How the cobas liat assay panels improve STI detection

In a recent interview with Contemporary OB/GYN, Denise Heaney, PhD, chief medical partner for molecular solutions and infectious diseases at Roche Diagnostics, discussed the cobas liat STI multiplex assay panels and their significance in improving sexually transmitted infection (STI) testing.

Heaney explained the capabilities and benefits of these FDA-cleared and CLIA-waived diagnostic tools. The cobas liat panels come in two versions: a 2-plex panel detecting Chlamydia trachomatis and Neisseria gonorrhoeae, and a 3-plex panel that also includes Mycoplasma genitalium. These tests utilize real-time polymerase chain reaction (PCR) technology, a highly reliable molecular method that individually identifies the presence of each pathogen. The ability to differentiate these infections is crucial for appropriate treatment and antibiotic stewardship.

One of the major advantages of these panels is their speed. Results are available within 20 minutes, allowing for rapid diagnosis and treatment within a test-to-treat model. Unlike traditional STI testing, which often requires samples to be sent to high-throughput laboratories, these tests can be conducted in decentralized settings such as urgent care centers, emergency rooms, and physician office labs. This significantly enhances access to testing, ensuring patients receive timely diagnoses and appropriate treatments in a single visit.

Heaney emphasized the importance of expanding STI testing accessibility, particularly given the high prevalence of infections in the United States, where 1 in 5 individuals may have an STI. By making testing available in non-traditional settings, these assays help reduce barriers to care, improve patient outcomes, and contribute to antibiotic stewardship by ensuring that infections are accurately diagnosed and treated with the appropriate medication.

The FDA 510(k) clearance and CLIA waiver of these tests mark a significant shift in STI testing capabilities. Historically, molecular diagnostic tests were considered complex and restricted to specialized laboratories. However, with these approvals, such advanced testing can now be conducted in point-of-care settings, making diagnostics more accessible and reducing the time to treatment.

Clinicians using the panels should recognize the impact of rapid, on-site STI testing. Traditionally, most STI screening focuses on chlamydia and gonorrhea, but with advancements in rapid diagnostics, broader pathogen detection can enhance patient management. The ability to test and diagnose within a single visit aligns with long-standing clinician demands for more efficient STI management, ultimately leading to improved patient care.

Heaney concluded by highlighting the broader public health benefits of these rapid assays. Given the rise in STI cases, particularly during the COVID-19 pandemic, expanding access to testing can help reduce transmission rates, improve early detection, and ensure appropriate treatment. Roche is enthusiastic about the potential impact of these assays in bringing high-quality STI testing closer to patients, ultimately enhancing disease control and prevention efforts.