Here's a very comprehensive, but very long, guide to home lab tests. I cut and pasted it from the Medibolics site.
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If youve been to the drugstore lately, you may have noticed an increase in the number of medical tests you can use in the privacy of your own home. Advances in testing technologyand changing attitudes towards patients responsibility for their own health carehave made home testing a worldwide, billion-dollar-and-growing market.
In fact, the word patient itself is gradually disappearingpeople like you, who used to think of themselves as patients, are now hearing themselves called consumers who are taking charge of their own health care. People today arent satisfied with just being told everythings fine, says Jim Nichols, PhD. They want to know the exact number [on a test result] and what it means.
Nichols directs the Clinical Chemistry Laboratory and Point-of-Care Testing at Baystate Medical Center in Springfield, MA. He says that recent market surveys indicate at least 25% of all medical tests are conducted outside the hospital laboratory. But, he adds, you should be cautious when purchasing over-the-counter testssometimes there are tradeoffs between convenience and quality. Tests you buy in your local supermarket can be of similar quality to what we perform in the hospital at the bedside, Nichols says, but not necessarily similar to the quality of testing performed in the lab.
In the lab or at the bedside, for example, nurses, EMTs, and laboratory technicians must be trained and certified in the testing procedure, the instrumentation used to perform the test, and quality control practices.
There is no such requirement for consumers who purchase home tests, even the ones prescribed or recommended by their doctors. Yet these tests, especially those designed to monitor diseases like diabetes, are important to your quality of life if you live with chronic illness.
Home glucose testing, for example, allows you to monitor your blood sugar level and adjust diet or medication accordingly, without having to make frequent lab visits or risking precarious highs and lows in energy levels. Home testing offers many benefits, to be sure. But its also important to recognize the potential tradeoffs between quality and convenience and take steps to protect yourself against bogus tests, the possibility of false results, and your own lack of training.
Home tests can be used to screen for, diagnose, or monitor disease. Although a few home tests (for example, those that monitor blood-thinning medication) must be prescribed by your doctor, most are available over the counter (OTC) in local supermarkets or pharmacies or directly from manufacturers by Internet, phone, or mail order. Categories of tests cleared by the Food and Drug Administration (FDA) for home use include those that measure cholesterol, for assessing risk of heart disease;
glucose (FDA Lab Safety Tip for glucose meters) for monitoring diabetes;
the presence of illegal drugs and drugs of abuse;
hCG, to screen for pregnancy;
HIV-antibody, for determining HIV infection;
prothrombin time, for monitoring blood thinning and clotting;
fecal occult blood, to screen for colorectal cancer; and
luteinizing hormone, to predict ovulation.
Some home tests, like those for pregnancy, produce immediate results. Others are sold as collection devicesyou use the device to collect a specimen (for example, urine or stool) and then mail the device containing the sample to the laboratory for evaluation. For example, if you want to know if youve contracted HIV, the virus that causes AIDS, you collect a blood sample at home on special filter paper and then send it to a laboratory for analysis.
Convenient, Timely, but Not Necessarily Perfect
Although home tests offer convenience, privacy, and real-time results, they may not be the last word in diagnosis or monitoring. Your doctor may require a confirmatory pregnancy test, for example, even though youve already done one at home.
Many times, results from pregnancy tests may be invalid, Nichols says. This is usually because people make mistakes in performing the test.
Errors can arise because of how you collect the sample, the time of day you collect it, how precisely you time the test, or the impact of medications you may be taking.
In a study of pregnancy home use tests sold in France, for example, though nearly all of the negative specimens were interpreted correctly, 53% of urine specimens with pregnancy hormone concentrations at the minimal detection limit were considered negative. And 39% of specimens with twice the detection limit were considered negative. Investigators said that the main problem seemed to be the consumers difficulty in interpreting instructions on the package insert and in following them explicitly.
Obviously, then, there can be severe consequences if either you or your health provider acts on results that are not valid. Nichols says that clinicians get really skittish about tests that monitor blood-thinning medications like coumadin. If the number is erroneously low, treatment could cause blood to clot. If the number is erroneously high, treatment could cause bruising or internal bleeding.
The importance of repeated (and continuous) monitoring was underscored in a report from a 1999 workshop on the standardization of blood coagulation devices. Alan Jacobson, MD, a panelist at the workshop, said that testing frequency, as much or more than testing accuracy, was responsible for most adverse treatment effects.
The average Medicare patient on coumadin gets tested only four times per year, he said. Cheap testing, but high price in adverse outcomes.
In contrast, at Jacobsons institution, patients perform a test that is then verified by additional, separate tests performed by a clinician and a nurse to verify that the patient can competently perform the test, and to develop reference ranges for longitudinal studies.
