When you are developing a product, it is important to scour the market for rivals and competitors. Trust me, if it is a good idea there is going to be several options with their own unique features and drawbacks. We are developing rapid diagnostic tests for bacterial sexually transmitted diseases and this is a great idea, so we have our rivals.
Our first look was to see the what was available from the clinics. So, I called a couple of clinics near our accelerator, RebelBio, to get more information about their offerings and their views on people testing themselves at home. I came across Better2Know, who had locations in Ireland, the UK, South America. They offered at-clinic visits, nurse at-home visits, and box kits that allow self-collection for lab testing. Seeing this as a possible avenue for distribution of our rapid Chlamydia test, I checked out their Better2Know’s central website to learn more about their organization. It turns out they had a rapid test already for Chlamydia!
We had learned about a couple tests that were rapid, but had drawbacks for several reasons. The first is easy to use, but a blood based test. This test is primarily used in low resource settings and can tell if there was once Chlamydia there, but it doesn’t distinguish the past from a current infection. The second test, available for online order, does test for current infections, but it, too, has several drawbacks. First, they had multiple steps where the user could get lost and mess up the results. The test instructions were poorly translated from Chinese, the location of the kits manufacturer. And lastly, these kits were just not reliable. Half of the time they would tell the user that they didn’t have Chlamydia when they actually did.
So what was Better2Know using? Were they aware of these drawbacks of these rapid tests? Were they even using these tests that we knew of? So, I wrote their contact email and asked for more information. As a Sex Educator, I wrote:
I saw that you had instant Chlamydia tests. Being from the states I am used to slow turnaround times for testing for bacterial infections as they use complicated lab processes.
Are your tests developed in house? If not, would you be able to give me the distributor information?
Thank you for your work in this important field!
I got a prompt response that quickly denied me the information I was seeking. I thought this was strange, as patients should have the right to know about the administered test’s reliability, the test distributor in case of a recall or any information that could impact their health!
The good news, dear reader, is that I had another way of finding out the information I was seeking. I was going in as a patient and I was going to question everything and watch how the test worked. My appointment is tomorrow. No matter how many times I have gotten tested, I always get butterflies. #StaypositiveTestnegative :)
A little about the science about the two tests for those inquisitive souls. Both of the rapid tests available use the same immunology based technology as a HIV rapid test or pregnancy test. Both of these tests use immune proteins to recognize a target, but one looks for the subjects personal immune proteins while the other looks for the hormone or bacteria directly. A color tag is added to the immune protein which changes color once it has attached to its target. The user sees this as a blue line if enough of the immune proteins find their target.
In the HIV test, the immune proteins in the test look for the subject’s own immune proteins that are made only when the person has caught the disease. This is how the test in the low resource settings works. While this is appropriate for latent viral infections, because subject always has the disease, for bacterial infections it can be misleading. Chlamydia can be caught and cured multiple times. That means with this type of test, if someone tests positive once they will always test positive, even if they were cured.
The second test works like a pregnancy test where the immune proteins look for the signal protein itself, human gonadotropin, or the bacteria in this case. This test uses a swab sample from the user, which is then suspended in a developing fluid. These proteins link to the the bacteria in the sample and only that type of bacteria. In a way the protein fits with the bacteria like two matching puzzle pieces. When enough of the protein bacteria pair up, a blue line is seen in the test window on the kit. While these tests can tell whether or not there is a current bacterial infection, but not reliably. Most of the time and infection is missed because it require 100,000 or more bacteria to be present and hopes that the outside of the bacteria doesn’t change, which it does.
Look for our upcoming blogs about my findings and milestones as we bring your at-home STI test into reality.