Expanded HIV Testing: Benefits May Warrant Costs

Sunday, July 5, 2009

By Lori Whitten, NIDA NOTES Staff Writer

Offering voluntary HIV testing on a routine basis in outpatient health care settings would slow the spread of HIV and improve the survival of many of the estimated 280,000 Americans who are unaware that they are infected. The value of extending HIV screening to relatively low-risk populations in outpatient settings would be on par with the value of routine screening for other common conditions, such as colon cancer, according to two studies funded by NIDA.

Study Predicts Routine Voluntary HIV Testing Would Extend Survival Compared with HIV detection based on symptoms, routine voluntary HIV testing would enhance the life expectancy of people with the infection by getting them into life-prolonging care earlier. Estimates are based on the assumption that state-of-the-art therapy would be initiated when patients had a relatively favorable CD4 count of 350 cells/m3 as opposed to 175 cells/m3, the average count associated with detection based on symptoms. The CD4 count is a measure of immune system health.

In the United States, about one-quarter of the 1.04 million people estimated to be HIV infected do not know they have the virus. Under current testing guidelines, many of these individuals are likely to remain ignorant of their status for as long as they remain relatively healthy, because they do not belong to any of the high-prevalence subgroups to whom testing is recommended, and only those who live in areas with high infection rates will be screened as hospital inpatients. Meanwhile, their disease advances undiagnosed, compromising their prospects for future health and survival. They remain unaware of the need to take precautions against spreading the infection, and according to estimates from the Centers for Disease Control and Prevention (CDC), transmit the virus to 27,000 others each year.

Lead investigators in the two studies, Dr. A. David Paltiel of Yale University School of Medicine and Dr. Gillian Sanders of Duke University's Clinical Research Institute, used computer models to determine whether it would be cost-effective to extend routine voluntary screening to subpopulations with moderate prevalence of infection or to the whole population. The models use data on the estimated cost associated with an HIV test, the number of additional people who would be tested and the number of cases likely to be diagnosed sooner (and how much sooner), the greater benefits of therapy in earlier as opposed to later stages of infection, and the number of new infections that will be avoided when people who find out they are infected take precautions against transmission. Their work updates previous cost analyses by incorporating the use of state-of-the-art antiretroviral treatment (HAART) for HIV. The analyses yield estimates of the cost of each additional year of life expectancy that would be gained by expanded testing. Policymakers use such analyses to decide how to allocate funds for health.

Benefits of Early Detection

Dr. Sanders, Dr. Douglas Owens of the Veterans Affairs Palo Alto Health Care System, and their colleagues analyzed a hypothetical group of patients typical of those in general health care settings. The researchers assumed the patients' average age was 43 and their rate of unknown HIV infection was 1 percent, the level at which the CDC recommends routine testing. A 1 percent prevalence of unknown infection is probably high compared with the overall U.S. population (0.1 percent), but lower than high-risk populations currently screened (3 percent). By comparing three different scenarios of HIV detection—symptom-based diagnosis, a one-time voluntary test, testing every 5 years—the researchers were able to assess the lifetime benefits to patients and their partners, as well as the costs, of expanded testing.

The analysis found that one-time HIV testing would increase the life expectancies of individuals in the hypothetical population by an average of 4.7 quality-adjusted days and cost about $15,078 for every year of life gained. Patients whose HIV was discovered earlier and treated sooner would live on average 1.5 years longer as a result of the testing.

The $15,078 figure assumes that earlier HIV detection would reduce the spread of infection by 20 percent. Some such reduction would be likely because once people know they have HIV, they tend to change their behavior to avoid infecting others, and when they start antiretroviral treatment their body fluids become less infectious. If transmission were not reduced, one-time HIV testing in the hypothetical population would cost $41,736 per year of life gained—comparable to the cost-effectiveness of routine testing for colon cancer, hypertension, and type 2 diabetes. The researchers further suggested that one-time testing might be justified in terms of value in a hypothetical population with an HIV infection prevalence as low as 0.05 percent.

In the second study, Dr. Paltiel and his colleagues compared current practice with routine voluntary HIV testing among high-risk communities (3 percent prevalence), communities with 1 percent prevalence, and the general population of the United States (0.1 percent prevalence). They estimated that adding a one-time voluntary HIV test to current care for people at high risk of infection would cost $36,000 per life-year gained. Testing a population that meets the 1 percent threshold raises the cost to $38,000—a figure similar to the $41,736 estimate of Dr. Sanders and colleagues. In the high-risk population, testing every 5 years would cost $50,000 per added life-year, rising to $63,000 if testing were done every 3 years. The findings suggest that voluntary testing every 3 to 5 years in all populations except those with the lowest prevalence would increase survival at a comparatively attractive cost by U.S. standards, says Dr. Paltiel. A one-time voluntary screening in the general population may also be cost-effective, but merits further investigation, he adds.

HIV Testing and Other Routine Tests: Cost-Effectiveness Compared
Test	$/QALY* Gained
HIV test: All inpatients†	38,600
HIV test every 5 years: People at high risk (3% prevalence)†	50,000
HIV test one time (1% prevalence)‡ Individual benefit only Including benefit to others	41,736 15,078
HIV test one time: U.S. general population (0.1% prevalence)†	113,000
Breast cancer test: Annual mammogram, age 50-69§	57,500
Colon cancer test: FOBT + SIG every 5 years, age 50-85§	57,700
Type 2 diabetes test: Fasting blood glucose, age >25§	70,000
Hypertension testing§	48,000
FOBT indicates fecal occult blood test; SIG, sigmoidoscopy. *In quality-adjusted life years (QALYs), which account for both longevity and health-related quality of life. †Paltiel et al. (2005); ‡Sanders et al. (2005); §Adapted from personal communication, Sanders and Paltiel, 2005.

"Expanding voluntary HIV testing will require an investment—but it delivers better value for money than many other chronic disease testing programs that are routinely used in the United States today," says Dr. Paltiel. Neither research project addressed who should pay for expanded HIV screening, but the findings serve as a springboard for policy discussions involving all people with a stake in the decision. "Cost-effectiveness is just one consideration in policy decisions. Implementing expanded HIV testing also will require people believing it's an important use of limited resources," says Dr. Sanders.

The findings have made an impact in the state with the largest HIV caseload in the nation. Citing the research, the New York State Department of Health has revised its HIV guidelines, urging State health care providers to integrate routine testing into their medical care, use rapid HIV testing, and refer patients with positive test results to care, among other things.

Study Estimates Range of Value Associated With Routine Voluntary HIV Testing Dr. Sanders and colleagues estimated that routine HIV testing would be relatively economical even if the prevalence rates of undiagnosed infection were as low as 0.05 percent (half that of the U.S. general population estimate) when reduced transmission to partners is considered (dashed line). Even when transmission is not considered (solid line), HIV testing might be a financially attractive option at prevalence rates well below 1 percent.

"People may think of computer-based analyses as isolated and abstract, but this AIDS modeling program encourages researchers to use findings from a wide range of relevant disciplines and incorporate advice from clinicians," says Dr. Peter Hartsock of NIDA's Division of Epidemiology, Services and Prevention Research. "These two studies integrated data from many perspectives, and their results provide rigorous but practical information that can guide the societal discussion of what to do about the problem."

Too few Americans get HIV test early enough

oo many Americans with HIV are diagnosed late in the course of their disease and miss out on the optimal benefit of effective treatments, U.S. health officials reported Thursday.

As many as 1 million Americans are infected with HIV, but up to a third don't know they have the disease because they haven't been tested for it, according to the U.S. Centers for Disease Control and Prevention. That's why the agency recommends that HIV testing be a routine part of any medical examination.

“People are learning about their HIV infection several years after being infected,” explained lead researcher Dr. R. Luke Shouse, from the CDC's Division of HIV/AIDS Prevention in the National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“This means that they may have unknowingly transmitted HIV,” Shouse said. “It also means that there is a time when they had HIV when they were not under appropriate medical care, so there are missed opportunities for prevention and care.”

The new report on HIV testing appears in the June 26 issue of the CDC's Morbidity and Mortality Weekly Report, to coincide with National HIV Testing Day on June 27. The day promotes testing as an important strategy to prevent and control transmission of HIV in the United States, according to the CDC.

According to the report, which collected data on people diagnosed with HIV/AIDS in 34 states from 1996 to 2005, 38.3 percent of those diagnosed with HIV were diagnosed with AIDS within a year, and 6.7 percent were diagnosed with AIDS over the next two years.

Since progression from HIV to AIDS typically takes about 10 years without treatment, these findings highlight the importance of testing for HIV early, when antiretroviral treatments can deliver maximum benefit, Shouse said.

Minorities were more likely to be diagnosed late, compared with whites, and more minorities than whites progressed to AIDS within three years, the researchers found.

In addition, people whose initial HIV diagnosis occurred when they were older were more likely to progress to AIDS within three years. Men diagnosed with HIV were also more likely to develop AIDS within three years, the researchers noted.