Protection for Consumers
Many manufacturers are promoting home tests on the Internet. This could be riskyunless you get savvy about which tests and sites are legitimate and which are bogus.
FDA Consumer Magazine, for instance, reported prosecuting an individual on wire fraud charges stemming from selling illegal HIV and Hepatitis C testing kits for home use to consumers and to pharmacies. Testers submitted blood samples on band-aid-like strips to the manufacturer, who neither sent samples to a lab for analysis nor used any scientific or factual principles to derive results. Nor did he provide counseling, which manufacturers are required to do when they inform users of test results.
The FDA, which regulates the home testing market, holds manufacturers of home tests to a rigorous pre-market approval process. For instance, manufacturers who want their tests approved for home use must demonstrate that lay testers get results comparable to those obtained in a professional laboratory.
In addition, manufacturers must pass an intensive review of proposed labeling. A major issue in the review is whether the instructions clearly communicate information to lay usersand in a way that leads to actions that promote personal or public health and minimize illness.
What to Expect: The Future of Home Testing
Over the past few decades, health care has become more decentralized. Mark Hughes, senior consultant for Enterprise Analysis Corporation in Stamford, CT, says this shift means that the home testing marketwhich doubled its revenues from $1.19 billion in 1994 to $2.34 in 2000will continue to grow.
Technology will make testing formats easier to perform and more accurate, Hughes says. The markets for diagnosis and monitoring will expand; we could also see an increase in tests for screening chronic diseases. Hughes notes that pharmacies in the UK, for example, are installing tests that use biochemical markers to screen for osteoporosis (these are not yet available in the U.S.).
First-generation tests, like prothrombin time (used to monitor blood thinners) will lead to improved second- and third-generation devices, in the same way that computer hard drives evolved from storage capacities of 20 megabytes in the early 1990s to more than 20 gigabytes in 2001.
One of the biggest benefits [to home medical devices that monitor disease conditions] is connectivity, Nichols says. Theyre not quite wireless yet, but most can store data and show individual health trends.
In the future your doctor may be able to plug these devices into a computer and analyze your results by smart algorithm. Or you may be able to use devices that sync with your own computer, prompting it to issue regular reminders to take a reading.
A survey conducted by Enterprise Analysis Corporation predicts that in the next seven years, up to 45% of testing will be done outside the core laboratory. That is, 45% of testing will be performed at the patients bedside, in the emergency room, in the doctors office, or at home, by consumers who are performing essentially the same tests used at these other points of care.
The issue then becomes consumer education. Think about how often you have a prescription for medicine that you have to take four times a day, Nichols says, and how many times you forget to take it.
But for patients who are taught well by their clinician, he adds, that [home test] can be a godsend.
Caveat Emptor (Let the Buyer Beware)
Home testing offers a way for you to test for medical conditions in the privacy of your own home and to monitor chronic health conditions. If you use home tests, however, protect yourself against the possibility of bogus tests, false results, and your own lack of training by following these guidelines.
Make sure that the test you are purchasing is FDA approved. The FDA requires manufacturers to meet stringent controls for quality, precision, and accuracy. Approved home tests must also meet FDA labeling requirements.
Check the expiration date. Do not buy tests if they have expired. The chemicals in the test may have lost their effectiveness, and the results may not be valid.
Follow the package directions on where and how to store the test. Dont leave temperature-sensitive tests in conditions that dont meet storage requirements.
Note and follow any special precautions before performing the test. For example, check to see when the test is to be performed (morning, evening), or under what conditions (fasting, no physical exertion, etc.).
Perform the test EXACTLY as instructed. If you have questions or are at all unsure about how to use the test, consider talking to your doctor or health provider. If you have privacy or security concerns, call the 800 Help number listed on the package insert.
Make sure you understand the meaning of the test results, and what to do about them. If you do not, call the Help number provided by the manufacturer, or call your health provider. The FDA encourages manufacturers to provide professional counseling and referral services through an 800 number.
If you have any questions or concerns about the legitimacy of the product or about whether there have been any adverse effects associated with the device, contact the Manufacturer and User Facility Device Experience Database (MAUDE). An online search is available. You can search CDRH's database on medical devices that may have malfunctioned or caused death or serious injury.
Consult the following agencies for additional consumer information. These are general links that will require additional searching for relevant information.
Food and Drug Administration
Lists publications, toll-free directories, and agencies like the Federal Consumer Information Center (1-800-688-9889). Searchable.
National Library of Medicine
Billed as the worlds largest library of medicine and health information. Sponsor of Medline. Searchable.
