Evaluation of a high-throughput assay for use on the cobas 5800/6800/8800 omni Utility Channel.

(formerly known as ) is an emerging worldwide fungal pathogen associated with difficult-to-treat nosocomial infections. Screening of patients for colonization is a recommended strategy to track and prevent hospital spread and outbreaks caused by . To facilitate this, a high-throughput (HTP) assay with a short turnaround time and minimal manual processing has significant value. Here, we present ongoing research on the detection of by direct testing of nasal/axilla/groin swab samples using the HTP cobas 5800/6800/8800 family of systems that has the ability to process up to 1,056 samples in an 8 h shift. Based on testing of 200 surveillance swab samples, the cobas Utility Channel (UC) assay demonstrated 94% accuracy, 91% positive percent agreement, and 98% negative percent agreement when compared to an established nucleic acid amplification test (NAAT) (BD MAX Open System assay). In a secondary analysis of 159 out of the 200 samples, the assay was compared to standard-of-care culture results with an observed 95% accuracy, 92% sensitivity, and 90% specificity. The cobas UC assay was inclusive for clades I-V and exclusive to 15 other closely related fungal species based on wet lab testing. The data presented originated from internally conducted studies performed for research purposes. The cobas UC assay is not approved for diagnostic use.IMPORTANCE is an emerging multidrug-resistant fungal pathogen and considered a global public health threat. Rapid detection and identification of is critical for hospital infection prevention and control and outbreak surveillance. The standard-of-care testing for involves culture-based methods with a long turnaround time. A rapid assay with higher throughput and quicker turnaround time can facilitate measures to minimize potential spread and prevent outbreaks within healthcare facilities. In the internal research study presented here, we evaluated a fully automated HTP assay for direct testing of nasal/axilla/groin swab samples on a commercially available platform and compared the results to an established NAAT assay.