“It's important to be tested for HIV -- routine screening for folks 13 years and above with regular medical visits, and at-risk populations should be screened annually,” Shouse said.

Another report in the same issue of the CDC journal showed that too few high school students have been tested for HIV.

“When you look at the younger age groups, we estimate, a little under half of people 13-to-24 who are HIV-positive know they are infected,” said lead researcher Andrew C. Voetsch, also from CDC's Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention.

(Source: HealthDay News)

HEALTH-SOUTH AFRICA: Bringing HIV Testing Where It's Needed By Miriam Mannak

CAPE TOWN, Apr 7 (IPS) - In the ten months since the Tutu Tester's mobile clinic began touring Cape Town neighbourhoods offering quick, confidential tests for a number of chronic diseases including HIV/AIDS, more than 7,000 people have climbed into its colourful camper-van for testing and counselling.

Of these, 45 percent were people testing for the first time, indicating the clinic is making a valuable contribution to awareness of the disease in the poor neighbourhoods of Cape Town that are most severely affected by the pandemic.

"Many of our patients have told us that they prefer not to go to public clinics for an HIV test because they are afraid of being seen by people they know," said Liz Thebus, one of the Tutu Tester’s health workers. "Because we test for other diseases too, like diabetes and high blood pressure, the outside world does not know for what reason patients are waiting at our doors."

Every Wednesday afternoon, the rainbow-coloured mobile clinic pulls up at the entrance of Imizamo Yethu - a small township on the steep hill above Hout Bay, a coastal village near Cape Town.

Twenty-four year old Babalwa is one of those waiting for waiting for its arrival. She wants a test for HIV and high blood pressure.

"I don’t like to go to the clinic, because there is always someone you know," she told IPS. "I don’t want that. My health is no one’s business. Here, people don’t know whether I am tested for high blood pressure or HIV. The workers here do not take my name either, which makes me more relaxed. It means that if I lose my results, no one will know the results are mine."

Babalwa added that time is also an important reason why she rather goes to the Tutu Tester. According to her at Imizamo Yethu’s clinic it takers sometimes half a day before patients are seen.

"Sometimes you are even asked to come back the next day," she said. "I am working and cannot afford to stay away for that long. Here it takes thirty minutes."

The crew of the Tutu Tester screens an average of 40 to 60 people per day. "Since we hit the road in May 2008, we tested roughly 7,000 people," said Nienke van Schaaik, the Tester’s project manager. "About 40 percent of them were first-time testers."

Wedges, as he calls himself, has never had an HIV test in his life. "It is my first time. I just want to know if I am healthy," the twenty-year old said. "But I do not want to go to the clinic. What if I run into people I know and they get suspicious? I am not worried or afraid about finding out what my status is. I know that I am healthy, but I want to know for sure."

Thebus emphasised that the Tutu Tester does not provide treatment. "However, if applicable, we refer our patients to the clinic nearest to them for their medication. We follow up with the patient within a week after the consultation, to see how he or she is."

The crew of the Tutu Tester does however offer professional counselling to those who need it. "It is important to help people cope with bad news," said Nokwayiyo Racaza, one of the three Tutu Tester counsellors. "We want the patient to leave the mobile clinic being relaxed. We do not want the outside world to read the news from our patients’ faces."

Racaza added that counselling is not only offered straight after the testing. "Sometimes the shock comes afterwards and therefore patients can come talk to us the following week, or whenever they are ready."

Currently, the Tutu Tester is working to add a test for tuberculosis (TB) to its services. The disease is rampant in South Africa, especially in communities with a high HIV prevalence. It is believed that 54 percent of South Africans who are HIV positive are also infected with TB, which mostly affects the lungs and is transmitted through coughing, sneezing and spitting.

People who are HIV positive have weaker immune systems, and are therefore at greater risk to contract TB.

The Tutu Tester is not the only initiative operating beside the public health care system to test for HIV testing. New Start, which has mobile testing teams nation-wide, was established in 2004. In contrast to the Tutu Tester, New Start only screens for HIV.

"According to our experience, people do not seem to have a big problem getting tested for HIV or being seen at our testing sites," Miriam Mhazo, senior project manager at New Start, told IPS. "We barely are able to meet the demand and the number of patients we see on a monthly basis is increasing. Wherever we pitch, people line up. In February 2008, we screened 17,000 individuals for HIV and 18,000 in the following month."

Mhazo interprets this as a sign that the stigma attached to the disease is reducing. "We have not done research on the matter, but from a personal point of view the increase in the number of tests we have done shows that the stigma is not as strong as it used to be."

Raphael Mukhunga from Malawi moved to South Africa four years ago. While his wife lives in his home country, he has a girlfriend and a child in South Africa. To protect all of them, he goes for an HIV test every half a year, he said. Mukhunga prefers the Tutu Tester to the local clinic, and not because of the stigma.

"I do not care what other people think about me," he explained. "I come here simply because of time constraints, as at the Tutu Tester you know your status immediately. I think the fact that everything takes so long at the public clinic is an important reason why people only get tested when it is too late, when they are already ill. I have seen it myself."

First Rapid HIV Test Using Oral Fluid Approved

On March 26, 2004, the U.S. Food and Drug Administration (FDA) approved the first rapid diagnostic test for HIV, the virus that causes AIDS, that uses oral fluid samples rather than blood. Manufactured by OraSure Technologies, Inc., it is the same test method as their recently approved OraQuick Rapid HIV-1/2 Antibody Blood Test, but uses oral fluid (saliva) rather than blood from a fingerstick. It is estimated to be 99% accurate.

The test is simple to perform. Oral fluid is collected using an absorbent pad, which is used to wipe the outer gums. The pad is then inserted into a device and is treated with a solution that can detect antibodies to the virus. Colored bands appear in a window. One line indicates the test system is working properly. A second line indicates that HIV-1 antibodies are detected. Results can be available in 20 minutes.

This rapid turnaround time may improve the awareness of people’s HIV status since many people who are screened by traditional tests never return for follow-up visits to get their results. (These traditional tests may take days or weeks to get results.) Although the new test using oral fluid is currently approved for use only in laboratories, it is expected to receive a CLIA (Clinical Laboratory Improvements Amendments of 1988) waiver, like the fingerstick rapid test has, so that it can be used in other health care settings, such as clinics, which will increase its availability.

The oral fluid rapid screening test has slightly lower sensitivity and specificity than the fingerstick blood test, and it has been approved for use in detecting HIV-1 antibodies only, not HIV-2 antibodies. (HIV-2 is rare in the U.S. where most people infected by HIV are infected with the HIV-1 type of virus). Nevertheless, it offers several distinct advantages. The oral fluid rapid test provides a more appealing option to those test takers who do not like to have their blood drawn or finger stuck with a lancet. In addition, this test will help to reduce the risk of transmission of the virus to health care workers since HIV can be contracted through handling blood, but no cases of transmission through handling saliva have been documented.

As is the case with the fingerstick method, results using the oral fluid method should be confirmed by another, more specific method.

Why Should You Get Tested for HIV?

The federal Centers for Disease Control and Prevention (CDC) estimates that 38% to 44% of all adults in the United States have been tested for HIV and that between 16 and 22 million people aged 18-64 years are tested for HIV annually. However, of more than one million people living with HIV in the U.S., it is estimated that about one-quarter (252,000 to 312,000 persons) are unaware of their HIV status. Because they do not know they are infected, these individuals are unable to benefit from clinical care related to their HIV disease. In addition, some of these people may unknowingly be transmitting HIV to other people. The San Francisco AIDS Foundation strongly encourages people who are at risk for HIV to be tested regularly. Whether or not to take the HIV antibody test, however, is a personal decision that only you can make for yourself. That being said, here are some things you may wish to consider:

• Knowledge is power.
• If you find out that you are HIV-positive (infected with HIV), you and your healthcare providers can better plan early treatment and intervention, improving your chances of slowing down the progression of HIV disease.
• If you test negative, you may feel less anxious.
• By knowing your status, you can find out whether or not you can infect others, and what precautions you might take to prevent transmission to other people.
• Regardless of the result, testing tends to increase your commitment to overall good health habits. If you test positive, you can learn more about HIV and be proactive in taking care of your health.
• If you are considering having a baby, you can take advantage of treatments that potentially prevent transmission of HIV to the baby.

What Are HIV Antibody Tests?

As the body fights viruses, the immune system creates antibodies to that virus. HIV antibody tests do not measure or detect the virus itself but instead look for your body's reaction to the virus -- the presence of antibodies to HIV.

ELISA

The ELISA (also sometimes called EIA) is often used as the first screening tool. It is inexpensive and very sensitive for detecting the presence of HIV antibodies. In most cases, a blood sample is tested, but other types of ELISAs that use saliva and urine have also been developed. The actual ELISA takes 3.5 to 4 hours, but most test sites send samples to outside labs, where they are tested in batches, so you may have to wait one to two weeks for results.

