Do-It-Yourself Diagnosis

For just a few dollars, a few drops of blood or a little urine and the patience to wait for results, consumers can now test themselves for everything from pregnancy and cholesterol levels to cancer and HIV.As an alternative to an expensive--and perhaps embarrassing--visit to the doctor's office or clinic, home test kits are a blessing for the busy, the under-insured and the just plain shy. The increasingly accurate and easier-to-use tests have made home diagnosis and monitoring into a $1.07 billion-a-year industry, and the U.S. Food and Drug Administration is set to review and possibly approve a growing number of products that are battling for their lucrative places on drugstore shelves. The home test kit industry reported a 13.1 percent growth in sales between 1994 and 1995, and many manufacturers are predicting that the business will continue to expand.No doubt about it--home tests are easy, less expensive and more private than the traditional visit to the doctor, and their popularity among consumers is soaring. But there is a downside to the home-test phenomenon that has some health care professionals worried: Waiting at a doctor's office has been replaced by waiting by the phone, and if the news on the other end isn't good, the results can literally be disastrous."I'm horrified by some of these things," said Dr. Belle Cassidy, a licensed counselor who holds a doctorate in psychology and teaches ethics at CSU, Sacramento.Home tests are fine as a first step, she said, but especially with the HIV test, there's no substitute for face-to-face counseling about the results. "There's very strong concerns of suicide and--what's the general term?--'freaking out.'"The FDA cautions that the home tests should be thought of more as tools for monitoring existing conditions or for detecting possible problems than a substitute for a professional diagnosis, and home test results should be confirmed in a professional setting.Mike Musgrave, a lab coordinator for the student health center at California State University, Chico, said although a medical laboratory environment--coupled with counseling--is better-controlled, test kit directions are getting simpler and manufacturers continue to improve their products, making accurate results at home likely. "People should feel more comfortable and confident as the tests are getting more and more reliable," Musgrave said.While the tests may attract people who, for financial or privacy reasons, wouldn't otherwise be tested--and get needed medical care--user error, ethical concerns and confusion over test results can sometimes overshadow the convenience and anonymity touted by the kits' makers.Properly assessing someone's condition goes beyond delivering a positive or negative test result, said Dr. Cassidy."You have to sit down with them, you have to find out who they are [and] get a case history," she said, mentioning the availability of anonymous testing resources in communities. "It is just not ethical to counsel over the telephone."THE LONGEST MINUTESPeace Gardiner is seven weeks pregnant, but she wouldn't have known it from the home test she took a month ago.After getting a sample of her first morning's urine and waiting for the requisite five minutes, the 26-year-old Blue Lake, Calif. resident and her husband were left confused. Gardiner said that after staring at the results window, all they could determine was, "If you squint, I think maybe you could possibly see a line--it wasn't obvious. It was like, I don't know if I should believe it or not."The test's telephone help-line didn't clear things up, so she sent her husband out to buy two more tests, which yielded the same iffy result. "It was so weak a positive, we didn't believe it," Gardiner said. But a doctor's visit and blood test later that week "confirmed the incredibly weak home test," Gardiner said.Eight percent of Americans buy home pregnancy tests each year, making for a $150 million industry. As their users set timers and then set their hopes one way or the other, the pregnancy test goes to work.The tests can detect most, but not all, pregnancies within four or five days of conception, based on the level of the placenta-produced hormone, human chorionic gonadotropin (hCG), found in the urine. Testing too soon, or with diluted urine, an expired test and even taking some medications can interfere with results, usually in the form of a false negative. Conversely, a positive result is almost always correct.The most common reason for inaccurate results, according to the New England Journal of Medicine, is not following the instructions. Cindy Davis, trained in answering questions about the "e*p*t" Early Pregnancy Test, said Parke-Davis revamped its test just six months ago, replacing the