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. Supplementary Information The online version contains supplementary material available at 10.1007/s10096-021-04194-6.
【저자키워드】 COVID-19, bacterial pneumonia, Hospital-Acquired pneumonia, Rapid-diagnostic tests, Multiplex-PCR, 【초록키워드】 Pneumonia, Multiplex PCR, diagnostic, sensitivity, specificity, Critically ill, Concordance, Culture, predictive values, Pathogens, Bacterial pathogens, respiratory, multiplex, application, performance, Lower respiratory tract, COVID-19 patient, Negative predictive value, critically ill COVID-19 patients, supplementary material, 95%CI, 95% CI, positive, reference method, bacterial species, bacterial pathogen, SOC, Standard-of-care, residual, tested, evaluate, carried, were used, demonstrated, bacterial specy, HPN, LRT, PCR-based method, 【제목키워드】 Pneumonia, Diagnosis, bacterial pneumonia, COVID-19 patient, secondary bacterial pneumonia,