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Test and go
By Peter Tupper-contributing writer
Anita Massey, director of quality assurance at Biolytical Laboratories Inc., tears open a foil packet and takes out the contents: three small plastic bottles, a sterile lancet for pricking a person's finger, a tiny eyedropper for collecting a precise amount of blood and a white test pad that looks a little like an egg cup.
As if mixing a tiny cocktail, she pours test fluid into a bottle labeled "1," carefully shakes it, then pours the contents on to the white pad and adds the contents of bottles 2 and 3. Less than a minute later, she holds up the test pad and shows two small coloured dots, much like that seen in a pregnancy test.
The difference is that these dots indicate the presence of antibodies for the human immunodeficiency virus. If it had been done with someone's blood, that person would probably be infected with HIV, the virus that causes AIDS.
The INSTI HIV-1/HIV-2 Rapid Antibody Test is made by Biolytical Laboratories, a privately-owned company based in a small building in a Richmond industrial park, where it does both research and production. INSTI is one of a new generation of HIV tests promising to make testing for the disease faster, simpler and cheaper. The tests are already being mass-produced on a scrupulously clean Biolytical assembly line.
Proponents of rapid HIV tests believe they will aid in the fight against HIV and AIDS. Whether the test takes six weeks or 60 seconds, learning you are HIV-positive profoundly changes your life.
Everyone agrees that HIV testing should be done in conjunction with counselling and education so that people can learn how to live with their new condition and prevent the further spread of the disease. New, faster tests, their supporters say, are just another tool in controlling HIV, both in Canada and especially in developing nations.
"I think the population at risk for HIV in Canada is quite well served by the testing mechanism that we have in place now, in laboratories and through the public health lab system," says Rick Galli, Biolytical's director of research and development.
"But it can be better served with a high-quality, peer-reviewed, approved rapid test in the mix, for patients who may have difficulty in trusting the current HIV testing program. Patients who may be marginalized, who feel much more relaxed with their health care provider one-on-one, and who can deal with the testing right there on the spot."
When people go to a clinic for an HIV test, their blood samples are sent to a central laboratory and tested as part of a batch, with multiple confirmation tests. Their results come back weeks or even months after their blood was first drawn.
A "point of care" test, like INSTI, can be administered in a clinic, doctor's office or hospital emergency room. Unlike other rapid tests, INSTI uses whole blood instead of plasma, eliminating a step in testing. Biolytical also designed the test to be simple enough for doctors, nurses and lab workers to use after only half an hour of training.
Biolytical's Galli says positives from INSTI tests should always be confirmed by other standardized and accepted tests, like the Eliza and Western Blot tests, less likely to produce false positives.
"There's an algorithm of testing that entails a screen test and at least one, if not two, supplemental tests before results are given back to the patient. So, all rapid testing would be doing, in a sense, would be doing the screen testing on patients and then positives would be sent to the laboratory for standard confirmatory tests," says Galli.
In British Columbia, 421 people tested positive for HIV in 2003. From 1985 to the end of 2003, 11,510 people tested positive in B.C., according to the B.C. Centre for Disease Control.
According to British Columbia's Action on HIV/AIDS report from 2000, HIV is concentrated among gay men, injection drug users, aboriginal people, people in poverty and sex workers.
In the Bute Street clinic in the West End, where Paul Harris, a registered nurse, has worked for the past eight years with a largely gay clientele, the new tests would be welcomed.
"It will be very popular in the gay community," Harris predicts. The clinic used a previous quick test, Fast-Check, which is no longer available. "It was a great service to be able to provide to the people, and it was much missed when it was pulled off the market."
Harris believes any product that can reduce the wait time for test results is beneficial.
"If it's implemented correctly and used with sensitivity at the point of care, I think it can be an effective educational tool as well. It can be an effective prevention tool."
The sooner a person knows they are HIV positive, the sooner they can begin safer sex practices, which can help prevent the infection of others. Harris says rapid tests do not necessarily mean poor counselling.
"The actual processing of blood may take three minutes, but the pretest can take as long as you need to get somebody prepared. That's more easy to do in a controlled environment like this clinic.
