Product Manual
Page 2 of 15
Sofia Strep A FIA
REAGENTS AND MATERIALS SUPPLIED
25-Test Kit:
Individually Packaged Cassettes (25): Polyclonal rabbit anti-Group A Streptococcus antibodies
Reagent Tubes (25)
Reagent Solution Bottles (25): 4M Sodium Nitrite and 0.2M Acetic Acid inside glass ampoule
Fixed Volume Pipettes (25)
Sterile Rayon Throat Swabs (25)
Positive Control Swab (1): Swab is coated with heat-inactivated, non-infectious Group A Streptococcus
Negative Control Swab (1): Swab is coated with heat-inactivated, non-infectious Group C Streptococcus
Package Insert (1)
Quick Reference Instructions (1)
QC Card (located on kit box)
Printer Paper (1)
MATERIALS NOT SUPPLIED IN KIT
Timer or watch for use in READ NOW Mode
Sofia analyzer
Calibration Cassette (supplied with Sofia Installation Pack)
WARNINGS AND PRECAUTIONS
For in vitro diagnostic use.
Do not use the kit contents beyond the expiration date printed on the outside of the box.
Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
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Use of Nitrile or Latex (or equivalent) gloves is recommended when handling patient samples.
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Dispose of containers and used contents in accordance with Federal, State and Local requirements.
Do not reuse any used Cassettes, Reagent Tubes, Fixed Volume Pipettes, solutions, or Control Swabs.
The user should never open the Foil Pouch of the test Cassette exposing it to the ambient environment until the
Cassette is ready for immediate use.
Discard and do not use any damaged Cassette or material.
The Reagent Solution contains an acidic solution. If the solution contacts the skin or eye, flush with copious amounts of
water.
Testing should be performed in an area with adequate ventilation.
For more information, consult the Safety Data Sheet available on quidel.com.
The Reagent Solution Bottle contains glass, break cautiously.
If the Reagent Solution Bottle is missing the glass ampoule or the solution is green prior to the breaking of the ampoule,
discard and use another Reagent Solution Bottle.
To obtain accurate results, the Package Insert instructions must be followed.
The Calibration Cassette must be kept in the provided storage pouch between uses.
Inadequate or inappropriate specimen collection, storage, and transport may yield false test results.
Specimen collection and handling procedures require specific training and guidance.
If transport media will be used, use only the Transport Media and configuration recommended in this Package Insert.
Use rayon-tipped swabs to collect throat specimens. The performance claims in the Performance Characteristics section
were obtained with the Swabs provided in the kit. Use of the provided Swabs is recommended. Do not use calcium
alginate, cotton-tipped or wooden shaft swabs.