splash guard (some women were urinating on it rather than pushing it back) with a pull-off cap--a reflection of the industry's desire to develop more accurate, more user-friendly tests.For Gardiner, the home test was a welcome pre-doctor's-visit screening tool, especially since she had been trying to get pregnant and didn't have the time or desire to pay for repeated trips to the physician's office.Gardiner, a former health care worker, said that despite her trouble reading the test results, she feels the kits are reliable. "When I worked at a lab, they used Fact Plus," she said, recalling cases of the home test kits stored at the hospital for professional use.But Nancy DeWeese, a program coordinator at Planned Parenthood Mar Monte in San Jose, said home pregnancy tests may not always be the best way to go."I have a real preference for people getting some counseling," DeWeese said. "I would really worry about a young person taking this test and just feeling terribly isolated and not knowing where to turn. The downside is [home tests] may isolate people at the very moment when they need to have contact with people and resources."In a clinic, you're going to get very specific counseling about how to protect yourself," she said.LIFE-OR-DEATH CALL?The need for counseling is intensified when consumers are home testing for HIV, the virus that causes AIDS.After phone counselor Steve Diego gave one caller the positive result to his HIV home test, he had to shout and plead with the understandably disturbed caller not to hang up. The two ended up talking for 45 minutes.Diego assured the caller that AIDS is not a death sentence, that medical treatments have advanced. Eventually, "He started coming up with his own questions and answering our questions," Diego said.Diego is one of several trained HIV counselors working for the test-kit manufacturer Home Access. A five-month Home Access employee, Diego had previously been a social worker in the AIDS/HIV field.He said that although some callers are initially wary, they welcome the reassurance without judgment that the phone HIV counseling provides. "I think that's real key because of all the stigma attached to HIV currently," Diego said. And, he added, people seem more free to be honest about their at-risk behavior and future plans when they're anonymous. "It's like the airplane syndrome where you sit next to a person on the airplane and you tell them your whole life story because you're never going to see them again."I think the counselor has to be there to help the people," Diego said. "Really, it doesn't matter what you did in the past--what matters is you're doing the right thing now by being tested."Kevin Johnson, spokesperson for Illinois-based Home Access, said the company's goals are altruistic as well as commercial. As some insurance plans discourage patients' access to diagnostic medicine, the home test industry is answering with an expanded selection of products. "We see ourselves as trying to fill that void," Johnson said. "It's all part of people being aware of their health."We look at ourselves as the house call of the 21st century," he said.The 4-year-old company got the federal OK to sell its HIV test kits in July 1996, and in recent months expanded availability from the phone lines to the checkout lines. Approval came after a year-long process with the FDA, along with clinical trials and a refining of the phone counseling system--dubbed "telemedicine" by Home Access.The company's research found that 30 million people a year would use an anonymous HIV home test system. Home Access cites a national Centers for Disease Control survey that found that 42 percent of people at risk for HIV would probably use an anonymous home test for the virus. Of the estimated 605,000 to 900,000 Americans who have contracted AIDS, about 35 percent are unaware that they are carrying HIV, according to the UC San Francisco AIDS Program at San Francisco General Hospital.After a rigorous training period that includes a "hell week" of simulated calls, the Home Access counselors are put on duty picking up the phone, knowing that the person on the other end of the line probably dialed with shaky fingers.Diego said the counselors learn to compensate for the lack of face-to-face contact, and ask open-ended questions, often keeping even HIV-negative callers talking for an hour or more. "You become a much better listener--inflections in the voice, labored breathing, things like that," Diego said. "We're trained to listen for those cues in the voice."Johnson said the whole testing process (from finger-prick to pre-paid mailer to toll-free call) is so anonymous, Home Access couldn't find a kit user if it wanted to. "Once you have the kit, we have no way of knowing what [confidential