The Unyvero Hospital-Acquired pneumonia panel for diagnosis of secondary bacterial pneumonia in COVID-19 patients
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Abstract
The study was undertaken to evaluate the performance of Unyvero Hospitalized Pneumonia (HPN) panel application, a multiplex PCR-based method for the detection of bacterial pathogens from lower respiratory tract (LRT) samples, obtained from COVID-19 patients with suspected secondary hospital-acquired pneumonia. Residual LRT samples obtained from critically ill COVID-19 patients with predetermined microbiological culture results were tested using the Unyvero HPN Application. Performance evaluation of the HPN Application was carried out using the standard-of-care (SoC) microbiological culture findings as the reference method. Eighty-three LRT samples were used in the evaluation. The HPN Application had a full concordance with SoC findings in 59/83 (71%) samples. The new method detected additional bacterial species in 21 (25%) and failed at detecting a bacterial species present in lower respiratory culture in 3 (3.6%) samples. Overall the sensitivity, specificity, positive, and negative predictive values of the HPN Application were 95.1% (95%CI 96.5–98.3%), 98.3% (95% CI 97.5–98.9%), 71.6% (95% CI 61.0–80.3%), and 99.8% (95% CI 99.3–99.9%), respectively. In conclusion, the HPN Application demonstrated higher diagnostic yield in comparison with the culture and generated results within 5 h.
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SciScore for 10.1101/2020.11.24.20237263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has a few limitations. Currently, we do not have the clinical data of the patients from whom the present study samples were obtained. Because of this we could not determine the: i) the proportion of samples that were …
SciScore for 10.1101/2020.11.24.20237263: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Institutional Review Board Statement not detected. Randomization not detected. Blinding not detected. Power Analysis not detected. Sex as a biological variable not detected. Table 2: Resources
No key resources detected.
Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:Our study has a few limitations. Currently, we do not have the clinical data of the patients from whom the present study samples were obtained. Because of this we could not determine the: i) the proportion of samples that were sent to the microbiology laboratory prior the administration of antibiotics; ii) the proportion of samples that were false positive by the HPN Application due to the detection of bacterial DNA from a past infection. Another limitation of the present study is that we could not determine the performance characteristics of the HPN Application for the detection of genes conferring antimicrobial resistance, due to the fact that only few samples yielded drug resistant phenotypes by culture in this study cohort (data not shown here). Despite these limitations, our study identified that the Unyvero HPN Application is a reliable and rapid diagnostic test with excellent negative predictive value for detection of bacterial pathogens from lower respiratory tract samples. In conclusion, rapid diagnostics such as the Unyvero HPN panel are imperative to evaluate and test patients for bacterial pneumonia earlier in their hospital journey for more prompt and appropriate treatment. Unyvero HPN demonstrated a higher diagnostic yield than culture; it is significantly faster, with turnaround time of <5 hours from sample to results compared with average of 2.5 days for culture, providing clinicians earlier data to inform antimicrobial decisions, especially in critically ill ...
Results from TrialIdentifier: No clinical trial numbers were referenced.
Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
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