Reagent Kit Atellica® IM Antigen Detection SARS-CoV-2 Antigen For Atellica IM Analyzer 100 Tests

The Atellica® IM SARS-CoV-2 Antigen (CoV2Ag) assay is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigen in anterior nasal (AN) swab specimens collected in Siemens Healthineers Sample Inactivation Media, from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset, using the Atellica® IM Analyzer

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet the requirements to perform moderate or high complexity tests

The Atellica IM SARS-CoV-2 Antigen (CoV2Ag) assay does not differentiate between SARS-CoV and SARS-CoV-2

Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status

Positive results do not rule out bacterial infection or co-infection with other viruses

Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities

Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management may be performed; negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions

Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19

The Atellica IM SARS-CoV-2 Antigen (CoV2Ag) assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in in vitro diagnostic procedures and proper infection control procedures

For Use Under Emergency Use Authorization Only

For in vitro diagnostic use only

For prescription use only

Kit contains: 1 ReadyPack primary reagent pack containing Atellica IM CoV2Ag Lite Reagent and Solid Phase, 1 ReadyPack ancillary reagent pack containing Atellica IM CoV2Ag Ancillary Reagent, Atellica IM CoV2Ag master curve and test definition

The following materials are required to perform this assay, but are not provided: 11208048 Atellica IM CoV2Ag CAL (calibrator) and 11207863 Atellica IM CoV2Ag QC (quality control material)