Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

GMDN information is as follows: Code: 64747 Name: SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) Definition: A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection. The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19) in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs). To use this product, SARS-CoV-2 nucleic acid is first extracted, isolated, and purified from upper and lower respiratory specimens. The purified nucleic acid is then reverse transcribed into cDNA followed by PCR amplification and detection using CoPrimer technology. The Logix Smart Coronavirus Disease 2019(COVID-19) kit includes the following materials o rother authorized materials: Logix Smart COVID-19 Master Mix, Logix Smart COVID-19 Positive Control, and Nuclease Free Water The product requires the following control materials, or other authorized control materials, that are to be run as outlined in the instructions for use. All controls listed below must generate expected results for a test to be considered valid, as outlined in the instructions for use: • Internal positive control (IPC)- RNase P (RP) control in clinical specimens: The RP primer and probe set is included in each run to test for human RNase P, which controls for specimen quality and demonstrates that nucleic acid generated by the extraction process. • Logix Smart COVID-19 Positive Control-blend of SARS-CoV-2 synthetic templates. The positive control is used to monitor for failures of PCR reagents and reaction conditions • No Template (Negative) Control (NTC- Nuclease-free, molecular-grade water used to monitor non-specific amplification, cross contamination during experimental setup, and nucleic acid contamination of reagents