Prospective Study for Clinical Validation of the Molecular-Based GenePOC Strep A, C/G Assay for the Detection and Identification of Group A β-hemolytic Streptococcus (Streptococcus Pyogenes) and Pyogenic Group C and G β-hemolytic Streptococcus (Streptococcus Dysgalactiae Subsp. Equisimilis) Nucleic Acids From Throat Swab Samples Obtained From Patients With Signs and Symptoms of Pharyngitis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 497
- 试验地点
- 16
- 主要终点
- Performance characteristics of the GenePOC Streap A, C/G assay
研究概览
简要总结
The primary purpose of this clinical investigation is to establish the performance of the GenePOC Strep A, C/G assay on the revogene. This will be achieved by comparing the test to a conventional method for detection of Group A β-hemolytic Streptococcus (GAS) and pyogenic Group C and G β-hemolytic Streptococcus (GCS/GGS) in throat swab samples.
详细描述
The GenePOC Strep A, C/G assay will be performed using the revogene™ instrument. The revogene instrument, used in conjunction with appropriate reagents, is capable of automated cell lysis, dilution of nucleic acids from multiple sample types as well as automated amplification and detection of target nucleic acid sequences.
A dual swab sample is collected when ICF is signed by patient. One of the swab will be tested on the revogene™, and the second swab will be tested with standard microbiology method at a Reference Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Samples from patients suspected of having signs and symptoms of a pharyngitis infection
- •Patient that signed the approved Informed Consent Form (if applicable)
- •Patient older than 2 years of age
- •Only one (1) compliant sample per patient is allowed
- •Use of dual swab with either liquid Stuart or liquid Amies transport Medium
排除标准
- •Patient/sample not meeting inclusion criteria above
结局指标
主要结局
Performance characteristics of the GenePOC Streap A, C/G assay
时间窗: Up to 14 months
To establish the performance characteristics of the GenePOC Strep A, C/G assay for its use in determining the presence of Strep A, C/G in throat swab samples obtained from patients with signs and symptoms of pharyngitis infection. * Sensitivity will be estimated as the proportion of positives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method. * Specificity will be established as the proportion of negatives that are correctly identified by the GenePOC Strep A, C/G assay when compared to the Reference Method.
次要结局
- Unresolved sample results(Up to 14 months)
- Indeterminate sample results(Up to 14 months)
- Positive and Negative Predictive Values (PPV and NPV)(Up to 14 months)