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Trends in surveillance indicators for central-catheter-associated bloodstream infections in a tertiary hospital in Switzerland 瑞士一家三级医院中心导管相关血流感染监测指标的变化趋势。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-10 DOI: 10.1016/j.jhin.2024.09.019
T. Obenhuber , M. Pfister , C. Reiber , M. Dunic , C. Falk , W. Zingg , P.W. Schreiber

Background

Central line-associated bloodstream infections (CLABSIs) are associated with relevant morbidity and mortality. Longitudinal dynamics in CLABSI incidence and the spectrum of causative microorganisms are limited.

Aim

To describe trends in CLABSI incidence, use of central lines, and causative pathogens.

Methods

We analysed prospectively collected data on CLABSI at a Swiss tertiary care hospital between January 2016 and December 2023. We investigated longitudinal changes of incidence densities, catheter utilization and causative pathogens.

Findings

A total of 707 CLABSIs were observed, corresponding to an incidence density of 1.69 (95% confidence interval 1.56–1.81) CLABSIs per 1000 catheter-days. There was no significant trend of CLABSI incidence density per 1000 catheter-days (z = 0.86, P=0.391), but an increase of catheter utilization ratio (z = 8.88, P<0.001). Coagulase-negative staphylococci (N = 207, 23.4%) and Enterococcus spp. (N = 134, 15.2%; E. faecium N = 94, 10.6%; E. faecalis N = 37, 4.1%; other Enterococcus spp. N = 3, 0.34%) were the most frequent causative pathogens. Over the years, the proportion of Enterococcus spp. (z = 3.4, P<0.001), driven by an increase of E. faecium (z = 3.2, P=0.001), and yeast (z = 2.3, P=0.020) increased, whereas coagulase-negative staphylococci decreased (z = -6.1, P<0.001).

Conclusions

Prospective CLABSI surveillance indicated stable incidence densities per 1000 catheter-days, but there were significant shifts of causative microorganisms over time.
背景:中心静脉相关性血流感染(CLABSI)与相关的发病率和死亡率有关。CLABSI发病率和致病微生物谱的纵向动态变化十分有限:我们旨在描述 CLABSI 发病率、中心静脉置管的使用和致病病原体的变化趋势:我们分析了一家瑞士三级医院在 2016 年 1 月至 2023 年 12 月期间前瞻性收集的 CLABSI 数据。我们调查了发病密度、导管使用和致病病原体的纵向变化:结果:共观察到 707 例 CLABSI,发病密度为每 1000 个导管日 1.69(95% CI 1.56 - 1.81)例 CLABSI。每1000导管日CLABSI发病密度无明显趋势(z=0.86,P=0.391),但导管使用率有所上升(z=8.88,PConclusions:前瞻性 CLABSI 监测表明,每 1000 个导管日的发病密度保持稳定,但致病微生物随时间发生了显著变化。
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引用次数: 0
Counselling sessions for patients in contact isolation due to multi-drug-resistant organisms improve informedness and reduce dissatisfaction 为因感染 MDROs 而被隔离的患者提供咨询课程,提高他们的知情程度,减少他们的不满情绪。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-10 DOI: 10.1016/j.jhin.2024.09.022
V. Gillitzer , A. Rath , A. Caplunik-Pratsch , S. Däumling , W. Schneider-Brachert , S. Gaube

Background

The spread of multi-drug-resistant organisms (MDROs) is a critical health issue. Isolation measures imposed to prevent transmission may result in adverse psychological effects among affected patients. This emphasizes the need for better communication and information to improve their hospital experience and mental well-being as well as to prevent inadequate treatment.

Aim

The present study examined whether tailored counselling sessions during contact isolation could enhance patients' understanding of their situation concerning the significance of their MDRO status and enhance their well-being.

Methods

A pre-post-intervention study was conducted in a German tertiary-care hospital in which N = 64 patients who were isolated due to MDROs received tailored counselling. The counselling included information about MDROs, the reason for hospital isolation measures, and appropriate behaviour during and after hospitalization. Participants completed questionnaires before and after the counselling sessions to assess its impact on their informedness, patient (dis)satisfaction and well-being measures.

Findings

Prior to the counselling session, patient dissatisfaction was associated with anxiety and inadequate informedness about MDROs. After the counselling, patients reported a significantly improved comprehension of their MDROs-related situation and a notable decrease in dissatisfaction with their hospital situation, primarily attributed to the acquired information.

