OpGen, Inc. announced the release of a new peer-reviewed journal publication from a study conducted at Karolinska University Hospital (KUH), Solna, Stockholm, Sweden. The publication highlights the ability of the Unyvero Hospitalized Pneumonia panel in detecting potential pneumonia pathogens earlier than culture or very early during an infection. The performance characteristics of the Unyvero Hospitalized Pneumonia panel, in comparison with microbiological culture for detection of bacterial pathogens from lower respiratory tract samples obtained from critically ill COVID-19 patients, were recently published by the investigators at Karolinska Institute.

The study results demonstrated that Unyvero HPN provides a higher diagnostic yield than bacterial culture. This enables reliable and rapid diagnosis of pathogens of concern in these patients directly from native lower respiratory tract samples, and provides identification of bacterial co-infections in hospitalized patients with COVID-19 pneumonia in just five hours. Sixty-nine samples obtained from 27 adult subjects (fifteen patients with two, nine patients with three, and three patients with four samples collected on separate days) admitted in the intensive care unit with COVID-19 were included.

Data was categorized based on full concordance (results from Unyvero were identical for the presence or absence of one or more pathogens by culture), concordance by correlation (Unyvero was positive for a pathogen that was negative by culture from the same sample but was positive by culture in a previous or a subsequent sample from the same patient within ±7 days), partial concordance (Unyvero detected the same pathogens that were detected by culture plus additional pathogen(s) that were not detected by culture and failed achieving concordance by correlation), discordance (an on-panel pathogen was culture positive but was not detected by Unyvero; discordant results were also considered when a sample had only one pathogen detected by Unyvero but was not detected by culture), concordance and discordance (samples that were positive for more than one pathogen by Unyvero but was not detected by culture; one pathogen was concordant by correlation by culture in a previous or a subsequent sample from the same patient within ±7 days, the other pathogen was not detected by culture). Results were analyzed in two ways: The first evaluation (Evaluation I) was performed in a typical manner for a comparative study where Unyvero results were compared with culture results per subject. The second evaluation (Evaluation II) explored interpretation of Unyvero false positive results which were then corroborated by culture from a different sample taken at a later or at an earlier time point from the same patient.

In this approach, all Unyvero false positives results were considered true positives, if culture confirmed this result for any other sample (collected at an earlier or later time point) from the same subject. The latter approach highlights an important point because published literature reports sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) comparisons with the assumption that conventional microbiologic techniques are 100% sensitive and specific when in fact microbiological culture is acknowledged to be far from being an optimal gold standard due to its diagnostic performance. Several key findings emerged in this study: Unyvero detected at least one additional pathogen in 20/69 (29%) of the samples tested.

The additional pathogens detected by Unyvero in 12/20 (60%) samples were detected by culture from a previous or a subsequent sample collected (± 7 days) and tested from the same subject in six samples each. This observation emphasizes the ability of the Unyvero panel in detecting a potential pneumonia pathogen earlier than culture or very early during an infection.