Center for Devices and Radiological Health (CDRH)
Medical device approvals. Daily updates available. Searchable.
Centers for Disease Control and Prevention (CDC)
Promotes health and quality of life by preventing and controlling disease, injury, and disability. Resources also available in Spanish. Searchable.
Sources
Article written by Joanne M. Lozar Glenn, MS
Reports:
Farley, Dixie. In-Home Tests Make Health Care Easier. FDA Consumer; December 1994. [Available on-line: http://www.fda.gov/bbs/topics/CONSUMER/CON0292f.html]
Frost and Sullivan; cited in Home Tests by Deborah Shelton for amednews.com. [Available on-line: http://www.ama-assn.org/sci-pubs/amnews/pick_99/feat0405.htm]
International Workshop on the Standardization of Whole Blood Coagulation
Devices (transcript). August 13, 1999. Sponsored by the Department of Health and Human Services, the FDA, the Center for Devices and Radiological Health (CDRH), and the College of American Pathologists (CAP). Report available on the FDA website as a PDF (http://www.fda.gov/cdrh/ode/wbcw-transcript.pdf) or
from Miller Reporting Company, Inc., 507 C St. NE, Washington, DC 20002.
Kurtzweil, P. Internet Sales of Bogus HIV Test Kits Result in
First-of-Kind Wire Fraud Conviction. FDA Consumer; 1999.
[Available on-line: http://www.fda.gov/fdac/departs/1999/499_irs.html]
Weissman DW. Over-the-Counter Test Sales Are a Growing Market. Laboratory Industry Report; 2001;X(2):9. [Additional information available at: Diagnostic Testing and Technology Report, Feb 2001. Enterprise Analysis Corporation.]
Interviews:
Mark Hughes and Joseph Keane, Enterprise Analysis Corporation, Stamford, CT, 7/3/01 and 7/2/01.
James Nichols, PhD, Baystate Medical Center, Springfield, MA, 6/21/01.
Internet:
Center for Devices and Radiological Health:
http://www.fda.gov/cdrh/consumer/index.shtml
Dr. Koop's Conditions and Concerns Medical Encyclopedia:
http://www.drkoop.com
Medline Medical Encyclopedia:
http://www.nlm.nih.gov/medlineplus/
National Library of Medicine, National Institutes of Health:
http://www.nih.gov
U.S. Food and Drug Administration:
www.fda.gov
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If youve been to the drugstore lately, you may have noticed an increase in the number of medical tests you can use in the privacy of your own home. Advances in testing technologyand changing attitudes towards patients responsibility for their own health carehave made home testing a worldwide, billion-dollar-and-growing market.
In fact, the word patient itself is gradually disappearingpeople like you, who used to think of themselves as patients, are now hearing themselves called consumers who are taking charge of their own health care. People today arent satisfied with just being told everythings fine, says Jim Nichols, PhD. They want to know the exact number [on a test result] and what it means.
Nichols directs the Clinical Chemistry Laboratory and Point-of-Care Testing at Baystate Medical Center in Springfield, MA. He says that recent market surveys indicate at least 25% of all medical tests are conducted outside the hospital laboratory. But, he adds, you should be cautious when purchasing over-the-counter testssometimes there are tradeoffs between convenience and quality. Tests you buy in your local supermarket can be of similar quality to what we perform in the hospital at the bedside, Nichols says, but not necessarily similar to the quality of testing performed in the lab.
In the lab or at the bedside, for example, nurses, EMTs, and laboratory technicians must be trained and certified in the testing procedure, the instrumentation used to perform the test, and quality control practices.
There is no such requirement for consumers who purchase home tests, even the ones prescribed or recommended by their doctors. Yet these tests, especially those designed to monitor diseases like diabetes, are important to your quality of life if you live with chronic illness.
Home glucose testing, for example, allows you to monitor your blood sugar level and adjust diet or medication accordingly, without having to make frequent lab visits or risking precarious highs and lows in energy levels. Home testing offers many benefits, to be sure. But its also important to recognize the potential tradeoffs between quality and convenience and take steps to protect yourself against bogus tests, the possibility of false results, and your own lack of training.
Home tests can be used to screen for, diagnose, or monitor disease. Although a few home tests (for example, those that monitor blood-thinning medication) must be prescribed by your doctor, most are available over the counter (OTC) in local supermarkets or pharmacies or directly from manufacturers by Internet, phone, or mail order. Categories of tests cleared by the Food and Drug Administration (FDA) for home use include those that measure cholesterol, for assessing risk of heart disease;
glucose (FDA Lab Safety Tip for glucose meters) for monitoring diabetes;
the presence of illegal drugs and drugs of abuse;
hCG, to screen for pregnancy;
HIV-antibody, for determining HIV infection;
prothrombin time, for monitoring blood thinning and clotting;
fecal occult blood, to screen for colorectal cancer; and
luteinizing hormone, to predict ovulation.