Beyond the Window Period ELISA tests are very rarely "false negative." This means if you have a negative test result, and you had met the Window Period guidelines after the last potential exposure, you are really HIV negative. An ELISA test may rarely be "false positive." False positive ELISA results can occur if someone is tested right after events that temporarily stimulate the immune system, such as viral infections or immunizations. They could also occur because of lab error, or because of the test's very high sensitivity, discussed below.

For these reasons, positive ELISA results must always be confirmed with a Western Blot or IFA (below), and at reputable test sites this is commonly done automatically -- meaning you don't have to have another blood sample drawn.

A relatively new test, called a detuned ELISA, which has been used in research settings, will soon become more widely available to other test sites. The detuned test, which is used only after HIV antibodies are confirmed by a Western Blot test, can determine if the HIV infection is recent (within the last six months), which may be useful for deciding upon possible early treatment options.

Western Blot (WB) Assay

The WB is a confirmatory test: it is only performed if an ELISA or rapid test is positive. The WB can be positive, negative, or indeterminate. Indeterminate tests are neither positive nor negative. An indeterminate result usually means that a person has just begun to seroconvert at the time of their test. In the rare cases in which this occurs, the person will need to be retested, usually about one month later. False positive results are extremely rare with the WB, so it confirms (proves) that HIV antibodies are present.

Indirect Immunofluorescence Assay (IFA)

The IFA can be used instead of the WB to confirm ELISA results. Like the WB, IFA tests for the presence of antibodies in a blood sample. The exact strategy is slightly different in that it uses a microscope. It can be faster than a WB, so the few labs that use it can get results to the patient more quickly.

Rapid Tests for HIV

Rapid testing for HIV has become one of the most prominent ways that people receive HIV tests today. In as little as 20 minutes, you can find out your HIV status.

Rapid tests work similarly to traditional HIV test: they look for antibodies to HIV, not the virus itself. Most commonly, a rapid test is adminestered by sampling the oral mucosa (the mucous that is everywhere in your mouth) and putting it through a test to see if HIV antibodies are present.

Some people may think that, since the test uses the mouth to test for HIV, that HIV can be transmitted to other people through saliva, spit and/or oral mucosa via kissing, sharing utensils, or sharing glasses. This is not true. For more information, see this website's section on How HIV is Spread.

A rapid test runs for 20-40 minutes, after which you will receive a result. Rapid tests are extremely accurate. However, since rapid tests have a small margin of error (ranging from 1 to 3 per 1,000), all positive (reactive) results have to be put through a confirmatory test.

The most common type of rapid test currently in use in Callifornia is the OraQuick Advance. The availability of rapid tests varies by city. Some testing locations in California charge for this type of test, but there are many locations that will provide the test for free. For testing locations, you can call the California HIV/AIDS Hotline at 1-800-367-AIDS or you can do your own referral search by visiting www.aidshotline.org.

Window Period

The "window period" is the time it takes for a person who has been infected with HIV to react to the virus by creating HIV antibodies. This is called seroconversion.

During the window period, people infected with HIV have no antibodies in their blood that can be detected by an HIV test, even though the person may already have high levels of HIV in their blood, sexual fluids, or breast milk.

Here is what the CDC says about the window period:

"Antibodies generally appear within three months after infection with HIV, but may take up to six months in some persons."

This CDC definition of a three to six month window period has been commonly used for a number of years.

What does this mean for you?

• The three month window period is normal for most of the population. Many people will have detectable antibodies in three or four weeks. Very, very rarely (i.e., only a few cases ever), a person could take six months to produce antibodies.
• You may be anxious to be tested soon after an encounter which you perceive to be risky (for a discussion of what behaviors put you at risk for HIV and which ones do not, see the section on How HIV Is Spread). You want to know: can I be antibody tested without waiting three months? How accurate is the test after, say, six weeks?
  
  Unfortunately, we simply don't know.
  
  Think about this: if you got a negative test at six weeks, would you believe it? Would it make you less anxious? If so, then go for it. But to be certain, you will need to be tested again at three months. Some test centers may recommend testing again at six months, just to be extra sure.

Although HIV may not be detected by a test during the window period, HIV can be transmitted during that time. In fact, individuals are often most infectious during this time (shortly after they have been exposed to HIV).

Interpretation of Test Results

A positive (reactive) result means:

• You are HIV-positive (carrying the virus that causes AIDS).
• You can infect others who come into contact with your blood, semen or vaginal fluid. You should take necessary precautions to avoid transmitting HIV to others.

A positive result does NOT mean:

• You have AIDS.
• You will necessarily get AIDS.
• You are immune to AIDS, even though you have antibodies.

A negative (non-reactive) result means:

• No HIV antibodies were found in your blood at this time.

A negative result does NOT mean:

• You are not infected with HIV (you may still be in the "window period").
• You are immune to HIV.
• You have a "resistance" to infection.
• You will never get HIV.

An indeterminate result (which is rare) means:

• The Western Blot (WB) result is unclear. The entire HIV test must be repeated with a new blood sample, usually several weeks after the first blood test.
• Indeterminate results usually occur if the test is performed just as the person begins to seroconvert.

Accuracy of Antibody Tests

Antibody tests are extremely accurate, whether receiving a rapid test or a more traditional ELISA. Rapid test, for example, have an accuracy rate exceeding 99%. However, positive results from a rapid or ELISA test must be confirmed by another test to ensure that a person is HIV-positive.

The accuracy of a medical test is a combination of two factors: sensitivity and specificity. The ELISA is extremely sensitive (about 99.5%), which means it will detect very small quantities of HIV antibody. This high sensitivity reduces the odds of reporting a "false negative" when HIV antibodies are present. Assuming you are being tested beyond the "window period" and have not engaged in activities that put you at risk for HIV, if the ELISA is "negative," there is virtually no chance you have HIV.

The high sensitivity of the test creates a slightly lower specificity. This means the result could (infrequently) be "false positive." To compensate for this, confirmatory tests are automatically performed after a positive ELISA. The WB and IFA are highly specific for HIV antibodies, so they rule out false positive ELISAs nearly every time.

The CDC states that the combined accuracy of the ELISA plus either the WB or IFA is greater than 99%.

The CDC recommends retesting any positive (reactive) ELISA twice; if either retest is positive (reactive), then a confirmatory test is performed. Only when the confirmatory test is also reactive is the result reported as HIV positive. Again, reputable test sites automatically follow this procedure, so results reported to you as positive can be relied upon completely. It is also important to note that if you test positive through the use of a rapid HIV test (with results provided in 20 minutes or less), your result is still preliminary. A confirmatory test must be performed to verify whether you are infected with HIV and these results will take several days.

What does this mean for you?

• If you are beyond the window period and were reported HIV negative by a rapid test or an ELISA, and you are not subsequently at risk for HIV, you should consider yourself HIV negative.
  If you want to discuss these issues further -- for example, you want to find out if a certain activity put you at risk for getting HIV -- call an AIDS hotline. Within California, call the San Francisco AIDS Foundation's California AIDS Hotline toll free at 800/367-AIDS. Outside California, call your state's AIDS Hotline or the CDC-INFO toll free at 800/CDC-INFO. To find the number for your state's aids hotline, go to www.aidshotline.org and click on Other AIDS Hotlines.
• Some individuals, perhaps wanting results without waiting for the window period, may be curious about a PCR or other types of viral load (RNA) testing (testing directly for the virus itself). Viral load testing is generally used to allow physicians to track with great accuracy the progression of HIV in the body -- thus helping HIV-infected patients make choices about appropriate treatment strategies. Most people concerned about their HIV status do not need viral load testing. The antibody test is the cheapest, easiest, and overall most reliable way for individuals to learn their HIV status.

That being said, individuals who have had a recent exposure to HIV and experience symptoms consistent with seroconversion (flu-like symptoms), can request a viral load test from their doctor in addition to the HIV antibody test. This may help identify HIV infection during the window period (before HIV antibodies have developed), though it should be noted that an antibody test is ultimately needed to confirm that one is HIV-infected.

Anonymous HIV Testing

Free anonymous testing is available at Anonymous Test Sites in most counties in California. Anonymous testing means that no one has access to your test results since your name is never recorded at the test site.

Anonymous test sites are preferred by some individuals because:

• The quality of the education and counseling is usually very good.
• The testing is usually free.
• The testing is reliable and automatically includes confirmatory tests.
• It protects you from any and all risks of discrimination or adverse impact.

People with HIV infection and AIDS are generally reported by name to local and state public health officials (see HIV name reporting section below). Anonymous test results, however, are not reported to the government and can not be because an individual's name is never provided. In addition, anonymous testing sites never give written results. Some sites that provide anonymous testing also provide confidential testing, which may include written results. If you live in California, visit www.aidshotline.org to find sites that offer anonymous or confidential testing or you can call the California AIDS Hotline, toll free, at 1-800-367-AIDS.

