Quidel Sofia User Manual
Quidel Sofia 2 Flu A+B Starter Kit Sofia 2 instrument with 3 Sofia Flu kits (Fisher Cat 23-043-070. Sofia 2 Fluorescent Immunoassay Analyzer collects hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. User interface: Intuitive, fast and easy-to-use interface allows operators to quickly run patient. Sofia 2 Fluorescent Immunoassay Analyzer Sofia 2 collects hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give you an objective result you can rely on.
Quidel Sofia 2 User Manual Flu Shot
QUICK REFERENCE INSTRUCTIONS For use with Sofia only.
Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.
IMPORTANT! Read instructions carefully before beginning. The test procedure below is unique to the Sofia Strep A FIA and may differ from other Sofia FIA procedures.
Test Procedure 1
2
3
4
5
6
Verify that Sofia is set to the desired Mode: WALK AWAY or READ NOW. See the “Using Sofia” section for more information.
Squeeze ONCE to break the glass ampoule inside the Reagent Solution Bottle, just prior to running the assay.
Vigorously shake the Bottle five times to mix the solutions. Solution should turn green after the ampoule is broken.
Remove the cap. Holding Bottle vertically, fill the Reagent Tube to the line (approximately 6 drops).
001f Immediately add the patient Swab sample to the Reagent Tube.
Leave the Swab in the Reagent Tube for 1 minute.
001f Vigorously mix the solution by plunging the Swab five (5) times in an up and down motion in the tube. NOTE: Best results are obtained when the specimen is vigorously extracted in the solution.
1
! Vigorously plunge up and down 5x
Leave for 1 minute.
Fill to Line
7
8
9
Vigorously mix the solution again by plunging the Swab five (5) times in an up and down motion in the Tube.
Express as much liquid as possible from the Swab by squeezing the sides of the Tube as the Swab is withdrawn.
Fill the provided yellow Fixed Volume Pipette with the sample:
Discard the Swab in accordance with your biohazard waste disposal protocol.
a) FIRMLY squeeze the top bulb.
10
To fill the Fixed Volume Pipette (100 µL) with the sample: b) Still squeezing, place the Pipette tip into the sample. c) With the Pipette tip still in the sample, release pressure on bulb to fill the Pipette.
11
Firmly squeeze the top bulb to empty the contents of the Fixed Volume Pipette into the Cassette sample well. Extra liquid in the overflow bulb is OK.
Proceed to the next section, “Using Sofia,” to complete the test.
NOTE: The Fixed Volume Pipette is designed to collect and dispense the correct amount of patient sample. Discard the Pipette in your biohazard waste.
Squeeze here
! Pipette
P
E R
T S
Vigorously plunge up and down 5x
A
Sample Well
Sample
Using Sofia WALK AWAY/READ NOW Modes Refer to the Sofia User Manual for operating instructions. Sofia may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY MODE
READ NOW MODE
In WALK AWAY Mode, the user immediately inserts the Cassette into Sofia. The user then returns after 5 minutes to get the test result. In this mode, Sofia will automatically time the test development before scanning and displaying the test result.
Allow the test to develop for the full 5 minutes BEFORE placing it into Sofia.
5
The user must first place the Cassette onto the counter or bench top for 5 minutes (outside of Sofia) and manually time this development step. Then, the user inserts the Cassette into Sofia. In READ NOW Mode, Sofia will scan and display the test result within 1 minute.
1
5 r Feed
Pape
A+B
FLU
Reader A+B
FLU
Reader
Print
Eject
T S
P
E
R T S
P
E
R T S
P
E R
A
A
A
Using Sofia (cont.) RUN TEST 3. Press Start Test and the Sofia drawer will automatically open.
1. Input the User ID using the handheld barcode scanner or manually enter the data using the key pad.
NOTE: If you mistakenly scan the
wrong barcode, use the Arrow Keys on Sofia to re-highlight the field and simply rescan using the correct barcode. The previous one will be overwritten with the right barcode.
r Feed
Pape
Print
ID B005 tor Opera Eject
A+B
r Feed
Pape
FLU
4. Verify that the correct mode, WALK AWAY or READ NOW, has been selected. Insert the Cassette into the drawer. Then gently close the drawer.
Reader
2. Input the Patient ID and/or Order # using the handheld barcode scanner or manually enter the data using the key pad. Print
ID B005 tor Opera Eject
5. Sofia will start automatically and display the progress. In WALK AWAY Mode, the test results will be displayed on the screen in approximately 5 minutes. In READ NOW Mode, the test results will be displayed on the screen within 1 minute. See Interpretation of Results section.
Interpretation of Results When the test is complete, the results will be displayed on the Sofia screen. The results can be automatically printed on the integrated printer if this option is selected. Test Lines, which are fluorescent, will never be visible to the naked eye. Results: The Sofia screen will display results for the procedural control being “valid or invalid.” If the control is “invalid,” retest with a new patient sample and new test Cassette.
Reader Display
Interpretation
Strep A: Positive
Positive Test for Strep A (Strep A antigen present)
Strep A: Negative
Negative Test for Strep A (no antigen detected)
Strep A: Invalid Procedural Control: Invalid
Result Invalid
External Quality Control (External Positive and Negative Swabs are supplied in the kit) 1
From the main menu, select Run QC.
2
Following the prompt on the screen, scan the QC Card (located on the kit box).
3
Sofia will then prompt the user to run the External Control Swabs.