Some home tests, like those for pregnancy, produce immediate results. Others are sold as collection devicesyou use the device to collect a specimen (for example, urine or stool) and then mail the device containing the sample to the laboratory for evaluation. For example, if you want to know if youve contracted HIV, the virus that causes AIDS, you collect a blood sample at home on special filter paper and then send it to a laboratory for analysis.
Convenient, Timely, but Not Necessarily Perfect
Although home tests offer convenience, privacy, and real-time results, they may not be the last word in diagnosis or monitoring. Your doctor may require a confirmatory pregnancy test, for example, even though youve already done one at home.
Many times, results from pregnancy tests may be invalid, Nichols says. This is usually because people make mistakes in performing the test.
Errors can arise because of how you collect the sample, the time of day you collect it, how precisely you time the test, or the impact of medications you may be taking.
In a study of pregnancy home use tests sold in France, for example, though nearly all of the negative specimens were interpreted correctly, 53% of urine specimens with pregnancy hormone concentrations at the minimal detection limit were considered negative. And 39% of specimens with twice the detection limit were considered negative. Investigators said that the main problem seemed to be the consumers difficulty in interpreting instructions on the package insert and in following them explicitly.
Obviously, then, there can be severe consequences if either you or your health provider acts on results that are not valid. Nichols says that clinicians get really skittish about tests that monitor blood-thinning medications like coumadin. If the number is erroneously low, treatment could cause blood to clot. If the number is erroneously high, treatment could cause bruising or internal bleeding.
The importance of repeated (and continuous) monitoring was underscored in a report from a 1999 workshop on the standardization of blood coagulation devices. Alan Jacobson, MD, a panelist at the workshop, said that testing frequency, as much or more than testing accuracy, was responsible for most adverse treatment effects.
The average Medicare patient on coumadin gets tested only four times per year, he said. Cheap testing, but high price in adverse outcomes.
In contrast, at Jacobsons institution, patients perform a test that is then verified by additional, separate tests performed by a clinician and a nurse to verify that the patient can competently perform the test, and to develop reference ranges for longitudinal studies.
Protection for Consumers
Many manufacturers are promoting home tests on the Internet. This could be riskyunless you get savvy about which tests and sites are legitimate and which are bogus.
FDA Consumer Magazine, for instance, reported prosecuting an individual on wire fraud charges stemming from selling illegal HIV and Hepatitis C testing kits for home use to consumers and to pharmacies. Testers submitted blood samples on band-aid-like strips to the manufacturer, who neither sent samples to a lab for analysis nor used any scientific or factual principles to derive results. Nor did he provide counseling, which manufacturers are required to do when they inform users of test results.
The FDA, which regulates the home testing market, holds manufacturers of home tests to a rigorous pre-market approval process. For instance, manufacturers who want their tests approved for home use must demonstrate that lay testers get results comparable to those obtained in a professional laboratory.
In addition, manufacturers must pass an intensive review of proposed labeling. A major issue in the review is whether the instructions clearly communicate information to lay usersand in a way that leads to actions that promote personal or public health and minimize illness.
What to Expect: The Future of Home Testing
Over the past few decades, health care has become more decentralized. Mark Hughes, senior consultant for Enterprise Analysis Corporation in Stamford, CT, says this shift means that the home testing marketwhich doubled its revenues from $1.19 billion in 1994 to $2.34 in 2000will continue to grow.
Technology will make testing formats easier to perform and more accurate, Hughes says. The markets for diagnosis and monitoring will expand; we could also see an increase in tests for screening chronic diseases. Hughes notes that pharmacies in the UK, for example, are installing tests that use biochemical markers to screen for osteoporosis (these are not yet available in the U.S.).
First-generation tests, like prothrombin time (used to monitor blood thinners) will lead to improved second- and third-generation devices, in the same way that computer hard drives evolved from storage capacities of 20 megabytes in the early 1990s to more than 20 gigabytes in 2001.
One of the biggest benefits [to home medical devices that monitor disease conditions] is connectivity, Nichols says. Theyre not quite wireless yet, but most can store data and show individual health trends.
In the future your doctor may be able to plug these devices into a computer and analyze your results by smart algorithm. Or you may be able to use devices that sync with your own computer, prompting it to issue regular reminders to take a reading.