registration] number is in the kit," he said.Similarly, Confide HIV Testing Service, the first to go on the market, in May 1996, tests by anonymous numbers and if consumers don't want to be seen toting a kit through the drugstore, they can pull a "silent request form" from the shelf, handing it to a pharmacist to ring up as a "diagnostic kit."The presence of some other types of home HIV tests, not approved for sales in the United States, has raised social and ethical issues. One saliva-based test shows positive results with a red dot, which appears after a series of steps: collect saliva, add two drops of Solution A, absorb, add four drops of saliva sample, absorb, add two drops of Solution B, absorb, add two more drops of Solution A and read the results--all of which can be a daunting task for an already-nervous home tester.Dr. Cassidy said very basic phone counseling might be helpful if it is limited to referrals to local medical and psychological resources, but, "People should be very cautious of telephone counseling issues. You don't know who's on the other end."If it shows positive, you need resources," Dr. Cassidy said. A home test, she said, should never be taken as the final word on someone's medical condition. "Really, a professional needs to read the results--not just you."Still, many agree, people who wouldn't otherwise seek testing are being served by the home-use kits.Drew Johnson, chief of HIV counseling and testing for the state's Department of Health Services Department of AIDS, said, "I think that if people who would not otherwise be tested purchase a test, it's a good thing."However, he said, "A face-to-face contact is always better, because you can read people better."He said that since negative results are often given by way of a recorded message, a caller may not get crucial information. "A lot of people that are HIV-negative are engaging in high-risk behavior," he said. "[Home testing] has some downsides to the positive person and also to the negative person."Diego, with Home Access, welcomes the chance to counsel callers both before and after they take the HIV test. "Every counseling call, it's an opportunity to educate," he said. "Generally, those opportunities really give you a chance to educate someone on what I call AIDS 101 Basics."I've had people who feel very relieved because they know they've taken some risks," Diego said of negative results. With HIV-positive callers, "A lot of times the person becomes very quiet and is very numb. They don't want to talk. It's very challenging, because some people just want their result and just want to hang up."THE POSTMAN HAS YOUR URINESunny Cloud believes one way to build communication and trust with one's teenagers is to test them for drug use."If you ask a child, obviously they're not going to admit it," Cloud said from her Marietta, Ga. office.Cloud offers her Parent's Alert drug test kits at $40 a pop, which she says not only lets parents know if their child is into drugs ranging from alcohol to marijuana to cocaine, but also gives a teenager a good excuse to stay clean: Mom's waiting at home with a little cup."If a parent is going to be legally responsible to the behavior of their child, they'd better have an accessible tool," said Cloud, who started the company after suspecting one of her teenage sons of drug use.Plus, she said, it avoids the embarrassment and legal problems of being tested at a doctor's office. "It's a privacy issue and can be handled in the home with no other interference."A urine sample is mailed in a pre-paid envelope to Parent's Alert, which uses a certified lab and has results ready in about 72 hours--with what Cloud says is only a one in 10,000 chance of a false positive.Cloud was almost deterred from her mission by the FDA, which is still deciding if the Parent's Alert kit should be subject to government approval and monitoring. Two years ago, the FDA decided not to grant over-the-counter status to drug-use tests, mainly because of concerns about interpreting false results.Dr. Steven Gutman, then-acting director of the FDA's division of clinical laboratory devices, stated in a December 1994 issue of FDA Consumer, "Drugs of abuse have a real punch in terms of emotional impact. The harm from a slight error, with, say, a cholesterol test is the user might go out and eat a piece of chocolate cake. But a false positive in a test for drugs of abuse might lead to a person being fired or divorced, or a youngster being falsely accused and punished."Cloud, indignant that the FDA hasn't similarly interfered with testing by private industry, schools or law enforcement, said, "When I do that for parents, all of a sudden FDA wants us to apply for their approval."They were afraid it would cause discord in the family," she said. "If