4
Follow the Test Procedure of this Quick Reference Instructions.
INTENDED USE The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection. Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
ASSISTANCE If Sofia or the assay do not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [email protected], or your local distributor.
Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.
Quidel Corporation San Diego, CA 92121 USA quidel.com
1192502 (01/14)
Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.
IMPORTANT! Read instructions carefully before beginning. The test procedure below is unique to the Sofia Strep A FIA and may differ from other Sofia FIA procedures.
Test Procedure 1
2
3
4
5
6
Verify that Sofia is set to the desired Mode: WALK AWAY or READ NOW. See the “Using Sofia” section for more information.
Squeeze ONCE to break the glass ampoule inside the Reagent Solution Bottle, just prior to running the assay.
Vigorously shake the Bottle five times to mix the solutions. Solution should turn green after the ampoule is broken.
Remove the cap. Holding Bottle vertically, fill the Reagent Tube to the line (approximately 6 drops).
001f Immediately add the patient Swab sample to the Reagent Tube.
Leave the Swab in the Reagent Tube for 1 minute.
001f Vigorously mix the solution by plunging the Swab five (5) times in an up and down motion in the tube. NOTE: Best results are obtained when the specimen is vigorously extracted in the solution.
1
! Vigorously plunge up and down 5x
Leave for 1 minute.
Fill to Line
7
8
9
Vigorously mix the solution again by plunging the Swab five (5) times in an up and down motion in the Tube.
Express as much liquid as possible from the Swab by squeezing the sides of the Tube as the Swab is withdrawn.
Fill the provided yellow Fixed Volume Pipette with the sample:
Discard the Swab in accordance with your biohazard waste disposal protocol.
a) FIRMLY squeeze the top bulb.
10
To fill the Fixed Volume Pipette (100 µL) with the sample: b) Still squeezing, place the Pipette tip into the sample. c) With the Pipette tip still in the sample, release pressure on bulb to fill the Pipette.
11
Firmly squeeze the top bulb to empty the contents of the Fixed Volume Pipette into the Cassette sample well. Extra liquid in the overflow bulb is OK.
Proceed to the next section, “Using Sofia,” to complete the test.
NOTE: The Fixed Volume Pipette is designed to collect and dispense the correct amount of patient sample. Discard the Pipette in your biohazard waste.
Squeeze here
! Pipette
P
E R
T S
Vigorously plunge up and down 5x
A
Sample Well
Sample
Using Sofia WALK AWAY/READ NOW Modes Refer to the Sofia User Manual for operating instructions. Sofia may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY MODE
READ NOW MODE
In WALK AWAY Mode, the user immediately inserts the Cassette into Sofia. The user then returns after 5 minutes to get the test result. In this mode, Sofia will automatically time the test development before scanning and displaying the test result.
Allow the test to develop for the full 5 minutes BEFORE placing it into Sofia.
5
The user must first place the Cassette onto the counter or bench top for 5 minutes (outside of Sofia) and manually time this development step. Then, the user inserts the Cassette into Sofia. In READ NOW Mode, Sofia will scan and display the test result within 1 minute.
1
5 r Feed
Pape
A+B
FLU
Reader A+B
FLU
Reader
Eject
T S
P
E
R T S
P
E
R T S
P
E R
A
A
A
Using Sofia (cont.) RUN TEST 3. Press Start Test and the Sofia drawer will automatically open.
1. Input the User ID using the handheld barcode scanner or manually enter the data using the key pad.
NOTE: If you mistakenly scan the
wrong barcode, use the Arrow Keys on Sofia to re-highlight the field and simply rescan using the correct barcode. The previous one will be overwritten with the right barcode.
r Feed
Pape
ID B005 tor Opera Eject
A+B
r Feed
Pape
FLU
4. Verify that the correct mode, WALK AWAY or READ NOW, has been selected. Insert the Cassette into the drawer. Then gently close the drawer.
Reader
2. Input the Patient ID and/or Order # using the handheld barcode scanner or manually enter the data using the key pad. Print
ID B005 tor Opera Eject
5. Sofia will start automatically and display the progress. In WALK AWAY Mode, the test results will be displayed on the screen in approximately 5 minutes. In READ NOW Mode, the test results will be displayed on the screen within 1 minute. See Interpretation of Results section.
Interpretation of Results When the test is complete, the results will be displayed on the Sofia screen. The results can be automatically printed on the integrated printer if this option is selected. Test Lines, which are fluorescent, will never be visible to the naked eye. Results: The Sofia screen will display results for the procedural control being “valid or invalid.” If the control is “invalid,” retest with a new patient sample and new test Cassette.
Reader Display
Interpretation
Strep A: Positive
Positive Test for Strep A (Strep A antigen present)
Strep A: Negative
Negative Test for Strep A (no antigen detected)
Strep A: Invalid Procedural Control: Invalid
Result Invalid
External Quality Control (External Positive and Negative Swabs are supplied in the kit) 1
From the main menu, select Run QC.
2
Following the prompt on the screen, scan the QC Card (located on the kit box).
3
Sofia will then prompt the user to run the External Control Swabs.
4
Follow the Test Procedure of this Quick Reference Instructions.
INTENDED USE The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection. Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control.
ASSISTANCE If Sofia or the assay do not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), 858.552.1100 (outside the U.S.), [email protected], or your local distributor.
Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert.
Quidel Corporation San Diego, CA 92121 USA quidel.com
1192502 (01/14)