FRIZ Biochem Clinical Performance Study EU IVDR for CYCLE® Dx System Respiratory Viruses (CliPReV)

Conditions: Viruses studied: Influenza A & B, RSV, SARS-CoV-2

Registration Number: DRKS00032909

Lead Sponsor: FRIZ Biochem GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 1200

Inclusion Criteria

• Subject (and legally authorized representative, if applicable) has voluntarily provided signed written informed consent. For children under the age of 14 years assent is sufficient on a verbal basis and after having been informed of all aspects of the study that are relevant for the decision to participate and prior to any study specific procedure. Additionally, written consent of the legal representative is required.
• For the groups of positive subjects: Should be under suspicion for respiratory diseases, represented e.g., by reasonable (combinations of) disease-specific symptoms or previous exposition to other patients with (suspected) respiratory tract infection or even apparently healthy individuals that might have been exposed to other patients with (suspected) respiratory tract infection. It is the examining doctor’s decision whether the subject is under suspicion for respiratory diseases or not.

Exclusion Criteria

• High risk patients such as emergency patients suffering from life-threatening injuries / sickness.
• Subject is unable or unwilling to provide informed consent.
• Subject already participated in the study
• Subject is involved in the conduction of the study according to the Delegation of responsibilities document

Study & Design

Study Type: observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of the clinical performance of the CYCLE® Dx system. The primary objective is to demonstrate, that the CYCLE® Dx system is at least clinically acceptable compared to the gold standard method.

Secondary Outcome Measures

Name	Time	Method
• Viral load evaluation: Relative diagnostic sensitivity in relation to different viral load ranges expressed by Ct values of the comparator/resolver product.<br>• Site-to-site evaluation: Comparison of the diagnostic sensitivity and diagnostic specificity between all participating study sites in dependence of the collected specimen type