"In the gay community, people, by and large, are more cognizant of the issues around HIV and HIV testing, and are often well-prepared for at least the concept of HIV testing and what the impact of a positive test would be."
Many people in health care are leery of the new testing technology. In 2000, the Canadian HIV+AIDS Legal Network published a report questioning the value of rapid HIV screening at the point of care. The report's writers wondered if people who take a quick test could get false positive results, receive inadequate counselling in case of positives, or have their confidentiality breached by health care workers who aren't properly trained.
Across town, James Tigchelaar, a registered nurse, is the outreach team leader for the street nurse program who has worked in the Downtown Eastside for 14 years. His clients for HIV tests include intravenous drug users, sex workers and others from the street. "If a test like this [INSTI] were available, we'd probably still choose not to use it with this population," he says.
Tigchelaar is concerned people who get a positive result on a point of care test may not fully understand what the result means. "You have to confirm it with a full-on regular blood test. It's essentially the same as a reactive on the first stage of the four-step HIV test."
Dealing with his clients is often difficult at the best of times.
"Sometimes, when you've got somebody who's really heavily into the streets here, they've got five minutes for you. In that five minutes, we can do as quick a risk assessment as we can, draw their blood and try to make arrangements to meet up with them again two weeks later. If we handed them a potentially inaccurate result with a test like this, and they interpreted that as, 'I am positive'.... we don't get the chance to reconnect with them because they have no fixed address.... It opens a lot of doors we'd just rather not have open."
Tigchelaar says speed isn't always a virtue.
"We're in no big hurry.... We still have to confirm a positive on a test like this with a blood test so we have to wait anyway. The advantage to waiting is that, when you're dealing with folks who have a multitude of risk factors in their lives, you have to spend time with them, essentially, to do effective counselling, to do effective sexual health management and addictions management work.
"Somebody blasting in the door and wanting a three-minute test, and in a big hurry to blast out the door, doesn't give you that opportunity. It doesn't give you that opportunity to sit down and say, 'Hey, what are the issues here? What are the things that are putting you at risk? How can we work with you to start to ameliorate those risks?' Sometimes when you say to somebody, 'You've got to come back in a week or two to get your result,' it gives them time to think."
Even a negative test is an opportunity to help a person consider the risk factors in his or her life and perhaps do some prevention.
INSTI, like most HIV tests, detects the antibodies for HIV, rather than the virus itself, and those antibodies don't appear until three weeks to six months after infection.
Biolytical has completed its clinical trails of INSTI and Health Canada is reviewing the INSTI test to see if it meets the standards for point-of-care testing. If approved, it would be the only approved point-of-care test in Canada.
There are other rapid tests. MedMira, a Halifax-based company, received Health Canada approval for laboratory use of its Reveal rapid tests in 2004. In the U.S., medical professionals can use the OraQuick testing system by Epitope, Inc.
But there are also much less scrupulous entries drawn into the testing field by the money to be made.
"Unfortunately," says Galli, "the world of rapid HIV testing has been muddied with a lot of very poor quality, fly-by-night operations that are in it to make a quick buck."
Several tests have been recalled from the market because they weren't as reliable as claimed. In 2002, Health Canada warned that anyone tested with the Fast-Check tests (manufactured by BioChem ImmunoSystems Inc., now Adaltis U.S. Inc.) should be retested with standard methods. The B.C. CDC found the sensitivity was well below what it should be: in one part of the evaluation, Fast-Check kits were used on 63 HIV-positive patients at St. Paul's Hospital, and at least seven kits failed to detect the virus.
Worse than unreliable tests are the outright frauds, sold to the general public via mail order or the Internet to satisfy people's need for privacy and speed. (There is one legitimate, FDA-approved test called Home Access, which allows people to collect blood samples at home and send them to a laboratory for testing. Clients receive their results anonymously by phone.)
