Clinical performance study of SARS-CoV-2 Antigen Self Test Nasal & SARS-CoV-2 Rapid Antigen Test 2.0 Nasal - Nasal Ag Tests

SD Biosensor INC0 个研究点目标入组 452 人开始时间: 2023年2月6日最近更新: 2024年8月19日

适应症

试验速览

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•General inclusion criteria for all study parts I/II (A, B, C):
•Subject and/or their legal representative has signed the study specific informed consent form AND
•Additional, subpart specific inclusion criteria:
•Part I, A and Part II, A:
•Positive subject is recruited within seven days after the onset of symptoms (symptomatic patients) OR within seven days from contact with a SARS-CoV-2 positive person (asymptomatic patients) AND
•Twenty of recruited positive patients plus dropouts (2 for study part I, 1 for study part II) will be asymptomatic

•General exclusion criteria:
•- Subject is a high-risk patient suffering from life-threatening injuries/sickness OR
•- Subject is unable or unwilling to provide informed consent OR
•- Subject orally confirms that he/she has preexisting medical condition that previously caused a hypersensitivity OR
•- Subject is younger than 2 years old OR
•Additional, subpart specific exclusion criteria:
•Part I, B-C and Part II, B:
•- Subject has been confirmed positive for SARS-CoV-2 with a rapid antigen test or RT-PCR within last seven days
•- Subject has received a professional training in performing the antigen test (e.g., professionally collecting swab samples or performing rapid antigen tests)
•Part II, C:
•- Subject’s SARS-CoV-2 status is known (e.g., subject was tested for SARS-CoV-2 over the past 72 hours)

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