Evaluation of a Screening Program for SARS-CoV-2 Infection in the General Population Based on the Use of New Detection Approaches or for Diagnostic Orientation on Saliva (COVID-19)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5,197
- 试验地点
- 1
- 主要终点
- Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus
研究概览
简要总结
The investigators hypothesize that detection of SARS-CoV2 on saliva samples will increase the performance of the screening program compared to the reference strategy (RT-PCR on a nasopharyngeal swab).
详细描述
Containment of the COVID19 pandemic relies on mass screening to allow rapid identification and isolation of cases to break transmission chains. The reference diagnostic method is based on detection of viral genomes by PCR on a nasopharyngeal swab sample (NPS).
However, the pandemic has generated a very high demand causing a shortage of specific swabs and difficulties in the supply of reagents and consumables. Nasopharyngeal sampling requires skilled personnel, and is sometimes poorly accepted by patients. These issues can reduce the quality of sampling and therefore the sensitivity of the test. This strategy also requires sending samples to specialized laboratories, generating a delay in providing results.
New diagnostic approaches on saliva samples are being developed allowing 1) an easier sampling procedure and 2) a diagnostic technique that can be performed in point-of-care.
Previous evaluations suggest that these approaches have a lower sensitivity than the reference strategy (PCR on NPS), around 50 to 90% depending on the technique used.
Despite lower sensitivity compared to the reference strategy, the investigators hypothesize that detection of SARS-CoV2 on saliva samples will improve the performance of the screening program by considerably increasing the number of individuals tested in shorter times.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult or child subject able to receive nasopharyngeal swab, regardless of age
- •Subject in whom nasopharyngeal swab is performed for detection of SARS-CoV-2 as part of the screening system managed by APHP
- •Subject or parent not opposed to saliva sampling and data collection as part of this research
排除标准
- 未提供
研究组 & 干预措施
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
干预措施: Nasopharyngeal swab (Diagnostic Test)
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
干预措施: Saliva sample (Diagnostic Test)
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
干预措施: axillary sweat sample (Diagnostic Test)
Salicov
Ambulatory adults or children requiring screening for SARS-CoV-2 by nasopharyngeal swab
干预措施: Data collection (Other)
SalicovII (ancillary study)
Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected.
干预措施: Saliva sample (Diagnostic Test)
SalicovII (ancillary study)
Ancillar study : Children and teachers / staff from middle and high schools in Ile de France Saliva samples is collected as part of care. Only a self-rated questionnaire is collected.
干预措施: Data collection (Other)
结局指标
主要结局
Positivity of RT-PCR on nasopharyngeal swab for the SARS-CoV-2 virus
时间窗: At diagnosis
RT-PCR on nasopharyngeal is considered as gold standard
次要结局
- Positivity of RT-PCR on saliva sample for the SARS-CoV-2 virus(At diagnosis)
- Practicability to samples(At diagnosis)
- Practicability to premises(At diagnosis)
- Positivity of new detection approach on saliva sample for the SARS-CoV-2 virus(At diagnosis)
- Practicability to render time(At diagnosis)
- IgG Antibody detection in saliva(At diagnosis)
- Positivity of antigenic test on nasopharyngeal swab for the SARS-CoV-2 virus(At diagnosis)
- Patient tolerance of the salivary self-sampling(At diagnosis)
- Practicability to interpretation(At diagnosis)
- IgA Antibody detection in saliva(At diagnosis)
- Positivity of canine olfactory detection of SARS-CoV-2(At diagnosis)
- Operator tolerance of the salivary self-sampling(At diagnosis)
- Cost of each approach(At diagnosis)
- IgM Antibody detection in saliva(At diagnosis)