Quidel Sofia User Manual

Page 2 of 57
Delete User ................................................................................................................................ 28
Review Data ................................................................................................................................... 29
Review Patient Results .............................................................................................................. 29
Review QC Results ..................................................................................................................... 29
Review Calibration Results ........................................................................................................ 30
View Lot Status .......................................................................................................................... 30
View Test Types ......................................................................................................................... 30
Sofia Statistics ................................................................................................................................ 30
View Analyzer Info ..................................................................................................................... 31
View User History ...................................................................................................................... 31
View Message Log ..................................................................................................................... 31
Load/Save ...................................................................................................................................... 31
Save Settings to SD Card ............................................................................................................ 31
Load Settings From SD Card ....................................................................................................... 32
Save Test Records to SD Card .................................................................................................... 32
Update ........................................................................................................................................... 32
Load Sofia Firmware .................................................................................................................. 32
Load Firmware from SD Card ..................................................................................................... 33
Load Firmware from Cloud ........................................................................................................ 33
Test Cloud Connection ............................................................................................................... 33
Load Language File ..................................................................................................................... 33
Load Language File from SD Card .............................................................................................. 34
Load Language File from Cloud ................................................................................................. 34
Test Cloud Connection ............................................................................................................... 34
Calibration Check ........................................................................................................................... 34
Perform Sofia Calibration Check ................................................................................................ 35
Calibration Results ..................................................................................................................... 35
Run QC ........................................................................................................................................... 35
QC Results .................................................................................................................................. 36
Run Patient Specimens .................................................................................................................. 36
Change Development Mode .......................................................................................................... 37
Enter the User ID ....................................................................................................................... 37
Enter the Patient ID ................................................................................................................... 37
Enter the Order #, if applicable ................................................................................................. 38
Test Procedure ........................................................................................................................... 38
Press START Test ........................................................................................................................ 38
Patient Test Results ................................................................................................................... 38
Network Configuration .................................................................................................................. 39
Update Settings ............................................................................................................................. 40
Laboratory Information System (LIS) ............................................................................................. 41
LIS Parameters and Settings ...................................................................................................... 41
Send Results to LIS ......................................................................................................................... 42
Surveillance Mode ......................................................................................................................... 42
Sofia and Virena Router Connection Installation ...................................................................... 43
Set Network Configuration ........................................................................................................ 43
Surveillance Mode Set Up .......................................................................................................... 43
Virena Router Connection Verification.......................................................................................... 44
Performing Tests in Surveillance Mode ..................................................................................... 46
Send Results to SURV Receiver .................................................................................................. 46

Quidel Sofia Specifications

General

Detection Method	Fluorescence
Result Time	15 minutes
Humidity	10-90% non-condensing
Assay Type	Immunoassay
Storage Temperature	2°C to 30°C
Product Type	Point-of-Care Diagnostic
Technology	Fluorescence Immunoassay
Connectivity	USB
Operating Temperature	15-30°C
Reportable Range	Qualitative (Positive/Negative)