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Home-Use Tests

This section provides information about home-use tests to screen for certain diseases or conditions. For tests prescribed by your doctor, see the section on lab tests. You can also use the glossary from this page.

What Are Home-Use Tests?

Home-use tests allow easy access to medical information about your health status. They can be cost-effective, quick, and confidential. Home tests can help:

  1. detect possible health conditions when you have no symptoms, so that you can get early treatment and lower your chance of developing later complications (i.e. cholesterol testing, Hepatitis testing).
  2. detect specific conditions when there are no signs so that you can take immediate action (i.e. pregnancy testing).
  3. monitor conditions to allow frequent changes in treatment (i.e. glucose testing to monitor blood sugar levels in diabetes).

Despite the benefits of home testing, you should take precautions when using home-use tests. Home-use tests are intended to help you with your health care, but they should not replace periodic visits to your doctor. Many times, you should talk to your doctor even if you get normal test results. Most tests are best evaluated together with your medical history, a physical exam, and other testing. Always see your doctor if you are feeling sick, are worried about a possible medical condition, or if the test instructions recommend you do so.

See also: Home Diagnostic Tests: The Ultimate House Call?


How Can You Get the Best Results With Home-Use Tests?

Follow the tips listed here to use home-use tests as safely and effectively as possible.

  • Read the label and instructions carefully.
    Review all instructions and pictures carefully to make sure you understand how to perform the test. Be sure you know:
    • what the test is for and what it is not for
    • how to store the test before you use it
    • how to collect and store the sample
    • when and how to run the test, including timing instructions
    • how to interpret the test
    • what might interfere with the test
    • the manufacturer's phone number if you have questions
  • Only use tests regulated by FDA.
    There are several ways to find out if a home-use test is regulated by FDA. You can ask your pharmacist or the vendor selling the test. You can also search for the product in FDA's databases (see "How Can You Know If A Home-Use Test Is Regulated By FDA.") If a test is not regulated by FDA, the U.S. government has not determined the product to be reasonably safe or effective, or substantially equivilant to another legally marketed device.
  • Follow all instructions.
    You must follow all test instructions to get an accurate result. Most home tests require specific timing, materials, and sample amounts. You should also check the expiration dates and storage conditions before performing a test to make sure the components still work correctly.
  • Keep good records of your testing.
  • Call the "800" telephone number listed on your home-use test if you have any questions.
  • When in doubt, contact your doctor.
    All tests can give false results. You should see your doctor if you believe your test results are wrong.
  • Don't change medications or dosages based on a home test without talking to your doctor.


How Can You Know If an Over-The-Counter Test Is Regulated By FDA?

To find out if an Over-The-Counter use test is regulated by FDA, you can look for it in IVD Over-The-Counter Database. To search the IVD Over-The-Counter Database:

  • Enter any word in the name of the test in the first space on the page where it says “Test Name."
  • You might also want to select the “Test Type” from the drop down menu if you know what kind of test it is.
  • You do not need to enter any other information.
  • Select Search at the bottom of the screen to submit your request.

The database will search for records that match your request. It will list the records, and you can select any that interest you. If the database finds no record of the test you requested, the test may not be regulated by FDA.

Search IVD Over-The-Counter Database Now

If the database did not find any record of the test you requested you may contact us for further information.

Contact Us Now


How Can You Get Consumer Information About Home-Use Tests?

Home-use tests can be used to screen for different types of diseases or conditions. Some tests require a doctor's prescription, but most are available over the counter (OTC) at your local pharmacy. Each of the links below describe one type of home-use test.


Should You Buy Home-Use Tests Online?

Although many good home-use tests are available online, others may not work or may even be harmful. Some tests sold online are illegal, that is, being sold without FDA's knowledge. If you think that you have a medical condition or disease, see your doctor or healthcare professional. Don't try to diagnose yourself with questionable products obtained over the Internet.

See also: Buying Diagnostic Tests From the Internet: Buyer Beware!


How Can You Find Out About Problems Reported To FDA For Medical Tests?

FDA keeps data on medical devices that have malfunctioned or caused a death or serious injury in the Manufacturer and User Facility Device Experience (MAUDE) database.
Search the MAUDE database.


How Can You Report Your Own Problems With a Test?

