SiQHT19_Clinical performance study of the STANDARD™ i-Q COVID-19 Ag Home Test - SiQHT19

SD Biosensor INC0 个研究点目标入组 431 人开始时间: 2022年6月3日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•General inclusion criteria (for all study parts):
•The participant provided signed written informed consent prior to any study-specific procedure AND
•Specific inclusion criteria:
•Part I, A + Part II, B
•o SARS-CoV-2 positive patients AND
•o Symptomatic subjects are recruited within seven days after the onset of symptoms OR within seven days from the viral infection (e.g. contact with a SARS-CoV-2 positive patient) OR
•Part I, B + Part II, A
•o Apparently healthy subjects AND
•o SARS-CoV-2 negative subjects
•Part II, C
•o Subjects with unknown SARS-CoV-2 status, meaning that:
•- Subject was not diagnosed SARS-CoV-2 positive / negative within the last 60 days AND
•- Subject was not tested (e.g. self-test) for SARS-CoV-2 within the last 72 hours

•General exclusion criteria:
•The participant is unwilling or unable to provide an informed consent OR
•Specimen type other than defined in the study protocol was collected (e.g. collection of oropharyngeal or throat samples) OR
•High risk patients such as emergency patients suffering from life-threatening injuries / sickness OR
•Subjects younger than 2 years
•Specific exclusion criteria:
•Part I, B
•o Patients/Subjects that were diagnosed positive for SARS-CoV-2 within the last 60 days (according to RKI)
•o Healthcare professionals regularly performing swab sample collection
•Part I, B + Part II, A
•o Patients/Subjects that had contact within the last 14 days to a person that has been diagnosed positive for SARS-CoV-2 OR
•o Patients/Subjects showing SARS-CoV-2 related symptoms

发起方