Alexander Jeffrey, Martins-Sorenson Natacha, Moghaddasi Arrash, Hill Andrew T, Harris Jody, McCune Stephen, Gick Erin, Zhu YanChun, Chaturvedi Sudha, Lewinski Michael, Cady Kyle C
Roche Molecular Systems, Pleasanton, California, USA.
Roche Molecular Systems, Santa Clara, California, USA.
Microbiol Spectr. 2025 Jul;13(7):e0025425. doi: 10.1128/spectrum.00254-25. Epub 2025 May 16.
(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.
（原名为 ）是一种新出现的全球真菌病原体，与难以治疗的医院感染有关。对患者进行定植筛查是追踪和预防由 引起的医院传播和暴发的推荐策略。为便于开展此项工作，一种周转时间短且人工操作最少的高通量（HTP）检测方法具有重要价值。在此，我们展示了正在进行的关于使用HTP cobas 5800/6800/8800系列系统直接检测鼻/腋窝/腹股沟拭子样本中的 的研究，该系列系统能够在8小时轮班内处理多达1056个样本。基于对200份监测拭子样本的检测，与既定的核酸扩增检测（NAAT）（BD MAX开放式系统检测）相比，cobas实用通道（UC）检测显示出94%的准确率、91%的阳性百分比一致性和98%的阴性百分比一致性。在对200个样本中的159个进行的二次分析中，将该检测与标准护理培养结果进行比较，观察到准确率为95%、灵敏度为92%、特异性为90%。基于湿实验室检测，cobas UC检测对I - V进化枝具有包容性，对其他15种密切相关的真菌物种具有排他性。所呈现的数据源自为研究目的而内部开展的研究。cobas UC检测未被批准用于 诊断。重要性 是一种新出现的多重耐药真菌病原体，被视为全球公共卫生威胁。对 的快速检测和鉴定对于医院感染预防与控制以及暴发监测至关重要。 的标准护理检测涉及基于培养的方法，周转时间长。一种具有更高通量和更快周转时间的快速检测方法有助于采取措施将医疗保健机构内的潜在传播降至最低并预防暴发。在此呈现的内部研究中，我们评估了一种用于在商用平台上直接检测鼻/腋窝/腹股沟拭子样本的全自动HTP 检测方法，并将结果与既定的NAAT检测进行比较。