If your symptoms don't seem to agree with your test results, or if your test or device does not seem to be working properly, you can report it to FDA's MedWatch program.
Report Problems to MedWatch program.

If you want to notify OIVD directly of a problem with a home-use test, contact us at


How Does FDA Evaluate Home-Use Tests?

Before home-use tests come to market, FDA receives a submission from the manufacturer describing the product. FDA reviews these submissions to determine if:

  • the user will get acceptable results from the test compared to the results obtained when a professional performs the test;
  • the user will be able to interpret test results correctly; and
  • the benefits of the test outweigh its risks.

See also: FDA Review of Home-Use Devices


Lab Safety Tips

Home Pregnancy Tests – How to Use a Popular Test Wisely

(posted 4/2/04)

The first home pregnancy tests were marketed in the mid 1970’s. These tests are one of the most popular products for home diagnostic testing. It is estimated that about 33% of women have used these tests. The tests are popular because they allow women rapid access to highly sensitive and personal information. These tests can lead to earlier diagnosis and can provide pregnant women an opportunity to seek earlier health care intervention.

FDA is involved in the premarket review of these tests. Since the 1976 Medical Device Amendment, FDA assures that new pregnancy tests perform as well as those tests on the market since 1976. Premarket compares test performance between a new test and an established test. In these kinds of pregnancy devices the new test is compared to varying levels of the hormone human chorionic gonadotropin (hCG) that is the marker for pregnancy.

Recent investigators point out that the FDA review of analytical performance does not always mean a woman is pregnant. This discrepancy is because different tests have different abilities to detect low levels of hCG. Also hCG levels differ between pregnant women depending on the timing of the onset of pregnancy with regard to a menstrual period and depending on each woman’s unique biology.

The result is that pregnancy tests may be labeled up to 99% accurate when compared to other hCG tests, not to pregnancy. This may be true based on information submitted to the FDA. Therefore, labeling of these tests should clearly indicate that there is a possibility for both false positive tests and false negative tests, so patients should contact their health care provider to discuss any result.

Patients may frequently recognize incorrect results with the passage of time. False negatives may be detected by ongoing failure to have a period or the development of other obvious signs of pregnancy. False positives may be demonstrated by the unexpected onset of menses (regular vaginal bleeding associated with “periods”.) Repeat testing and/or other investigations such as ultrasound may provide corrected results.

If a patient has a negative result, it is always wise to consider this a tentative finding. Women should not use medications and should consider avoiding potentially harmful behaviors, such as smoking or drinking alcohol, until they have greater certainty that they are not pregnant.

Since September of 2003, studies for pregnancy tests have been posted on the Office of In Vitro Diagnostic Web Page ( under new 510(k)s – decision summaries. FDA is considering what educational or regulatory tools might be available to help clarify the status, use, and interpretation of these tests.


Common Problems with the Use of Glucose Meters

Glucose Testing Tips:

Diabetes care has come a long way since the introduction of insulin and the first oral anti-hyperglycemic medicines. Life span and quality of life have improved for majority of affected individuals. Even better, a large part of diabetic care formerly performed in hospital clinics can now be managed at home with use of well designed home based glucose meters, a telephone and a good patient-doctor relationship.

The Office of In Vitro Diagnostics (OIVD) is charged with the job of evaluating many devices, including glucose meters. OIVD helps these meters come to the public market. Another of its tasks is the continuous evaluation of the same devices for long term safety and effectiveness not just of the devices, but of how the devices are used.

OIVD is taking this opportunity to provide some friendly tips in Point of Care glucose testing inspired by some comments we have received from manufactures and users of these devices.

Causes of false results may be patient/sample based or user/device based. Some common problems and their effects on meter glucose readings are listed below.

