Quidel Sofia influenza a+b User manual

120 µL Pipette

Test Procedure

NOTE: The procedures for testing swab specimens versus liquid specimens in viral transport media are different. Read carefully.

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 or

Sofia 2 is set to the

desired Mode:

WALK AWAY or

READ NOW. See

the “Using Sofia”or

“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.

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”or

“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 Influenza A+B FIA and may differ from other Sofia

FIA procedures.

CLIA Complexity: Waived for direct nasal swab, nasopharyngeal

swab and nasopharyngeal aspirate/wash specimens

QUICK REFERENCE

INSTRUCTIONS

For use with Sofia and Sofia 2.

Rx only

CLIA Complexity: Moderate for nasopharyngeal swab and

nasopharyngeal aspirate/wash specimens eluted in

transport media

120 µL

Pipette

Verify that Sofia or

Sofia 2 is set to the

desired Mode:

WALK AWAY or

READ NOW. See

the “Using Sofia”or

“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.

Fill the provided Large, Pink

250 µL Fixed Volume Pipette

with patient sample from the

collection cup.

To fill the Fixed Volume

Pipette with the sample:

a) FIRMLY squeeze the top

bulb.

b) Still squeezing, place the

Pipette tip into the patient

sample.

c) With the Pipette tip still in

the patient sample, release

pressure on bulb to fill the

Pipette.

NOTE: To obtain accurate

results, avoid mucoid

substances when filling the

Large, Pink 250 µL Fixed

Volume Pipette with patient

sample from the collection cup.

Firmly squeeze the top bulb to

empty the contents of the

Large, Pink 250 µL Fixed

Volume Pipette into the

Reagent Tube. Extra liquid in

the overflow bulb is OK.

NOTE: Once the sample is

added to the Reagent Tube,

vigorously mix prior to

adding the sample to the Test

Cassette.

NOTE: The Fixed Volume

Pipette is designed to collect

and dispense the correct

amount of patient sample.

Discard the Pipette in your

biohazard waste.

Fill the provided Small,

Clear 120 µL Fixed

Volume Pipette with

patient sample from the

Reagent Tube.

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: Do not pour sample

from the Reagent Tube.

Use the provided Small,

Clear 120 µL Fixed Volume

Pipette.

Proceed to the

“Using Sofia”or

“Using Sofia 2”

section to complete

the test.

250 µL

Pipette

Liquid Specimens Test Procedure

250 µL

Pipette

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.

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.

The user places the Test Cassette onto the counter or bench top for 15 minutes (outside of

Sofia). The user manually times this development step. The Test Cassette MUST remain on

the bench for 15 minutes to get an accurate result. Then, the user inserts the Test Cassette

into Sofia. In READ NOW Mode, Sofia will scan and display the test result in 1 minute. Note:

Results will remain stable for an additional 15 minutes after the recommended

development time of 15 minutes.

RUN TEST

1. Input the User ID with the barcode scanner or enter

the data using the key pad.

NOTE: If you 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.

3. Press Start Test and the Sofia drawer will

open.

4. Verify that the correct mode (WALK

AWAY or READ NOW) has been selected.

Insert the Test Cassette into the drawer.

Then gently close the drawer.

2. Input the Patient ID or Order # with the barcode

scanner or enter the data using the key pad.

5. Sofia will start automatically and display the progress. In WALK AWAY

Mode, the test results will be displayed in

approximately 15 minutes. In READ NOW

Mode, the test results will be displayed in

1 minute. See Sofia Interpretation of

Results section.

Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia.

WALK AWAY Mode

READ NOW Mode

Using Sofia

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.

Reader Display

Interpretation

Flu A: Positive

Flu B: Negative

Procedural Control: Valid

Positive Test for Flu A

(influenza A antigen present)

Flu A: Negative

Flu B: Positive

Procedural Control: Valid

Positive Test for Flu B

(influenza B antigen present)

Flu A: Positive

Flu B: Positive

Procedural Control: Valid

Positive Test for both Flu A and Flu B

(influenza A and B antigen present)

Flu A: Negative

Flu B: Negative

Procedural Control: Valid

Negative Test for Flu A and Flu B

(no antigen detected)

Flu A: Invalid

Flu B: Invalid

Procedural Control: Invalid

Result Invalid

From the main menu, select

Run QC.

