AdvanDx Inc., Woburn, Massachusetts, USA.
J Clin Microbiol. 2012 Jun;50(6):1994-8. doi: 10.1128/JCM.00225-12. Epub 2012 Apr 4.
A novel rapid peptide nucleic acid fluorescence in situ hybridization (FISH) method, Staphylococcus QuickFISH, for the direct detection of Staphylococcus species from positive blood culture bottles was evaluated in a multicenter clinical study. The method utilizes a microscope slide with predeposited positive- and negative-control organisms and a self-reporting 15-min hybridization step, which eliminates the need for a wash step. Five clinical laboratories tested 722 positive blood culture bottles containing gram-positive cocci in clusters. The sensitivities for detection of Staphylococcus aureus and coagulase-negative staphylococci (CoNS) were 99.5% (217/218) and 98.8% (487/493), respectively, and the combined specificity of the assay was 89.5% (17/19). The combined positive and negative predictive values of the assay were 99.7% (696/698) and 70.8% (17/24), respectively. Studies were also performed on spiked cultures to establish the specificity and performance sensitivity of the method. Staphylococcus QuickFISH has a turnaround time (TAT) of <30 min and a hands-on time (HOT) of <5 min. The ease and speed of the method have the potential to improve the accuracy of therapeutic intervention by providing S. aureus/CoNS identification simultaneously with Gram stain results.
一种新型的快速肽核酸荧光原位杂交（FISH）方法，Staphylococcus QuickFISH，用于直接检测阳性血培养瓶中的葡萄球菌属，在一项多中心临床研究中进行了评估。该方法利用载玻片预存阳性和阴性对照物，以及 15 分钟的自我报告杂交步骤，无需洗涤步骤。五个临床实验室测试了 722 个含有革兰阳性球菌的阳性血培养瓶。检测金黄色葡萄球菌和凝固酶阴性葡萄球菌（CoNS）的敏感性分别为 99.5%（217/218）和 98.8%（487/493），该检测的综合特异性为 89.5%（17/19）。该检测的阳性和阴性预测值分别为 99.7%（696/698）和 70.8%（17/24）。还对污染培养物进行了研究，以确定该方法的特异性和性能敏感性。Staphylococcus QuickFISH 的周转时间（TAT）<30 分钟，实际操作时间（HOT）<5 分钟。该方法的简便性和速度有可能通过同时提供革兰氏染色结果来提高治疗干预的准确性，从而鉴定金黄色葡萄球菌/凝固酶阴性葡萄球菌。