Sensor strips not fully inserted into meter
false low
always be sure strip is fully inserted in meter
Patient sample site(for example the fingertip) is contaminated with sugar
false high
always clean test site before sampling
Not enough blood applied to strip
false low
repeat test with a new sample
Batteries low on power
error codes
change batteries and repeat sample collection
Test strips/Controls solutions stored at temperature extremes
false high/low
store kit according to directions
Patient is dehydrated
false high
stat venous sample on main lab analyzer
Patient in shock
false low
stat venous sample on main lab analyzer
Squeezing fingertip too hard because blood is not flowing
false low
repeat test with a new sample from a new stick
Sites other than fingertips
results from alternative sites may not match finger stick results
Test strip/“Control” solution vial cracked
false high/low
always inspect package for cracks, leaks, etc.
Anemia/decrease hematocrit
false high
venous sample on main lab analyzer
Polycythemia/increased hematocrit
false low
venous sample on main lab analyzer

The advantage of Point of Care testing is eliminated if proper technique is not followed. In addition to the above recommendations, laboratory professionals must remember to wash hands and change gloves between patients. Also, clean the surface of the meter if blood gets on it. This each time, every time approach helps protect both the patient and the health care worker from blood borne agents like HIV and HCV.

All operators, from patients to non-lab health care workers to medical technologists and physicians, should be thoroughly familiar with any device prior to using it. The best way to do this is to read the package insert and user manual carefully before using a device for the first time. It sounds simple, and it is. If you have any questions, ask someone who is familiar with the device. Another option is calling the customer service telephone number located on most package inserts. The people on the other end are there to help. Another good tip is to reread the package insert every few months. It is a good practice and their may be changes.

Next, watch an experienced laboratory professional, doctor, nurse or diabetic educator perform the test. Then perform the test in front of someone who has experience in using the glucose meter and instructing others on its performance. Ask for tips.

Specific problems come up from time to time including glucose readings that don’t make sense. For example you might feel fine when the glucose meter reading is obviously too high or too low. Remember, the best way to resolve any questionable result, and the best sample from any sick patient, is still a venous blood sample tested at a central lab. Even then any result that does not fit the clinical picture needs to be investigated and, at a minimum, repeated.

For more information also see FDA’s diabetes website at:

Updated 5/1/03


Glucose Meter Test Results: Useful Tips to Increase Accuracy and Reduce Errors

Have you ever wondered why you got a bad glucose meter test result when there is nothing obvious wrong with your meter, your test strips are new, and you’ve been running glucose tests for years? The simple answer is that glucose meters are not perfect, and neither are the people who use them! This chart lists some tips to help you get the most accurate results from your glucose meter.

Make sure you...
  • follow the user instructions about sample size. Repeat the test if you have any doubt that enough blood was added.
If there is insufficient blood on the test strip, the meter may not be able to read the glucose level accurately. Although many meters are designed to alert you when the sample size is too small, some meters detect only large errors. There have been cases where meters have displayed glucose levels that were less than half the actual levels without displaying error messages.
  • insert the test strip completely into the meter guides.
When a test strip is not fully inserted into the meter, the meter cannot read the entire strip area. Many meters are designed to detect strip placement errors and will not provide a result. But, just as described above, many meters detect only large problems. There have been cases where meters have displayed glucose levels that were significantly higher or lower than the actual levels when there was only a small error in strip placement.
  • keep the meter clean.
Even small amounts of blood, grease, or dirt on a meter’s lens can alter the reading.
  • check the test strip package to make sure the strips are compatible with your meter.
Test strips are not always interchangeable, and meters cannot always detect incompatible strips. Test strips that look alike may have different chemical coatings. Small variations in strip dimensions can also affect results.
  • check the expiration date on the test strips.
As a test strip ages, its chemical coating breaks down. If the strip is used after this time, it may give inaccurate results.
  • enter the correct calibration code from the outside of the strip bottle each time you run a test (if applicable).
Results can vary significantly between manufactured lots of reagent strips; the calibration codes help the meter compensate for these variations.
  • run quality control as directed.
Running quality control is typically the only way to know when test strips have gone bad. Test strips do not always last until the expiration date on the bottle. This may be because the manufacturer has over-estimated the dating or because the cap was not replaced promptly after use.
  • check the results from your meter against laboratory results as often as possible.
Over time, test systems can drift apart. Since results from either test system maybe used to treat your patients, it is important for the systems to remain synchronized.
  • question results that are not consistent with physical symptoms. If a test result seems wrong, have a blood sample tested by the main laboratory.
There may be many reasons why a test result is incorrect. In addition to the items above, some physiological conditions such as dehydration, hyperosmolarity, high hematocrit, or shock may significantly affect test results.



Updated March 3, 2006

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