Symptoms related to vaginitis are one of the most common reasons people present for evaluation in the primary care setting. These bothersome symptoms can be caused by a variety of pathogens including yeast, bacterial vaginosis, Chlamydia trachomatis, Neisseria gonorrhoaea, Trichomonas vaginalis, or a combination of these types. Current in office testing modalities, such as microscopy or visual inspection of discharge, can be highly subjective, time consuming, or may require special training or equipment- risking a missed diagnosis.
This presentation will educate the audience on the infections themselves, the available testing modalities and the value of increasing sensitivity of diagnosing symptomatic women with vaginal co-infections.
- Define the disease state of common causes of vaginitis (BV, VVC, TV) and most common non-viral STIs (TV, CT, GC)
- Review current testing methodologies for vaginitis
- Identify downfalls of those methods that serve as barriers to comprehensive diagnosis (i.e. wet mount, Amsels)
- Recognize the clinical utility of testing for both vaginitis and STIs together in symptomatic women so to avoid missed diagnoses
Speaker: Catherine Dezynski, DNP, CNM/WHNP – Medical science liaison, BD Life Sciences-Integrated Diagnostic Solutions
- Minute 1:05 – Introduction & objectives
- Minute 1:30 – Current state of STIs in the United States
- Minute 6:15 – Health repercussions of untreated STIs
- Minute 7:25 – CDC STI testing guidelines
- Minute 9:05 – Disease state: Vaginitis
- Minute 13:40 – Current testing methodologies for vaginitis
- Minute 17:25 – Molecular assays for accurate diagnosis
- Minute 18:50 – Why test for both vaginitis and STIs?
- Minute 22:30 – Q&A
Mary Beth Dineen: Hello and welcome to today's webinar. My name is Mary Beth Dineen from McKesson. Today's presentation is being recorded. Please use the Q&A feature to submit questions to our speaker. Today's presenter is Catherine Dezynski. Catherine is medical science liaison for BD. She is licensed as a certified nurse midwife and nurse practitioner in Illinois. At BD, Catherine focuses on the women's health portfolio products. Catherine holds both a Bachelor and Master of Science in Nursing from Loyola University, Chicago, in addition to a doctor of nursing practice from the University of Illinois, Chicago. Please join me in welcoming Catherine.
Catherine Dezynski: Hi. Thank you so, much for that introduction and thank you so, much to our audience for joining us today. I'm like you said, a women's health nurse practitioner and a certified nurse midwife. I practiced for close to 12 years before making the transition to BD. So, I hope that today I can offer you some new and interesting information.
So, we have three objectives today. First, to define the disease state of common causes of vaginitis and non-viral STIs. I'll review the current testing methodologies for vaginitis and also, educate you on the value of using sensitive molecular tests for diagnosis in symptomatic women for both vaginitis and STIs.
First, let's discuss the current state of STIs in the United States. The recent CDC data from 2018 shows that one in five people in the United States have an STI with an overall prevalence of 26 million new STI diagnoses in 2018, totaling 68 million infections in 2018. And half of those new infection cases are among youths aged from 15 to 24 years old. And these infection rates do continue to increase, despite the longstanding recommendation from CDC that we should be screening women under 25 years old due to their age-related risks. These infections do come with a cost in the billions per year. In 2018, the direct cost in the United States was $16 billion, which does not include the costs related to the loss of productivity, non-medical costs, and STI preventive costs as well.
We do have challenges when it comes to diagnosing STIs. There can be symptom overlap of the more common symptoms, so, that makes clinical differentiation difficult. While some STIs have no symptoms at all, which makes your history taking and sexual health assessments so, vital, and among our younger patients we may have co-infections. So, that's highlighting the importance of being really thorough with the diagnostic test that you offer.
Trichomonas is a protozoa parasite that we often under screen for either in combination with other tests or testing in isolation. And you may be surprised to know that the incidence of trichomonas is more than chlamydia, gonorrhea, and syphilis combined. So, the trichomonas incidence, which is the number of new infections, is estimated to be around 6.9 million cases per year. And the fact that 70% to 85% of those carrying trichomonas infections are asymptomatic certainly contributes to our issue with under screening.
And trichomonas is an STI that is not reportable. So, generally surveillance is not being done. So, making it a reportable STI could help monitor those epidemiologic trends and stimulate public health research. Important to note too, for your patients who have a trichomonas infection, it does have an association with HIV acquisition, so, that really accentuates how important our awareness of trichomonas is.
Together, chlamydia, gonorrhea, and trichomonas do cause a serious burden to our health care system. Again, highlighting that trichomonas is the most common non-viral STI followed by chlamydia, then gonorrhea. And those numbers on the right are cost in the millions in 2018, with chlamydia carrying the largest financial burden at $691 million in 2018.
