Product Manual

ManualsBrandsQuidel ManualsCoronavirus TestsSofia 2 Flu A/B + SARS-CoV-2 Antigen FIA Nasal Swab Test - 25/Kit

120 µL Pipette

Test Procedure

All specimens must be at room temperature before testing.

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.

Verify that Sofia 2 is

set to the desired

Mode: WALK

AWAY or READ

NOW. See the

“Using 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. Leave the Swab in

the Reagent Tube for

1 minute.

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 2”

section to

complete the

test.

Swab Test Procedure (Nasal/Nasopharyngeal)

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 2 Flu + SARS Antigen FIA and may differ from other

Sofia and Sofia 2 FIA procedures.

QUICK REFERENCE

INSTRUCTIONS

For use with Sofia 2.

Rx only

For use under the Emergency Use Authorization

(EUA) only

For in vitro diagnostic use

Summary of content (4 pages)

PAGE 1
QUICK REFERENCE INSTRUCTIONS For use with Sofia 2. Rx 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 2 Flu + SARS Antigen FIA and may differ from other Sofia and Sofia 2 FIA procedures.
PAGE 2
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. 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 3
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 control is or , retest with a new patient sample and new Test Cassette. .
PAGE 4
from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests.