This transcript was automatically generated from the audio recording and may contain inaccuracies, including errors or typographical mistakes.

Sara Thier: Welcome to Segment 1 of the Decera Clinical Insights Podcast, Right Test, Right Setting, Integrating Rapid Point-of-Care Testing for Sexual Health into Practice. I'm joined by Dr. Joseph Cherabie, Senior Medical Director of Research at Howard Brown Health in Chicago, Illinois, and Dr. Jenell Stewart, Assistant Professor, Department of Infectious Diseases, Hennepie Healthcare at University of Minnesota in Minneapolis.

Dr. Cherabie: Thank you, and hello, Dr. Stewart.

Dr. Stewart: Hi, Joe. Can I call you Joe?

Dr. Cherabie: You can call me Joe, and I will call you Jenell. How's that sound?

Dr. Stewart: Perfect.

Dr. Cherabie: Alright, so we're here today to talk about what point-of-care testing is, especially for STIs, right? And I know point-of-care testing is something that you and I have heard a lot about, we've spoken a lot about. It's brought up in conferences all the time, it is a new hot topic within our field. But rarely do we actually get to discuss what it means to implement this stuff.

What is point-of-care testing? What are the different types of point-of-care testing? What makes certain testing different than other testing? And so, I'm excited to get into this discussion with you, but, can we first, like, start off by going through what is traditional laboratory testing, and how that differs from point-of-care testing?

Dr. Stewart: Yeah, you know, traditional laboratory testing has taken some turns over the years, but, you know, it hasn't really changed a lot. I'll talk about what the updates have been more recently, but typically what happens is you have a patient coming in for care in the U.S., symptoms, no symptoms. We have them screened, send off swabs to the lab. That lab will run those tests, and we get results in 2 days, 5 days, depending on your setting.

Some of the updates have been making sure we're testing people in more than one place that they may have been exposed on their body, getting those throat cultures, but also the PCR testing, and rectal swabs. And now, thankfully, moving towards self-collected swabs, so it's a lot more patient-centered.

I think we've made some major headway in improving that by having self-collected swabs, by recognizing that people have exposure at more than one place in their body, but there's still some hang-ups with it.

I already mentioned the turnaround time. Those few days of waiting can impact people's well-being while they're nervous about waiting. Sometimes it means I lose track of a patient, and I can't get ahold of them again to tell them that they have gonorrhea, for example.

And then sometimes if someone does have symptoms when they come in, knowing that there's a wait, I'm gonna give them treatment right then and there, but I don't know what's causing their symptoms, so I'm gonna treat 3 or 4 different things, so that I don't miss a serious infection.

But if I had those results right away, I might be able to avoid several of those medicines and just kind of focus in on what they are dealing with. And I think, you know, I work in an urban setting, and I know you do as well, but I think in rural areas and places where people have to travel a lot farther to get those tests. There's an even bigger delay in getting some of those results and sometimes a bigger delay in just being able to get in and get that test done at all.

So I'm pretty excited about some of the new technology being developed around, true, rapid, point-of-care testing. And…do you want to talk through, really, what that means? You know, I say rapid point of care with a wink towards the rapid, because some of the new technology is not that rapid, and I think it's worth going through some of those differences.

Dr. Cherabie: Yeah, and I love what you had to say. You know, a lot of what you said rings very true. I worked at the St. Louis County Sexual Health Clinic before I moved to Chicago, and you know, it would be 4 to 7 days before we get some of those results back from the states, and a lot of the health departments we worked with in the region, again, it would take time for those results to come back.

So, you're weighing two issues within infectious diseases that many clinicians can understand, right? Do we empirically treat and therefore over-treat, and maybe expose people to unnecessary antibiotics? Or do we wait and see, target treatment properly, but risk actually losing that patient out into the ether?  And if you're asymptomatic, you're probably not going to be too worried, and you might end up, you know, having sex again, or inexplicably, unintentionally spreading the infection that you didn't even know you had, right? So, I hear that in my soul.

So, point-of-care testing, when we talk about rapid point-of-care testing, there's so many different things, and I want you to understand, these are not mutually exclusive ideas. Some of these things overlap, and hence why some of these definitions are used interchangeably.

So, what we're talking about point-of-care testing is kind of just saying that this test can be performed at or close to the site of patient care, wherever that patient care exists. So,like, if we're doing mobile testing, and mobile care outreach, for example, then you could do testing at that site. And that allows you to get hopefully a little bit more of a rapid result.

