BD’s Molly Broache, Associate Director of U.S. Medical Affairs, discusses the current state of STI testing in the U.S. with MLO editor in chief, Christina Wichmann
Molly Broache serves as Associate Director, US Region, Medical Affairs for BD Diagnostic Solutions and is also licensed as a women’s health nurse practitioner in both Maryland and Virginia. Molly manages a team of medical science liaisons responsible for specimen management, microbiology, and women’s health & cancer.
Molly’s clinical areas of expertise include women’s healthcare, gynecology, infectious disease diagnostic tests, and women’s health screening guidelines. She is a member of the American College of Obstetricians and Gynecologists (ACOG), Nurse Practitioners in Women’s Health (NPWH), American Society for Colposcopy and Cervical Pathology (ASCCP), and the Medical Science Liaison Society (MSLS). She serves on the membership committee for ASCCP and the Cervical Cancer Screening Initiative – Provider Workgroup for the American Cancer Society.
Molly holds two bachelor’s degrees from Johns Hopkins University, in molecular biology and nursing. She also holds a master’s degree in nursing from Georgetown University, where she received her training as a nurse practitioner. Molly is currently completing her Doctor of Nursing Practice degree at the University of Maryland, Baltimore.
MLO: Since the pandemic, we have heard that STIs are on the rise in the United States. Could you tell me what the current statistics look like?
Ms. Broache: I first just wanted to say that I'm so glad that the abbreviation STI, which means sexually transmitted infection, has become the new term used for this condition. I think a lot of people previously heard sexually transmitted disease, or STD, and “disease” carried more stigma.
Unfortunately, STIs are on the rise in the U.S. Data from the CDC from 2018 showed that one in five people in the U.S. have an STI. One of the sad things about STIs as well is that half of reported cases of gonorrhea, chlamydia, and primary and secondary syphilis were among young people. So those in the ages of 15 to 24 and also most racial and ethnic minority groups experience these disproportionate rates of STIs. So, this is a big problem in the U.S. and something that needs to be addressed.
MLO: What factors are driving the rise in STI rates in the United States besides seeing it in certain populations like the young and minorities?
Ms. Broache: I believe the rise in STI rates in the U.S. is due to a lack of sexual health education, which includes the importance of getting regularly screened for STIs. An STI screen is recommended for all sexually active women younger than 25 years of age and for anyone with risk factors like newer multiple sex partners or sex partner with an STI. The thing about STIs that's pretty interesting is that unlike some other diseases or infections that we know about, they do not often have symptoms. So, the only way to know if you have a condition or infection is screening — going to your healthcare provider even if you aren't having bothersome symptoms, and you know, I think that can be a hard thing for people to realize. Because normally what is triggering people to go to their healthcare provider is something's not right. With STIs, you often don't even have that clue. And, unfortunately, once you do have symptoms, that means your infection likely has progressed or might have been there for a while in order to cause those symptoms.
MLO: Why do you think there is a lack of overall testing for STIs, besides, one factor being some patients are symptomless?
Ms. Broache: Unlike getting screened for something like diabetes or cholesterol, there is this overall stigma I believe that goes along with STI testing and maybe shame on the part of the patient. Particularly, I think in the younger population, like the fifteen- to eighteen-year-old age, they are possibly worried about a parent or guardian being informed of the fact that they had testing and being notified of results.
I think going back to statistics like the one in five people in the United States having an STI can take away that stigma by just recognizing that these are overwhelmingly common infections that occur in the United States, and if people thought of this more of like a highly contagious illness like the flu maybe some of that stigma would be taken away. Obviously, that's not going to happen overnight, but treating this like any other condition that you would be screened for by your healthcare provider would help increase patient testing.
MLO: What are the most common STIs in the United States?
Ms. Broache: The most common non-viral STIs in the U.S. are chlamydia and gonorrhea. Those two infections are caused by bacteria. And then Trichomoniasis, also known as “trich,” is also a very, very common non-viral STI that is caused by a protozoan parasite, which we don't typically think of when we think of STIs. There are other common STIs in U. S. that are caused by viruses. Some of those are human papillomavirus (HPV) and HIV but the ones that are most commonly screened for are chlamydia and gonorrhea.
MLO: What is Trichomoniasis (Trich)? Why is this particular STI not talked about as much as other common STIs?
Ms. Broache: Trich is one that a lot of people haven't heard about. So, trich is caused by an infection from a parasite called Trichomonas vaginalis, and interestingly, it is the most prevalent non-viral STI worldwide. It's very common, and it can be treated with an antibiotic, but it's often left untreated as many patients are asymptomatic. However, it can increase the risk of getting and spreading other STIs.