Conclusions

This is the first German study to show how improved information about MDROs impacts patient satisfaction in hospitals. The findings stress the crucial need for improving healthcare workers' interaction and communication with patients affected by MDROs.
背景:耐多药生物(MDROs)的传播是一个严重的健康问题。为防止传播而采取的隔离措施可能会对受影响的患者造成不良的心理影响。目的:本研究探讨了在接触隔离期间进行有针对性的辅导是否能提高患者对其 MDRO 感染情况重要性的认识,并改善他们的心理状况:方法:在德国一家三级医院开展了一项干预前-干预后研究,对 N = 64 名因感染 MDRO 而被隔离的患者进行了量身定制的咨询。咨询内容包括有关 MDROs 的信息、采取医院隔离措施的原因以及住院期间和住院后的适当行为。参加者在咨询前后填写了调查问卷,以评估咨询对其知情度、患者(不)满意度和幸福感的影响:咨询前,患者的不满意与焦虑和对 MDROs 的知情度不足有关。咨询结束后,患者对 MDROs 相关情况的理解能力明显提高,对医院状况的不满意度明显降低,这主要归功于获得的信息:这是德国的第一项研究,显示了改进有关 MDROs 的信息如何影响患者对医院的满意度。研究结果强调了改善医护人员与受 MDROs 影响的患者之间的互动和沟通的重要性。
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引用次数: 0
Risk factors for non-isolation of patients admitted for pulmonary tuberculosis in a high-incidence department: a single-centre retrospective study 一个高发省份肺结核住院病人未隔离的风险因素:一项单中心回顾性研究。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-10 DOI: 10.1016/j.jhin.2024.09.020
S. Oubbéa , B. Pilmis , D. Seytre , A. Lomont , T. Billard-Pomares , J-R. Zahar , L. Foucault-Fruchard

Background

Pulmonary tuberculosis (PTB) is an airborne disease, warranting the identification of suspected cases on admission, and their hospitalization in individual rooms with the implementation of airborne supplementary precautions (ASPs).

Aim

To identify the frequency of non-isolated PTB and the factors associated with the delay in implementing ASPs in a high-prevalence hospital.

Methods

This retrospective observational study included patients with at least one Mycobacterium tuberculosis-positive specimen. Patient demographic and clinical data, as well as data related to the mode of admission, were collected. Univariate and multi-variate statistical analyses were performed.

Findings

During the study period, 256 patients were included. Among them, 134 (52.3%) had PTB (75% males, median age 39 years, 70% foreign-born). Among these patients, 46 (34%) were isolated beyond 24 h of admission. The average time to implement ASPs was 4.3 days, and seven patients (5.2%) were not isolated throughout their hospital stay. Multi-variate analysis indicated that three factors were associated with isolation. Previous consultation with a general practitioner was associated with greater likelihood of isolation, whereas admission through the emergency department was not. The presence of so-called ‘cardinal clinical signs’ and a suggestive chest x-ray were also associated with greater likelihood of isolation. Finally, European patients were isolated less frequently than foreign-born patients.

Conclusion

In this study, 34% of patients admitted with PTB were not isolated on admission. The likelihood of non-isolation was three times higher in cases admitted via the emergency department, and European patients were isolated less frequently than foreign-born patients. The presence of cardinal signs and prior consultation with a general practitioner were associated with greater likelihood of isolation.
肺结核(PT)是一种通过空气传播的疾病,因此有理由在可疑患者入院时对其进行识别,并在其住院期间在单人病房实施空气传播补充预防措施(ASP)。本研究的目的是在一家高发病率医院中确定非隔离型肺结核的发病率以及与延迟实施 ASP 相关的因素。这是一项回顾性观察研究,研究对象包括至少有一份结核分枝杆菌阳性标本的患者。研究收集了患者的人口统计学和临床数据,以及与入院方式相关的数据。进行了单变量和多变量统计分析。在研究期间,共纳入了 256 名患者。其中 134 人(52.3%)患有 PT。其中包括 100 名(75%)男性,中位年龄为 39 岁,70% 在国外出生。在这些患者中,有 46 人(34%)在入院 24 小时后仍被隔离。实施 ASP 的平均时间为 4.3 天,有 7 名患者(5.2%)在整个住院期间未被隔离。通过多变量分析,有三类因素与隔离有关。曾向全科医生就诊具有保护作用,而通过急诊科入院则不具有保护作用。存在所谓的主要临床症状和胸部 X 光片提示也是保护因素。最后,欧洲病人较少被隔离。在我们的研究中,34% 的 PT 患者在入院时未被隔离。经急诊科入院的患者未被隔离的风险是经急诊科入院的患者的三倍,而欧裔患者的隔离率较低。出现主要体征和事先咨询全科医生与较高的隔离频率有关。
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引用次数: 0
Impact of duodenoscope reprocessing factors on duodenoscope contamination: a retrospective observational study 十二指肠镜再处理因素对十二指肠镜污染的影响:回顾性观察研究
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-09 DOI: 10.1016/j.jhin.2024.09.018
K. van der Ploeg , M.C. Vos , N.S. Erler , A.J.C. Bulkmans , B.C.G.C. Mason-Slingerland , J.A. Severin , M.J. Bruno