One of the things that most people are kind of familiar with is, like, HIV testing, right? When we talk about rapid HIV testing, you're used to drawing that blood, waiting 20 minutes, doing the whole counseling thing, and seeing what the result is, and then counseling after that test result. And the idea with STI testing was kind of to do the same. Maybe for gonorrhea and chlamydia, sometimes for trichomonas, and then newer stuff has other organisms such as, you know, mycoplasma genitalium, for example. But, like, ugh, we'll get to that. We're going to talk about it, I promise.

The whole goal of point-of-care testing was to provide rapid results, and for you to be able to direct your treatment right then and there and prevent unnecessary antibiotic exposure from empiric treatment. But also, not lose the patient. So, it really has to be timely. You have to get that result quite quickly.

Now, what other things do people use when they say point-of-care testing? Some people think about at-home testing. Whether that is you do the test at home and you send it into a laboratory, or you get the result live at home. So, things very similar to our COVID test, right, what we do at home. You get that result right then and there. There are certain HIV tests, for example, like the OraSure test that you can do at home and get that result right away. There's over-the-counter testing now. There's the new over-the-counter syphilis test that you can also get the result of. There's mail-in testing, and then people also use patient sample testing as, like, point-of-care testing as well. Making sure, you know, we're testing at the site people are having sex.

But again, these are not mutually exclusive constructs. You can have point-of-care testing, that is patient-sampled. You can have at-home testing that you send to a laboratory. But I think what we're trying to zoom in on here, and what this discussion… most of what we want to discuss, especially during this podcast, is the… rapid test, that you get a rapid result, that occurs close to the site of patient care.

Dr. Stewart: I think it's worth discussing, you know, how long will a patient wait, right? So, a patient collects a swab, and then we have our rapid test right there in clinic, and we run the swab. If it comes back in 30 minutes, are they still there? If they… if there's a backup, because there were 3 patients that came in before them, and we have to test those first before we can test theirs, are they gonna wait the, you know, 2 hours?

For me, in my experience working with patients and using point-of-care testing, if it's more than 20 minutes, it's not likely to be a true point-of-care test. I might call that a same-day result.

Dr. Cherabie: Yeah, and I think that's important to discuss. When we have these discussions, and I think part of the clinical implementation of this is giving patients a realistic understanding of when their results will come out. And so, when it's a same-day result, you know, we really want to talk to people and say, “Hey, this is going to be a same-day result. Just look out for the results within the next 24 hours and try not to have sex during that time period, you know, especially if you're worried about an STI.”

I love what you just said there, how important it is for us to have that discussion of what the time period is, when people can expect to get results. And sometimes, you know, it's not as rapid as we would like it to be.

The other thing that I just wanted to comment while we're just, like, going through definitions and stuff like that is also making sure, laboratory testing is one thing, and then there's a term that's thrown out left, right, and center, which is CLIA. And they say, “CLIA-waived,” right? And I would sit in conferences, and I'm like, who's CLIA? You know, who is she? How did she wave that…?

Dr. Stewart: Does she wave at you?

Dr. Cherabie: You know, she waves all the time, right? And I didn't know what it was, and so, you know, it's Clinical Laboratory Improved Amendments. When something is CLIA-waived, it means that that testing modality can be used outside of the laboratory setting. It means that it is approved for home use or outside the clinical setting. You don't need laboratory technicians or specific lab people or a certified laboratory to run that test.

And, so the reason why I'm bringing this up is because, again, while it's important that we have these tests, and there's new tests on the market every day, and we're defining what point-of-care testing is, it is really important that these tests be FDA approved and CLIA-waived. Because if they're… if those two things do not exist, those test results can't be validated.

I say this because I get to hear about all of the times when people get these wild test results, and I'm like, what modality did you use? And, I think it's really important, especially, when people do this, to know what these terms mean, what we're talking about. Point-of-care testing, we've defined.

Dr. Stewart: I think that speaks to, patient demand, right? When you're having these patients coming in, getting who knows what test off of the internet that's not actually CLIA-waived, and they're getting a result that is not validated. I think why that raises concern as a clinician, we need to be aware that that's happening, but also that means patients either aren't feeling comfortable coming in and talking to a provider about getting that test done, or they don't have access in the way that they want to. And I think we really do need to rise to meet that demand as a public health entity and as providers.

Dr. Cherabie: Perfect segue into the next topic that I would like to ask about. What are the benefits of this style of testing? I know we spoke about getting a more rapid result and avoiding, like, unnecessary treatment, but, like, what are the public health benefits that we are trying to seek out… through this, and then also, what are the limitations, challenges, obstacles, that kind of stuff? So, you know, let's start with the benefits, let's start with the good stuff.

