Product Manual

_________________________________________________________________________________
Sofia SARS Antigen FIA Page 6 of 22
External Quality Control
External Controls may also be used to demonstrate that the reagents and assay procedure perform properly.
Quidel recommends that Positive and Negative External Controls be run:
◼ once for each untrained operator
◼ once for each new shipment of kits – provided that each different lot received in the shipment is
tested
◼ as deemed additionally necessary by your internal quality control procedures, and in accordance with
Local, State and Federal regulations or accreditation requirements.
The user must first select Run QC on the Main Menu of Sofia or Sofia 2and then, when prompted, scan the QC
Card (located on kit box). This card provides information specific to the kit lot, including lot number and
expiration date.
The user will select the desired mode (WALK AWAY or READ NOW) then run the External Control swabs.
External Positive and Negative Control swabs are supplied in the kit and should be tested using the Swab Test
Procedure provided in this Package Insert or in the Quick Reference Instructions. The SARS Positive Control
Swab contains SARS antigen. The Positive Control Swab must be run first, followed by the Negative Control
Swab.
When the QC run is complete, each result will be displayed as “Passed” or “Failed” on Sofia or or on Sofia
2, for the Positive Control and the Negative Control.
Do not perform patient tests or report patient test results if either of the QC test results fail. Repeat the test or
contact Quidel Technical Support before testing patient samples.
For example: This display shows an
invalid result on Sofia 2.
For example: This display shows an
invalid result on Sofia.