In 1997, a California man named Lawrence Greene was convicted of wire fraud for selling supposed HIV test kits on the Internet and to local pharmacies. Greene's test consisted mainly of a bandage for collecting a drop of blood and a postcard for mailing it back to him. According to his wife, Greene tested the blood spot for HIV by holding it up to a light and visually examining it.
In 2004, the U.S. Federal Trade Commission asked Federal Express and U.S. Customs to confiscate shipments of the faulty and unapproved Discreet home HIV test kits, produced by Gregory Stephen Wong of North Vancouver, BC.
In February 2005, the U.S. FDA issued a warning against using the rapid HIV test kits and other home use kits marketed by Globus Media of Montreal, Quebec.
Health professionals and researchers agree rapid tests should be used with confirmation tests and counselling, which are vital parts of the Canadian health care system. But in countries without sophisticated or well-funded health care, products like INSTI might be the only testing available.
The World Health Organization estimates that in December 2004, there were 39.4 million HIV-positive people worldwide. Sub-Saharan Africa alone is home to 25.4 million of them, where most people have no testing or treatment.
In a small office over the Canadian Bible Society on Kingsway, Rev. Paul C. Ndukwe, of Link International Ministries, plans to bring the INSTI test to the people of his homeland Nigeria.
"Testing is a powerful way of preventing spread [of HIV-AIDS] and those who are negative are motivated to stay that way, and those who are positive are more likely to change their behaviour if they know they could affect someone else," he says.
Nigeria, in West Africa, has the third largest number of people infected with HIV in the world, after South Africa and India. A national survey in 2003 found five per cent of the population was infected, and the rate was as high as 12 per cent in one state.
In Ndukwe's home state of Abia, two labs, one privately owned and one government-run, can test for HIV, and both charge for testing. Each test costs about the same as a government worker's monthly wage. The labs are also located far from the rural villages, so many people don't have the time or the money to travel to them. Legally, all pregnant women must be tested, but in practice most can't afford it. Exchanging sex for money or access to education, jobs, medical care and anything else of value is commonplace. The price of one condom can feed a family for a day.
Ndukwe's organization plans to use the INSTI test with mobile clinics sent into the rural villages. Community health workers and nurses will be trained to administer the tests and provide face-to-face counselling and education. The tests are cheap (estimated retail price of $5 each), easy to use, and don't need refrigerated storage. Since they provide results immediately, and no other options are readily available, the person being tested wouldn't need to come back later. The mobile clinics would be funded by charitable groups, governments, corporations and private citizens.
Ndukwe acknowledges diagnosing HIV is only the beginning. "If you go to the root of HIV," says Ndukwe, "you will see poverty. You will see abuse in economics. You will see wealth that's not well distributed, you see exploitation. HIV becomes the result of these negative things, so to fight the pandemic, you have to fight poverty. You have to provide education, produce economic stability or else it does not work."
HIV testing programs in the field could also help gather detailed and accurate data on the spread of the disease. Epidemiology in developing nations is often based on guesswork. In nations like Nigeria, HIV estimates are primarily based on blood samples from syphilis tests of pregnant women and, more recently, national surveys. When HIV gives a person AIDS, it can easily be mistaken for malnutrition, tuberculosis, malaria or other illnesses.
Ndukwe's evangelical Christian group has partnered with the Biolytical Foundation, an offshoot of corporate Biolytical, dedicated to distributing the INSTI test in developing nations.
"We don't want to be perceived as being entirely about profit and making money, and to hell with the countries who can't afford our test," says Biolytical's Galli. "We want to at least make an attempt to offset costs by donations of kits, by channelling a certain percentage of the business holdings and recovery into a foundation that can distribute kits on a free basis, based on need, based on resources."
Galli is confident in the value of the INSTI test and other new technologies to help control HIV.
"We're entering into a phase of testing that may be unprecedented, and that's tied into the emerging availability of anti-retroviral therapy. In the past, people were very hesitant to get tested because there wasn't much anyone could do if you were positive. Again, I'm speaking of the developing world. But now, that's slowly starting to change. More and more and more people are coming forward for testing.... And all we're trying to do is inject a high quality test into what we think is a very needful market."
published on 07/27/2005
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