Lumipulse^® G SARS-CoV-2 S-IgG

For in vitro diagnostic (IVD) use as quality controls, to monitor the precision and accuracy of the Lumipulse G SARS-CoV-2 S-IgG assay on the automated LUMIPULSE G System. The assay using this control is performed to quantitatively measure IgG antibodies to SARS-CoV-2 Spike (S) Receptor Binding Domain (RBD) in human serum or plasma and is intended to be used in the assessment of the immune response to the SARS-CoV-2 S protein.

For in vitro diagnostic (IVD) use with the Lumipulse G system for the quantitative measurement of IgG antibodies to SARS-CoV-2 nucleocapsid (N) protein in human serum or plasma. SARS-CoV-2 N antibody measurement is intended to be used as an aid in the assessment of immune response to the SARS-CoV-2 N protein.

Qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and saliva specimens from individuals with signs and symptoms of infection who are suspected of COVID-19.

Real-time RT-PCR test for the qualitative detection of SARS-CoV-2 nucleic acids in various sample types. 

Real-time RT-PCR test for the qualitative detection of HA gene from Influenza A/B virus and N and ORF1a gene from SARS-CoV-2 in nasopharyngeal swab.