you want to see discord, walk in on your child smoking marijuana some dayÉ If I suspect my child is doing drugs, the trust relationship is already damaged." A negative test will make a parent feel better and be an I-told-you-so for the child, Cloud said. "I think it's great ammunition. It's an opportunity for the child to shine."A LAB IN YOUR BATHROOMMusgrave, the health center lab coordinator, said although the test kits sold over-the-counter are considered reliable, there is always room for error. "People think that they're following the directions and they're not," he said. "You have to put the human factor in there."A good practice is to see a health care professional to confirm the results of a home test, especially with so many free and sliding-scale anonymous resources available.Usually, the test answers will match up, said Tom Beckman, director of CSU, Chico's health center. But, he reiterated, the home tests aren't foolproof. A consumer may have trouble following directions, gathering the proper sample size, processing it and timing the test--all points at which human error can lead to skewed results, which in turn can result in someone allowing a medical condition to worsen, or a pregnant woman not getting immediate prenatal care."There's a lot of information that people need to have about the test and what it does and doesn't do," Beckman said. "Certainly, counseling is extremely important. That's the advantage we have, of course, when we see people face-to-face."He said a clinician can judge what a patient already knows and what additional information he or she needs to make health decisions. "You don't just walk in and say, 'I want one of these,'" he said.Soon, a short trip to the corner store may outfit one's home into a virtual chemical laboratory. Pregnancy and ovulation test kits have found a solid place in home use. Home blood glucose tests are a necessity for many insulin-dependent diabetics, who must monitor fluctuations in their blood sugar levels.Cholesterol tests are considered reliable, differing less than 5 percent from lab results. But since 15-minute blood tests like ChemTrak's Accumeter Cholesterol Self-Test (which became the first approved for home use in 1993), only indicate a total cholesterol level, the patient won't know if it's the "good" or the "bad" type. Since these levels fluctuate from day to day, results should be viewed with caution. ChemTrak plans to develop additional varieties of home tests.Ovulation predictors are another popular product. These home tests measure a lutenizing protein in urine to predict when a women is likely to ovulate, which in turn indicates the best time to get pregnant.Then there are the home test kits that, for about $6, supply tissue wipes or chemicals to be added to the toilet bowl that can be used to test for hidden blood in the stool--an indicator of colorectal cancer. The Harvard Health Letter calls these tests "notoriously fallible." The tests fail to detect colon cancer 62 percent of the time, and false positives can be as high as 95 percent, identifying hemorrhoids, aspirin use and rare meat as blood presence. And since many cancers don't bleed all the time, results may not indicate a problem, providing only a false sense of security.The FDA has also approved home tests for urinary tract infections, and blood pressure kits have been on the market for years.For the safest, most effective use of at-home lab tests, the FDA cautions people to check expiration dates, store products at an appropriate temperature, learn the limitations of each test, seek direction if confused about an aspect of the test, use clean specimen containers and follow instructions (and time measurements) exactly.Before the FDA will approve over-the-counter sales of a home test kit, its manufacturer or sponsor must prove that users are able to interpret the results accurately. The FDA warns: no test is 100 percent accurate.Still, home test kits continue to increase in popularity, and are now--inevitably and predictably--being marketed on the Internet.Lela Cargill has turned home tests into a home business, offering dozens of different test kits through her company's site on the World Wide Web (http://www.hometest.com).The Texas-based medical technician buys test kits ranging from glucose monitors to pregnancy, the EZDetect colorectal screen and HIV tests, reselling them at a profit--although business is not exactly booming yet, she admitted.Cargill said that in starting Hometest.com four months ago, she banked on consumers' desire for privacy and convenience in diagnosing conditions."I was thinking, well, all of us have an interest in knowing our HIV status, but I didn't really want to be standing in line at the drugstore holding one," she said.Johnson, the