Background

Despite adherence to reprocessing protocols, duodenoscopes frequently remain contaminated, highlighting significant knowledge gaps in reprocessing efficiency.

Aim

To identify risk factors in duodenoscope reprocessing procedures affecting contamination rates.

Methods

Cultures from Pentax ED34-i10T2 duodenoscopes collected between February 2022 and December 2023 were included. Contamination was determined by the presence of micro-organisms of gut or oral origin (MGO). Data on duodenoscope use, reprocessing lead times and personnel were retrieved from electronic medical records. Risk factors were derived from reprocessing guidelines and literature. These included a delay >30 min in initiating manual cleaning, manual cleaning duration of ≤5 min, drying time <90 min, personnel reprocessing frequency, and storage exceeding seven days. A logistic mixed-effects model evaluated these factors' impact on duodenoscope contamination.

Findings

Out of 307 duodenoscope cultures, 58 (18.9%) were contaminated with MGO. Throughout the study period, the duodenoscopes underwent 1296 reprocessing cycles. Manual cleaning times of ≤5 min significantly increased contamination odds (adjusted odds ratio (aOR): 1.61; 95% confidence interval (CI): 1.10–2.34; P = 0.01). Increased usage of a duodenoscope was associated with reduced odds of contamination (aOR: 0.80; 95% CI: 0.64–0.995; P = 0.045). Other studied risks showed no clear association with contamination rates.

Conclusion

Manual cleaning times of ≤5 min increased the odds of contamination with MGO. Delays in reprocessing initiation and incomplete drying, traditionally considered as risk factors, were not associated with an increased risk of contamination in this study. Future research should explore whether enhanced surveillance of reprocessing times can mitigate duodenoscope contamination.
背景:目的:本研究旨在确定影响十二指肠镜污染率的十二指肠镜再处理程序中的风险因素:我们纳入了 2022 年 2 月至 2023 年 12 月期间收集的宾得 ED34-i10T2 十二指肠镜培养物。污染根据是否存在肠道或口腔微生物 (MGO) 来确定。有关十二指肠镜的使用、再处理周期和人员的数据均来自电子病历。风险因素来自再处理指南和文献。这些因素包括手动清洗延迟时间超过 30 分钟、手动清洗持续时间为 5 分钟或更短、干燥时间少于 90 分钟、人员再处理频率以及储存时间超过 7 天。一个逻辑混合效应模型评估了这些因素对十二指肠镜污染的影响:在 307 份十二指肠镜培养物中,58 份(18.9%)受到 MGO 污染。在整个研究期间,十二指肠镜经历了 1296 个再处理周期。手动清洁时间为五分钟或更短会显著增加污染几率(aOR = 1.61,95%CI:1.10-2.34,p=0.01)。有趣的是,十二指肠镜使用次数的增加与污染几率的降低有关(aOR= 0.80,95%CI:0.64-0.995,p=0.045)。其他研究风险与污染率无明显关联:结论:手动清洁时间在五分钟以内会增加MGO的污染几率。在本研究中,传统上被视为风险因素的再处理启动延迟和未完全干燥与污染风险增加无关。未来的研究应探讨加强对再处理时间的监控是否能减轻十二指肠镜污染。
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引用次数: 0
Chlorine in cleaning – are we concentrating enough? 清洁中的氯--我们的浓度够吗?
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-05 DOI: 10.1016/j.jhin.2024.09.015
M.I. Garvey , F. Offorbuzor , M.A.C. Wilkinson , M. Kiernan , E. Holden
{"title":"Chlorine in cleaning – are we concentrating enough?","authors":"M.I. Garvey ,&nbsp;F. Offorbuzor ,&nbsp;M.A.C. Wilkinson ,&nbsp;M. Kiernan ,&nbsp;E. Holden","doi":"10.1016/j.jhin.2024.09.015","DOIUrl":"10.1016/j.jhin.2024.09.015","url":null,"abstract":"","PeriodicalId":54806,"journal":{"name":"Journal of Hospital Infection","volume":"155 ","pages":"Pages 37-39"},"PeriodicalIF":3.9,"publicationDate":"2024-10-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142382401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Hospitalized patients on proton pump inhibitors for stress ulcer prophylaxis have a higher risk of Clostridioides difficile infection compared with those on histamine-2 receptor antagonists 与服用组胺-2 受体拮抗剂的患者相比,服用质子泵抑制剂预防应激性溃疡的住院患者感染艰难梭菌的风险更高。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-05 DOI: 10.1016/j.jhin.2024.09.016
L-H. Wu , J-L. Wang , Y-H. Liu , C-C. Su , Y-H.K. Yang , S-J. Lin , C-L. Cheng

