J Mol Diagn. 2021 Aug 23:S1525-1578(21)00254-3. doi: 10.1016/j.jmoldx.2021.08.002. Online ahead of print.
Diagnosis and management of bacterial pneumonia still relies on bacterial culture and antimicrobial susceptibility testing. The Unyvero® Lower Respiratory Tract (LRT) panel is a multiplex molecular assay that provides results within ∼4.5 h. This study evaluated the analytical performance of the LRT on bronchoalveolar lavages (BAL) fluids and bronchial washings (BW) in a cancer patient population and retrospectively determined clinical impact on therapy. Sensitivity and specificity of LRT on BAL and BW compared to bacterial culture and susceptibilities was calculated. Chart reviews were performed to determine if antibiotic management would have changed based on the LRT results. A total of 113 BALs and 123 BWs respiratory samples from 191 patients were included. The overall sensitivity and specificity were 91.7% [95% CI: 77.5% to 98.3%] and 92.0% [95% CI: 87.3% to 95.4%] respectively. Staphylococcus aureus was the most common target detected (n=21) with 89.5% [95% CI: 66.8% to 98.7%] sensitivity and 98.2% [95% CI: 95.4% to 99.5%] specificity. Based on availability of LRT results, 4.8% of patients could have been de-escalated faster. The LRT demonstrated an overall high accuracy for the detection of common bacteria associated with pneumonia. In this cancer inpatient cohort, treatment adjustment based on LRT results would have occurred in a small number of cases. Larger studies are necessary to understand the real-world impact within specific high-risk populations.