Clinical Performance Study for EDAN's COVID-19/Flu A/Flu B/RSV Test Kits on Subjects Suspected of Respiratory Infection

NCT06175611 | Unknown

• 1 other identifier: CL30_2023_08
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objective of this clinical performance study is to evaluate and further validate the clinical performance of:

1. 1.ClariLight Influenza A/B \& SARS-CoV-2 test kits and
2. 2.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.

Conditions

SARS-CoV2 Infection; Influenza A; Influenza B; Respiratory Syncytial Virus (RSV)

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

  Day 1. No follow-up is required for this study.

Secondary Outcomes (1)

• 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.

Study Arms (3)

Site 1. Laboratorio Central Health Diagnostics Quirónsalud

COVID-19/Flu A/Flu B/RSV Test Kit

Device: COVID-19/Flu A/Flu B/RSV Test Kit

SIte 2. Hospital General Universitario Dr. Balmis de Alicante

COVID-19/Flu A/Flu B/RSV Test Kit

Device: COVID-19/Flu A/Flu B/RSV Test Kit

Site 3. Hospital Universitario de Getafe

COVID-19/Flu A/Flu B/RSV Test Kit

Device: COVID-19/Flu A/Flu B/RSV Test Kit

Interventions

COVID-19/Flu A/Flu B/RSV Test Kit DEVICE

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.

SIte 2. Hospital General Universitario Dr. Balmis de Alicante; Site 1. Laboratorio Central Health Diagnostics Quirónsalud; Site 3. Hospital Universitario de Getafe

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• EDAN Instruments Inc.: lead

Study Sites (3)

Hospital General Universitario Dr. Balmis de Alicante

Alicante, 03010, Spain

RECRUITING

Laboratorio Central Health Diagnostics Quirónsalud

Madrid, 28108, Spain

NOT YET RECRUITING

Hospital Universitario de Getafe

Madrid, 28905, Spain

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Anterior nasal and oropharyngeal swabs

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

DAVID TOMÉ

CONTACT

34 93 609 62 69; david.tome@medivd.com

MARIA SORIA

CONTACT

maria.soria@mdxcro.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: December 19, 2023
• Study Start: December 10, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)