Product Manual

Potential Biohazard!
To reduce the risk of biohazard:
◗ Dispose of used specimens in accordance with federal, state and
local requirements.
◗ Treat specimens and patient samples as potentially biohazardous
material.
◗ Ensure Sofia is cleaned per the Maintenance and Cleaning
section prior to storage, transport or disposal.
◗ Seek specific training or guidance if you are not experienced with
specimen collection and handling procedures.
◗ Use of Nitrile, Latex, or other gloves is recommended when
handling patient samples.
Caution!
To reduce the risk of incorrect results:
◗ Sofia should only be used by trained operators.
◗ Do not use if Sofia is reporting an error condition that cannot be
corrected.
◗ To obtain accurate results, refer to the assay-specific Package
Insert for details on specific tests.
◗ Use the Test Kit within the expiration dating.
To reduce the risk of Sofia damage:
◗ Sofia is designed for counter top operation under laboratory
conditions.
◗ Sofia is not designed to withstand moisture, extreme humidity,
or extreme temperatures.
◗ Sofia is not designed to withstand severe shock or vibration.
◗ Do not open or disassemble the device.
Failure to follow the precautions mentioned above will invalidate the
warranty.
To reduce the risk of environmental contamination:
◗ Contact Quidel Technical Support at 800.874.1517 for return or
disposal of Sofia. For additional contact information (page 3).
◗ Clean Sofia per the Maintenance and Cleaning section of this
User Manual prior to return or disposal.
Note: Always dispose of Sofia and accessories in accordance with
federal, state and local requirements.
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., Positive, Negative, or
Invalid) on the screen. The results can also be automatically printed on
an integrated printer if this option is selected, saved on a SD card and
sent to a 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.
Introduction
Introduction
General Information8
9