Chlamydia is the most frequently reported bacterial STI in the United States and again more common in younger people with two out of three new chlamydia infections occurring among youth aged 15 to 24. Highlighting that routine screening is so, important in your higher risk age groups. Chlamydia is also, often silent, so, your patients may not seek out testing since they're feeling well. And in fact, the vast majority of people have no symptoms at all. We also, had an increase in chlamydia rates by 25% between 2013 and 2018 despite public health efforts to test and treat people.
Gonorrhea is the second most common bacterial STI in the United States, and there was a historic low in 2009, but now the rates of reported cases of gonorrhea have increased by 111%. And in 2020 we had over 677,000 new gonorrhea infections. And what's really concerning is that half of those infections are becoming resistant to at least one antibiotic, which is making treatment more challenging. So, I encourage everyone to be sure that you have the latest updates from CDC regarding the recommended treatments for gonorrhea. And again, this can be an asymptomatic infection, but those with symptoms may mistake it for a bladder infection or a non-STI vaginal infection, so, they may not get the right testing or treatment.
There are multiple downstream health consequences to STIs if they're untreated. So, we're probably most familiar with things we see in clinics, PID, infertility, pregnancy complications, ectopic pregnancy, and chronic pelvic pain. But there are some other maybe less common complications to keep on your radar as well. Fitz-Hugh-Curtis Syndrome is a condition where there's swelling of the tissue covering the liver as a result of having a pelvic inflammatory infection, so, your symptoms may have pain in the right upper abdomen, fever, nausea, vomiting. Reactive arthritis or Reiter's syndrome it's usually preceded by an infection by a bacteria such as chlamydia or even a foodborne illness like salmonella.
Disseminated Gonococcal infection occurs when the gonorrhea pathogen enters the bloodstream and spreads to distant sites in the body, which could lead to serious complications like septic arthritis, polyarthralgia, skin lesions, bacteremia, or on rare occasions, endocarditis or meningitis. So, these complications certainly add to the increased costs that we see from these STIs.
The CDC does have long standing guidelines that we should follow in order to protect women from STIs and their possible long-term consequences. So, this includes annual STI screening for all sexually active women under the age of 25 for both chlamydia and gonorrhea. And if you include trichomonas in your testing, you may start to be surprised by all the infections that you'll find. And remember the risk for co-infection. You may have, for example, a positive chlamydia result, but they could also, have a trichomonas infection. So, comprehensive STI testing allows you to be more complete.
BD does have a solution for testing for these three non-viral STIs In one sample, the CTGCTV2 assay, which can be ran as a vaginal swab, patient or clinician collected. It can be an endocervical swab. They may also, be ran off of liquid based cytology or in urine, both for men and women with the one caveat that the endocervical sample and the liquid-based cytology sample is only result for chlamydia and gonorrhea.
So, we definitely strive at BD to have the most sensitive diagnostics, which CDC does advise the vaginal swab as the method to test your patient. And the vaginal swab with our assay will give you all three STI results. So, it's one sample, one instrument run to detect the three most prevalent non-viral STIs. And ultimately, we don't want patients to have to come back again for testing if they weren't tested for trichomonas. So, you can receive all of these test results in one sample which offers really excellent clinical utility in your practice.
So, now we'll move on to vaginitis, which is also, quite a significant problem for the women that you're seeing. Vaginitis or vulvovaginitis is the most common gynecologic condition in the United States, resulting in more than 10 million office visits annually. And there is a wide spectrum of symptom severity from mild to severely bothersome vaginal and vulvar symptoms that can interrupt someone's quality of life. The three most common diagnoses composing 90% of cases include bacterial vaginosis, vulvovaginal candidiasis, and trichomonas, which trichomonas is both an STI and a cause of vaginitis.
So, the bacterial vaginosis, it accounts for about 22% to 50% of vaginal cases caused by changes in the vaginal microbiome, namely an increase in anaerobes and a decrease in lactobacilli, which we need lactobacilli to maintain the vaginal environment and PH. Common symptoms for BV are discharge, odor, sometimes a burning sensation with urination, genital irritation, or pelvic discomfort. Vulvovaginal candidiasis or VVC accounts for 17% to 39% of vaginitis cases and is caused by fungal infection by the candida species. Commonly, symptoms can include thick, cheesy discharge, vulva itching or burning vulva erythema, edema, painful intercourse and burning sensation with urination as well.
