Multiplex Strip PCR for Valid, Fast and Comprehensive Multi-pathogen Detection to Support the Diagnosis of Eye Infection Diseases (Endophthalmitis, Keratitis, Corneal Ulcers) From Corneal Scraping Samples
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Higher sensitivity and specificity by multiplex strip PCR than current gold standard
研究概览
简要总结
The aim of this study is to see if multiplex strip PCR will detect the pathogen that causing eye infection from the corneal scraping samples with higher sensitivity and specificity than the current gold standard.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered as new patients since July 2019 in RSCM Kirana
- •Age more than 18 years
- •Have an eye infection (keratitis, endophthalmitis and corneal ulcer) which required corneal scrapping sampling for further diagnosis
排除标准
- •Not willing to become the participants by not filling the informed consent
结局指标
主要结局
Higher sensitivity and specificity by multiplex strip PCR than current gold standard
时间窗: 4 months
Ferrer and Alio (2011) report from 10 years of study shown that culture test as current gold standard will provide positive value by 59.3% for detecting keratitis pathogen. Based on this report, we see the potential increase of positive value by using multiplex PCR around 20 points (70%). Sensitivity will be calculated by true positive divided by all positive patients and specificity will be calculated by true negative divided by all negative patients. The results will be compared with the current gold standard with target increase 20 points or 70%.
次要结局
未报告次要终点
研究者
Made Susiyanti, Dr., dr., SpM(K)
Research Coordinator, Principal Investigator
Fakultas Kedokteran Universitas Indonesia