Centre for Clinical Infection and Diagnostics Research, King's College London and Guy's and St Thomas' NHS Foundation Trust, Westminster Bridge Road, SE1 7EH, London, UK.
Cepheid Europe, Maurens-Scopont, France.
Infect Dis Ther. 2014 Dec;3(2):295-306. doi: 10.1007/s40121-014-0038-6. Epub 2014 Sep 10.
In the developed world, Clostridium difficile infection (CDI) is the most important cause of nosocomial infectious diarrhea. In addition to providing epidemiological data and helping to indicate that a local outbreak may be occurring, laboratory tests are used to augment clinical decisions on individual patients. Very rarely do diagnostic tests provide results at the point of decision making; in the intervening period between requesting investigations on a patient with suspected CDI and return of the laboratory result, decisions must be made regarding patient isolation and treatment.
A 22-month, real-world feasibility study was conducted in patients with clinically significant diarrhea, in a London Hospital between March 2011 and January 2013, in three older persons' wards and two intensive care units (ICUs) to determine acceptability, ease of use, change in turnaround time and clinical utility of a rapid, polymerase chain reaction (PCR)-based point-of-care test (POCT) (Cepheid GeneXpert(®), Sunnyvale, California, USA) for diagnosis of Clostridium difficile. Nurses in the older persons' ward and laboratory technicians in the ICU were trained to perform the test. Residual samples were sent to the centralized laboratory for parallel testing using a two-step algorithm.
A total of 335 samples were tested using the POCT with a median turnaround time of 1.85 h compared with 18 h for the centralized laboratory test. Overall agreement with centralized laboratory testing was 98.1%. Discrepant samples were more frequent on elderly wards than ICU. Overall 20/335 (6%) processing errors were encountered and were highest in the first few months of the study. Significantly more processing errors occurred on the older persons' wards 13/102 (12.7%) than on ICU 7/271 (2.6%). Older persons' patients who had POCT were significantly less likely to have a test requested for bacterial stool culture (3.1% vs. 10.9% p = 0.044). This difference was not observed in the ICU patients. No other differences in ancillary test requesting, mortality or length of stay were observed.
The majority of users reported that the POCT was easy to perform and was an acceptable part of their job. POCT using this system is feasible and acceptable to nursing staff and technicians working within these two hospital-based settings.
在发达国家，艰难梭菌感染（CDI）是最重要的医院获得性感染性腹泻病因。除了提供流行病学数据并有助于表明当地可能发生暴发外，实验室检测还可辅助临床医生对个体患者做出决策。诊断检测很少能在决策点提供结果；在对疑似 CDI 患者进行检查并等待实验室结果的期间，必须对患者的隔离和治疗做出决策。
2011 年 3 月至 2013 年 1 月，在伦敦的一家医院中，对三个老年人病房和两个重症监护病房（ICU）中的具有临床意义的腹泻患者进行了为期 22 个月的真实世界可行性研究，以确定一种快速、基于聚合酶链反应（PCR）的即时护理点检测（POCT）（Cepheid GeneXpert®，加利福尼亚州森尼韦尔，美国）用于诊断艰难梭菌的可接受性、易用性、周转时间变化和临床实用性。对老年人病房的护士和 ICU 的实验室技术人员进行了检测培训。将残留样本送到集中化实验室，使用两步算法进行平行检测。
共使用 POCT 检测了 335 个样本，中位数周转时间为 1.85 小时，而集中化实验室检测的周转时间为 18 小时。与集中化实验室检测的总符合率为 98.1%。在老年人病房发现的差异样本比 ICU 更频繁。研究的头几个月中，共发现 20/335（6%）处理错误，其中老年人病房的处理错误最高，共 13/102（12.7%），而 ICU 为 7/271（2.6%）。接受 POCT 检测的老年人患者进行细菌粪便培养的检测请求明显减少（3.1%对 10.9%，p=0.044）。在 ICU 患者中没有观察到这种差异。未观察到其他辅助检测请求、死亡率或住院时间的差异。
大多数用户报告 POCT 易于执行，并且是他们工作的可接受部分。在这两个基于医院的环境中，使用该系统的 POCT 是可行且可接受的，可被护理人员和技术人员使用。
