Prospective Multi-Center Study for Clinical Validation of the Molecular-Based GenePOC CDiff System for the Detection of Toxin B Gene From Toxigenic Clostridium Difficile Strains in Unformed (Soft or Liquid) Human Stool Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,461
- 试验地点
- 7
- 主要终点
- Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
研究概览
简要总结
The primary purpose of this clinical investigation is to verify the performance of the GenePOC CDiff test on the GenePOC instrument. This will be achieved by comparing the GenePOC CDiff test to the Toxigenic Culture (TC) and cell cytotoxicity neutralisation assay (CCNA), a conventional method considered as gold standard for detection of toxigenic Clostridium difficile in stool specimens.
详细描述
The GenePOC CDiff test performed on the GenePOC™ instrument is a qualitative in vitro diagnostic (IVD) test that utilizes automated sample preparation and real-time polymerase chain reaction (rtPCR) to detect the toxin B (tcdB) gene of toxigenic Clostridium difficile (C. difficile) in unformed (liquid or soft) stool specimens obtained from patients suspected of having C. difficile infection (CDI).
The GenePOC CDiff system comprises the GenePOC instrument and the GenePOC CDiff test, which consists of:
- Transfer Loop (TL)
- CDiff disposable microfluidic cartridges (PIE) (described in this document as PIEs because of the shape of the cartridge)
- CDiff Sample Buffer Tube (SBT)
- Disposable Transfer Tool (DTT).
The GenePOC Instrument is fully automated and integrates sample lysis, dilution, amplification and detection of the target sequence in complex samples using real-time Polymerase chain reaction (rtPCR). User intervention is only required for discharging the patient sample into the SBT (sample Buffer Tube), transferring the sample into the PIE and for loading/unloading the PIEs into the instrument. The GenePOC instrument consists of a rotor to spin the PIEs, temperature control, fluorescence detection, a tactile user-friendly interface, two barcode readers, and integrated firmware and software to deliver results to the user. The PIE is a closed system that prevents the risk of contamination.
An unformed (soft or liquid) stool specimen is collected using standard stool collection device. Using a disposable 5µL inoculating loop (transfer loop) dipped into the homogenized stool specimen, stool material is transferred into SBT and vortexed. Sample is then transferred to the GenePOC CDiff PIE. The GenePOC CDiff PIE is then automatically processed by the GenePOC Instrument. On completion of a run, the user removes the processed PIEs from the instrument and discards them according to local biological waste management procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unformed Stool specimens from patients suspected of having CDI for whom diagnostic tests are indicated and ordered;
- •At least 1.25mL of unformed stool specimen (defined as specimen assuming the shape of its container);
- •Only one (1) specimen per patient will be included in the study;
- •Materials use within their expiration date;
- •Transport, storage times, and conditions (e.g. room temperature and/or refrigerated) within requested indications.
排除标准
- •Specimens from patients for whom CDI diagnostic tests have not been ordered;
- •Transport and storage times and conditions that exceed these Study Protocol requirements;
- •Formed or hard stool specimens or rectal swabs.
研究组 & 干预措施
Accuracy Testing
Comparison between GenePOC PCR and Reference Method
干预措施: Comparison between GenePOC PCR and Reference Method (Device)
结局指标
主要结局
Performance Characteristics : Clinical Sensitivity (True Positive Rate) and Clinical Specificity (True Negative Rate) in Comparison to the Reference Method
时间窗: At the time of the results with Reference Method is confirmed, up to 3 months
To establish the performance characteristics of the GenePOC CDiff System for its use in determining the presence of CDiff in liquid/unformed stool specimen obtained from patients suspected of having C. difficile infection (CDI). Sensitivity will be established as the proportion of positives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method. Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC CDiff System, when compared to the Reference Method.
次要结局
- Positive and Negative Predictive Values (PPV and NPV)(At the time of the results with Reference Method is confirmed, up to 3 months)
- Unresolved Sample Results(At the time of the results with Reference Method is confirmed, up to 3 months)
- Indeterminate Sample Results(At the time of the results with Reference Method is confirmed, up to 3 months)