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  Instructions for Use
14. Limitations of Use
􏰀 Any diagnosis of COVID-19 disease must be made in conjunction with the entire clinical profile of the patient, including results of any other clinical laboratory tests which are available.
􏰀 The assay may not perform correctly if these instructions are deviated from or if inhibitory substances are present in the specimens.
􏰀 Possible cross-reactivity with SARS coronavirus should be considered in relation to any positive result.
IFU-024 Rev 03 Page 28 of 31





























































































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