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临床试验/NCT06720519
NCT06720519已完成不适用

Multiparametric Molecular Panel Evaluation "QIAstatDxMeningitis/Encephalitis" for Diagnosis of Infections of the Central Nervosous System

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2024年4月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
170
试验地点
1
主要终点
The analytical sensitivity of the multiparameter panel

研究概览

简要总结

Infections involving the central nervous system (CNS), such as meningitis/encephalitis (ME), are serious clinical conditions associated with high morbidity and mortality rates, as well as significant long-term consequences. ME can be caused by a wide variety of pathogenic agents. Clinical symptoms may vary and it has been shown that early identification of the pathogens causing ME allows for timely and appropriate treatment, thus reducing permanent neurological damage. The multiparameter panel "QIAstat-Dx®Meningitis/Encephalitis" can detect in one hour on a sample of 15 bacterial, viral and fungal pathogens. In the diagnostic routine, Real-time PCR takes an average of 3 hours and culture examination 2 days. In addition, compared to other comparable rapid molecular systems, the "QIAstat-Dx" platform has the ability to generate a cycle-related threshold value (Ct) for the targets detected. This value may have a correlation with the viral load and thus provide in a short time not only the result of positivity, but also an indication of the amount of virus present. Other commercially available multiparameter molecular tests provide only qualitative data.

详细描述

The study is on biological samples of cerebrospinal fluid, positive for viruses or bacteria of interest, retrospective, monocentric, non-pharmacological.

For each sample included in the study (170 total samples), the molecular/culture test result, provided by the normal diagnostic process at the Microbiology Unit, is available for comparison with those obtained with the multiparameter panel QIAstat-Dx® Meningitis/Encephalitis (ME) and QIAstat-Dx 1.0 analyzer.

The aim of the study is:

  1. To evaluate the analytical sensitivity of the test by identifying positive samples for bacteria (culture comparison) and positive samples for viruses (qPCR comparison).
  2. Compare the value of Ct obtained with the number of viral copies per ml of cerebrospinal fluid obtained by qPCR.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 170 samples of CSF positive for virus and/or bacteria;
  • Samples stored at -80°C, less than 5 years;
  • Samples with a volume of at least 800μL.

排除标准

  • Samples of a different matrix than CSF;
  • Samples stored at room temperature;
  • Samples for which diagnostic test results are not available;
  • Samples with a volume of less than 800μL;
  • Samples already thawed and refrozen.

结局指标

主要结局

The analytical sensitivity of the multiparameter panel

时间窗: 6 months

The analytical sensitivity of the test is assessed by comparing the results obtained with those known from routine diagnostic tests.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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