Clinical performance study of the STANDARD™ Q COVID-19 Ag Test and the STANDARD™ Q COVID-19 Ag Test 2.0 - Standard Q Tests

SD Biosensor INC0 个研究点目标入组 1,100 人开始时间: 2023年1月26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 (A1/ A2, B1/ B2 and C1/ C2):
•Subject (and legally authorized representative, if applicable) has voluntarily provided signed written informed consent, for children assent might be sufficient, 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 AND
•Additional study part-specific inclusion criteria:
•For study part A1/ A2:
•o Subject has been previously confirmed positive for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours) AND
•o SARS-CoV-2 positive subject is recruited within seven days after COVID-19 symptom onset OR in case of asymptomatic subjects within ten days after the first exposure to a confirmed COVID-19 case
•For study part B1/ B2:
•o Subject has been previously confirmed negative for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours)
•For study part C1/ C2:
•o Subject has been previously confirmed negative for COVID-19 by a documented CE marked molecular test (within the last 24 hours) or professional antigen test (within the last 12 hours) AND
•o Subject is currently treated as an in-patient in a hospital

•General exclusion criteria for all study parts (A1/ A2, B1/ B2 and C1/ C2):
•Subject is a high-risk patient such as emergency patients suffering from life-threatening injuries/ sickness OR
•Subject is unable or unwilling to provide informed consent

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