Follow the prompts on the screen. Scan the QC Card (located on the kit box).

Sofia prompts the user to select the desired mode (WALK AWAY or READ NOW).

Run the External Control Swabs.

Follow the Swab Test Procedure of this Quick Reference Instructions. First test the

Positive Swab, followed by the Negative Swab.

After both the Positive and Negative Swabs have been run, the results will be

displayed as “Passed” or “Failed.”

Sofia Interpretation of Results

Sofia External Quality Control (External Positive and Negative Swabs are supplied in the kit)

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.

In WALK AWAY Mode, the user immediately inserts the Test Cassette into Sofia

2. Sofia 2 scans the Test Cassette periodically during the test development time.

Positive test results will be displayed between 3 and 15 minutes. Negative test

results will be displayed at 15 minutes.

The user first places the Test Cassette onto the counter or bench top for 15 minutes

(outside of Sofia 2). The user manually times this development step. The Test Cassette

MUST remain on the bench for 15 minutes to get an accurate result. Then, the user inserts

the Test Cassette into Sofia 2. In READ NOW Mode, Sofia 2 will scan and display the test

result within 1 minute. Note: Results will remain stable for an additional 15 minutes after

the recommended development time of 15 minutes.

RUN TEST

1. Input the User ID with the integrated barcode scanner

or manually enter the data using the key pad.

NOTE: If you scan the wrong barcode, re-highlight the

field using the touchscreen on Sofia 2. The previous

one will be overwritten with the right barcode.

3. Verify that the correct mode (WALK

AWAY or READ NOW) has been

selected. Press and open the Sofia

2 drawer.

4. Insert the Test Cassette into the

drawer. Then gently close the drawer.

2. Input the Patient ID and Order # (if applicable) with

the integrated barcode scanner or manually enter the

data using the key pad.

5. Sofia 2 will start automatically and display the progress. In WALK AWAY

Mode, the test results will be displayed in approximately 15 minutes. In

READ NOW Mode, the test results will be displayed within 1 minute. See

Sofia 2 Interpretation of Results section.

Allow the test to develop for the FULL 15 minutes BEFORE placing it into Sofia 2.

Using Sofia 2

WALK AWAY Mode

READ NOW Mode

Reader Display

Interpretation

Flu A:

Flu B:

Procedural Control:

Positive Test for Flu A

(influenza A antigen present)

Flu A:

Flu B:

Procedural Control:

Positive Test for Flu B

(influenza B antigen present)

Flu A:

Flu B:

Procedural Control:

Positive Test for both Flu A and Flu B

(influenza A and B antigen present)

Flu A:

Flu B:

Procedural Control:

Negative Test for Flu A and Flu B

(no antigen detected)

Flu A:

Flu B:

Procedural Control:

Result Invalid

From the main menu,

select Run QC.

Follow the prompts on the screen. Scan the QC Card (located on the kit box).

Sofia 2 prompts the user to select the desired mode (WALK AWAY or READ NOW).

Run the External Control Swabs.

Follow the Swab Test procedure of this Quick Reference Instructions. First test the

Positive Swab, followed by the Negative Swab.

After both the Positive and Negative Swabs have been run, the results will be displayed as

or .

INTENDED USE

The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in direct nasal swab, nasopharyngeal swab, and nasopharyngeal

aspirate/wash specimens and nasopharyngeal swab and nasopharyngeal aspirate/wash specimen in transport media from symptomatic patients. This qualitative test is intended for use

as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections. The test is not intended to detect influenza C antigens. A negative test is presumptive and it

is recommended these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative results do not preclude influenza virus infections and should not

be used as the sole basis for treatment or other patient management decisions. The Sofia Influenza A+B FIA may be used with Sofia or Sofia 2.

ASSISTANCE

If Sofia, Sofia 2 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.), technicalsupport@quidel.com, or

your local distributor.

Sofia 2 Interpretation of Results