Last week, the United States had two reasons to celebrate.

I bet you can guess one of them. (Clue: you likely had the day off for it and ate way too many hotdogs as a result of it.) The other, although briefly covered in the media, has mainly gone under the radar for how impactful it will prove to be for thousands of Americans within the next few years.

On July 3, the U.S. Food and Drug Administration approved the first over-the-counter human immunodeficiency virus (HIV) test. This monumental decision suggests that soon anyone will be able to pick up a kit from their local drugstore and discover their HIV status in the privacy of their own home.

Before we explore the implications of this exciting and potentially controversial new method of HIV screening, let’s first reacquaint ourselves with the basics of this infectious disease as well as the screening tools currently used to detect it.

Beware, heavy reading ahead.

A Brief and Brutal Refresher

It would be nearly impossible and dishonorable to summarize the entire scope of this virus in a few sentences. But here goes nothing.

HIV, discovered in the early 1980s, is a pathogen that infects over 50,000 Americans each year and is transmitted by direct blood contact (think IV drug use) as well as indirect blood contact (think micro-abrasions in skin during intercourse). A newly-infected person may at first complain of flu-like symptoms or be completely asymptomatic.

Despite these vague initial symptoms, over many years without treatment this virus can cause acquired immune deficiency syndrome (AIDS), damaging multiple vital organs and suppressing the immune system to the point where other pathogens can easily co-infect.

Although still considered a very serious and often deadly infection, antiretroviral (ARV) drugs, the mainstay therapy for most patients with HIV, have slowed the AIDS progression to the point where patients may live for decades before succumbing to the many complications associated with this disease (or quite often succumbing to other health issues first).

The Gold Standard

The conventional HIV screening test used today is confusingly known as both the enzyme immunoassay (EIA) and the enzyme-linked immunosorbent assay (ELIZA).

This test indirectly detects the presence of HIV in the bloodstream by identifying antibodies to the virus in a sample of the patient’s blood. EIA is highly regarded in HIV medicine due to its remarkable sensitivity, or ability to detect a very large percentage of infected individuals in a set population.

The issue with this assay, as with most tests with high sensitivity, is that it is not uncommon for a patient to receive a false positive. (This occurs when the lab test indicates one has the disease when in fact he or she does not.) Fortunately, another technique, known as the western blot, is used as a confirmatory test for all EIA-positive samples due to its high specificity, or ability to discern these false positives from truly infected specimens.

This type of HIV screening has been the method of choice for years due to its accuracy as well as cost-effectiveness (between $20-40).

The New Kit on the Block

OraQuick®, made available by OraSure Technologies, functions as the first rapid home HIV test approved by the FDA. Similar to the EIA, this product also detects antibodies to the virus.

The difference, however, lies in its method: OraQuick allows an individual to simply use a mouth swab at home as opposed to giving a blood sample in a clinic. The swab is then placed inside a vial of solution for 20-40 minutes before the kit displays easy-to-interpret results akin to a home pregnancy test.

Breaking It Down

Well done, readers. You have made it through to the other side with only a few yawns and exasperated sighs. Now let’s break it down.

How will this new test affect the world of HIV medicine?

First, the good.

A study released by the CDC estimated that in 2006, over 200,00 people in the U.S. were living with HIV without knowing it. Whether this is due to lack of health care access or simply the lack of HIV education, the intention of introducing this new home HIV kit is to provide a novel way in getting these individuals into treatment earlier as well as preventing them from inadvertently spreading the virus to others.

Sound reasoning.

Another unique characteristic of this test is its ability to determine individuals’ HIV status in the privacy and comfort of their own home. It is not uncommon for people to avoid clinics and hospitals due to the discomfort of seeing a physician (waiting rooms, white coats, etc.). Therefore, this home test offers a wonderful solution by getting this part of the population tested without forcing them to unnecessarily deal directly with the health care system.

I get this, although I am slightly offended.

Now, the not-so-good.

Although the OraQuick® home HIV kit has a similar sensitivity to EIA in detecting the virus, it is recommended that individuals receiving positive results at home should also get a confirmatory western blot test due to the very real possibility of a false positive.

Consider how stressful it would be sitting with a false positive result for days while waiting for this additional test to be reported. In comparison, it is customary in hospitals to reflexively examine the initial EIA-positive samples with western blot in the laboratory prior to contacting the patient with results.

Being the high-octane hypochondriac that I am, it is obvious which scenario I’d prefer.

And what if the test is truly positive?

The HIV home kit does not come with a home physician to take care of emotional needs, burning questions, and complex management decisions. An HIV diagnosis deserves this respect, and I can only imagine the kind of burden a newly diagnosed individual will unnecessarily carry without the immediate support of their doctor.

Take-Home Point

In the larger scale, the newly FDA-approved home HIV test will prove to be a worthy foot soldier in the battle against AIDS. But as in any war using a novel weapon, there will be individual tragedies along the way that will question its ethical utility.

My advice? Use with caution.

Brian Secemsky, M.D.

Medical writing for patients, students
and practitioners.

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