Over The Counter Rapid HIV Testing Is Not Ready For Prime Time

The future of at home or over the counter rapid HIV testing is dangerously approaching dread and apprehension unless OraSure Technologies figures out what to do with the percentage of the “quarter of a million” people that “do not know it” out of which some may not think reasonably. As I read in the Fortune article Crunch Time for an HIV Test, Simmons, John. (May 22, 2006). “The potential consumer for this test is any American who’s sexually active.”  This is a unique and interesting way to sell the test. The CDC has stated that as many as 250,000 people are HIV-positive and do not know it. I am not sure if this data has also been changed or updated since recently there have been a few upsets in the area of HIV data. “Annual U.S. HIV infections may be as much as 50 percent higher than the government has estimated since 2001, say AIDS activists who complain health officials aren’t releasing new figures in a timely manner” AIDS Activists Riled by U.S. Refusal to Release Infection Data, Lauerman, John December 3, 2007 (Bloomberg).  The OraQuick Advance HIV-1/2 test could prove to be a boom for OraSure Technologies Inc. The sales may paint smiles across shareholders faces and pharmaceutical companies will follow-up with more medications for the new patients. However, what about the people that do not think rationally or reasonably? They too are part of the quarter of a million who naively walk the land infected with HIV.

I read on a bit further and the next paragraph pointed to the purple elephant in the middle of the room. This time the writer communicates clearly the trepidation the FDA is experiencing in giving this test their approval for over the counter sales. What about the customers that without counseling perform this test on themselves and find they are HIV-positive? How many people that belong in the population of this quarter of a million think reasonably enough to handle this type of a test result? This population includes a little bit of everyone including those with mental health and substance abuse issues. There are the people who through counseling, medication and 12-step programs blend right into the rest of our society;  functioning addicts who show no symptoms of any problems until it’s too late. I remember on more than one occasion at more than one Community Based Organization (CBO) at which I have worked, when a person stated that they were going to commit suicide when they were told they were HIV-positive. What horror stories might we hear with this nouveau and speedy at home HIV testing method? Do we even know how many people in a quarter of a million may have mental health or substance abuse issues? This fragment of this population is not going to collectively have the same response. Besides, perfectly “normal” people – whatever that is – are capable of freaking out and becoming suicidal when told they have the most tabboo sickness in our modern times. What about the ones that, as we have already seen, decide what’s good for the goose is good for the gander? Someone infected them and so now they feel a little eye for an eye is in order. What if some do not decide on suicide but instead may go on to infect others as an act of revenge? It has already happened and the tests are currently available that will allow someone to test himself or herself at home and possibly wind up in a panic if they test positive.  

OraSure experienced a slight misfortune in December of 2005. This will prove to be OraSure’s largest barrier. Clinics performing pilot projects to prove if OraSure could be used to help assess people’s HIV status hit that barrier. A 1% false positive rate was found. The FDA found that this error was due to human error because practitioners failed to follow directions. Now, c’mon! I’ve done this! The directions are extremely  simple. After the specimen is collected using the oral fluid the specimen collection tool is placed in a tiny bottle immersing the tool into a solution and it is to sit there for twenty minutes. That’s pretty simple right? After the twenty minutes you can plainly see which test in negative and which is positive. It’s like a pregnancy test, you read the bars! The only strict rule is that no test can be read before the twenty minutes. Not even at the eighteenth or nineteenth minute because during trials some specimens did not fully show positive until very late into the twenty-minute period. Also, the specimen cannot be read after forty minutes, but who in health care has forty minutes…for a patient…today?     

When I was Program Coordinator for a pilot study in rapid HIV testing using this very same technique, I found that the tests were being read before the twenty minutes. I received the email about the obligatory visit by the grantors of our program. I immediately sent word to my colleagues and staff that the site visit was coming and that I would be coming by in the next few days to “spy on them.” I purposely used humor when I said that I would be spying on them to take the edge off because everybody gets nervous when they know they are going to be reviewed and possibly found faulty in some area of work. Well, let’s just say that I found more than one area that was not performing up to snuff. Gone was the protocol. Never mind all those quality assurance guidelines that we painstakingly worked on. And who needs to properly fill out assessment forms? “All these cumbersome forms are so hard to keep upwith when we’re strapped for time.” This was the major whine of the day, every day, always, all the time. The icing on the cake was the time. Nobody had time for anything it seemed, except when his or her cell phone rang. Many PAs were simply too rushed. They had too many patients to see, they were tired, overworked and underpaid or their break was due in less than twenty minutes. I don’t know what the exact reasons were. I really don’t care! What makes my ears red and blow smoke is that during the less than one year I had the distinct pleasure of working for this messy organization, we performed nearly 1000 tests and we did not have one positive result. Is there anything weird about this last statement? It didn’t help that this clinic was in an area of town where I knew risks were being taken. Not only were there STDs occurring in this population but every morning when I got out of my car I saw syringes and empty plastic baggies on the street. Not one positive in a thousand tests!

 I left this place. I quit. I felt awful. I knew that if I tried to fight the issue, I would only wind up stressed out. Stress will kill you. I am already positive. I drove to and from work everyday wondering how many people in this study are HIV positive and they don’t know it? At least they’re trying their best to work with the system that’s provided and they still do not know their true result! It is out of their control. I also wondered how many other point-of-care tests are they also reading wrong as well? My stomach was churning acid and I had to go. If you have a rapid HIV test performed, the type that uses an oral swab, be keenly aware that after your specimen has been taken no one should have a result for you for twenty minutes! If you have a rapid test done and anyone speaks the word negative or positive before twenty minutes, run – don’t walk – away! Make sure to cover your butt – no pun intended – just in case you are having a rapid HIV test performed in a bustling location where many patients are being seen at breakneck speeds. And, if there is any doubt in your mind about the test’s result; positive or negative, ask for the traditional blood test. It may take a week or two but blood is thicker than oral fluid! 

Ó 2007 Carlos A. Perez