Multi-target Molecular Panels Help Overcome Challenges in STI Testing

Sexually transmitted infections (STIs) are a significant and growing global public health concern. According to the World Health Organization (WHO), more than 1 million STIs are now acquired each day globally, and that number appears to be climbing [1]. The latest reports from the European Centre for Disease Prevention and Control (ECDC) show a sharp increase in STIs across 27 European Union/European Economic Area (EU/EEA) countries [2]. Similarly, in the United States from 2014 to 2018, the rates of reported cases of primary and secondary syphilis, congenital syphilis, gonorrhea, and chlamydia rose 71%, 185%, 63%, and 19%, respectively [3]. A subsequent study showed continuation of this trend, with STIs in the U.S. reaching an all-time high in 2021 [4].

Statistics like these point to the urgent need for STI testing—not only to meet patient demand, but also to optimize surveillance and identification of potential outbreaks. However, as Cyndi Clark, PhD, Senior Scientist, BioPharma Aegis Sciences Corporation, explains in the Utilization and Value of a Multiplex PCR Test for Sexually Transmitted Infections webinar, global trends are just one of many factors labs need to consider before implementing STI testing.

Watch the webinar

Clark speaks from experience. She opens her presentation by explaining how Aegis has evolved its offerings, initially focusing on diagnostics for pain management and behavioral health but then shifting to COVID-19 testing a few years ago. At the height of the pandemic, the lab was achieving a throughput of more than 100,000 COVID-19 PCR tests per day (for a total of over 14 million COVID-19 tests in all).

When the need for COVID-19 testing began to wane, the company looked to pivot again, weighing its newfound capabilities, capacity, and clients, as well as its patient population and community needs. “All arrows pointed to [testing for] sexually transmitted infections, given our experience with infectious diseases and our client and patient population,” Clark recalls. “So we didn’t have to argue much on the need for this type of testing and the importance of it for public health. But really what we had to establish from a company perspective, was the business case. How does this fit into our workflow? How does it complement what we are already doing?”

Choosing a multi-target molecular panel for STI testing

Clark devotes the rest of the 40-minute webinar to offering valuable insights for labs considering a similar shift. She doesn’t shy away from the challenges her team encountered,

discussing how they evaluated different testing options and navigated method validations, payer policies, and MolDx technical assessments.

Ultimately, Clark and her team chose a multiplex RT-PCR test that detects DNA from the most common sexually transmitted infections: chlamydia trachomatis, neisseria gonorrhoeae, and trichomonas vaginalis. Clark goes into detail about how the lab established clinical validity, clinical utility, and payer policies around these tests, and explains why they’re particularly effective for STIs, which can be difficult to identify because they are often asymptomatic and/or multi-pathogenic. She also includes a case study that points to the value of reflexing from a negative UTI test to a multi-target STI panel.

Improving patient care and client satisfaction

Clark concludes that using multi-target molecular panels for STI testing is proving to be faster, cheaper, and easier, with a higher throughput than other options.

“When we’re catering to our patient population, thinking about treatment centers and urgent care centers, these are the places where [STI testing] needs to be easy. It needs to be quick. And it needs to be hassle-free for not only the patient, but also for our nurses and doctors,” she says.

To better understand emerging STI testing trends and what it takes to make the business case for STI testing, watch the webinar Utilization and Value of a Multiplex PCR Test for Sexually Transmitted Infections on demand.

For more information surrounding STI and vaginal infections, including causes, symptoms, treatments, and molecular research testing products, additional resources are available by visiting this educational webpage.