At some anonymous test sites, you must make an appointment; in others, appointments are not necessary -- you can just drop in. You choose, or are given, a letter/number code that will match you to your test results. Most anonymous test sites provide pre-test counseling and risk assessment. A blood sample is sometimes drawn, but some sites now use rapid HIV testing, which can be done needle-free or utilizes blood taken from a finger-stick. You must return, in person, in about one to two weeks to obtain results, unless the rapid HIV test is used, which can determine your results in less than 20 minutes.

Confidential HIV Testing

HIV antibody testing can be ordered through a private physician, some clinics, and hospitals. If you give your name, even if the test site says your name is known only to them and not the lab, the test is technically confidential, not anonymous. Confidential antibody testing means that you and the health care provider know your results, which may be recorded in your medical file. There are also testing sites that offer confidential testing. Those who are tested confidentially and are found to be infected with HIV are reported to local public health officials so that the government can better track the extent of the disease in the population as a whole.

HIV Name-Based Reporting

California requires those who are infected with HIV to be reported by name to local public health officials. It is important to note that AIDS diagnoses have been reported by name in California and throughout the United States since the early 1980s. The federal Centers for Disease Control and Prevention has urged all states to collect HIV infection reports by name and the vast majority of states now do so.

Fortunately, public health reporting by name has been in place for many years for other communicable diseases and this information has been successfully protected by public health officials. More than 80 other diseases and conditions are currently required to be reported by name in California, including Hepatitis, tuberculosis, syphilis and Chlamydia.

This information is collected to allow public health officials to track these diseases. HIV reporting will make it easier for localities to collect information about the epidemic, providing the government with valid, uniform data for service and prevention planning.

It is important to note that only public health officials have access to the information that is reported; employers and insurance companies do not. Additionally, the names of HIV-positive Californians will only be reported to the county in which they live and to the state. The federal government will only receive a unique code for each HIV-positive individual, not their actual name. California law includes provisions that ensure the highest degree of confidentiality of name-based HIV data and significant financial penalties for inappropriate disclosure of that information. In addition, stringent laws exist at the federal, state and local levels to protect individuals with HIV and AIDS from discrimination in housing, employment and public services.

Because public health reporting data are so carefully protected, California's HIV reporting policy should not discourage you from seeking HIV testing and treatment. For those who do have strong concerns about having their HIV status reported to government officials, it may be advisable to seek out HIV testing at an anonymous test site. Because your name is never provided at an anonymous test site, you cannot be reported to the government. It is important to note, however, that if you test positive at an anonymous test site and then seek care for HIV disease from a physician, you will likely be reported by name at that time.

Partner Notification

Voluntary partner notification programs -- also known as partner counseling and referral services (PCRS) -- allow individuals who have tested positive to get help in notifying previous sex or needle sharing partners that they may have been exposed to HIV. Partner notification programs are not new; they have been used for years with tuberculosis, syphilis, and other communicable diseases.

Through these services you will receive counseling about how to notify partners yourself or you can have a public health officer do it for you. The health official will ask for the names, addresses, e-mails and/or phone numbers of other people (contacts) with whom you have had sex or shared needles. The health department will then try to locate each contact to tell them that they have been exposed to someone with HIV and could be at risk. They will advise these contacts to be tested for HIV. The health department does not disclose the name of the person who has tested positive, but in some cases, it may be obvious to the contact, particularly if he/she has had sex with only one or few other people.

Orasure Test for HIV

The OraSure HIV antibody test method, approved by the FDA in 1996, uses a sample of oral mucus obtained with a specially treated cotton pad that is placed between the cheek and lower gum for two minutes. Testing oral mucus has also been called "oral mucosal transudate testing." It is similar to the rapid oral test. In fact, the same company makes both products. The only difference between the two is the amount of time that it takes to receive your results.

Note: the saliva and oral mucus contain antibodies to HIV, not HIV itself, so HIV is not transmitted through these fluids.

Some public test sites offer this oral test as an alternative to blood testing.

The sample is sent to a lab, where it undergoes an ELISA procedure. All positive ELISA samples undergo a Western Blot confirmatory test (using the same pad).

The combined accuracy of OraSure ELISA and WB procedures is comparable to traditional blood testing, so it is very high.

Home HIV Antibody Tests

At this time, one company, Home Access, offers an FDA-approved at-home antibody test. This test costs about $45 to $70, depending on whether you pay for 72-hour results (they give you a pre-paid express delivery envelope to expedite shipping your sample to the lab) or standard 7-10 day results.

Home Access uses a blood sample from a finger prick, which you then send to a certified laboratory for testing. You must call a toll-free number to register your sample prior to shipping. Enclosed in the test kit is an identifying number. Results take three days to one week. To obtain results, you give the operator the ID number and they will look up the result of the test. This number system provides you with an anonymous test result so your result cannot be reported to anyone else.

Home Access uses traditional ELISA and Western Blot procedures, so the results are as accurate as one would receive with an antibody test at an anonymous testing site. The privacy of the home test offers some consumers more comfort than going to a public test site.

Remember, as with testing at an anonymous or confidential site, you must wait three to six months (the window period) after your potential exposure to take the at-home test, to be certain if the activity you are concerned about did or did not infect you with HIV.

With the availability of the HIV rapid test, some companies are now considering developing a new type of 'at-home' testing that could provide preliminary test results in less than 30 minutes. Similar to at-home pregnancy tests, consumers would be able get these preliminary results at home without having to mail in a blood specimen (as is required by the Home Access test that is currently available). Such a test has not yet been approved by the FDA. It should be noted that even if it is approved, the person being tested still must wait the 'window period' as previously described, and take a 'confirmatory test' if there is a preliminary positive result.

Urine Test for HIV

A test that detects HIV antibodies in urine was approved by the FDA in 1996. This test is not generally available to consumers. It is usually marketed to insurance companies and to other countries. Note: urine has antibodies for HIV, not HIV itself, so HIV is not transmitted by urine. Manufactured by Seradyn, it is called the "Sentinel" test.

A sample of urine is tested at a certified lab, using a modified ELISA procedure. This test must be ordered by a physician; this means the urine HIV test, by definition, is confidential, not anonymous.

Because it is less sensitive than a blood test, positive results must be confirmed by a traditional blood sample (ELISA plus WB).

RNA / NAAT Testing

The "NAT" or "NAAT" test (nucleic acid amplification test) is used to detect the presence of genetic material that is specific to HIV. It is not approved for the use of diagnosis of HIV infection perhaps with the exception of diagnosing infection in newborns of infected mothers who have antibodies to HIV that are transferred from the mother.

However, this test is being increasingly used to detect recent infection at the viral load 'spike' that occurs when HIV is first contracted. This is usually at 2 -- 4 weeks after infection. Although a letter of diagnosis and actual treatment is not given until a three month antibody test is confirmed, this does allow providers to get a patient into health care options sooner. It also lets the client know early on so hopefully they can make risk reducing behavioral choices. It is thought that when this initial infection spike occurs that people are at their most infectious stage, so this test can be used to try and combat that as well.

There is research suggesting that between 10-50% of new infections happen during the acute infection stage. Many feel that identifying and making interventions during this period will greatly reduce infection rates.

A cost-effective and efficient way to combine standard ELISA tests with viral load tests is called a "pooled PCR". Viral load tests are expensive to do individuallys. Instead of performing viral load tests on individual blood samples, they have found a way to combine or "pool" samples and test multiple people's specimens at one time. If a pooled sample tests positive, the laboratory technicians test individual samples in the pool until they find the sample that is positive.

For-Profit Test Sites

There are various for-profit sites that offer HIV testing, but we cannot confirm that they all offer appropriate HIV-related counseling and risk assessment. In addition, many of these companies offer the initial test at a certain publicized fee, but do not tell the consumer that any additional tests (including confirmatory tests) may cost extra.

Most businesses charge a premium because they offer faster results. Remember, standard ELISA tests take only 3.5 hours to do, but most non-profit sites send samples away to central labs to lower costs, which is why their tests are free or low-cost. It is the transit (turnaround) time, not the actual test that takes longer. Some people with high anxiety about exposure may be tempted to use this faster service.

Testing Issues for Specific Populations

Pregnant Women

The number of children reported with AIDS due to perinatal HIV transmission in the United States peaked at 954 in 1992 and declined 95% to 48 in 2004, largely because of the effectiveness of ensuring that pregnant women are encouraged to be tested for HIV and, for those who are infected, to receive treatments that can significantly reduce the risk of transmitting HIV to a newborn. The CDC reports that perinatal transmission rates can be reduced to less than 2% if women are aware that they are infected with HIV and take appropriate treatments to prevent transmission.

Perinatal HIV transmission continues to occur mostly among women who lack prenatal care or who are not offered voluntary HIV counseling and testing during pregnancy. Many of the perinatal HIV infections each year can be attributed to the lack of timely HIV testing and treatment of pregnant women.

However, the antibody test may not be sufficient for a pregnant woman who has had known recent exposure to HIV. In such cases, a viral load test that tests for the actual virus (rather than antibodies) may be ordered by a physician to help the woman make more informed decisions.

