Quidel Lyme FIA Sofia 2, User Manual

Page: 12 / 49

Page 11 of 48
Introduction
Intended Use
Sofia 2 is a benchtop analyzer intended to be used with Cassette-based immunofluorescent in
vitro diagnostic assays manufactured by Quidel Corporation. Sofia 2 is intended for professional
and laboratory use.
Rx Only
After the patient sample has been added to the Test Cassette, depending upon the User
’s choice,
the Test Cassette is either placed inside of Sofia 2 for automatically timed development (WALK
AWAY Mode) or placed on the counter or benchtop for a manually timed development and then
placed into Sofia 2 to be read (READ NOW Mode). Sofia 2 will read the test strip and measure the
fluorescent signal by processing the results using method-specific algorithms. Sofia 2 will display
the test results.
Refer to assay-specific Package Insert for details on specific tests.
Product Description
Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate
specific results.
In each test, an internal procedural control line is also read. This ensures that sample flow has
occurred within the Test Cassette to permit an accurate reading.
Sofia 2 then displays the test results to the User on the screen and automatically saves them on
the device. If configured, the results may also be sent to an attached printer or stored in the cloud
using Virena.
Calibration Check and Quality Control (QC)
Sofia 2 Calibration Check and External Quality Control Tests must be performed on a periodic
basis.
◼
Sofia 2 Calibration Check: Calibration Check is a required function that checks the internal
Sofia 2 optics and systems. A Calibration Check must be performed every 30 days or less.
A special Calibration Cassette is provided with Sofia 2. For replacement Calibration
Cassettes, contact Quidel Technical Support.
◼
External Quality Controls: Refer to assay-specific Package Insert for details on specific
tests.
Instructions are provided in the
Run Calibration and Run QC sections.