Dr. Stewart: I think it might help to start with an anecdote. So, I worked with Dr. Maria Corcoran in Seattle, Washington, to expand STI testing for women who were using drugs, and many of whom were selling and exchanging sex. And we worked with Dr. Sharisha Danaretti and Aurora Commons to provide clinical care at a clinic inside of a drop-in center or a day shelter for these folks.

And people were showing up definitely concerned about their sexual health. It's bad for business if you have an STI. Also, it's uncomfortable to have an STI, and so there was definitely a demand, but we were at an off-site satellite clinic, collecting swabs, putting them in coolers, transporting them at the end of the day to the… I mean, it was days until we had results, and this is a patient population with a lot of chaos in their life and a lot of competing priorities. It was so hard to make sure that people got timely treatment after a diagnosis, and there were many diagnoses, given, the risk factors, and frequent exposures, that this population had.

So, to meet that need, we set up a van clinic in a parking lot, right next to Krispy Kreme, and a Home Depot. And we chose that location not because of the donuts, but because that was a parking lot where drugs were being sold and purchased, and that's where sex was being sold and purchased, and so we wanted to bring testing to people where they needed it.

And we found that people were really interested. We had a lot of engagement. Women were really, really interested in stepping into that van clinic, doing a self-collected swab and getting some results right there.

That was the plan we set out with. It was not always that easy. We were able to provide some results right then and there.

The tests we were using, one of them… was a lateral flow point-of-care rapid test, where they were looking for antigen of trichomonas. And what that means is that it's basically a similar style to an at-home pregnancy test or an at-home COVID test, where it is a single strip, and then a couple of lines show up. That is fast. It's 10 minutes, no technology, right there on our counter. We can run as many at a time as we want. We've treated a lot of trichomonas in real time.

To diagnose chlamydia and gonorrhea, we used one of the newer machines. This one happened to be by Binx HealthIO, and it is a rapid PCR test, and so it does require electricity. A lot of the rapid, and then also point of care PCR tests require electricity, and unfortunately, our van did not support the electricity needed for that test, so we had to buy an external battery. And that was a solution for the power, but the external battery increased the temperature in the van, warmer day, we couldn't temperature control the testing setting, and the test platform didn't work.

So, it was great when it worked, but it still had a lot of challenges, and I think, you know, when we're thinking about how do we move forward, and should clinics be thinking about this? You really do need to think about, what does the patient need? You know, do you have a small patient population that needs test results in a quick fashion? Or do you have a huge patient population, where lining up your countertop with test cartridges and different machines being plugged in isn't really feasible?

And then, thinking through some of those other logistical challenges, like, does the technology actually meet your clinical setting?

Dr. Cherabie: Yeah, and I think you bring up a very valid point and highlight a lot of the challenges that many people face with these modalities, right? We want to be able to use these for outreach clinics and mobile clinics, and that's a lot of the time where people bring this stuff up. Emergency departments, urgent cares, STI clinics, rapid throughput places. However, many of these modalities require you to run one test at a time. Each test takes 20-30 minutes, right? And so, either you get multiple testing kits, or, you know, testing modalities, or you… run one at a time, and you can't run more than one at a time, and then you face temperature issues as well. And I, you know, Missouri summers are very hot and humid, and it's very hard to quality control.

And so, I also think about, you know, rural health settings and rural health, and trying to get these out to certain people, either through the mail, or having them send test stuff back to us. And that is really hard to do in a hot, humid place. And if they are doing the results at home by themselves, then you really need, for example, someone to be able to… they need to understand what that result is, and they need to be able to call it in for care as well. So that's another barrier.

Dr. Stewart: And then on our side, you know, if there is a rapid result, who enters that into the system so that it's recorded? Who's calling the public health department? So, if your public health department still has funding to be able to do contact tracing that that can take place. You know, these are things to think about.

There are workflow things that need to be incorporated. Part of that is space for the technology, does it meet your population size, and then who are the people responsible for some of that key record keeping that keeps us at a high functioning level for public health, even though we're really modifying workflow to meet the needs of patients.

Dr. Stewart: So, Joe, given all of the potential benefits, we talked about all of these challenges, do you think we should be pushing for an integration of point-of-care testing for STIs?

Dr. Cherabie: Yes. And… in the right place, at the right time, in the right setting. And I think the title of this podcast was chosen purposefully. Like, we need people to, you know, we want people to have access to point-of-care testing, when it is right for them. And I think that's a really, really important thing to talk about here.