Newborns and Children

During pregnancy a mother's antibodies to HIV are transferred to the baby. Therefore, for the first 12-18 months, a child born to an HIV-positive woman will test positive with an antibody test. This does not mean that the child is infected. After 12 to 18 months, the child will shed the mother's antibodies. If he/she is infected, the child will continue to test positive with an antibody test after this period. For this reason, the antibody test is not a reliable indicator of HIV status for children under 18 months. In cases such as these, the viral load test may be used to provide additional information about the child's immune system.

HIV testing may present special problems and situations for children and youth.

• Children under 12. California's Anonymous Testing Sites will not perform an antibody test on children under 12. Children under 12 have to be tested through a private physician or clinic.
• Youth 12 to 25 may schedule individual youth appointments at the anonymous testing sites. This means they will receive more personalized counseling from the same counselor before and after the test. See the Referral Database for complete listings of HIV-related services for youth in California (keyword: "adolescents").

Immigrants

[adapted from HIV and Immigrants: A Manual for AIDS Service Providers, published by the National Lawyers Guild with support from the San Francisco AIDS Foundation.]

All applicants for U.S. residence must take an HIV antibody test as part of the compulsory medical exam. Those who test positive are denied residence automatically. This measure also applies to all people requesting change in residence status, including citizenship applications.

Let's say you are an immigrant who has tested HIV positive. Besides worrying about testing HIV positive, you also fear what will happen to you because you are not a U.S. citizen. You may wonder whether your immigration status will change the kind of services you can get. You may ask: Will I be deported? Will I lose my immigration status? Can I work or get public benefits to help me if I need them? Will getting benefits make it hard to get another immigration status? If I can't work or get benefits, is there anything I can do to get another immigration status that will help me?

• Contact a local immigration assistance agency. For California agencies, go to the Referral Database. Use the keyword "refugee" to find local agencies.
• Do not go to the United States Citizen and Immigration Services (USCIS), formerly known as Immigration and Naturalization Services (INS), office by yourself. No one should speak to USCIS or go to USCIS before talking to an immigration law expert. If non-citizens go to USCIS by themselves, USCIS may arrest them and remove them from the US before they have had the chance to talk to a lawyer.
• Become informed about confidential versus anonymous testing. Before taking an INS medical exam, a non-citizen should get tested at a local clinic. Anonymous testing will give them the results without connecting those results to a name and may be safer in these circumstances.

Military Personnel

The Defense Department requires all military personnel on active duty and all members of the reserve and National Guard to be tested for the presence of HIV antibodies at least biennially. Soldiers who receive overseas assignment instructions, or are scheduled for overseas duty that will exceed 179 days, must have tested negative within six months of the departure date.

Soldiers who are infected with HIV will not be deployed outside of the continental United States. Soldiers serving outside the continental U.S who are confirmed as HIV-positive will be expeditiously reassigned to the continental U.S.

The U.S. Army Special Operations Command and Ranger organizations are totally closed to those who are infected with HIV. HIV-positive soldiers may face additional restrictions as determined by the U.S. Department of Defense.

A military doctor can notify the spouse of a reservist, if that reservist has tested positive for HIV.

How does an oral HIV test work?

When the CDC announced in September 2006 that everyone between the ages of 13 and 64 should start getting tested for HIV as regularly as they get tested for, say, a normal heartbeat or high cholesterol, it created a bit of stir in the medical community. While most health experts applaud the recommendation on principle, the logistics of widespread, regular HIV testing for people not typically considered to be at risk may be problematic. Testing can be expensive, time-consuming (for patients, doctors and laboratories alike) and upsetting. And some people just cannot bear to be stuck with a needle.

At least on that last point, there's a viable solution: a recently FDA-approved rapid HIV test (one that doesn't have to be sent to a laboratory for processing) that can use blood, serum or oral fluids with equal accuracy. A simple swab of the mouth and gums is all that's required for the OraSure OraQuick Advance test, which is the only HIV test approved for oral use as of September 2006. Depending on who you ask, the oral test is either just as accurate or a partial percentage point less accurate than a blood-based test, with false positives being slightly more likely than false negatives.

The OraSure test doesn't use saliva. It uses an fluid called oral mucosal transudate, which lives in the cheeks and gums. Aside from the fluid it uses for testing, the oral HIV test works just like the HIV blood tests -- it's testing for HIV antibodies, not the actual disease. When a person has HIV, his or her immune system produces antibodies in a futile attempt to kill the virus (see How Your Immune System Works to learn about the antibody response). So if a person has HIV, he also has HIV antibodies. And while an infected person's oral fluid contains hardly any of the HIV virus itself -- that's why kissing won't transmit the disease -- it contains plenty of HIV antibodies. The thing that makes antibodies a good substance to test for is that when the immune system produces antibodies in response to the proteins for a specific disease, which are called antigens, the antibodies bind to those antigens in an attempt to fight off the disease. If you add another protein, or enzyme, into the mix that reacts to the binding of antibody to antigen, you have yourself a good test for the disease. That's basically what the oral HIV test does.

Generalized illustration of oral HIV-testing process

The OraQuick Advance device holds a test strip. High up on the test strip, within the plastic casing, a substance with the makeup of HIV antigens has been applied. A patient places the end of the test strip in his or her mouth and swabs his cheeks and gums. The test administrator then places the end of the device in a vial that holds an enzyme solution that reacts to any antibody-antigen binding. As the oral fluid and the enzymes make their way up the test strip, they encounter the HIV-antigen substance. If there are HIV antibodies in the oral fluid, they start to bind to the antigens, and the enzyme reacts, causing a color change on the strip. This produces a line on the read-out portion of the device. This line indicates a reaction -- it is not considered to be a definite positive. As with all other HIV tests, OraQuick requires a repeat test before a patient is considered to be HIV positive. If no line appears at the site of the antigen substance, that's considered a negative result (no HIV antibodies present).

The oral HIV test takes about 20 minutes to produce results. The OraQuick device is not available over the counter and should not be used for home testing. For an oral HIV test, you should go to your doctor or to a clinic that provides the service. Following this test, you must still return to your doctor for a more specific one because HIV antibodies may not appear until three to six months after infection.

For more information on HIV testing and related topics, check out the following links:

• How AIDS Works
• How Your Immune System Works

• CDC: A Rapid Review of Rapid HIV Antibody Tests
• Forbes.com: CDC Says HIV Tests Should Be Routine - Sept. 21, 2006
• OraSure Technologies, Inc.

ZIMBABWE: Routine HIV testing a long way off

HARARE, 14 January 2009 (PlusNews) - When Mercy Mangwende*, 38, walked into her doctor's surgery in Harare, the Zimbabwean capital, three years ago with flu and chest pains, she had no idea her life was about to change forever.

This was the third time in less than three months she had had flu, but, eager to avoid the high consultation fees charged by private doctors, Mangwende had been relying on home remedies such as tea with lemon and non-prescription medicines.

She finally decided to see a doctor when she developed a splitting headache and had difficulty breathing, and was admitted to a private hospital with an acute respiratory infection.

An X-ray showed she had swollen lymph nodes in her chest - a sign that her body was fighting off a chronic infection. Her doctor advised that she be tested for HIV and tuberculosis.

"It was three years after my husband had died from an accident. I had not been with a man since then and I didn't think I was at risk. I didn't understand where the doctor was coming from," she told IRIN/PlusNews.

Mangwende felt offended by his recommendation, but now says she owes her life to his frankness. After testing positive for HIV, she learned that her CD4 cell count [which measures immune system strength] was dangerously low and she immediately began antiretroviral treatment (ART). Today her CD4 cell count is normal and she feels "healthier than ever".

The World Health Organisation (WHO) and UNAIDS published guidelines on Provider Initiated HIV Testing and Counselling (PITC) in 2007, stating that health workers should recommend an HIV test to all patients with infections common in people with HIV, such as oral thrush, tuberculosis, retinitis and herpes zoster.

Supporters of PITC argue that the low uptake of Voluntary Counselling and HIV Testing (VCT) services in Zimbabwe and elsewhere in southern Africa is a major obstacle to HIV/AIDS responses. Many people only discover their HIV-positive status when their immune systems are too weak to support ART and they may have unknowingly infected many others.

"With VCT, HIV/AIDS programmers rely on the fact that one day someone will wake up and decide to get tested, but the problem is that some people do not think they are at risk and see no reason to get tested, or others are afraid, so that they never come forward," said HIV/AIDS activist and counsellor Chitiga Mbanje.

Although agreeing on the benefits of PITC for the earlier diagnosis of HIV, experts and activists alike are sceptical that it is feasible in the context of Zimbabwe's collapsed public health sector.

In October 2008, a work boycott by health personnel over poor salaries and working conditions led to the closure of referral hospitals and many government-run HIV/AIDS clinics.

