POC Chlamydia and Gonorrhea Combo Test Gives Results in 30 Minutes

Despite the existence of highly sensitive and specific laboratory-based molecular diagnostic tools, the U.S. has seen a steady rise in Chlamydia trachomatis and Neisseria gonorrhea (CT/NG) infections in recent years. Surprisingly, about 50% of eligible women don't get screened for these STIs according to the guidelines laid down by the Centers for Disease Control and Prevention (CDC). The traditional testing processes for CT/NG often lead to less-than-ideal outcomes. Patients sometimes receive potentially inappropriate treatments, may not always comply with prescribed treatments, and might face a treatment delay, having to wait nearly 10 days for lab results. By introducing rapid point-of-care (POC) tests, the time between diagnosing and treating these STIs can be reduced, subsequently lowering the chances of further transmission and related complications.

The binx io Platform from binx health (Boston, MA, USA) is the first FDA-approved, CLIA-Waived CT/NG molecular test suitable for both genders, enabling on-the-spot diagnosis and treatment. This platform can deliver results equivalent to those of lab-based tests in just about 30 minutes, in contrast to the days or weeks often required by traditional methods. The binx io platform combines the binx health io CT/NG Assay, an automated, fast, and qualitative test, and the binx health io Instrument, to detect CT/NG DNA using the polymerase chain reaction (PCR) process. By combining ultra-rapid PCR with unique electrochemical detection, the platform ensures results that are as reliable as those available from central labs. The desktop-sized device is user-friendly, allowing operation by staff who might not have formal lab training, even in CLIA-Waived environments.

The binx health io CT/NG Assay is a versatile test; it can use swabs from females (either clinician-collected or self-collected in a clinic) or male urine samples to diagnose CT/NG infections. A recent study compared the workflow of the io CT/NG Assay to traditional lab-based tests. Findings revealed that the time clinic staff spent operating the binx io CT/NG test wasn't statistically different from the time spent preparing samples for a lab. Essentially, while the tasks might differ, the total time spent remains similar. The major advantage, however, is that the binx io delivers actionable results in roughly 30 minutes. This means it can integrate smoothly into a typical patient visit, shifting the focus from sending out samples for lab testing to immediate in-clinic testing without creating an extra workload for the clinic staff.

“The data further support that the binx io provided test results reasonable for a single patient-visit compared to 16 hours for the laboratory-based results,” said Jeffrey Luber, Chief Executive Officer of binx health. “This time-to-result is extremely important for providing clinically actionable information and improving the quality of a patient’s care.”

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