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ManualsBrandsQuidel ManualsCoronavirus TestsSofia SARS-CoV-2 COVID-19 Antigen Nasal Swab Test Kits - 25/Kit

120 µL Pipette

Test Procedure

All specimens must be at room temperature before testing. For use with direct anterior nasal swab samples.

Expiration date: Check expiration date on each individual test package or outer box before using. Do not use any test past the expiration date on the label.

Disposable gloves and safety glasses are recommended when running this test. Wash hands thoroughly after handling any patient sample.

Verify that Sofia,

Sofia 2 is set to the

desired Mode:

WALK AWAY or

READ NOW. See

the “Using Sofia,

Sofia 2” section for

more information.

Dispense all of the Reagent

Solution into the Reagent

Tube. Swirl the Reagent Tube

to dissolve its contents.

Place the patient swab

sample into the Reagent

Tube. Roll the swab at

least 3 times while

pressing the head

against the bottom and

side of the Reagent

Tube.

Roll the Swab head

against the inside of the

Reagent Tube as you

remove it. Dispose of

the used Swab in your

biohazard waste.

Fill the provided Small, Clear

120 µL Fixed Volume Pipette with

patient sample from the Reagent

Tube.

To fill the Fixed Volume Pipette

with the patient sample:

a) FIRMLY squeeze the top bulb.

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.

Firmly squeeze the top bulb to

empty the contents of the Small,

Clear 120 µL Fixed Volume Pipette

into the Test Cassette sample well.

Extra liquid in the overflow bulb is

OK.

NOTE: The Fixed Volume Pipette is

designed to collect and dispense the

correct amount of patient sample.

Discard the Pipette in your

biohazard waste.

NOTE: Do not pour sample from the

Reagent Tube. Use the provided

Small, Clear 120 µL Fixed Volume

Pipette.

Proceed to the

“Using Sofia, Sofia

2” section to

complete the test.

Swab Test Procedure (Direct Anterior Nasal)

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 SARS Antigen FIA and may differ from other Sofia

and Sofia 2 FIA procedures.

QUICK REFERENCE

INSTRUCTIONS

For use with Sofia and Sofia 2 only

For use under the Emergency Use Authorization (EUA) only

For in vitro diagnostic use

Summary of content (6 pages)

PAGE 1
QUICK REFERENCE INSTRUCTIONS For use with Sofia and Sofia 2 only Study the Package Insert and User Manual thoroughly before using Quick Reference Instructions. This is not a complete Package Insert. For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use IMPORTANT! Read instructions carefully before beginning. The test procedure below is unique to the Sofia SARS Antigen FIA and may differ from other Sofia and Sofia 2 FIA procedures.
PAGE 2
Using Sofia WALK AWAY/READ NOW Modes Refer to the Sofia User Manual. Sofia may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY Mode In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia. Sofia will automatically time the test development, and the results will be displayed in 15 minutes. READ NOW Mode Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia.
PAGE 3
Sofia 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 will not be visible to the naked eye. Results: The Sofia screen will display results for the procedural control as being “valid or invalid.” If the control is “invalid,” retest with a new patient sample and new Test Cassette.
PAGE 4
Using Sofia 2 WALK AWAY/READ NOW Modes Refer to the Sofia 2 User Manual. Sofia 2 may be set to two different modes (WALK AWAY and READ NOW). The procedures for each mode are described below. WALK AWAY Mode In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia 2. Positive and negative test results will be displayed at 15 minutes. READ NOW Mode Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia 2.
PAGE 5
Sofia 2 Interpretation of Results When the test is complete, the results will be displayed on the Sofia 2 screen. Test Lines will not be visible to the naked eye. Results: The Sofia 2 screen will display results for the procedural control as being or . If the control is , retest with a new patient sample and new Test Cassette. If used on asymptomatic individuals for serial testing, a second test should be obtained with at least 24 hours (and no more than 36 hours) between tests.
PAGE 6
The Sofia SARS Antigen FIA is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings, and proficient in performing tests using the Sofia, Sofia 2 and Sofia Q instruments. The Sofia SARS Antigen FIA is only for use under the Food and Drug Administration’s Emergency Use Authorization. The Sofia SARS Antigen FIA should be used with Sofia, Sofia 2.