OpGen Announces Publication of Results of Unyvero Hospitalized Pneumonia (HPN) Panel for Detection of Bacterial Respiratory Tract Pathogens from Serial Specimens Collected from Hospitalized COVID-19 Patients
ROCKVILLE, Md., June 22, 2022 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen” or “the Company”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today 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 published1 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.
In their new publication titled “Evaluation of a pneumonia multiplex PCR panel for detection of bacterial respiratory tract pathogens from serial specimens collected from hospitalized COVID-19 patients2”, the investigators conducted a follow-up study aimed to examine the concordant and discrepant results comparing the Unyvero HPN and culture results for detection of microorganisms from serial specimens collected from the same patient.
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 frst 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 performance3.
Several key findings emerged in this study:
The investigators reported that Unyvero detected an additional pathogen from at least one sample collected from 14/27 (52%) patients. Among these 14 patients, 10 of them had exposure to antibiotics before the collection of samples for culture and it is plausible that the exposure to the antibiotics had a negative influence on the yield of the cultures from these samples. The authors conclude that “The additional pathogens detected by Unyvero HPN from a given lower respiratory tract sample could be confirmed in many instances by culture positivity for the same microorganism from a previous or a subsequent sample obtained from the same subject. This observation underscores the ability of the Unyvero HPN in detecting a potential pneumonia pathogen earlier than culture and/or very early during infection.”
Faranak Atrzadeh, OpGen’s Chief Marketing and Scientific Affairs Officer commented: “The findings in this study highlight the accurate and reliable performance of the Unyvero Pneumonia panel and its diagnostic and clinical utility in detecting bacterial pneumonia earlier to enable more prompt and appropriate antibiotic treatment.”
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