Background

Previous studies on Clostridioides difficile infection (CDI) in proton pump inhibitor (PPI) users generally enrolled a heterogeneous population and did not include a control group of histamine H2 receptor antagonists (H2RAs) users or adjust for confounding variables, such as previous antibiotics. It is uncertain whether hospitalized patients using PPIs for stress ulcer prophylaxis (SUP) are at a higher risk of CDI compared with those using H2RAs. This study aimed to compare the association between CDI and the usage of antisecretory drugs (ASDs): PPIs and H2RAs, for SUP among hospitalized patients, and the impact of the duration of their use on CDI.

Methods

In this nationwide population-based cohort study using the Taiwan National Health Insurance Database, hospitalized patients using ASDs for SUP were identified between 2017 and 2018. A total of 63,266 and 69,269 individuals were included in the PPI and H2RA groups, respectively. The primary endpoint was a 90-day monitoring of CDI occurrence.

Findings

The incidences of CDI were 1.6/10,000 and 0.5/10,000 person-days in the PPIs and H2RAs groups, respectively. After adjusting for confounding factors, the risk of infection in the PPIs group remained significantly higher than in the H2RAs group (hazard ratio (HR), 2.49; 95% confidence interval (CI), 1.63–3.81). In the subgroup analysis, during hospitalization, the risk of CDI for patients using high-risk antibiotics or admitted to the intensive care unit (ICU), as well as patients with immunodeficiency, using PPIs for SUP, was higher than using H2RAs. Furthermore, the risk of CDI was higher in patients using ASDs for durations >14 days than in those using them for <7 days (adjusted HR, 3.66; 95% CI, 2.34–5.75).

