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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