The FDA has authorized a new diagnostic test based on bacteriophage technology to detect methicillin-resistant Staphylococcus aureus (MRSA) colonization more quickly than traditional culture-based techniques allow.

“Diagnostics that are able to provide accurate results more quickly can offer health care providers an advantage when trying to prevent and contain the spread of resistant bacteria,” Tim Stenzel, MD, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. The US Centers for Disease Control and Prevention (CDC) has estimated that 323 700 hospitalizations and 10 600 deaths resulted from the drug-resistant bacterium in 2017.

The cobas vivoDx MRSA assay is used with an automated processing system to detect MRSA cells in nasal swab samples from patients who are at risk of nasal colonization. The technology uses bioparticles that bind to MRSA bacteria and insert custom-made DNA, which directs the expression of a bioluminescent enzyme. Live bacteria will then produce light that shows they’re present and viable. Detection can take as little as 5 hours, compared with 24 to 48 hours for conventional cultures. Faster identification of the microbe can help prevent MRSA from spreading.

FDA已批准一项基于噬菌体技术的新诊断测试，以比传统的基于培养的技术所允许的速度更快地检测耐甲氧西林的金黄色葡萄球菌（MRSA）定植。

FDA体外诊断与放射健康办公室主任Tim Stenzel，医学博士，“能够更快地提供准确结果的诊断可以为医疗保健提供者在试图预防和遏制耐药细菌扩散时提供优势” ，在一份声明中说。美国疾病控制与预防中心（CDC）估计，2017年该耐药菌导致323700例住院治疗和10600例死亡。

cobas vivoDx MRSA分析与自动处理系统一起使用，可检测来自有鼻殖民化风险的患者的鼻拭子样本中的MRSA细胞。该技术使用与MRSA细菌结合并插入定制DNA的生物颗粒，该DNA指导生物发光酶的表达。活细菌然后会发出光，表明它们的存在和存活。检测时间可短至5个小时，而传统培养需要24到48个小时。更快地鉴定微生物可以帮助防止MRSA传播。