Conclusions

The risk of occurrence CDI for hospitalized patients using PPIs for SUP was higher than using H2RAs. It is recommended not to exceed 14 days of any gastric ASDs for SUP during hospitalization, especially for patients who have used high-risk antibiotics, have been admitted to the ICU, or have immunodeficiency.
背景:以往关于质子泵抑制剂(PPIs)使用者艰难梭菌感染(CDI)的研究一般都是在不同人群中进行的,并没有包括组胺 H2 受体拮抗剂(H2RAs)使用者对照组,也没有对既往使用过抗生素等混杂变量进行调整。与使用 H2RAs 的患者相比,使用 PPIs 预防应激性溃疡(SUP)的住院患者是否具有更高的 CDI 风险尚不确定。本研究旨在比较 CDI 与抗分泌药物 (ASD) 使用之间的关系:方法:在这项基于人口的全国性队列研究中,使用了台湾国民健康保险数据库,确定了 2017-2018 年间使用 ASDs 进行 SUP 的住院患者。PPI组和H2RA组分别纳入了63266人和69269人。主要终点是90天的CDI发生率监测:PPIs组和H2RAs组的CDI发病率分别为1-6/10,000人天和0-5/10,000人天。调整混杂因素后,PPIs 组的感染风险仍显著高于 H2RAs 组(危险比 [HR],2-49;95% 置信区间 [CI],1-63-3-81)。在亚组分析中,在住院期间,使用高风险抗生素或入住重症监护室(ICU)的患者以及免疫缺陷患者使用 PPIs SUP 的 CDI 风险高于使用 H2RAs 的患者。此外,使用ASDs时间大于14天的患者发生CDI的风险高于使用ASDs时间小于7天的患者(调整后HR,3-66;95% CI,2-34-5-75):结论:使用 PPIs 治疗 SUP 的住院患者发生 CDI 的风险高于使用 H2RAs 的患者。建议住院期间使用任何胃药ASD治疗SUP的时间不要超过14天,尤其是使用过高风险抗生素、住过重症监护室或有免疫缺陷的患者。
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引用次数: 0
A nosocomial outbreak of Crimean–Congo haemorrhagic fever in a tertiary-care centre in Pakistan 巴基斯坦一家三级医疗中心爆发克里米亚-刚果出血热疫情。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-05 DOI: 10.1016/j.jhin.2024.09.014
S. Hanif, I. Khanum, S. Shariq, A. Fareed, A. Hafeez, M. Fatima, M. Azhar, N. Nasir
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引用次数: 0
Efficacy of air cleaning units for preventing SARS-CoV-2 and other hospital-acquired infections on medicine for older people wards: a quasi-experimental controlled before-and-after study 空气净化装置对预防老年人病房 SARS-CoV-2 和其他医院获得性感染的功效:一项前后对照的准实验研究。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-05 DOI: 10.1016/j.jhin.2024.09.017
R.C. Brock , R.J.B. Goudie , C. Peters , R. Thaxter , T. Gouliouris , C.J.R. Illingworth , A. Conway Morris , C.B. Beggs , M. Butler , V.L. Keevil

Background

Nosocomial infections are costly, and airborne transmission is increasingly recognized as important for spread. Air cleaning units (ACUs) may reduce transmission, but little research has focused on their effectiveness on open wards.

Aim

To assess whether ACUs reduce nosocomial severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), or other, infections on older adult inpatient wards.

Methods

This was a quasi-experimental before-and-after study on two intervention–control ward pairs in a UK teaching hospital. Infections were identified using routinely collected electronic health record data during 1 year of ACU implementation and the preceding year (‘core study period’). Extended analyses included 6 months of additional data from one ward pair following ACU removal. Hazard ratios (HRs) were estimated through Cox regression controlling for age, sex, ward and background infection risk. The time that the ACUs were switched on was also recorded for Intervention Ward 2.

Findings

ACUs were initially feasible, but compliance reduced towards the end of the study (average operation in first vs second half of ACU time on Intervention Ward 2: 77% vs 53%). In total, 8171 admissions for >48 h (6112 patients, median age 85 years) were included. Overall, the incidence of ward-acquired SARS-CoV-2 was 3.8%. ACU implementation was associated with a non-significant trend of lower hazard for SARS-CoV-2 infection [HR core study period 0.90, 95% confidence interval (CI) 0.53–1.52; HR extended study period 0.78, 95% CI 0.53–1.14]. Only 1.5% of admissions resulted in other notable ward-acquired infections.