According to a report on Zimbabwe's healthcare crisis, released on January 13 by international advocacy group Physicians for Human Rights, access to free VCT has declined since the hospital closures, while an HIV test at a private clinic now costs around US$200 - a sum well beyond the reach of most Zimbabweans.

"The gains Zimbabwe has made in HIV prevention could be swiftly reversed if free public HIV testing is not made immediately accessible," notes the report.

Speaking at a recent discussion forum organised by the Southern African AIDS Information Dissemination Service (SAFAIDS), HIV/AIDS specialist and general practitioner Dr Paul Chimedza commented that even under more normal conditions, introducing PITC in the public health sector was problematic.

"I think asking for nurses and doctors to treat dozens and dozens of patients, and then after that to pre-counsel and post-counsel patients for HIV testing would be asking for too much," he said. "We all know the work load in public hospitals."

Mbanje agreed that the current state of the health delivery system would not support the introduction of PITC. "We need motivated health workers, availability of support services after testing HIV positive, access to ART," he said. "Presently, we know many people living with HIV are not accessing ARVs [antiretrovirals] and have been on the government waiting lists for ages."

Of the estimated 320,000 people in need of ARV drugs in Zimbabwe, only about 100,000 are accessing the medication at public health facilities. The Physicians for Human Rights report notes that HIV programmes cannot enrol any new patients on ARVs, and that supply of the medicines is erratic.

Dr Chimedza argued that knowing one's HIV status and receiving proper counselling when it was positive, was still beneficial. "Even where ARV drugs are not available, interventions such as cotrimoxazole prophylaxis [an antibiotic] can boost one's immune system and prevent the body from picking up many infections."

About HIV

About HIV

Many people infected with HIV don't know they have it because they have never been tested for the presence of the virus in their blood. Another reason they may not know they are HIV positive is because it can take five years or more for the symptoms of' the infection to show up. When a persons blood contains HIV, the person is said to be HIV positive.

HIV damages the nerves and brain, the nervous system. It also attacks and destroys the body's natural defence system against disease-the immune system. Specifically, HIV destroys the CD4 cells of the immune system. Without enough of these special cells, the body has difficulty fighting off infections. When the immune system becomes so weakened by the attacking virus that certain life-threatening infections set in, and if the CD4 cell count is low in the person's blood, the person is said to have AIDS.

While it is true that an HIV infection has no cure, treatment is available today that can help people enjoy an improved quality of life and live longer. Treatment can also help lessen the risk of passing the virus to an unborn child.

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HIV, Women and Their Children

The number of women of childbearing age who are infected with HIV is increasing. A pregnant woman can pass HIV to her unborn baby. Many babies infected with HIV die within three years unless they are treated. Today, there is a treatment to reduce the risk of passing HIV from an infected mother to her baby. That is why every woman thinking about becoming pregnant, and those women who are already pregnant, should strongly consider being tested for HIV. If you are unsure, talk with your health provider and read this pamphlet to find out more about HIV, AIDS and pregnancy. In addition, consider talking with a counselor in your community who specializes in HIV.

Every pregnant woman in Canada should be offered HIV testing during pregnancy. If your doctor doesn't mention testing you for HIV before you get pregnant or during your pregnancy-ask to be tested.

How HIV is Passed From Person to Person

HIV is found in an infected person's body fluids, semen, blood, vaginal secretions and breast milk. Most commonly, the virus is spread from an infected person to a non-infected person during sex. However, the virus can also enter a person's bloodstream by way of a contaminated needle if you share needles with an HIV positive intravenous drug user. An infected mother can pass the virus to her baby during pregnancy, delivery or while breast-feeding. Very rarely (in Canada the blood supply is carefully screened for the presence of disease and is considered very safe) can an HIV infection occur from a blood transfusion.

Checklist for Protection

Things you can do to protect yourself from becoming infected with HIV:

• Use a latex condom each and every time you have sex, learn how to use them properly by reading the instructions on the package and carry them with you all the time.
• Limit the number of sexual partners you have, the more partners you have, the greater the risk for getting HIV and other sexually transmitted diseases (STD).
• Don't take part in risky sex, the most unsafe is vaginal or anal sex without the protection of a latex condom.
• Ask questions about your partner's sexual history, who you have sex with, in this era of AIDS, should not be a casual decision. Instead, the decision should be given a great deal of thought. It is important to know the sexual and drug use history of the person you are sleeping with. Ultimately, it is best to test before having sex and keep talking about monogamy and safe sex during your relationship.
• If you use injectable drugs, use clean needles never share needles with anyone.

Testing for HIV

Most people cannot be completely sure whether or not they have been exposed to HIV and this by itself is good reason to be tested. Testing for the presence of the virus in your blood is usually done by way of blood test.The first test used is the enzyme-linked immunosorbent assay (ELISA). It is a test to see whether your blood contains HIV antibodies. Antibodies develop after a person has been infected. If HIV antibodies are present, it means that you are HIV positive. It does not mean you have AIDS. If the first test is positive, a repeat ELISA test will be done, and then a second test (called a Western blot) will be done to make sure there were no mistakes. Although it is extremely rare (about 1 out of every 20,000 tests,) a test may give a false-positive result.. A false-positive test says you are infected when you are not. If there are any doubts, you can be retested.

If Your Test Result is Negative

If your test result is negative, it only means the test did not find any HIV antibodies in your blood at the time of testing. This can mean one of two things:

1. You are truly negative
2. Or, you may be positive but there were not enough antibodies in your blood to measure at the time of the test. This can happen if your test was done so soon after you were infected that your body didn't have enough time to develop enough antibodies to measure. (It takes about 6-12 weeks after exposure to the virus to develop enough antibodies to measure.) In this situation, the test may have indicated you are not infected when you are. This is known as a false-negative test result. For this reason, some people choose to be tested again in 6 months.

Remember, even though a test result is negative, you can still become infected at any time after the test was done if you are exposed to the virus. You should always take precautions against HIV.

If Your Test Result is Positive

If your test result is positive, you will need guidance, emotional support and special health care-particularly if you are pregnant. Remember a positive test result does not mean you have AIDS. It means you have been infected with the virus that causes AIDS. It does mean that as a carrier of HIV you can pass it on to other people. For many, it is comforting to know that a great deal of medical research over the past decade has produced some very beneficial treatments which have helped HIV positive people to live healthier, longer lives.

Privacy During Testing

If you wish, you can ask to have your name left off the test tube and paperwork. This common request is called a non-nominal test. In this case, you will be assigned a "code number" for testing purposes, that only you and your doctor will know. The results will be placed in your medical file.

Only certain health care professionals will know the results or have access to your results. In some provinces, health care authorities are notified confidentially.

HIV and Pregnancy

About 0.2% (2 of every 1,000 women) of pregnant women are HIV positive. Of them about 1/3 (one out of every three) will pass the virus to their baby before it is born if no treatment is given. This is because the virus can cross to the baby from the mother's bloodstream through the placenta--as early as a woman's 8th week of pregnancy. In addition, an HIV positive mother can pass the virus to her baby at the time of' the baby's birth---when there is an exchange of body fluids. It may not make a difference whether a woman delivers a baby vaginally, or by caesarean section, since in many cases the fetus may have already been infected with HIV before its birth.

HIV and Breast-feeding

HIV is found in breast milk and therefore HIV positive mothers can pass the virus on to their nursing babies. Even mothers who tested negative for HIV during their pregnancy can still pass the virus on to their babies if they become newly infected during the period of time they were breast-feeding. Mothers infected with HIV, or those who continue to have risk activities associated with HIV infections, should formula feed their babies.

Treatment for Positive HIV Test Result in Pregnancy

If you are pregnant and you decide to go on with the pregnancy, you can lessen the risk of passing the virus on to your unborn child by up to 60%. Studies have shown that when HIV positive women (with no symptoms of AIDS) are given a drug (pill) called AZT (zidovudine) while pregnant, and during their labour and birth, they are much less likely to pass the virus to their fetus. You may need to continue taking it after the baby is born-depending on your health status. AZT will also be given to your newborn baby until he or she is six weeks old. This drug can cause some side effects. Therefore, it is very important to tell your doctor all the symptoms you may be having so that your doctor can bc sure you get the proper care. Without AZT treatments, the chances of your baby becoming infected are one in four (25%). With the treatments, the chances drop to one in twelve (8%). Another option is to end the pregnancy.

Additional Testing During Pregnancy

If you are HIV positive, your doctor will want to test you to see if you have other infections because your immune system (your disease fighting system) may be weakened. In particular, he or she may test you for other sexually transmitted diseases (STD). In addition, your HIV viral load and your CD4 cell count will be carefully monitored throughout the pregnancy. A lowered CD4 cell count and a high viral load cause an increased chance of passing the virus to the fetus.

Drug therapy treatment is available to help prevent the spread of HIV to your unborn baby.

