Demonstrating the value of STI testing at the point of care

November 1, 2024
 

One in five people in the United States has a sexually transmitted infection (STI).¹ With these infections totaling more than 68 million each year,¹ the Centers for Disease Control and Prevention (CDC) has recommended that STIs be a top public health priority.² When left undiagnosed and untreated, STIs can lead to harmful and lasting consequences that can impact both health and well-being, thus supporting the importance of CDC STI testing guidelines.

Molecular point-of-care (POC) testing may very well hold the key to addressing both the rising incidence and adverse health effects of STIs. Largely due to the underutilization of testing, STIs are both some of the most undertreated and overtreated medical conditions. In a December 2023 whitepaper on POC testing, the Point of Care Testing Association asserted that “POCT (point-of-care testing) represents an opportunity to timely address STIs by allowing clinicians to provide immediate test results and prescribe appropriate treatment, thus reducing risk of morbidity and spread of infection.”³

With the majority of STI testing currently completed in central labs, timely diagnosis can be challenging. Yet diagnosis is critical to ensuring appropriate treatment. In a real-world study analyzing more than 23 million instances of patients presenting with symptoms of a urogenital condition, 89% of patients who received antibiotics received their treatment within the first three days of their initial appointment, likely before results from CT (Chlamydia trachomatis)/NG (Neisseria gonorrhoeae) testing would be available. The findings suggest presumptive therapies for diseases that should be tested for and treated accordingly, contributing to suboptimal antimicrobial and diagnostic stewardship.⁴ The study, which focused on STI testing and treatment patterns in the United States, also showed that fewer than two in 10 individuals received CT/NG testing, despite showing symptoms,⁴ also demonstrating the underutilization of STI testing.

Benefits for patients, implications for patient care

For symptomatic patients in certain settings, STI testing at the point of care provides a seamless connection of gold-standard molecular diagnostics and treatment. In under 30 minutes,³ a patient can learn what they have contracted and how to treat it. Just as significant, patients can also benefit from the opportunity to be tested and receive treatment during the same visit. With PCR technology previously used only in a lab, molecular POC testing provides the same high level of accuracy as the lab in a CLIA-waived setting.⁵ Offering clinicians confidence in diagnosis, this test-to-treatment approach helps address potentially high loss to follow-up rates, making treatment more likely and contributing to thoughtful antibiotic and diagnostic stewardship.

Related to access and barriers to care, it’s important to note that with the closure of STI clinics,⁵ more patients are using point-of-care settings such as urgent care centers, emergency departments, women’s health clinics, primary care provider offices, and public and student health clinics for diagnosis and treatment. Molecular POC testing, in addition to delivering high specificity and sensitivity across a variety of diseases, is evolving to meet customer needs, providing rapid results directly at the location of care, and often, for multiple disease targets in one assay.

Also of note, point-of-care testing has the potential to break down barriers in access to care and treatment. Meeting patients where they are through easily accessible health care sites or organized community outreach, providers have the potential to reach various populations at risk for STIs, including underserved groups or those facing stigmas and discrimination.

The future of molecular POC testing and sexual health

There are currently only a handful of FDA-cleared, CLIA-waived POC tests to diagnose STIs, which can barely scratch the surface of the epidemic that the U.S. and world are facing. However, innovation in this space is well underway, with expectations for molecular POC testing to cover the full spectrum of STIs, including expansion to genital lesions, mpox, vaginosis pathogens and possibly HIV.

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