would perform to check the stool for blood. The danger is that if someone does a home colon cancer test and it's negative, they may think they don't need any further testing. Certain factors, such as too much vitamin C in your diet, may lead to incorrect results. Even if the test is negative, you still need a colonoscopy if you are over 50 or if colon cancer runs in your family.

CardioCheck provided this written response to Dr. Marie Savard's interview on "Good Morning America":

"You cannot make an informed choice on a cholesterol reading from one point in time."

This is one major reason CardioChek was developed. Once you and your physician have identified lifestyle changes and/or prescribed medications to lower your cholesterol, the CardioChek can be used between doctors' visits to check your results and identify trends. Why wait to learn if medication or changes in diet and exercise are having the desired effect?

The CardioChek can help you stay on track with whatever changes you make -- diet, exercise, or medication. It is like a scale when you are trying to lose weight.

Another use for the CardioChek is for those who have a family history of high cholesterol. CardioChek can be used at home to check the cholesterol levels of you and your family to indicate if a visit to your physician may be required.

"Total cholesterol is only one risk factor to be concerned with."

True. Total cholesterol is only one indicator that you may have a problem, which is why we have enabled the CardioChek to test other related things. CardioChek can test:

Total cholesterol

HDL ("good cholesterol")

Triglycerides

If you fast before testing your triglycerides, and also measure your total and HDL cholesterol, you can even estimate you LDL, or "bad cholesterol" with the CardioChek. And we hope to have a direct, nonfasting LDL test available to consumers in the future.

Other risk factors include family history, high blood pressure, being overweight, age, low HDL ("good" cholesterol) and smoking. Knowing your risk factors is an important first step toward lowering your risk for heart disease.

Are results accurate?

Yes, the results are accurate. The CardioChek system has been certified by the Cholesterol Reference Method Laboratory Network* (CRMLN) as meeting very strict standards for both Total Cholesterol and HDL Cholesterol results. Having said this, CardioChek is meant to augment, not replace testing by your healthcare professional.

* The Cholesterol Reference Method Laboratory Network (CRMLN) certifies diagnostic products that measure total cholesterol, HDL or LDL. The CRMLN laboratories use reference methods or designated comparison methods that are rigorously standardized to the Centers for Disease Control and Prevention reference methods.

High cholesterol is one of the risk factors for heart disease. You can know your cholesterol and other lipid numbers by using the CardioChek. This is powerful information — if you know you have high cholesterol, you can work with your doctor to manage it. And managing high cholesterol is important to heart health. When you have high cholesterol, it can build up in the walls of your arteries. Thick deposits that form on your arteries are called plaque. When too much plaque builds up, it can block the flow of blood. If an artery that supplies blood to your heart or to your brain is completely blocked, the result can be a heart attack or a stroke.

Home Access cholesterol test provided this written response to "GMA":

"You can't make informed choices on how to treat your cholesterol because you don't know how reliable the test is at one point in time."

We agree that, as it relates to treatment choices, more than one cholesterol measurement should be taken, in fact at least two, at different points in time. Specifically, our Instant Cholesterol literature says, "Always keep in mind that because cholesterol can change from day to day...experts recommend averaging the results from several measurements."

Our CheckUp America Cholesterol Panel literature says, "A single point measurement may not represent an individual's usual levels, therefore before any treatment decision is made, at least two measurements of cholesterol on separate occasions should be available for your doctor's review."

By providing access to accurate and convenient (i.e. at home) cholesterol testing, we provide an opportunity for more people to "know their numbers," and therefore become aware of their cholesterol levels. The educational "FAQ" information in our packaging gives our customers the tools they need to understand their results, and guidance to share their results with their physician. We also maintain a medically-directed call center to assist our customers with any questions they may have as it relates to our products, their use and the related test results.

"You should be working with your doctor to determine your goal."

We agree. Home Access exists to provide access to professional laboratory services at the consumer level, and to ensure that our customers have the educational tools they need to have an informed discussion with their physician. And because we make testing easy, there is no more "excuse" for being "too busy" to take care of your health. We encourage and expect our customers to share their results with their physician.

"The accuracy of the test results could be misleading. Cholesterol is just one aspect of heart health. The numbers might not provide the whole health picture."

Cholesterol is just one aspect of heart health, along with diabetes, smoking habits, blood pressure, weight management, family history of heart disease -- there are several risk factors to be concerned with, but according to the Centers for Disease Control and Prevention, "High blood cholesterol is a major risk factor for heart disease, the leading cause of death in the United States." Literature in both our Instant Cholesterol test and our CheckUp America Cholesterol Panel describe the other risk factors affecting heart health, in addition to cholesterol levels.

By FedEx (for Saturday delivery) we have sent you a demo kit of our new CheckUp America Cholesterol Panel, endorsed by the American Diabetes Association, which will be availabe for sale mid-February.

At Home Access, we believe that convenient, accurate laboratory testing serves to improve access to health care in America. Thank you for the opportunity to more fully describe who we are and what we do, and the value to our customers of at-home testing.