Counselling

A positive test result is a very frightening event for almost everyone. During such a difficult time in a person's life, counselling can be very helpful. A trained counsellor will not only give you emotional support you will need, he or she will teach you about HIV and help you to learn ways to cope with the disease. In addition, counselling is a very important part of helping you learn ways to avoid passing the virus on to someone else.

Final Thoughts

Medical researchers, and many famous AIDS activists have increased the awareness of AIDS tremendously over the past few years. As a result, people tend to focus on living with HIV in a more positive light and much of' the stigma attached to being HIV positive has subsided. Nowadays, people are getting tested more often in order to begin early treatment. That being said, HIV infections continue to be a threat to people all over the world, including children. If you are thinking about getting pregnant or are already pregnant, it is best to test!

Quest Diagnostics Launches HIV Test to Determine Patients Suitable for Entry Inhibitors

GEN News Highlights

Quest Diagnostics reports the availability of a test to help determine whether a patient with a history of HIV drug resistance will respond to the latest class of HIV antiretroviral therapies. The HIV-1 Coreceptor Tropism Test reports results in approximately half the time of the nearest competing test, Monogram’s Trofile HIV tropism test, according to Wendy H. Bost, spokesperson for the company.

HIV co-receptor tropism refers to the preference of strains of HIV to bind to, activate, and infect cells based on the type of co-receptor on the cell’s surface. The newest class of antiretroviral drugs, called entry inhibitors, targets the tropism process involving one or both co-receptors, CCR5 or CXCR4, found on CD4 cells. Guidelines from the U.S. Department of Health and Human Services recommend tropism testing prior to the start of a CCR5 inhibitor like Pfizer’s Selzentry.

“CCR5 antagonist entry inhibitors have given physicians new options for treating thousands of patients with HIV who have shown resistance to earlier HIV therapies,” remarks Jay G. Wohlgemuth, M.D., vp of Science and Innovation, Quest Diagnostics. “Yet they are only suitable for about half of these patients due to the different ways that the virus tries to infect cells.

“With our new tropism test, we expect to report results within seven days of receiving a patient specimen, compared to the leading commercial HIV tropism test, which requires two weeks of processing time once a sample is received. Considering that tropism status can change in as little as a few weeks in patients with a history of HIV drug resistance, faster results potentially translate into earlier initiation of efficacious therapy.”

Quest Diagnostics, using samples from patients with a history of drug resistance, found that the HIV-1 Coreceptor Tropism test demonstrated 74% agreement with Trofile and 74% agreement with SensiTrop™ II, a genotypic tropism test previously available from Pathway Diagnostics. The SensiTrop II test, which is no longer commercially available, was 73% percent in agreement with Trofile.

Quest Diagnostics had offered a prior version of the SensiTrop test through a license with Pathway Diagnostics before acquiring the company during the fourth quarter 2008. The company’s new HIV-1 co-receptor test employs a novel molecular-based technology developed by Quest Diagnostics scientists.

In addition to HIV tropism testing, Quest Diagnostics’ services range from HIV diagnostic testing to monitoring HIV viral load, determining a viral genotype, and testing for the HLA-B*5701 genetic marker as an aid in predicting a hypersensitivity reaction to GlaxoSmithKline’s Ziagen.

Opt-out HIV testing feasible and acceptable

Opt-out HIV testing in a sexual health clinic is feasible and acceptable, Dutch investigators report in the May edition of Sexually Transmitted Infections, but the patients most likely to opt out tend to be those with the highest risk of HIV.

There is concern across Europe about the large number of HIV-positive individuals who are undiagnosed. In the Netherlands, it is estimated that as many as 80% of heterosexual HIV infections are undiagnosed, as are between 40 and 60% of infections in gay men. A significant proportion of HIV cases in the UK are also undiagnosed, a situation which a recent editorial in The Lancet called “appalling”.

Due to concerns about the large number of undiagnosed individuals in the Netherlands, the sexual health clinic in South Limburg implemented a policy of opt-out HIV testing in 2004. It was the first sexual health clinic in the Netherlands to adopt such a policy.

Services offered by the clinic are free. Limburg has a population of 630,000 and because of its geographical location also attracts patients from Belgium and Germany.

Investigators retrospectively analysed the effectiveness of HIV testing between 2003 and 2007 and examined the reasons why individuals refused a test.

In the period of the study there were just under 13,000 consultations at the clinic. The number of consultations increased annually from a little over 1900 in 2003 to almost 4000 in 2007. The majority of patients (53%) were women, with 38% being heterosexual men and 9% gay men. A third of patients were over the age of 30.

Following the introduction of the opt-out testing policy, there was a marked increase in the number and proportion of patients tested for HIV. In 2003, 84% of patients tested for HIV, and this had increased to 96% in 2007.

Increases in HIV testing were observed in all demographic groups. There was also a marked decline in the proportion of patients refusing an HIV test, and in the second half of 2007 only 3% of heterosexual men and women and 2% of gay men refused an HIV test.

A total of 45 individuals (0.4%) tested HIV-positive. After the introduction of opt-out testing, the number of patients diagnosed with HIV increased from four in 2003 to ten in 2007.

The investigators found that the risk factors for refusing an HIV test appeared to be suggestive of a greater risk of HIV. The likelihood of HIV testing for heterosexuals decreased as their number of sexual partners increased. Furthermore, refusal of a test by heterosexuals was also associated with having a sexually transmitted infection present at the time of the visit to the clinic, symptoms of an infection, or being contacted by a partner and advised to attend for a sexual health check-up. For gay men, refusal of an HIV test was associated with age over 30 years, current symptoms of a sexually transmitted infection, and partner recommendation to attend the clinic.

Individuals refusing an HIV test were asked why, and the answer was recorded on their notes. A third of heteroseuxals and 11% of gay men said that this was because they thought they were in the 'window period'. A little over a fifth of heterosexuals and 28% of gay men perceived themselves to be at low risk of HIV, and 15% of heterosexuals and 18% of gay men reported a previous HIV test. Few heterosexual patients said they refused an HIV test because they feared the result, but this answer was given by 11% of gay men who declined an HIV test.

“We assessed a marked increase in the absolute and relative number of HIV tests at our STI clinic”, write the investigators.

They stress that for opt-out HIV testing to be effective it must be linked to HIV treatment and care services.

“Result of this study showed that standard testing on HIV in a STI clinic is feasible and effective in increasing awareness of one’s HIV status”, conclude the investigators. They add, “implementation of opting-out in a STI clinic can lead to more traced HIV infections and more people receiving timely anti-HIV treatment. It should be an essential part of STI screening…and should be considered in other healthcare settings for specific risk groups as well.”

Reference
Dukers-Muijrers NHTM et al. Effectiveness of an opting-out strategy for HIV testing: evaluation of 4 years of standard HIV testing in a STI clinic. Sex Transm Infect 85: 225-30, 2009.

Rapid Oral HIV Test Procedure

To perform an oral test, the tester takes the device that has an absorbent pad at one end, places the pad above a person’s teeth along the outer gum, and swabs once around both the upper and lower gums. The tester then inserts the device into a vial containing the developing solution.

In 20 minutes, the device indicates whether HIV-1 or HIV-2 antibodies are present. If one line appears on the strip, it means that the person is not infected with HIV (with 99.8% accuracy). If two lines appear, the person is likely infected (99.3% accuracy). If the result is positive, it has to be confirmed with an additional, more specific test.

Typical HIV tests require an entire vial of blood and take up to 2 weeks to get results. Two years ago, the FDA approved a rapid HIV test that uses only a drop of blood and gives results within 20 minutes.

Hospitals use these rapid HIV screening tests mostly to tell if health workers have been exposed to HIV-infected blood and to test women in labor who had not been previously checked. This way, workers and newborns can get anti-HIV drugs immediately, to possibly prevent infection. In 2003, the CDC emphasized the use of these rapid HIV screening tests at shelters, drug treatment centers, and other nonmedical facilities. The new rapid oral tests are the same kind of HIV test as the one used to rapidly test blood specimens. The difference is that the tests now include a way to collect the oral fluid from the gums.

When the rapid oral HIV test started being used, the maker of the test was not able to sell it outside of hospitals, large health clinics, and certified laboratories. A law restricted the performance of certain medical tests to certified laboratories, and a waiver was needed before the oral test could be sold to outreach clinics and other noncertified medical settings. However, in June 2004, the waiver for the test was received, and now both tests are allowed to be sold outside of certified medical settings.

The cost for the new tests is about $8 per test for public health officials and $8-$20 for other organizations. This is comparable to the price of the rapid blood test.

HIV test kit evaluations

Laboratory diagnosis of HIV infection generally focuses on detection of antibody to HIV. However, the new generation assays also incorporate HIV antigen detection to increase the sensitivity of the assay. In this way, a HIV antigen-antibody combination assay is helpful in closing the window period (the time between HIV infection and appearance of antibodies to HIV) as HIV antigen is present in the blood before antibodies to HIV can be detected.

