Evaluation of the Diagnostic Performance of the DM-DIV (in Vitro Diagnostic Medical Device) TestNPass for the Diagnosis of SARS-CoV-2 Infection Using a Nasopharyngeal Sample
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Analytics performance (specificity) of TestNPass
研究概览
简要总结
The COVID-19 pandemic has created a major global health crisis that requires a rapid and effective response, particularly in the field of diagnostics.
The first tests used, based on PCR (polymerase chain reaction) performed through a deep nasopharyngeal swab, have shown limitations in controlling the epidemic. The current need is to develop new tests that are rapid, affordable, and easy to use, and that can be implemented on a large scale in outpatient settings to reduce the burden on healthcare teams. In addition, a test that is easy to produce and can be stored at room temperature would help overcome the significant logistical challenge of regularly testing the general population to specifically isolate carriers of the virus.
In this context, an innovative test called TestNPass has been developed. TestNPass is a rapid and affordable antigen test for screening and diagnosis that provides a secure digital passport and/or QR code upon request.
The objective of this study is to evaluate the diagnostic performance of TestNPass using nasopharyngeal swabs for the detection of SARS-CoV-2 infection.
详细描述
The COVID-19 pandemic and the global spread of SARS-CoV-2 are historic events in terms of their magnitude and the collective response elicited from medical teams, governments, and the general public. This situation requires a rapid and effective response to identify solutions, particularly in the field of diagnostics.
While the initial tests used were based on PCR (polymerase chain reaction) and deep nasopharyngeal swabs, this approach has shown limitations in controlling the epidemic. The significant logistical resources required for implementation limit its large-scale use beyond current applications. In addition, deep nasopharyngeal sampling is not feasible for repeated testing of healthy populations as part of primary screening.
The current need is the development of new point-of-care (PoC) testing methods that are rapid, affordable, and easy to use. These characteristics would enable mass deployment in outpatient settings, reducing the burden on healthcare teams. Furthermore, a test that is easy to produce and can be stored at room temperature would address the immense logistical challenge of regularly testing the general population to specifically isolate virus carriers.
In this context, an innovative test called TestNPass has been developed by the Grenoble-based start-up company Grapheal. TestNPass is a rapid and low-cost antigen test for screening and diagnosis that delivers a secure digital passport and/or QR code upon request. This type of device may also be used to detect various antigens, such as those of influenza, streptococcus A, or shingles.
The objective of this study is to evaluate the diagnostic performance of an in vitro diagnostic medical device (IVD) for the detection of SARS-CoV-2 infection using a nasopharyngeal swab. To achieve this, an additional nasopharyngeal swab sample will be collected immediately after the sample taken as part of routine healthcare procedures.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥18 years of age
- •Consulting or hospitalized at the University Hospital of Grenoble Alpes, for whom a SARS-CoV-2 RT-PCR test via nasal swab is considered due to symptoms or context (hospitalization in a double room, ongoing epidemic outbreak)
- •Having provided informed consent to participate in the study.
- •Patient having the rights to French social insurance
排除标准
- •Contraindication to nasopharyngeal swabbing:
- •Anatomical abnormalities or medical conditions:
- •Severe nasal septum deviation or nasal polyps
- •History of recent nasal or facial surgery
- •Severe sinusitis or nasal infections
- •Bleeding disorders
- •Extreme sensitivity or phobias related to medical procedures
- •Participation in an exclusion period of another SARS-CoV-2 performance study: Minors
- •Pregnant or breastfeeding women, Individuals under guardianship or curatorship, Individuals deprived of liberty or involuntarily hospitalized, Individuals under administrative or judicial supervision, Persons unable to provide informed consent
- •Staff with a hierarchical relationship with the principal investigator
研究组 & 干预措施
Cases: 100 cases will be recruited : Patient diagnosed by RT-PCR for a COVID19
Diagnostic Test: TestNPass Patients will undergo nasopharyngeal sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).
干预措施: nasopharyngeal swab. (Diagnostic Test)
Controls 300 controls : Patient suspected for a COVID-19 but negative by RT-PCR for a COVID19
Diagnostic Test: TestNPass Patients will undergo nasopharyngeal sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).
干预措施: nasopharyngeal swab. (Diagnostic Test)
结局指标
主要结局
Analytics performance (specificity) of TestNPass
时间窗: Baseline
Specificity in % of TestNPass using a nasopharyngeal swab. The specificity target is set at 99%.
次要结局
- Analytics performance (Sensitivity) of TestNPass(Baseline)