Evaluation of Accuracy of Rapid Tests for Group A Beta Hemolytic Streptococci in Out-patients With Sore Throat From Acute Pharyngitis at Siriraj Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 360
- 主要终点
- Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test.
研究概览
简要总结
The purpose of this study is to evaluate accuracy of rapid tests for group A beta hemolytic streptococci in patients who presented with sore throat at out patient department in Siriraj Hospital.
详细描述
The patients who presented with sore throat at out patient department less than 5 days and age over 6 years old would be enrolled by the primary physicians and the consent forms will be completed by researcher.
The throat swab would be performed by using Sofia, QuickVue rapid tests compare to the gold standard which is a throat swab culture to evaluate the accuracy of the rapid tests.
The sample size for validation of sensitivity and specificity of rapid tests is 358 patients.
The primary outcome is will be evaluated sensitivity and specificity of both rapid tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who came with sore throat less than 5 days.
排除标准
- 未提供
研究组 & 干预措施
Sofia
Patients who presented with sore throat will be performed throat swab and sent for Sofia which is rapid test.
干预措施: Sofia (Device)
QuickVue
Patients who presented with sore throat will be performed throat swab and sent for QuickVue which is rapid test.
干预措施: QuickVue (Device)
Throat swab culture
Patients who presented with sore throat will be performed throat swab and sent for throat swab culture which is gold standard.
干预措施: Throat swab culture (Device)
结局指标
主要结局
Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are positive for Group A Streptococcus by Sofia rapid test.
时间窗: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by Sofia rapid test, the percentage who are negative for Group A Streptococcus by Sofia rapid test.
时间窗: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are positive for Group A Streptococcus by QuickVue rapid test.
时间窗: Day 1
Establish sensitivity against a gold standard. Report as a percentage of participants with 95% confidence limits.
Of participants positive for Group A Streptococcus by QuickVue rapid test, the percentage who are negative for Group A Streptococcus by QuickVue rapid test.
时间窗: Day 1
Establish specificity against a gold standard. Report as a percentage of participants with 95% confidence limits.
次要结局
未报告次要终点
研究者
Adhiratha Boonyasiri
Dr.
Mahidol University