Performance Evaluation of the Luminex ARIES® C. difficile Assay in Comparison to Two Other Molecular Assays within a Multi-Hospital Health Care Center.
J Clin Microbiol
Clostridioides difficile infections (CDI) remain a serious issue in the U.S. Both fast and accurate diagnosis of CDI is paramount to achieve immediate infection control initiation, triaging and isolation, as well as appropriate antibiotic treatment. However, both, over- and under-diagnosis can lead to adverse patient outcomes, such as unnecessary administration of antibiotics or unwanted spread of spores in any hospital setting, respectively. In this prospective study, we evaluated the FDA-cleared ARIES® C. difficile Assay and compared its performance and workflow characteristics to the BD MAX Cdiff and Xpert C.difficile/Epi assays. Out of 302 samples tested, 55 (18.2%) samples were positive, and 234 (77.5%) samples were negative for C. difficile by all three testing methods. Comparison results showed a positive and negative percent agreement (PPA and NPA) between ARIES® and Xpert of 95.2% (PPA, 59/62) and 99.2% (NPA, 238/240), respectively. PPA and NPA between ARIES® and BD MAX were 91.8% (56/61) and 96.6% (230/238), respectively. Invalid rates were determined to be 2.6% for BD MAX, 1.0% for ARIES®, and 0% for Xpert. Hands-on time (HoT) and total turnaround time (TAT) varied considerably depending on sample number and instrument throughput. HoT ranged from 1.2 - 3.5 minutes per sample and TAT was 1 - 2.3 hours. Overall, the results demonstrated that the ARIES® assay is a rapid and sensitive method for the diagnosis of CDI in clinical laboratories.
School of Medicine
Pathology and Laboratory Medicine