I want people to get access to rapid results. As a clinician, I want to be able to treat people right then and there, and know what I'm treating right then and there. As an infectious disease doctor, I want to decrease exposure to unnecessary antibiotics. All of these things are things that I want. I also want clear answers with respect to what is affecting my patient, and to be able to give quick treatment that is correct.

But… what is the right setting for this? I think we've discussed a lot of the logistics here, of making sure that you have not only, you know, what to do, where this can be implemented, what your workflow looks like, what to do with the results afterwards, and who to report it to. All of that stuff is really, really important. But also, you know, I always tell people, don't order a test that you don't know what to do with the result.

And so, a lot of these tests, as they're coming out, they become more and more advanced, and they become more and more multiplex. You test for more, organisms and pathogens all on a single swab.

And while that may be good, there are certain pathogens that we don't necessarily need to test for. So, I had mentioned mycoplasma genitalium before, and I did… we both did “agh”… right? Because of the fact that initial screening for mycoplasma genitalium is not recommended by the CDC. It's not something that we recommend for people with straight-up urethritis, cervicitis, or concern for STIs. We recommend this for persistent urethritis and cervicitis.

And so, that means that after we've tested for chlamydia, gonorrhea, possibly treated, and they still have symptoms, then we would test for mycoplasma genitalium. And some of these modalities have mycoplasma genitalium on the panel, and so what that does is that causes us a little anxiety as STI docs, because we don't know the role of asymptomatic mycoplasma genitalium. And so, again, I think it's really important for us to know what is on the tests. What we want to be on the tests.

And many of us, I will say from our experience at WashU when we had implemented this, we had asked for mycoplasma genitalium to be hidden, or to not be included on the panel for this very reason. So, again, I think it's worth consulting your local infectious disease expert about this if this is not your specialty, but also you really want to make sure that these tests work for you, and you know what to do with the results. Similar issue, for example, with rapid, syphilis testing… Jenell, would you like to talk briefly about what we deal with rapid syphilis testing on a daily basis, especially point-of-care stuff.

Dr. Stewart: Yeah, I'll definitely touch on that briefly. Not the focus of today's conversation, but it's worth mentioning because it's messy. We also had a syphilis test in our van intervention. The syphilis tests that are available now really tell us if you've ever been exposed to syphilis, it does not have a quantitative RPR. I know some groups are working on that right now, but without that quantitative RPR, we can't really say if it's a new infection, if someone's been infected before, and in the places where these tests are needed the most, people might have had syphilis before, and so it kind of limits my enthusiasm about that.

In settings where there's low prevalence of syphilis. That can be a really helpful test, because if it's positive, it's likely your first time ever being diagnosed. But like I said, it's an era of new development. New tests are being developed, FDA-approved, CLIA-waived, all the time.

Right now, the majority of the tests for gonorrhea and chlamydia focus on a vaginal swab or urine, and that really kind of limits how much care we can provide people during point-of-care testing as well. So, I'm really looking forward to new studies being done that validate it in throat swabs and rectal swabs and tests that are faster and faster, so they can truly be considered a rapid point-of-care test.

Dr. Cherabie: So, our take-home points here for what we want, you want to make sure your test is FDA-approved, CLIA-waived. You want to look at that workflow and make sure from start to finish what each and every step of that process is. You want to see what the test is approved for, especially… I think you mentioned a great point.

You know, some tests are only vaginal swabs or urine swabs. You don't want to do a throat test on that. But nonetheless, you know, hopefully there will be a time when, you know, we take a good sexual history, we know that people are exposed in certain spots, and we can get to extragenital site testing and testing where people are having sex. And then we need to know what to do with those results and what they mean, if they mean anything at all, and who to report them to. Did I miss anything, Jenell? Is there anything else?

Dr. Stewart: If we're putting our dream list together, I want it to be less than 20 minutes.

Dr. Cherabie: Yes! Yeah, I want multiple tests that can be run at the same time that you could do less than 20 minutes, but again, I think the goal here is to make sure that we are getting people, access to testing that they need, that they deserve, that they want, where they are.

And, you know, things are developing every day. But there are limitations. Know what those limitations are. Ask the makers of these tests what those limitations are. And again, don't hesitate to reach out. We are more than happy to help with any of this stuff. So, I just want to thank you, Jenell, for this wonderful topic.

That's it! Thank you all for listening!

Sara Thier: In our next segment, Dr. Roland Merchant will discuss the operational and logistic aspects of integrating point-of-care testing into clinical workflows.