Trichomonas or TV is the protozoa parasite that can cause green or yellow frothy discharge, odor, vaginal pain, painful urination, painful intercourse, and that strawberry cervix appearance that you may see on speculum exams. So, you can see there is a great possibility for overlap of symptoms between these three diagnoses. So, a brief exam alone or reported symptoms alone may not be enough to differentiate what your patient needs.
So, millions of women are affected by the vaginitis disease prevalent in about 29% of US women between the age 14 and 49. So, that's making it the most common cause of vaginal symptoms in reproductive age. 75% of women will have had at least one episode of vaginal candida in their lifetime. And this is the second most common cause of vaginitis. And finally, trichomonas is quoted as about 2% among US women aged 14 to 49. However, we know clinicians are not testing for this regularly. And again, it's not a reportable infection, so, these numbers surely should be higher. And trichomonas, like we mentioned earlier, is the most common non-viral STI in the United States.
So, women suffering from these symptoms can have serious complications, and about 40% of women don't receive the appropriate treatment for vaginal symptoms. So, some women are living with these symptoms for months and not getting the right resolution. So, that, again, can lead to those downstream effects, not only financially, but other complications such as a higher risk for STI acquisition and for our pregnant patients, pre-term labor and low birth weight. Candida is also, associated with premature rupture of membranes in our pregnant patients, preterm birth, and fetal neonatal infections. And again, to highlight the risk that trichomonas has with increasing the risk for HIV acquisition. So, that risk can actually be increased by 2 to 3 times. And it's also, associated with preterm birth, infertility, and urogenital inflammation.
So, we have to keep in mind the chance again for coinfection up to 25% of patients may experience. So, mainly, in my practice experience I use microscopy and that's all I had to diagnose my patients. So, I tried my best to not stop looking at my slides once I saw that trichomonas or saw that [inaudible] because there can be more than one diagnosis in your patients. So, using that as your test can help you to thoroughly evaluate and treat your patient and it saves you time in clinic. And again, because of that symptom overlap, it is hard to pick apart their symptoms over telehealth or that brief exam. And often self-diagnosis and home treatment attempts can confuse your clinical picture even further. But we are really fortunate because we do have more advanced technologies available to diagnose vaginitis in your patients.
So, traditional methods like microscopy certainly are time consuming. You're doing your exam, getting your swabs collected, testing the PH, the [inaudible], preparing your slides, you're viewing slides and then going back in the room to talk to your patients. So, the findings too, are only as good as the examiners. So, if you perhaps weren't able to prepare your slides as well, or if you didn't have a good sample, you could be missing critical information.
The lab-based tests include sending culture or doing Nugent scoring, which may not even be an option depending on the lab that you're working with. So, molecular methods into the DNA probe test, which is on the market as our BD firm, and we also, have our molecular nucleic acid amplification test, or NAT, which includes both the FDA non-FDA cleared tests which are more sensitive and more objective for diagnosing vaginismus.
So, like I previously mentioned, there is a wide range of microscopy skills and training, and even in our clinical trial, highly trained providers often had difficulty with performing microscopy. Culture is available for Candida, but the issue there for symptomatic women is it could take a week to get the results. And in the meantime, maybe you prescribed something that wasn't the best treatment and possibly contributing to medication resistances in the community.
Gram stain and Nugent scoring for BV requires significant expertise and it involves counting the bacteria species. So, that's given a score and then the result can be negative or positive or can be indeterminate. So, if it's indeterminate, then it's really unclear what to do with these patients. So, because of the subjectivity and lack of sensitivity, about 40% of patients receive - don't receive the proper diagnosis right away, which I think is a substantial burden on your patients. They have to make another appointment, pay another copay, have another assessment, and at that point they're probably pretty frustrated and then still have their symptoms. So, we definitely have a really great opportunity to do better for our patients.
This slide just has a brief overview of what you're looking for when you're doing microscopy. Again, we all are familiar with Amsel's criteria, which you need three of the four to get to be the diagnosis. For Candida, you're looking for [inaudible] or yeast bugs on your PLH prep. And then trichomonas is probably the hardest one. You're looking for visualization of those motile trichomonas, which once that swab hits the cooler temperature outside of the body, those trichomonas begin to die. So, preserving your swab right away in saline can help. But even so, that could be missed on your slide review.
Also, review those lab tests. The yeast culture, like I mentioned, can take days, as can the trichomonas culture, which is not really used that commonly anyway. And again, Gram staining has that question of its availability at your lab. And then again, your lab needs to have a really high level of expertise to accurately quantify bacteria. And then again, the issue of having an indeterminate result.
