An Overview of Cholesterol Tests for Home

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If you have high cholesterol, home testing may seem convenient and less costly than lab testing. While this may be so, the tests are limited in the information they provide. Due to these limitations, home tests should never replace regular cholesterol testing at your doctor’s office.

Cholesterol home test
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Types of Home Cholesterol Tests

There are three basic types of home cholesterol tests that can be purchased online or at your local pharmacy:

  • Test strips: These involve paper test strips that you read visually. You add a drop of blood from a finger prick and read the color change after several minutes.
  • Electronic meters: The second type requires purchasing a small analyzer, much like a glucose meter. After placing a drop of blood on a test strip, the strip is inserted into the analyzer for a reading.
  • Mail-in tests: The third type of test requires you to send tiny blood samples to a laboratory. You have to wait for them to return your results, but the analysis is done by professionals.

The U.S. Food and Drug Administration (FDA) has approved several home cholesterol tests that measure total cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. There are other FDA-certified kits that measure low-density lipoprotein (LDL) cholesterol. You need to check the product packaging to see which values are tested.

If you decide to opt for home testing, it is best to only consider comprehensive kits, which are almost invariably the most expensive.

FDA Approved, Certified, and Registered

Do not confuse FDA-approved tests for FDA-cleared or FDA-registered tests. These latter tests have not been evaluated for efficacy or safety based on their intended use. Rather, they are either substantially similar to an approved device (certified) or are not subject to premarket review (registered).

Limitations

The American Heart Association hasn't taken a stance on the use of at-home cholesterol tests except to suggest that "it’s best for your primary care doctor to do the test.

Although at-home tests are improving in their sensitivity and accuracy, they cannot provide the information needed to assess your cardiovascular risk or decide when treatment is needed. Regular cholesterol testing through your doctor's office can.

According to the FDA, home-use tests are best interpreted when they are evaluated alongside your medical history, a physical exam, and other tests.

User Error

The biggest challenge associated with home cholesterol testing is user error. It is not like a home pregnancy test where you only need a positive or negative result. Just because you are able to get a reading doesn't mean you did it right or that the reading is accurate.

Here are just some of the things that can go wrong:

  • Instructions: Were any of the instructions confusing?
  • Fasting: Was fasting required and did you comply?
  • Blood sample: Did you get an ample drop of blood on the strip?
  • Timing: Did you read it at the right time?
  • Storage: Was the test kit was stored at the right temperature?
  • Expiration date: Were the strips within the expiration date?
  • Reading: Was there any confusion about the colors that the test reaction caused?
  • Interpretation: Do you know what the results mean and whether you need to speak with your doctor?

This shouldn't suggest that the test is complicated that no one can do it. It is only meant to suggest that one or two errors can lead to false results or misinterpretations.

If you get inconsistent results, see your doctor who can check the values of your device or kit against an in-office (point-of-care) test.

Test Accuracy

The FDA has stated the at-home tests they have approved are about as accurate as the tests done by your doctor if you follow the instructions correctly. These tests have their accuracy data printed on the product label.

For the majority of these devices, there is little data regarding the accuracy of at-home cholesterol tests. Even those approved by the FDA are based on data submitted by the manufacturers.

Product Performance

Of the four at-home cholesterol tests currently approved by the FDA (Accutech CholesTrak, CardioChek Cholesterol Analyzer, Home Access Cholesterol Panel Kit, Mission Cholesterol Test), there is little in the way of published research about their accuracy, even in relation to point-of-care versions of the same tests.

Of the available research, a 2014 study from Italy evaluated the three-year performance of the point-of-care version of CardioChek. The researchers noted the device, first introduced in 2002, had "limited (published) evidence of performance levels." After testing, it was concluded that the device was "adequate" for blood lipid screening. It is unclear whether the at-home version meets the same standard.

The same applies to mail-in services, many of which do not advertise the type of technology they use.

Consumer Use

A 2014 review of studies from Columbia University highlighted some of the pros and cons of at-home cholesterol testing, specifically in response to an electronic device called the AccuMeter Cholesterol Test.

According to research, 91% of users of the AccuMeter Cholesterol Test were able to use the device correctly, but only 75% reached the appropriate decision as to whether a doctor should be seen or not.

Before You Buy

At-home cholesterol tests can vary widely in price. Before purchase, check which lipid values are included in the test and whether the test is FDA-approved or at the very least FDA-certified. It often helps to ask a pharmacist which test they recommend and why.

If you are buying a cholesterol test or any other medical product online, the FDA recommends taking a few precautions:

  • Read the label: If the label and other packaging information are written in multiple languages, the product is likely made outside the United States. This could mean the test is not FDA-registered, not authorized for sale, and potentially fraudulent.
  • Talk to your doctor: If you are thinking about buying an at-home cholesterol test, speak with your doctor first about the benefits and limitations based on your medical history and current health.
  • Ask questions: If you have questions, call or e-mail the seller or manufacturer and ask if the FDA has approved or certified the product.

Be sure to follow the at-home test directions closely, keeping in mind that deviations from the instructions could affect the test results.

If you decide to use a mail-in service, opt for labs that are part of the Cholesterol Reference Method Laboratory Network certified by the Centers for Disease Control and Prevention (CDC). You can also check online to see if the lab on the CDC-certified list.

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Article Sources
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