for BioFire COVID-19 Test BioFire ® External Control Kit Quick Guide BioFire Defense, LLC | Salt Lake City, Utah, USA | 801-262-3592 | www.BioFireDefense.com DFA2-PRT-0084-01 Step 6: Review Results Run Summary Internal Controls: • If 'Passed', results are valid. • If 'Failed' or 'Invalid', RETEST CONTROL and refer to Instructions for Use. Result Summary • All 3 assays must be 'Detected' • If any one assay is 'Not Detected', RETEST CONTROL and refer to Instructions for Use. NOTE: External Control passes if all 3 assays are 'Detected' and the overall result is 'Detected'. Run Details Run Status: • If 'Completed', run is complete. • If 'Incomplete', 'Aborted', or any other error message, RETEST CONTROL, and refer to Instructions for Use. NOTE: Refer to Instructions for Use for reporting information. If repeated error messages are obtained, contact Biofire Defense Technical Support. DO NOT DISCARD: Important product-specific information For use under an Emergency Use Authorization (EUA) only 423748 (6 pk) Summary and Explanation of the Test BioFire Defense provides an external positive assayed quality control kit to monitor the performance of the BioFire COVID-19 Test performed on FilmArray ® 2.0 and FilmArray Torch ® systems. Good laboratory practice recommends running positive and negative external controls regularly. Evaluation of external controls is recommended prior to using a new shipment or new lot of BioFire COV- ID-19 Test Kits. Evaluation of external controls is also recommended when there is a new operator, and following replacement/repair of a FilmArray 2.0 or FilmArray Torch system. External controls may also be used in initial laboratory validations of the FilmArray 2.0 or FilmArray Torch system used with the BioFire COVID-19 Test in accordance with appropriate federal, state, and local guidelines or accreditation requirements, as applicable. Storage Instructions Store at 15 - 30ºC. Procedure / Interpretation / Limitations Users should refer to the BioFire COVID-19 Test Instructions for Use available on the BioFire Defense Website: www.biofiredefense.com/covid-19test An optional verification protocol is also available on this website. Questions / Support If you have questions or need additional support, please contact BioFire Defense Technical Support at support@biofiredefense.com. NOTE: Clean area thoroughly after testing External Positive Control to reduce risk of contamination.