瑞磁新冠病毒核酸檢測試劑可偵測SARS-CoV-2病毒的兩段 N區域基因。 本試劑無法用於檢測一般的冠狀病毒(OC43, HKU1, NL63, and 229E)、MERS-CoV 或 SARS-CoV。
本檢測可適用不同呼吸道的檢體型態，包括鼻腔拭子(NPS)、口腔式子(OPS)與肺部灌洗液(BAL)，為疑似感染新冠病毒的患者提供診斷。
*The BioCode® SARS-CoV-2 Assay has not been FDA cleared or approved; the test has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certied under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests. The BioCode® SARS-CoV-2 Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Emergency use of the BioCode® SARS-CoV-2 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.