Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Negative Percentage Agreement (NPA).
研究概览
简要总结
The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:
- ClariLight Influenza A/B & SARS-CoV-2 test kits and
- ClariLight Influenza A/B & RSV test kits, for the qualitative detection and differential diagnosis of SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus (RSV) present in anterior nasal and oropharyngeal swab, in combination with an automated molecular diagnostic analyzer and sample collection tube by comparing them against a CE marked, in-vitro diagnostic device, used in the standard of care.
详细描述
Prospective, non-randomized, observational, post-market, multicenter, clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection for evaluating the clinical performance of ClariLight Influenza A/B & SARS-CoV-2 Cartridge and the ClariLight Influenza A/B & RSV Cartridge by comparing them against a reference standard of care, CE marked, comparator device.
This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.
This clinical performance study:
- Does not involve surgically invasive sample-taking
- Is not interventional as test results will not influence patient management decisions neither they will be used to guide treatment
- There are no additional invasive procedures or other risks for the subjects. The device is being used within the scope of its CE marked intended purpose and for the specimen types claimed which include standard of care specimen collection procedures.
No specific follow-up of subjects providing swabs is required following termination, temporary suspension or early termination of the study, or withdrawal of the subject's informed consent. The participation of each subject for the total duration of the study will amount to 1 hour, finishing the participation in day 1. Subjects will be provided with the Investigator's contact information and be instructed to contact the Investigator if they experience any complications from the specimen collection procedures within twenty-four (24) hours of the visit".
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
- •Subjects with suspected respiratory infection who have physical signs/symptoms, such as chills, fever, headache, myalgia, fatigue, nasal congestion, sore throat, and other symptoms.
- •Subjects able to provide anterior nasal swabs and oropharyngeal swabs for testing on the study device according to the instructions for use of that device.
- •Subjects able to provide comparator samples according to the instructions for use of the comparator device.
- •Subjects able to provide study and comparator samples within 24 hours to allow for a valid comparison.
- •Subjects or their legal guardians willing and able to provide written informed consent.
排除标准
- •Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study.
- •Subjects who have undergone anterior nasal, or oropharyngeal sampling within the past 30 minutes (i.e. a minimum wait of 30 minutes is required before collecting swabs for the study device if previous anterior nasal or oropharyngeal samples were collected from the same subject).
- •Subjects or their legal guardians unwilling and unable to provide informed consent.
- •Subjects who have had a nasal wash or aspirate procedure within the past 24 hours.
- •Women who are pregnant or currently breastfeeding.
结局指标
主要结局
Negative Percentage Agreement (NPA).
时间窗: Day 1. No follow-up is required for this study.
The NPA is defined as the as the proportion of negative results from the comparator or reference method that are correctly identified as negative by the study device. NPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
Positive Percentage Agreement (PPA)
时间窗: Day 1. No follow-up is required for this study.
The PPA is defined as the proportion of positive results from the comparator or reference method that are correctly identified as positive by study device. PPA will be determined across all swab types tested (anterior nasal swab and oropharyngeal) against the standard of care comparator (NAAT and sequencing where appropriate) for all targets individually. Values will be estimated, with corresponding 2-sided 95% score confidence intervals (CIs).
次要结局
- Rate of adverse events, serious adverse events and device deficiencies leading to a serious adverse event.(Day 1. No follow-up is required for this study. Nevertheless, subjects who have undergone sample collection can contact the study's Principal Investigator throughout the whole clinical performance study.)