Some patients self-treat. I experienced that a lot in my clinic. A lot of patients would come to us once they had already tried home remedies or over-the-counter methods, which they may get right about half the time. The other half that are still having symptoms will go to their provider. And then there is a 50/50 there as well for correct diagnosis. So, for those people not being diagnosed correctly, we have this vicious cycle when proper diagnostics aren't used. And again, continued cost and ongoing symptoms in your patients.
So, BD, we do have good news that we have excellent essays available with greater sensitivity and specificity. So, the BD Max Vaginal panel, it's the first FDA-cleared molecular NAT, which is the advanced version of the BDA[?] firm from 20 years or so, ago, which it took all that time to do research on the vaginal microbiome to provide more sensitive and more accurate diagnosis of vaginitis, take into account multiple species of bacteria. And just to note to the max vaginal panel is an assay approved for use in symptomatic women, specifically.
The BD max vaginal panel, it actually gives you five results from one swab. So, the BD diagnosis is based on six bacterial species, not only Gard Morella, since we know there is more bacteria targets than just Gardnerella. And you're getting three yeast results as well, so, you're getting a glabrata [inaudible], which we know those have some treatment resistances. So, you're getting those results individually and then the other four type in a group. So, the albicans, tropicales[?], perhaps cirrhosis and [inaudible] those are in the positive or negative group analysis. And then the fifth result you're getting is trichomonas. So, the trichomonas is included in this assay as well. So, those are the five results that you're getting from that test.
So, why is this so, important remembering to test for vaginitis and STIs. So, women with vaginitis actually are at a higher risk for contracting STIs. And we did publish a study in 2019 that did a retrospective analysis on samples from the vaginal panel trial, and they tested those samples for STI and the women with BV alone or concurrently with Candida infections had high rates of STI coinfection around 25%, and those negative for vaginitis had a significantly significant lower positivity rate around 8%.
And I think that goes back to the conversation about stigma of offering STI testing versus vaginitis testing. But we may be doing a big disservice to our patients and only talking about vaginitis when they come in with symptoms. So, we have options to test for vaginitis and STIs in the single sample in most symptomatic patients with our assays. And again, the vaginal panels for the symptomatic patients, but the asymptomatic patients, you can also, do our CTGCTV screening test. Here again, also, a chance of being positive for more than one cause of vaginitis too. So, coinfection rates, there are around 23% and some people even had all three infections. Trichomonas, Candida and BV in about 2% of population. So, like I mentioned before, we may be at fault for stopping our slide review too soon when we're doing microscopy. So, using a NAT test offers you a superior diagnosis.
Okay. So, really great flexibility with the BD molecular swab collection kit. And remember, it is FDA-cleared so, that one swab gets results for chlamydia, gonorrhea, trichomonas BV and Candida, and your patients can also, self-collect swabs in the clinic settings. There's not home testing yet, but you can offer self-collection for your patients. The molecular test allows not only for more reliable diagnosis, but you're getting more time spent with your patients. And with all of us being so, overbooked and busy, this is one thing we can do better for our patients and give them that individualized care that they seek.
The CTGCTV2 to test for STIs is cleared for men as well to do in urine, which is a really acceptable testing modality in males. So, you could offer this test to the partners of your patients really easily. And again, you can also, collect it from female urine. The end of cervical swab. Although the end of cervical swab just gives you chlamydia, gonorrhea as the testing of the liquid based cytology. So, again, you're getting all these results with one swab, thus making everything easier for you and your patient. So.
[Inaudible] slide my last slide of content. So, again, just giving you a visual here of the five results that you're able to receive with that one swab, and I hope that you all were able to learn something new and may consider some changes to your clinical practice. I always refer people to our website, which is Women-Health-Solutions-BD.com if you're interested in learning more about our diagnostic solutions, which also, includes our BD Onclarity, HPV extended genotyping assay, and I believe on the next slide has my email address, which you're welcome to contact me if you have any other questions. And I'm really grateful for your attention and for listening, and I'm certainly available for any questions that hopefully I can answer.
Mary Beth Dineen: Thank you so, much, Catherine. Thank you. As a reminder, you can submit Q&A for Catherine to answer in the Q&A box. Okay, Catherine, we have our first question. Is does the BD Max and AAT give results for the presence of Candida or does it give a specific quantified level? How does it deal with colonization?
Catherine Dezynski: Yeah, yeah, it does. It gives the three different results. So, you have the glabrata and [inaudible] separately, and it's just a negative positive. So, it doesn't seem to be giving a quantified level of just giving you negative or positive. And then it groups the other four together, which does include the candida albicans. So, it's just positive or negative, but you're getting the individual result for those glabrata and [inaudible] which have treatment issues and then the four together and just a negative or positive group as well. So. Yeah. So, with that colonization too, I mean, it's just not giving any kind of specific level, but we have the specified cutoff for the assay for it to result is negative or positive.
