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Introduction
Intended Use
Sofia is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro
diagnostic assays manufactured by Quidel Corporation. Sofia is intended for professional and
laboratory use.
After the patient sample has been added to the Test Cassette, depending upon the assay and/or
the user’s choice, the Cassette is either placed inside of Sofia for automatically timed
development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed
development and then placed into Sofia to be scanned (READ NOW Mode). Sofia will scan the test
strip and measure the fluorescent signal by processing the results using method-specific
algorithms. Sofia will display the test results.
Refer to assay-specific Package Insert for details on specific tests.
Product Description
Sofia 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 scanned. This ensures that sample flow has
occurred within the Cassette to permit an accurate reading.
Sofia then displays the test results to the User (e.g., Quantitative, Qualitative, or Invalid) on the
screen. The results can also be automatically printed on an integrated printer if this option is
selected, saved on an SD Card and sent to an LIS if connected.
Calibration Check and Quality Control (QC)
Sofia Calibration Check and external Quality Control Tests must be performed on a periodic basis.
Sofia Calibration Check: Calibration Check is a required function that checks the internal
Sofia optics and systems. A Calibration Check must be performed every 30 days or less, as
set by the supervisor. A special Calibration Cassette is provided with the Installation Pack.
External Quality Controls: Refer to assay-specific Package Insert for details on specific
tests.
Instructions are provided in the Calibration Check and Run QC sections.
Development Modes
When a patient sample is added to the Test Cassette, it begins to flow through the test strip. The
development time required varies by test type. Refer to the assay-specific Package Insert to
determine the required development time of each test, and the required storage conditions of the
test and external controls.
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