A Laboratory-Based Performance Evaluation Study to Assess the Performance characteristics of Preganews – 06 days sooner (Urine Pregnancy Test Kit)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
研究概览
简要总结
This study is a prospective, non-interventional, laboratory-based study aimed at collecting urine samples from 50 healthy adult male and non pregnant female volunteers to evaluate the performance of the Preganews – 06 days sooner (Urine Pregnancy Test Kit) and to prepare contrived urine samples at predefined hCG concentrations. The study is designed to ensure that all collected samples are of sufficient quality and volume for analytical testing, without exposing participants to any investigational drug or therapeutic intervention. Each volunteer will participate in a single visit, during which eligibility will be confirmed based on inclusion and exclusion criteria, written informed consent will be obtained, and a midstream urine sample of at least 200 mL will be collected. Collected samples will be visually inspected for contamination, properly labeled with unique participant and sample identifiers, and transported to the laboratory under controlled conditions (2–8°C) within four hours of collection. Upon arrival, samples will be gently mixed and divided into aliquots, with one aliquot used for quantitative B-hCG testing and urine routine test to confirm negative status, and the remaining aliquots used for pooled urine matrix preparation and spiking to generate contrived samples at specific B-hCG concentrations. The primary objective of the study is to ensure the successful collection, processing, and storage of urine samples suitable for analytical evaluation of the test strip. As an non-interventional study, no investigational treatment is administered, and the study carries minimal risk, limited to the urine collection process and laboratory handling procedures. All study activities will be conducted in accordance with Good Clinical Practice (GCP) guidelines, ethical standards, and institutional regulations, ensuring participant safety, confidentiality, and data integrity throughout the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Male
入选标准
- •Healthy male and non-pregnant females aged 18 years to 45 years at the time of consent.
- •Able and willing to provide written informed consent prior to any study-related procedure.
- •Capable of providing at least 200 mL of midstream urine in a sterile collection container.
- •Participants who fail screening will not undergo sample collection.
- •Willing to comply with sample collection procedures and study requirements.
排除标准
- •Use of any medication or therapeutic agent containing hCG within the past 30 days.
- •Presence of visible contamination in urine (e.g., blood, feces, excessive mucus, or other impurities).
- •Confirmed urinary tract infection or any condition that may impact urine quality, as per self-report.
- •Inability or unwillingness to comply with the sample collection requirements.
- •Any condition that, in the opinion of the investigator, may interfere with safe participation or sample integrity.
- •Volunteers, in the opinion of investigator, deemed unfit for study participation.
研究者
Dr Maya Sharma
R P memorial hospital