Visby Medical™, along with Johns Hopkins Medicine Department of Emergency Medicine, has officially published results from a study, which evaluated a new approach to managing the three most common non-viral sexually transmitted infections (STI) in women. According to certain reports, the study basically discovered that use of the Visby Medical Sexual Health Test, a point-of-care (POC) polymerase chain reaction (PCR) test, trimmed down the process of specimen collection and generating a STI result to only 47 minutes per patient. This was compared to an average of 25 hours for the standard of care (SOC) lab-processed molecular send-out tests. Furthermore, it showed how Visby Medical test achieved higher rates of appropriate treatment and lower rates of over-treatment with antibiotics for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections, compared to SOC. Talk about the whole study on a slightly deeper level, named Management of Sexually Transmitted Infections in the Emergency Department: Evaluation of a Point-of-care Test, the effort practiced two approaches to testing female patients at the Johns Hopkins Emergency Department in Baltimore MD with potential STIs, and it did so during two separate four-month study periods during 2022 and 2023.
Like we briefly touched on, one of these approaches was SOC central laboratory testing with batched nucleic acid amplification testing (NAAT), whereas on other hand, we had the POC PCR Visby Medical Sexual Health Test. Pitted against each, the two approaches dueled in the context of STIs identified, median time-to-result intervals between the two phases, and rates of appropriate treatment (including over and under treatment) based on CDC recommended guidelines. Markedly enough, for patients testing positive (4.8% for CT, 2.7% for NG, 8.0% for trichomoniasis [TV], and 1.9% with co-infections), proportions of appropriate treatment were significantly higher among the POC group for CT (92.7% vs 75.1% p<0.001) and NG (87.1% vs. 74.3% p<0.001). In contrast, proportions of over-treatment were significantly lower among the POC group for CT-negative (7.0% vs 25.2% p<0.001) and NG-negative (13.0% vs. 25.5% p<0.001) patients. While there were no significant differences between the two testing groups for TV, median time intervals were significantly lower for the POC group, including time from specimen collection to STI results, time from ED arrival to STI results, and time from ED arrival to discharge.
“The rise in STIs has created a crisis for the nation’s hospital emergency departments because the conventional send out tests do not provide results fast enough to inform treatment decisions during the patient visit. Rather than lose a potentially infected patient, clinicians must decide whether to treat before they have definitive results, which isn’t ideal for anyone and contributes to antibiotic resistance,” said Gary Schoolnik, MD, an infectious disease expert, Chief Medical Officer at Visby Medical, and Professor of Medicine at Stanford University.
The development in question delivers a rather interesting follow-up to one STI surveillance report published in 2024 by the U.S. Centers for Disease Control (CDC), a report which claimed that STI had more than 2.5 million cases of its own in 2022. On top of that, the rate of inappropriate use of antibiotics to treat STIs has also contributed massively towards antimicrobial resistant NG strains, thus prompting the World Health Organization (WHO) to release new guidance to improve diagnosis of STIs, including POC tests, with special emphasis on reducing antimicrobial resistance. Fortunately enough, Visby Medical Sexual Health Test, which is currently the only “instrument-free” POC test available in the U.S. that provides PCR results in under 30 minutes, can be expected to solve a good chunk of this problem moving forward.
