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Rapid PCR Diagnostic Test for STIs Provides Accurate Results in Less than 30 Minutes at POC

By LabMedica International staff writers
Posted on 15 Mar 2023

Image: Visby’s second generation Sexual Health Test for women has received FDA clearance and CLIA waiver (Photo courtesy of Visby Medical)

Three of the most common and curable sexually transmitted infections (STIs) caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis, if left untreated, can have severe consequences for a woman's reproductive system, including infertility or potentially causing a fatal ectopic pregnancy. However, there is a significant gap in STI testing accuracy and the time needed for test results, which can take up to five days. Now, a fast, polymerase chain reaction (PCR) diagnostic test rapidly tests for these three most common STIs, allowing healthcare professionals to test, talk and treat patients in a single visit.

The Visby Medical Sexual Health test is Visby Medical’s (San Jose, CA, USA) second-generation point of care (POC) test that delivers accurate results in less than 30 minutes, allowing clinicians to confidently test, talk and accurately treat in a single patient visit. Visby has developed the first and only "instrument-free" platform that brings true PCR technology to the palm of the hand. The test has a new, sleeker design that transforms a simple-to-use device by converting four steps into one while maintaining an accuracy of approximately 97%. The new device offers significant improvements in workflow, manufacturability, and reliability over its predecessor.

"We are excited that the clearance of the second generation Sexual Health Test will enable us to move production to our fully automated lines, allowing us to deliver more tests to eagerly waiting customers," said Visby Medical Senior Vice President of Operations, Mark Medlen.

“Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit. This will help reduce overtreatment and undertreatment rates, as well as the number of patients who are lost to care,” added Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University. “By providing a prompt and accurate test result, the use of this test will lower the likelihood that an infected patient will develop pelvic inflammatory disease. It will expedite the treatment of that patient's sexual partner, and it will reduce the spread of sexually transmitted infections overall.”

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