Rapid Salivary Test to Detect SARS-CoV-2 (COVID-19): a Diagnostic Accuracy Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Specificity
研究概览
简要总结
The present Diagnostic Accuracy study aims at experimentally validating the use of a rapid salivary test to detect SARS-CoV-2 infection in both symptomatic and asymptomatic individuals as a preliminary approach to a mass screening program.
The study is based on a consecutive recruitment of both patients showing symptoms probably associated with COVID-19 (i.e., cough, dyspnea, fever) and asymptomatic patients with a low risk phenotype. The expected number of recruited individuals is 100.
The experimental test is a prototype of salivary test based on the Lateral Flow Immunoassay technique and is able to detect the presence of SARS-CoV-2 in saliva, especially the Spike protein (S). The comparison is represented by the nasopharyngeal swab, the gold standard of COVID-19 diagnosis.
Patients will undergo both salivary immunoassay and nasopharyngeal swab, thus the outcome assessors are blinded, since the results of the rRT-PCR analysis require at least 6 hours before being available.
The main outcomes are sensibility and specificity of the rapid salivary test, when compared with the gold standard (nasopharyngeal swab).
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
- Single (Outcomes Assessor)
盲法说明
The rapid salivary test will provide results within 5-10 minutes, while the rRT-PCR performed on nasopharyngeal swab shows results only after 6 hours, thus the outcome assessor of the experimental test is blinded
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who undergo nasopharyngeal swab to confirm or exclude SARS-CoV-2 infection
排除标准
- 未提供
研究组 & 干预措施
Symptomatic patients
Patients with symptoms associated with COVID-19, i.e., dyspnea, cough, fever, etc.
干预措施: rapid salivary test (Diagnostic Test)
Asymptomatic subjects
Asymptomatic patients with low risk phenotype, that means patients with a previous negative swab, no relatives affected by COVID-19 and with reduced social interaction within the last two weeks.
干预措施: rapid salivary test (Diagnostic Test)
结局指标
主要结局
Specificity
时间窗: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; specificity recorded through study completion, an average of 2 months.
TN/TN+FP (TN= True Negative; FP= False Positive)
Sensibility
时间窗: Salivary test will be interpreted after 10 minutes; the nasopharyngeal swab after 6 hours; sensitivity recorded through study completion, an average of 2 months.
TP/TP+FN (TP= True Positive; FN = False Negative)
次要结局
未报告次要终点
研究者
Lorenzo Azzi
Assistant Professor
Università degli Studi dell'Insubria