A survey conducted by Enterprise Analysis Corporation predicts that in the next seven years, up to 45% of testing will be done outside the core laboratory. That is, 45% of testing will be performed at the patients bedside, in the emergency room, in the doctors office, or at home, by consumers who are performing essentially the same tests used at these other points of care.
The issue then becomes consumer education. Think about how often you have a prescription for medicine that you have to take four times a day, Nichols says, and how many times you forget to take it.
But for patients who are taught well by their clinician, he adds, that [home test] can be a godsend.
Caveat Emptor (Let the Buyer Beware)
Home testing offers a way for you to test for medical conditions in the privacy of your own home and to monitor chronic health conditions. If you use home tests, however, protect yourself against the possibility of bogus tests, false results, and your own lack of training by following these guidelines.
Make sure that the test you are purchasing is FDA approved. The FDA requires manufacturers to meet stringent controls for quality, precision, and accuracy. Approved home tests must also meet FDA labeling requirements.
Check the expiration date. Do not buy tests if they have expired. The chemicals in the test may have lost their effectiveness, and the results may not be valid.
Follow the package directions on where and how to store the test. Dont leave temperature-sensitive tests in conditions that dont meet storage requirements.
Note and follow any special precautions before performing the test. For example, check to see when the test is to be performed (morning, evening), or under what conditions (fasting, no physical exertion, etc.).
Perform the test EXACTLY as instructed. If you have questions or are at all unsure about how to use the test, consider talking to your doctor or health provider. If you have privacy or security concerns, call the 800 Help number listed on the package insert.
Make sure you understand the meaning of the test results, and what to do about them. If you do not, call the Help number provided by the manufacturer, or call your health provider. The FDA encourages manufacturers to provide professional counseling and referral services through an 800 number.
If you have any questions or concerns about the legitimacy of the product or about whether there have been any adverse effects associated with the device, contact the Manufacturer and User Facility Device Experience Database (MAUDE). An online search is available. You can search CDRH's database on medical devices that may have malfunctioned or caused death or serious injury.
Consult the following agencies for additional consumer information. These are general links that will require additional searching for relevant information.
Food and Drug Administration
Lists publications, toll-free directories, and agencies like the Federal Consumer Information Center (1-800-688-9889). Searchable.
National Library of Medicine
Billed as the worlds largest library of medicine and health information. Sponsor of Medline. Searchable.
Center for Devices and Radiological Health (CDRH)
Medical device approvals. Daily updates available. Searchable.
Centers for Disease Control and Prevention (CDC)
Promotes health and quality of life by preventing and controlling disease, injury, and disability. Resources also available in Spanish. Searchable.
Sources
Article written by Joanne M. Lozar Glenn, MS
Reports:
Farley, Dixie. In-Home Tests Make Health Care Easier. FDA Consumer; December 1994. [Available on-line: http://www.fda.gov/bbs/topics/CONSUMER/CON0292f.html]
Frost and Sullivan; cited in Home Tests by Deborah Shelton for amednews.com. [Available on-line: http://www.ama-assn.org/sci-pubs/amnews/pick_99/feat0405.htm]
International Workshop on the Standardization of Whole Blood Coagulation
Devices (transcript). August 13, 1999. Sponsored by the Department of Health and Human Services, the FDA, the Center for Devices and Radiological Health (CDRH), and the College of American Pathologists (CAP). Report available on the FDA website as a PDF (http://www.fda.gov/cdrh/ode/wbcw-transcript.pdf) or
from Miller Reporting Company, Inc., 507 C St. NE, Washington, DC 20002.
Kurtzweil, P. Internet Sales of Bogus HIV Test Kits Result in
First-of-Kind Wire Fraud Conviction. FDA Consumer; 1999.
[Available on-line: http://www.fda.gov/fdac/departs/1999/499_irs.html]
Weissman DW. Over-the-Counter Test Sales Are a Growing Market. Laboratory Industry Report; 2001;X(2):9. [Additional information available at: Diagnostic Testing and Technology Report, Feb 2001. Enterprise Analysis Corporation.]
Interviews:
Mark Hughes and Joseph Keane, Enterprise Analysis Corporation, Stamford, CT, 7/3/01 and 7/2/01.
James Nichols, PhD, Baystate Medical Center, Springfield, MA, 6/21/01.
Internet:
Center for Devices and Radiological Health:
http://www.fda.gov/cdrh/consumer/index.shtml
Dr. Koop's Conditions and Concerns Medical Encyclopedia:
http://www.drkoop.com
Medline Medical Encyclopedia:
http://www.nlm.nih.gov/medlineplus/
National Library of Medicine, National Institutes of Health:
http://www.nih.gov
U.S. Food and Drug Administration:
www.fda.gov
