Quidel Lyme FIA Sofia 2 Quick Reference Instructions
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Also See for Lyme FIA Sofia 2:
- User manual (49 pages) ,
- Quick start manual (9 pages) ,
- Quick reference instructions (4 pages)
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Study the Package Insert and User Manual
thoroughly before using Quick Reference
Instructions. This is not a complete Package Insert.
Test Procedure
DO NOT open the foil pouch containing the Test Cassette until ready to test the sample. Place the Test Cassette on a clean and level surface.
All specimens must be at room temperature before testing.
Expiration Date: Check expiration on each individual test package or outer box before using. Do not use any test past the expiration date on the label.
Serum/Plasma
1
2
Verify that Sofia or Sofia 2
Fill a calibrated micropipette
is set to the desired
with 30 μL of the patient
mode: WALK AWAY or
serum/plasma sample.
READ NOW. See the
"Using Sofia" or "Using
Sofia 2" section for more
information.
Follow Package Insert for
Specimen Collection.
CLIA Complexity: Moderate
4
3
Add patient sample to the
Fill a calibrated micropipette
Reagent Vial and gently mix.
with 100 μL of diluted sample
from the Reagent Vial.
QUICK REFERENCE
INSTRUCTIONS
For use with Sofia and Sofia 2.
IMPORTANT! Read instructions carefully before beginning.
The test procedure below is unique to the Sofia Lyme FIA
and may differ from other Sofia FIA procedures.
5
Align the tip of the micropipette with the round
Test Cassette sample well and empty its contents.
6
Proceed to the "Using
Sofia" or "Using Sofia
2" section to complete
the test.
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Related Manuals for Quidel Lyme FIA Sofia 2
Summary of Contents for Quidel Lyme FIA Sofia 2
- Page 1 QUICK REFERENCE INSTRUCTIONS For use with Sofia and Sofia 2. IMPORTANT! Read instructions carefully before beginning. Study the Package Insert and User Manual CLIA Complexity: Moderate thoroughly before using Quick Reference The test procedure below is unique to the Sofia Lyme FIA Instructions.
- Page 2 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 Test Cassette into Sofia.
- Page 3 RUN TEST 1. Input the User ID using the handheld 3. Press Start Test and the Sofia barcode scanner or manually enter the drawer will automatically open. 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.
- Page 4 Sofia External Quality Control From the main menu, select Following the prompt on the screen, scan the QC Card (located on the assay kit box). Run QC. The user will select the desired mode (WALK AWAY or READ NOW) and then run the External Controls.
- Page 5 RUN TEST 1. Input the User ID using the integrated 3. Verify that the correct mode, barcode scanner or manually enter the WALK AWAY or READ NOW, data using the on-screen key pad. has been selected. Press and open the Sofia 2 drawer. NOTE: If you mistakenly scan the incorrect barcode, select the field again to re- highlight it.
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Page 6: Intended Use
Reference the Package Insert for Warnings and Precautions, Specimen Collection and Handling, and Quality Control. ASSISTANCE If Sofia, Sofia 2, or the assay does not perform as expected, contact Quidel Technical Support 800.874.1517 (in the U.S.), technicalsupport@quidel.com, or your local distributor.