Composition of the panel

Test kit evaluations are carried out at the WHO Collaborating Centre in Antwerp, on the WHO HIV reference panel of well characterised serum/plasma specimens of geographically diverse origin, seroconversion panels and low titer panels. This approach allows for comparative data. In addition, field evaluations are occasionally conducted.

Other specimen types

Assessment of the performance of test kits recommended for use with other specimens types such as whole blood, oral fluid and urine, are carried out in prospective studies as these samples can not be stored. Some of these tests may be useful for VCT testing settings and hard to reach populations.

Past evaluations

In recent years, 29 assays for the detection of HIV antibody have been evaluated, of which 19 were simple rapid tests and 5 tests were combined HIV antigen-antibody ELISAs.

Testing Yourself for HIV-1, the Virus that Causes AIDS

AIDS is a serious disease that can be fatal. You can determine if you are infected with the Human Immunodeficiency Virus-1 (HIV-1), the virus that causes AIDS, by taking a test for the presence of antibodies to the virus.

The tests that are approved by the United States Food and Drug Administration (FDA) for detecting whether or not you are infected with HIV are available through your doctor or at clinics. For more information on the HIV test kits approved by FDA, see "Licensed/Approved HIV, HTLV and Hepatitis Tests."

However, there is one HIV-1 Home Collection Test System that is currently approved by the FDA in which a sample for testing is collected in the privacy of your home and then sent to a laboratory for analysis. The "Home Access Express HIV-1 Test System" manufactured by Home Access Health Corporation is the only HIV-1 Home Collection Test System approved by FDA and legally sold in the United States.

Be aware that there are a number of different HIV home test systems and kits that are being marketed on the Internet and through magazine or newspaper promotions that claim to detect antibodies to HIV in blood or saliva samples and provide results in the home in 15 minutes or less. The FDA has NOT APPROVED these rapid HIV-1 home test kits being promoted on the Internet for use and marketing in the United States. Some of the HIV home test kits falsely claim to be approved by the FDA or manufactured in a FDA approved/registered/licensed facility. All HIV home sample collection kits approved to date by FDA require laboratory analysis and provide counseling for the consumerFDA warned consumers about an unapproved, fraudulently marketed home-use HIV test system labeled "Lei-Home Access HIV test" distributed by Lei-Home Access Care located in Sunnyvale, California in a press release issued on September 26, 1997. The "Lei-Home Access HIV test" was advertised on the Internet as the "Personal HIV Test Kit" and was offered for sale through several Central Valley pharmacies. After an extensive investigation by FDA, the businessman responsible for distributing this fraudulent HIV test kit was recently sentenced to over 5 years in prison for selling the medically useless HIV test kits to consumers in the United States.

The Center for Biologics Evaluation and Research is working with FDA's Office of Regulatory Affairs and Office of Criminal Investigations in investigating firms and persons involved in the sale, distribution, and manufacture of unapproved HIV home test kits in the United States.

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The following questions and answers may help to explain how HIV-1 home tests differ, and how to select a test that you can trust.

Q. How many different kits are available, and how do they work?

A. There are more than a dozen different HIV home test kits being advertised on the market today. Only the Home Access test system is FDA approved and legally marketed in the United States.

Because the Home Access test consists of multiple components, including materials for specimen collection, a mailing envelope to send the specimen to a laboratory for analysis, and includes pre- and post-test counseling, it is considered a testing system.

This approved system uses a simple finger prick process for home blood collection which results in dried blood spots on special paper. The dried blood spots are mailed to a laboratory with a confidential and anonymous personal identification number (PIN), and analyzed by trained clinicians in a certified medical laboratory using the same procedures that are used for samples taken in a doctor's office. The results are obtained by the purchaser through a toll free telephone number using the PIN, and post-test counseling is provided by telephone when results are obtained.

The advertisers of the unapproved HIV home test kits claim that the presence of a visual indicator, such as a red dot, within 5 to 15 minutes of taking the test shows a positive result for HIV infection. These unapproved test kits use a simple finger prick process for home blood collection or a special sponge device for saliva collection. The blood or saliva sample is then added to a plastic testing device containing a special type of paper. A developing solution is added to determine if the sample is positive for HIV. The samples are not sent to a laboratory for professional analysis. Although this approach may seem faster and simpler, it may provide a less accurate result than can be achieved using an approved test, which is analyzed under more controlled conditions than is possible in the home.

Q. How reliable are the unapproved HIV home test kits?

A. Diagnostic testing depends on precise science. Unapproved HIV home test kits do not come with any guarantee of the accuracy of the test, or the sensitivity of the reagents used in the analysis. Nor do they have a documented history of delivering dependable results. Proper training to interpret results is not provided with the kits, and they do not have a validated record of precision. This means that they may not be as accurate and that they may yield inconsistent results. Users can get a positive result when they are, in fact, not infected (called a false positive), or the test may indicate that a person is not infected with the virus, when, in fact, they are (called a false negative). Both of these outcomes can have grave consequences in terms of mental anguish, access to proper medical treatment, and on future transmission of the disease.

None of the unapproved tests have undergone the intense scrutiny and validation required for FDA marketing approval. Although unapproved tests might be promoted as sensitive and reliable, the consumer has no guarantee that the results produced by the test are, in fact, accurate. Even if they have been tested by independent laboratories, they have not been analyzed and validated by the FDA to assure that the test results were correct and reliable.

FDA is unaware of any data to confirm the reliability or accuracy of the process used in the unapproved HIV home test kits.

Q. How reliable are approved HIV test systems?

A. Approved HIV test systems, on the other hand, have undergone extensive study and review by the manufacturer of the product to ensure that they work, that the results they provide are specific, meaning that they will accurately detect antibodies to the HIV-1 virus that causes AIDS, and that they are sensitive, meaning that they can detect even low levels of these antibodies, indicating that someone has been exposed to HIV-1.

Clinical studies have shown that the approved HIV test system is able to correctly identify 100% of known positive blood samples, and 99.5% of HIV-1 negative blood samples.

In addition, manufacturer's tests on the approved HIV test system have been carefully reviewed by the FDA to assure that the tests conducted were themselves adequate to demonstrate that the system is capable of yielding accurate, dependable results. FDA review also assures that the system contains adequate directions for proper use, and that the quality standards will be monitored to ensure that each kit is as consistently accurate and sensitive.

Q. What about counseling?

A. The unapproved HIV home test kits do not provide direct counseling to help the user understand results, answer questions about the test or about HIV infection, or to discuss available options.

The approved HIV test system has a built in mechanism for pre-and post-test counseling provided by the manufacturer. Counseling is an important part of HIV testing. It is anonymous and confidential. Counseling, which uses both printed material, and telephone interaction, not only provides the user with an interpretation of what positive or negative results really mean, but provides information on how to keep from getting infected if you are negative, and how to prevent transmission of disease if you find you are infected. Counseling also provides you with information about treatment options if you are infected, and can even provide referrals to doctors that treat HIV-infected individuals in your area.

Q. Are approved HIV test systems really confidential?

A. The approved HIV home test system is anonymous. It can be purchased anonymously at pharmacies, or by mail order from the manufacturers. The mail-in system uses a confidential code number that is unrelated to the identity of the buyer or user.

Although some states require that new cases of HIV infection be reported to the health department, only the number of cases detected with home test systems can be reported. The identity of the user remains anonymous.

The number of cases reported allows local or state public health officials to assess the extent of infection to properly budget, plan and administer programs for people with HIV.

The lack of reporting of the number of new cases in a geographic area also means that adequate services for people with HIV infection may not be available in your area.

Q. Is one test better than another?

A. Since the approved HIV home test system has been independently tested, validated, and approved by the FDA for marketing, the consumer can feel confident that the approved HIV test system will provide the most accurate results available from an HIV-1 home test. In addition, the user is provided with counseling and referrals if needed. Use of an approved HIV test system also assures that accurate numbers of infection are reported to public health departments so that adequate services can be provided.

Q. Are there other ways I can be tested for infection with HIV-1?

A. There are several kinds of tests available through your doctor to determine if you are infected with HIV-1, the virus that causes AIDS. In addition to blood tests, there is a test that uses oral fluid, collected from between the cheek and gum of the mouth, and a urine test. All of these tests have been thoroughly tested and reviewed, and provide the highest possible level of confidence in determining HIV infection. All are collected in the doctor's office, and analyzed in a medical laboratory. Only a doctor or clinic can administer these tests.

So, ask yourself what is the best choice for you:

An HIV home test system that has been approved by the FDA for marketing after extensive review and in which you can feel confident about the results?

OR

An HIV home test kit that has not even been reviewed by the FDA and may not provide accurate results about whether you are HIV positive or negative?

Is it worth your time, money, mental anguish and your life to gamble on an unapproved HIV home test kit? Only you can answer that question.

If you are in doubt about whether an HIV home test kit you are considering using is approved, or if you have other questions related to HIV home test kits, you may call the HIV/AIDS Program of the FDA, in the Office of Special Health Issues for further information about this topic. The Office can be reached at 301-827-4460.