One of the reasons I think it may not be talked about as much is it is not one of the diseases or conditions where if you test positive your healthcare provider or lab has to report it to nationally notifiable database. Trichomoniasis is not a nationally notifiable disease at this point like chlamydia and gonorrhea. So, it is often not talked about as much.
In the past, there has been a little bit of debate about whether or not trich causes some of those negative downstream health consequences chlamydia and gonorrhea do such as negative outcomes on pregnancy and pelvic inflammatory disease but it's been pretty well proven that trich is associated with those negative downstream health outcomes and it's often more commonly seen in women with HIV. So, at some point I think there is a possibility that this would become a nationally notifiable disease and that would be sort of a decision the CDC makes. Having attended the CDC’s STD prevention conferences in the past, this has always been a hot a hot button topic, but I think trich just hasn't quite met all seven of the criteria that are required for the becoming a nationally reportable disease. But that could change in the future.
MLO: How can education about testing and treatment options be increased?
Ms. Broache: Healthcare providers should screen for STIs and offer testing to all patients — making sure that any patient that comes into the office gets proper screening and is asked the right questions. I think even for healthcare providers, this can sometimes be a difficult topic to talk about and maybe they feel like they're making their patients uncomfortable by asking about this. But again, with some people not having symptoms, unless you are asking patients’ questions about their history and risk, you will never know who to test. Also, on the other end, patients should feel comfortable being able to go to their providers and ask for this testing. STIs are overwhelmingly common in the U.S. and should be treated like any other infectious disease that you would receive testing and treatment for. And the good news is the non-viral STIs are all very treatable; generally, an antibiotic, or for Trichomoniasis, medicine that takes care of the parasite. It's usually a week or less of medication and most patients respond well and will be clear of the infection. But if people do not go to their healthcare provider to get this test, then they essentially just won't know they have the infection, and because of the incredibly infectious nature, they could end up infecting more people.
MLO: What does BD’s STI testing portfolio look like?
Ms. Broache: BD offers a test called the CTGCTV2 assay. And those acronyms are CT (chlamydia), GC (gonorrhea), and TV (Trichomoniasis). We offer it on two of our instruments now. Our BD Max instrument is more targeted for the small-to-medium sized labs, and then our BD COR High Throughput instrument is for larger labs. These satisfy different volumes of testing needs. The CTGCTV2 assay is an FDA-cleared test designed to detect the three most prevalent non-viral STIs simultaneously and separately. So, essentially, when the provider orders this test, they will be getting results for chlamydia, gonorrhea, and trich, but they are in separate result reports.
The test has some really cool things about it that increases its accuracy. So, the test includes dual-gene targets for gonorrhea, and that maximizes the assay’s specificity so both GC gene targets have to be required for a positive result. This is really important because you never want to give anybody a false positive for an STI result. It's a serious reportable condition that needs treatment, so you want to be delivering those accurate results. The technology that we're using with the CTGCTV2 assay is called nucleic acid amplification testing (NAAT), and that's used for detection of all three conditions. And the CDC does recommend for STI testing, specifically for chlamydia and gonorrhea, a highly sensitive molecular test. Another nice thing about the CTGCTV test is there are a variety of different sample types offered and this allows for flexibility and adapting to both patient and provider needs.
MLO: What can labs do to improve the testing gap and help get STI rates under control?
Ms. Broache: It's so important for labs to be offering accurate STI testing through amplification molecular methods, like NAAT, that includes all three of those most common conditions. Having a triplex test like that requires less work on both the provider and the lab. If you're separating STIs into different panels or requiring doctors to order all sorts of different combinations to test your patients, that is both more work on the lab and the physician. So being able to offer a test that multiplexes those most common conditions can really increase efficiency on both the lab and provider.
In the future, it's our hope at BD that we can expand access to STI testing. BD is working on developing quicker ways to test for STIs through point-of-care testing. We are currently enrolling patients in the clinical trials for point-of-care STI testing, and we plan to submit our package of data regarding our point-of-care testing to the FDA this year. I think that addresses a problem; unfortunately, sometimes patients will go in and get testing and then if the results are coming back in two or three days, the provider then can't get in touch with a patient to be able to deliver the results and give them treatment.
Point-of-care testing can be done in a short amount of time while the patient is still at a healthcare clinic. The goal is that you would deliver the result and be able to appropriately diagnose the patient and possibly either administer or prescribe medication that same day. Again, if we're screening people, the most important thing is those positive people are actually getting the follow-up they need. If there are no follow-ups, the infections continue to be spread.