Home Access spokesman, won't give out statistics on how many kits the company has sold over the phone and in drugstores. But the HIV test kits have been such good sellers, the company is planning tests for lyme disease, osteoporosis, breast cancer and prostate cancer."There's a big market for people wanting to take control of their own health care," Johnson said. "There's all kinds of things that you can tell with a blood spot or a urine sample."TESTING, ONE-TWO-THREE...A Sampling Of Home Test KitsThere are enough home test kits on the market to fill a shopping basket, but don't buy them all at once the way I did--you'll leave the store clerk thinking you're a serious hypochondriac.Limited funds meant we had to settle for one old standby, a couple that have just gained shelf status and one that has yet to receive FDA approval.Remember, if you're going to try this at home, most health care providers recommend using home test kits more as a screening tool than as the final word on what's going on in your body, and follow up with a professional diagnosing.Cholesterol Test:ChemTrak's business has boomed as consumers offer a small sample of blood in return for a reading of their total cholesterol level.This kit (about $12-$15 for one test; a little more than $20 for two) comes with a plastic testing device, two plastic lancets, a little bandage, a gauze pad and a measurement scale to read results.The CholesTrak kit is available at drug stores and through some Internet mail-order services. The help-line number is 1-800-927-7776.Pregnancy Test:There are dozens of home pregnancy tests on the market, some costing as little as $7 or $8, although the bargain-minded may find it hard to resist buying two at only a few dollars more. The $9 Answer test got the top rating from Consumer Reports last fall, but it's one of those two-step kinds with the little (stress little) cup that you have to plunk the stick in and somehow keep the whole cocktail from tipping over while waiting three minutes for a line or two. The manufacturers of the e*p*t Early Pregnancy Test (one-step, $10) recommend waiting until the first day after a missed period, or at least 14 days from possible conception to test. Testing too soon can yield a false negative result, but otherwise results are 99.5 percent accurate in detecting the hCG hormone produced by pregnant women. HIV Test:Home Access ($40) and the faster-turnaround and more-expensive ($50) Home Access Express reports 99.99-percent accuracy, and tests blood samples using the industry standards of the Enzyme Linked Immunosorbant Assay (ELISA) and the Immunoflourescent Assay as a confirmation test. Pre-test counseling is required when someone calls to register his or her anonymous code number and voluntarily answer demographic questions. After sending in a one-blood-spot sample, the user waits a week (three days with Home Access Express) before calling the toll-free number again. Negative results will usually be given via a recording, but the caller may speak to a counselor at any time.Its counterpart, Confide HIV Testing Service ($40 or less in drugstores; $50 by phone), asks for three finger-prick blood samples, which are then sent to the company in its pre-paid mailer. Users call back in seven days to learn results, which are anonymous and given by identification number. Both tests are now available in drug stores like Wal-Mart, Thrifty or Walgreens or over the phone. The number for Home Access Health Corporation is: 1-800-HIV-TEST, and is on the Web at (http://www.homeaccess.com). Confide, a product of Johnson & Johnson, can be reached at 1-800-THE-TEST or at (http://www.confide.com).Drug Test:The Parent's Alert drug test kit ($40) arrives by mail in a plain-looking cardboard box packed with goodies to foist upon your child, yourself or others. Included are two saliva strips that are 98 percent accurate in testing for alcohol, along with a collection cup, bottle and pre-paid mailer to send the specimen off to a certified lab in Kansas. In 72 hours, a parent can call Parent's Alert's toll-free number and learn--from a medical consultant if it's positive--if his or her child is on drugs including: methamphetamines, amphetamines, barbiturates, cocaine, marijuana, PCP, benzodiazepines or opiates. There's even a guide book and a contract a child can sign saying he or she will stay off drugs.We had fun with the Alco Screen strips, but were confused when, after drinking one mixed drink, our strips showed a color indicating a blood alcohol level at some indiscernible point between .08 percent and .30 percent--a big difference in our book.To get a kit, call 1-800-TEST170 or write to: Parent's Alert, P.O. Box 724146, Atlanta, GA 31139-1146.--D.A.

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