The Macurra SARS-CoV-2 PCR Kit is an Emergency Use Authorization (EUA) test authorized by the U.S. FDA for use by authorized laboratories. SARS-CoV-2 Fluorescent PCR Kit (for the COVID-19 Coronavirus) is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria.
- Single-well triple target assay to prevent missing detection:
Simultaneous detection of the three genes of ORF1ab / E / N in SARS-CoV-2. The assay has a full-process negative control, positive control and internal control.
- Added internal control to monitor the whole process:
For each test, an internal control is added to the test reagent to prevent false negative test results.
- Simulated virus to ensure quality:
The positive control and internal control of the kit are simulated RNA virus particles, which are similar to the virus structure, and coated with protein as well. The controls join the extraction step with the samples at the same time, which makes it easier to monitor the entire experimental process and ensure the reliability of the test results.
||SARS-CoV-2 Fluorescent PCR Kit
||Nucleic Acid Extraction Kit, Manual Version
|*QIAGEN QIAamp Viral RNA Mini Kit is an additional authorized extraction method for the Maccura SARS-CoV-2 Fluorescent PCR Kit (EUA Amendment Letter)
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and
- This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.