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一项需要跨国运输结膜腺病毒培养物并回收传染性病毒的抗病毒临床试验的可行性。

Feasibility of an antiviral clinical trial requiring cross-country shipment of conjunctival adenovirus cultures and recovery of infectious virus.

作者信息

Romanowski Eric G, Bartels Stephen P, Vogel Roger, Wetherall Neal T, Hodges-Savola Cheryl, Kowalski Regis P, Yates Kathleen A, Kinchington Paul R, Gordon Y Jerold

机构信息

Charles T. Campbell Ophthalmic Microbiology Laboratory, Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, USA.

出版信息

Curr Eye Res. 2004 Aug-Sep;29(2-3):195-9. doi: 10.1080/02713680490504830.

DOI:10.1080/02713680490504830
PMID:15512967
Abstract

PURPOSE

Accurate and timely laboratory diagnosis of adenovirus from conjunctival cultures is essential to ensure appropriate enrollment, and detection of residual infectious virus is essential to evaluate antiviral efficacy in any multicenter national clinical trial. As part of a feasibility study, we investigated those variables that might affect the successful recovery of infectious adenovirus from patient conjunctival cultures after cross-country shipment.

MATERIALS AND METHODS

Simulated adenovirus conjunctival cultures were prepared in viral transport media to evaluate the effect of four variables (adenovirus serotype, initial concentration, initial storage temperature [-20 degrees C, 0 degrees C, 20 degrees C], and preshipment storage times [1-5 days]) on the recovery of infectious adenovirus by a central laboratory in St. Paul, MN, following air shipment from Pittsburgh, PA. Upon arrival, the internal temperatures of the containers were recorded, and the samples were cultured on A549 cells using standard tube and/or shell vial culture.

RESULTS

Overall, adenovirus was recovered in 352/354 (99.4%) of the samples when the initial titer was greater than 1.0 PFU/ml. Adenovirus serotype, initial storage temperature, and preshipment storage times had no adverse effect on virus recovery.

CONCLUSIONS

Simulated conjunctival samples could successfully be shipped cross-country at ambient temperatures to a commercial laboratory for adenovirus isolation by culture. Having demonstrated feasibility, a clinical trial was subsequently carried out that confirmed the ease of shipment and recovery of infectious adenovirus from conjunctival cultures.

摘要

目的

从结膜培养物中准确及时地进行腺病毒实验室诊断对于确保合适的入组至关重要,而检测残留感染性病毒对于评估任何多中心全国性临床试验中的抗病毒疗效至关重要。作为一项可行性研究的一部分,我们调查了那些可能影响从患者结膜培养物中跨国运输后成功回收感染性腺病毒的变量。

材料与方法

在病毒运输培养基中制备模拟腺病毒结膜培养物,以评估四个变量(腺病毒血清型、初始浓度、初始储存温度[-20℃、0℃、20℃]和运输前储存时间[1 - 5天])对来自宾夕法尼亚州匹兹堡空运至明尼苏达州圣保罗的中央实验室回收感染性腺病毒的影响。到达后,记录容器的内部温度,并使用标准试管和/或空斑试验管培养法在A549细胞上培养样本。

结果

总体而言,当初始滴度大于1.0 PFU/ml时,352/354(99.4%)的样本中回收了腺病毒。腺病毒血清型、初始储存温度和运输前储存时间对病毒回收没有不利影响。

结论

模拟结膜样本可以在环境温度下成功跨国运输至商业实验室,通过培养进行腺病毒分离。证明可行性后,随后进行了一项临床试验,证实了从结膜培养物中运输和回收感染性腺病毒的简便性。

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