An observational study in SARS-CoV2 Infection, Influenza A and Influenza B, sponsored by EDAN Instruments Inc.. Recruiting at 3 sites in Spain. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by EDAN Instruments Inc. · Observational
The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:
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:
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".
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with EDAN Instruments Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
The study population comprises of subjects suspected of respiratory infection by their healthcare provider who meet the all the inclusion criteria and none of the exclusion criteria detailed in the CPSP.
Subjects must meet ALL the inclusion criteria described below to be eligible for this clinical performance study.
Exclusion Criteria:
Subjects who meet any of the exclusion criteria described below will NOT be eligible for this clinical performance study.
COVID-19/Flu A/Flu B/RSV Test Kit
Device: COVID-19/Flu A/Flu B/RSV Test Kit
COVID-19/Flu A/Flu B/RSV Test Kit
Device: COVID-19/Flu A/Flu B/RSV Test Kit
COVID-19/Flu A/Flu B/RSV Test Kit
Device: COVID-19/Flu A/Flu B/RSV Test Kit
The performance characteristics of EDAN's Test Kit will be evaluated in a prospective, non-randomized, observational, post-market, multicenter, comparison clinical performance study using anterior nasal and oropharyngeal swabs from subjects suspected of respiratory infection. Samples will be obtained fresh, collected prospectively and will be tested with the study device COVID- 19/Flu A/Flu B/RSV Test Kit. The results will be compared against a reference, CE marked, in-vitro diagnostic device, used in the standard of care. This clinical performance study has been designed to minimize any possible, discomfort, or other foreseeable risks to the participants.
Positive Percentage Agreement (PPA)
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).
Time frame: Day 1. No follow-up is required for this study.
Negative Percentage Agreement (NPA).
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).
Time frame: Day 1. No follow-up is required for this study.
Rate of adverse events, serious adverse events and device deficiencies leading to a serious adverse event.
Rate of adverse events that occur during the clinical performance study and that are critical to the evaluation of the study results. Rate of serious adverse events that have a causal relationship with the device, the comparator, or the study procedure or where such causal relationship is reasonably possible. Rate of device deficiencies that occur during the clinical performance study, which might have led to a serious adverse event, if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate.
Time frame: 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.
Plan to share: No
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