Improve STI Outcomes and Reduce AMR with RNA Multi-Testing
Better testing for M. gen reduces rates of undiagnosed illness and AMR likelihood
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Jamie Shutter, MD, serves as the Senior Vice President of Laboratory Development at Unified Women’s Healthcare and the Laboratory Medical Director for 5 of UWH-affiliated women's health laboratories. Dr. Shutter’s credentials include a gynecologic and breast pathology fellowship at the University of Virginia, a pathology residency at Columbia University Medical Center, and an OB/GYN internship at Johns Hopkins Hospital. He earned his medical degree from SUNY Upstate Medical University and is a recognized speaker and published author in his field.
What are some challenges with presentation and timely diagnosis of Mycoplasma genitalium (M. gen)? Do these challenges contribute to higher prevalence of infections?
M. gen is a microorganism that can cause cervicitis and urethritis and is considered a sexually transmitted infection (STI). M. gen has a high prevalence of 19.8 percent in women and 16.5 percent in men, and, in my opinion, the current medical literature suggests it should be tested for upfront in cases of patients with vaginal discharge and/or acute vaginitis. The biggest challenge with infections like this one is that they have overlapping symptoms with other conditions in the lower reproductive tract. It’s very difficult for a clinician to determine if it’s M. gen, gonorrhea, chlamydia, or a different, similarly presenting microorganism. Neglecting to test for the right pathogen can cause other health concerns. For example, the CDC estimates that there is a 2X increased risk of pelvic inflammatory disease, fertility problems, or adverse pregnancy outcomes in those diagnosed with an M. gen infection.
With the testing methods currently available for the detection of M. gen, can you describe limitations of DNA-based testing, in comparison to RNA-based testing, and how these limitations impact clinical lab testing?
Studies have shown that DNA-based tests are less sensitive than RNA-based tests such as the Aptima® Mycoplasma genitalium test. DNA-based tests can miss as much as 40 percent of infections compared to RNA-based tests. This is because there is typically a low microorganism load and therefore a lower overall sensitivity with DNA-based tests. These caveats allow this STI to go undiagnosed for a longer period of time.
What are the benefits of using a collection device like the Aptima® Multitest Swab, which has the ability to collect samples from a variety of specimen collection sites and also detect multiple infections and disease states?
The Aptima® Multitest Swab takes the benefits of RNA testing to a new level because it can detect multiple microorganisms. If a patient is not tested for an infection like M. gen and the remainder of the microorganisms tested for are not present, they may not come back to the office to be re-tested or, if they do, will have been without resolution of their symptoms for that period of time. The ability to test for multiple pertinent microorganisms in a single collection device makes it easier for the doctor to get a positive result on the first visit/test ensuring that the patient receives the most appropriate treatment as soon as possible.
M. gen was included on the CDC Antibiotic Resistance Watch List. How does testing for M. gen help combat antibiotic resistance?
An organism is placed on the CDC Antibiotic Resistance Watch List when it demonstrates a high level of antimicrobial resistance (AMR). Many patients are treated empirically for symptoms, and we know now that mismatched treatment exacerbates AMR. There are treatments specifically tailored for certain pathogens, such as M. gen, that are much more effective at fully treating the condition, thereby reducing the risk of AMR.
What does the future of M. gen testing hold in terms of incoming regulations and improved surveillance and diagnostics?
The CDC recently presented evidence in their publication where I concluded that M. gen testing should be part of the standard molecular microbiology panel when a patient comes in with symptoms. However, they fell short of recommending M. gen testing as a standard upfront microorganism to test for and only recommended performing testing on patients with recurrent symptoms or failure of initial therapy. My educated guess is that the CDC in their next publication will recommend M. gen testing as a standard upfront organism to test for on initial presentation of symptoms, as supportive evidence continues to accumulate. In addition, it is worth noting that M. gen testing is not currently recommended as a screening test and should only be tested for in a patient with symptoms.