Mary Beth Dineen: All right. Our next question is what CLIA category is the BD Max?
Catherine Dezynski: Now I'll just have to check in to that one for you, because I am not sure, but let me find an answer for you. In the meantime - actually, here I have the answer. Moderately complex. Thank you.
Mary Beth Dineen: All right. Our next question is at our clinical use, a three in one swab for a BV panel would the urine sample testing for all five be preferred.
Catherine Dezynski: So, the three in one slot for the BV panel. Well, urine testing, if you mean urine testing for BV that we would recommend the vaginal swab for that. So, it's only your only urine is for the - like the CTGCTV2 is only the urine. So, urine not acceptable for the vaginal panel, basically.
Mary Beth Dineen: Got it. Our next question is what is the procedure for self-collection?
Catherine Dezynski: Sure, sure. Yeah. And self-collection is - mainly the self-collection in my own clinical practice, I think patients accept it really, really well and like having that autonomy. So, basically the patient swabs need to be collected only in the clinic setting so, we don't have home testing right now. It's preferable they get it before their visit. So, when that patient's in the bathroom doing their urine, you can also, give them swab and they give them the swab and they would just take it and insert it two inches into the vagina without any lubricants or other products. They would then rotate the swab for ten to 15 seconds, withdraw the swab, and they would give the swab back to the medical assistant for them to put in the tube and then break off that tube so, the patient isn't putting it back in the tube themselves.
So, again, avoiding any kind of interfering substances and doing this before like an ultrasound or before a speculum exam is preferred because otherwise you run the risk of it not being able to be run successfully. So, not a home option for self-collection right now. And anything that is available for home collection is not FDA-approved, but hopefully we'll have something like that in the future. And I think there's are really high value in self-collection for patients who, for whatever reason, may decline an exam that day or for our patients who need to get in and out quickly. Again, we want you to test your patients and get that history and do everything as you see fit for your patient population. But self-collection is really a great opportunity, I think, for patients to self-collect.
Mary Beth Dineen: All right. Our next question is, can you test extra genital sites?
Catherine Dezynski: Sure. Sure. Yeah, we really appreciate that question because we recognize, too, that this is a really important issue. Our research and development teams are certainly working on it. It would be off label usage right now. So, right now we have the FDA approval for and not for accidental sites like oral pharyngeal or rectal. That would be off label usage at this time. But you can again use urine for men and women. With a vaginal swab you can do endocervical swab for chlamydia, gonorrhea and then liquid based cytology for chlamydia and gonorrhea as well.
Mary Beth Dineen: All right. And we have one last question for you today, Catherine, and that is, can you test for HPV with that swab?
Catherine Dezynski: Sure. Yeah. Well, that's our separate assay that we have, the BD Onclarity, which is extended HPV genotyping. It's actually the only FDA approved assay for extended genotyping and you're getting individual results. So, it's what's most unique to our test is it's giving you an individual result for HPV 31, which we know has a higher risk for cervical pre-cancer, second to HPV 16. So, the assay gives you six individual results in three smaller results. So, that's a totally different assay. But it is an STI and it is again a major problem in the United States that we have so, much HPV positivity. So, using - when you're talking to your patients for their cervical cancer screening, you can use an HPV tested primary, cervical cancer screening as well. But our test that we have, the BD Onclarity, is the only FDA approved extended genotyping assay in the United States. So, another great opportunity for screening for your patients.
Mary Beth Dineen: Okay, We had another question come in. So, on this test, are there interfering substances that are listed like blood, for instance?
Catherine Dezynski: Yeah, that's such a common question that we get because patients come in on their menses. Maybe patients have self-treated at home and they're still like medication. So, we don't have an exact, for example, timeline to say, do the swab once you spend three days after your period or a week after taking treatment? So, we would just recommend as much as possible to avoid any kind of interfering substances either with your exam. Otherwise, it may have a higher risk of being a test that can't be ran. But there are - is a list of interfering substances on the package insert, but we just recommend not using lubricants when possible.
Mary Beth Dineen: All right. Thank you, Catherine. You could just take a minute to review our disclaimers. And then we'd like to invite you to check out our upcoming webinars, which are available at mms.mckesson.com/educational-webinars. And in closing, I'd like to thank Catherine and BD once again for today's presentation and all of you for attending. Have a great rest of your day. Thank you.
Catherine Dezynski: Thank you.
Webinar originally aired on September 28, 2022
© 2022 McKesson Medical-Surgical Inc.