Accutech (cholesterol test) provided this written response to "GMA":

Fifteen percent of Americans have no health care insurance at all and don't have access to regular laboratory blood screenings. Our holesterol ome test provides them with low cost screening devices to initially check their cholesterol levels and encourage them to seek medical advise if they do.

Out-of-pocket deductibles for people with health insurance are continuing to rise, and in an effort to save money, consumers are electing to conduct some of their tests at home. Home tests offer a low cost, time saving and convienent alternative to help them monitor their cholesterol level.

Home Test is not meant to replace regular doctor check-ups. It is meant to supplement people's health care regime with additional at-home testing in between doctor visits, and for people with no other low-cost means at thier disposal.

ColonCARE provided this written response to "GMA":

Colon Cancer Tests

The physician advocates that a negative "home colon cancer test" still necessitates a colonoscopy and seems to imply that a colonoscopy should be performed every year.

This is what the American Cancer Society (ACS) recommends:

Colonoscopy once every 10 years

Fecal occult blood tests such as the immunochemical ColonCARE or immoCARE test every year

For many years physicians have performed fecal occult blood tests (FOB) in their offices. These tests are based on the guaiac method and check for hidden blood in stool. The patient collects stool samples and brings or mails them to their doctor. However, these types of tests are susceptible to numerous interferences. Most importantly, the patient must adhere to strict dietary restrictions before taking the samples to ensure proper test results. (Our guaiac test received FDA clearance in 1984.)

In order to improve fecal occult blood testing, we developed an improved test called ColonCARE. This test is based on the immunochemical testing methodology and was FDA cleared in 2003.

ColonCARE is the first immunochemical FOB test FDA cleared for home-use (patent pending). The same test is FDA cleared for professional use under the name immoCARE. It is exactly the same test. There is absolutely no difference in the testing methodology between the home-use test and the professional use test. However, many people still prefer to see their doctor although they could purchase an FOB test online or at a pharmacy.

Colon cancer is the one preventable cancer. That is why the American Cancer Society issued guidelines to prevent colon cancer and recommends colonoscopies once every 10 years (except for high-risk patients) and FOB tests once a year. The best way to reduce colon cancer deaths would be the implementation of mass screenings by using FOB tests which could be made available to everyone.

For example, immoCARE is presently used in a government-sponsored mass screening for everyone above the age of 40 in an Austrian province which has one of the highest colon cancer rates. Only if immoCARE shows a positive result, a colonoscopy is performed. This is the largest preventive mass screening, involving approximately 135,000 people over a period of four years. There is no reason why such a mass screening should not be possible in the U.S. Approximately 150,000 people are diagnosed with colon cancer every year in the United States and about 50,000 people die from it.

"An at-home colon cancer test is essentially the same test a doctor would perform to check for blood in stool."

This statement is only correct if the doctor uses an immunochemical test. Unfortunately, the overwhelming majority of doctors (maybe 95%) still use FOB tests based on the guaiac method. Guaiac tests will show a positive result for any blood in stool - human or animal. Therefore, no red meat should be consumed before stool samples are collected. There are other interferences as well, for example interferences resulting from Vitamin C, iron or consumption of certain fruits and vegetables.

Our home-use test ColonCARE is a superior test to the guaiac FOB tests performed in a doctor's office. Compared with guaiac tests, ColonCARE (FDA cleared in 2003) has the following advantages:

Only human hemoglobin is detected

No dietary restrictions

One stool sample instead of three samples

Results in 5 minutes

Hygienic and easier for the patient (no close handling of the sample)

Significantly improved performance data (sensitivity, specificity and clinical accuracy)

Our corresponding test for professional use is immoCARE. It is the same test as ColonCARE and is used in a mass screening of 135,000 people above the age of 40 in a province of Austria (the largest mass screening worldwide). This mass screening was developed for early detection of colon cancer. Colonoscopies are only performed if the immoCARE FOB test is positive.

"Even if the test is negative, you still need a colonoscopy if you are over 50 or if colon cancer runs in your family."

This statement implies that a colonoscopy is needed every year for people over 50. If that were to be the case, why should people over 50 go through the trouble of performing an FOB test? Just have yearly colonoscopies. Apparently, the American Cancer Society (ACS) disagrees. According to guidelines published by the ACS, a FOB test should be performed once every year and a colonoscopy every 10 years for people above 50. More frequent colonoscopies are only recommended for high risk patients.

Obviously, a colonoscopy is an invasive procedure. It is costly and has some risks. An FOB test such as ColonCARE is non-invasive and comparatively inexpensive. In order to significantly reduce colon cancer mass screenings of the population above 50 should be conducted by using FOB tests which are user-friendly and inexpensive. If traces of blood in the stool are detected further examinations should be conducted. This way cancerous polyps could be detected early which could then lead to corrective actions. Colon cancer is the one preventable cancer. Through the implementation of early detection measures such as screenings with FOB tests colon cancer deaths could be reduced greatly.