Conclusion

ACUs may reduce SARS-CoV-2 infection to a clinically meaningfully degree. Larger studies could reduce uncertainty, perhaps using a crossover design, and factors influencing acceptability to staff and patients should be explored further.
背景:非医院感染的成本很高,而空气传播越来越被认为是传播的重要因素。空气净化装置(ACU)可以减少传播,但很少有研究关注其在开放式病房中的效果。目的:评估空气净化装置是否可以减少老年人住院病房中的非典型肺炎-CoV-2 或其他感染:方法:对英国一家教学医院的两对干预-对照病房进行前后对比的准实验研究。在实施 ACU 的一年和前一年("核心研究期"),通过常规收集的电子健康记录数据确定感染情况。扩展分析包括取消 ACU 后一对病房 6 个月的额外数据。通过控制年龄、性别、病房和背景感染风险的 Cox 回归估算出危险比 (HR)。干预病房2.的研究结果也记录了ACU的开启时间:研究结果:ACU 最初是可行的,但在研究结束时,依从性有所下降(干预病房 2 ACU 上半年与下半年的平均手术率分别为 77% 与 53%)。研究纳入了 8171 名住院时间超过 48 小时的患者(6112 名患者,中位年龄为 85 岁)。总体而言,病房获得性 SARS-CoV-2 的发病率为 3.8%。实施 ACU 后,SARS-CoV-2 感染的风险呈下降趋势,但并不显著(核心研究期间的 HR 为 0.90,95% CI 为 0.53,1.52;扩展研究期间的 HR 为 0.78,95% CI 为 0.53,1.14)。只有1.5%的入院患者发生了其他明显的病房感染:ACU可在一定程度上减少SARS-CoV-2感染。更大规模的研究可以减少不确定性,也许可以采用交叉设计,同时应进一步探讨影响员工和患者接受程度的因素。
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引用次数: 0
The characteristics of postgraduate antimicrobial stewardship education resources: a nationwide survey in Japan 研究生抗菌药物管理教育资源的特点:日本全国调查。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-10-03 DOI: 10.1016/j.jhin.2024.09.012
T. Miwa , K. Okamoto , Y. Nishizaki , Y. Tokuda
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引用次数: 0
PMCA to demonstrate the efficacy of prion inactivation methods on reusable medical devices: a relevant alternative to animal bioassays PMCA 用于证明可重复使用医疗器械上朊病毒灭活方法的有效性:动物生物测定的相关替代方法。
IF 3.9 3区 医学 Q1 INFECTIOUS DISEASES Pub Date : 2024-09-30 DOI: 10.1016/j.jhin.2024.07.020
A. Igel , M. Moudjou , P. Destrez , P. Clayette , V. Béringue
Validation of prion inactivation processes for medical devices relies on in-vivo experimental protocols. However, bioassays are costly, long (1–2 years) and ethically disputable. Additionally, results obtained with one prion strain – for example, 263K (hamster-adapted strain originating from sheep scrapie) – cannot be easily extrapolated to relevant human prion strains, further questioning the utility of bioassays. Over the past two decades, cell-free prion amplification assays have emerged as potential alternatives to bioassays. Rather than measuring prion infectivity, they quantify prion seeding activity (i.e. the capacity to convert the normal prion protein into the disease-associated isoform). The results obtained from an optimized cell-free assay termed ‘miniaturized-bead protein misfolding cyclic amplification’ (mb-PMCA) with four processes using three different prion strains – 263K and two human prions derived from variant and sporadic Creutzfeldt–Jakob disease – were compared with published bioassays using the same three strains and processes, when available. Tests performed on reference processes (steam, sodium hydroxide, sodium hypochlorite) and low temperature H2O2 sterilization (STERRAD NXTM Advanced cycle) showed perfect alignment between mb-PMCA and available bioassays. STERRAD NXTM Advanced cycle was efficacious against all three prion strains. These data confirm that PMCA, particularly mb-PMCA, is a relevant alternative to animal bioassays for the assessment of prion inactivation processes, and highlight the interest of some low temperature H2O2 sterilization cycles.
医疗器械朊病毒灭活工艺的验证依赖于体内实验方案。然而,生物测定成本高、时间长(一至两年),而且在伦理方面存在争议。此外,用一种朊病毒菌株(例如 263K(源自绵羊瘙痒症的仓鼠适应菌株))获得的结果不能轻易推断到相关的人类朊病毒菌株,这进一步质疑了生物测定的实用性。在过去二十年中,无细胞朊病毒扩增测定法作为生物测定的潜在替代方法应运而生。它们不是测量朊病毒的感染性,而是量化朊病毒的播种活性,即把正常朊病毒蛋白转化为疾病相关异构体的能力。通过使用三种不同的朊病毒菌株(263K 和两种来自变异型克雅氏病和散发性克雅氏病的人类朊病毒),采用四种工艺进行了称为微型化珠蛋白错构酶循环扩增(mb-PMCA)的优化无细胞检测,并将其结果与已发表的使用相同的三种菌株和工艺(如有)进行的生物检测结果进行了比较。在参考工艺(蒸汽、氢氧化钠、次氯酸钠)和低温 H2O2 灭菌工艺(STERRAD NXTM 高级循环)上进行的测试表明,mb-PMCA 与现有的生物测定完全一致。STERRAD NXTM 高级循环对所有三种朊病毒菌株都有效。这些数据证实,PMCA,尤其是mb-PMCA,可以替代动物生物测定法来评估朊病毒灭活过程和某些低温 H2O2 灭菌循环的有效性。
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引用次数: 0
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Journal of Hospital Infection
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