The Unyvero Hospitalized Pneumonia (HPN) panel (OpGen, Inc., Gaithersburg, MD) identifies bacterial coinfections in <5 hours in hospitalized patients with coronavirus disease 2019 (COVID-19) pneumonia, according to a news release on the company’s website.

Preliminary results of this study were derived from samples obtained from 35 patients (median age, 58 years) admitted to intensive care units (ICUs) at 4 acute care hospitals in Sweden. All patients were screened and found to be positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, and 25% tested positive for a bacterial coinfection by microbiology. The researchers analyzed lower respiratory tract samples using the Unyvero HPN panel and compared the results with those from bacterial culture.

Preliminary data demonstrated that the Unyvero HPN panel was strongly concordant (98.2%) with bacterial culture for organism targets, confirming all pathogens reported by culture in 31 out of 35 patient samples. In addition, the Unyvero HPN panel detected additional pathogens in 7 patients, one of which was captured by microbiologic culture 7 days later and confirmed positive, highlighting that the panel may detect pathogens missed by culture.

Since time is critical in managing bacterial coinfections in ICU patients experiencing rapid respiratory deterioration, the Unyvero HPN panel is a promising rapid diagnostic test as it provides comprehensive diagnostic information to clinicians in <5 hours and requiring only minutes of actual hands-on time. The panel is able to detect 21 clinically relevant pathogens and 19 antibiotic resistance markers in just a few hours. Thus, instead of waiting several days for results with routine microbiologic pathogen identification, the early organism differential with the Unyvero HPN panel will allow clinicians to obtain information on antibiotic resistance markers, thus allowing for earlier treatment decisions and improving antimicrobial stewardship efforts.


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“This rapid testing technology is even more important in the face of a global pandemic when time is of the essence in preventing global spread,” said Oliver Schacht, PhD, CEO of OpGen. “We are encouraged by the preliminary results of our Unyvero HPN panel in Sweden and look forward to contributing testing capabilities to additional healthcare facilities around the world in the future,” he added.

Reference

OpGen releases preliminary data demonstrating its Unyvero HPN panel for pneumonia identifies life-threatening bacterial co-infections in COVID-19 patients in just five hours [news release]. Gaithersburg, MD: OpGen, Inc. Published June 9, 2020. http://ir.opgen.com/news-releases/news-release-details/opgen-releases-preliminary-data-demonstrating-its-unyvero-hpn. Accessed June 9, 2020.