A Multi-Site Clinical Evaluation of the ARIES Group B Streptococcus (GBS) Assay With Vaginal-Rectal Swab Specimens From Antepartum Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 918
- 试验地点
- 5
- 主要终点
- Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity
研究概览
简要总结
The ARIES GBS Assay is a real-time PCR based qualitative test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women between 35 - 37 weeks gestation.
详细描述
The ARIES GBS Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) nucleic acid from Lim Broth enriched vaginal-rectal specimen swabs obtained from pregnant women.
The objective of this study is to establish the diagnostic accuracy of ARIES GBS Assay through a multi-site, method comparison on prospectively collected, left-over enriched Lim broth specimens.
Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •An exemption from the requirement for Informed Consent has been granted by the site IRB to include the left-over patient specimens in the study.
- •Demographic information, including age, geographic location, and number of gestation weeks, is included with the specimen.
- •The specimen is from a female patient who is at 35 - 37 weeks gestation.
- •The specimen was collected in unexpired liquid Transport Media (e.g., Liquid Stuart or Liquid Amies).
- •Enrichment in Lim broth was grown for ≥18 hrs to ≤24 hrs.
- •The specimen is received in good condition (no leakage or drying of the specimen) and was accepted for testing by the site in accordance with established laboratory procedures.
- •The volume of the patient specimen after enrichment is sufficient (≥ 1.75mL) for completion of the study.
排除标准
- •The specimen was collected at a site which is not covered under the study IRB.
- •The specimen is from a patient for whom demographic data - age, geographic location and/or gestation weeks cannot be obtained.
- •The specimen was not properly collected, identified, transported, processed or stored according to the instructions provided by the Sponsor.
- •The specimen was enriched in Lim broth for <18 hrs or >24 hrs.
- •A swab specimen that cannot be placed in Lim broth within 4 days of collection.
- •Inconclusive latex agglutination results - weak agglutination, agglutination that occurs in more than one latex reagent or the results are otherwise considered inconclusive based on established laboratory procedures or the instructions included with the latex agglutination test kit.
- •Any specimen that was not tested per the complete testing algorithm provided by the Sponsor.
结局指标
主要结局
Diagnostic accuracy expressed in terms of clinical sensitivity and clinical specificity
时间窗: Within the first year of sample collection
次要结局
- Comparison of clinical performance per clinical site and per age group(Within the first year of sample collection)