Product Manual

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

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Sofia SARS Antigen FIA Page 1 of 22

For use under the Emergency Use Authorization (EUA) only

For in vitro diagnostic use

INTENDED USE

The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and

Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2

in direct anterior nasal swab specimens from individuals who are either suspected of COVID-19 by their

healthcare provider within the first five days of the onset of symptoms, or from individuals without symptoms

or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least

24 hours and no more than 36 hours between tests. 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. This test is authorized for use at the Point of Care (POC),

i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or

Certificate of Accreditation.

The Sofia SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2.

Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable

in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of

viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to

determine infection status. Positive results do not rule out bacterial infection or co-infection with other

viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States

and its territories are required to report all results to the appropriate public health authorities.

Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection, and should not be

used as the sole basis for treatment or patient management decisions, including infection control decisions.

Negative results should be considered in the context of a patient’s recent exposures, history and the presence

of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary,

for patient management. For serial testing programs, additional confirmatory testing with a molecular test for

negative results may be necessary, if there is a high likelihood of SARS-CoV-2 infection, such in an individual

with as a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high

prevalence of infection. Additional confirmatory testing with a molecular test for positive results may also be

necessary, if there is a low likelihood of SARS-CoV-2 infection, such as in individuals without known exposures

to SARS-CoV-2 or residing in communities with low prevalence of infection.

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 and Sofia 2 instruments. The Sofia

SARS Antigen FIA is only for use under the Food and Drug Administration’s Emergency Use Authorization.

Summary of content (22 pages)

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For use under the Emergency Use Authorization (EUA) only For in vitro diagnostic use INTENDED USE The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab specimens from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or from individua
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The Sofia SARS Antigen FIA should be used with Sofia or Sofia 2. SUMMARY AND EXPLANATION SARS-CoV-2, also known as the COVID-19 virus, was first identified in Wuhan, Hubei Province, China December 2019. This virus, as with the novel coronavirus SARS-1 and MERS, is thought to have originated in bats, however the SARS-CoV-2 may have had an intermediary host such as pangolins, pigs or civets.
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◼ Sofia or Sofia 2 Calibration Cassette (for use with either Sofia or Sofia 2) ◼ Sofia SARS Antigen Control Swab Set for additional QC (20384) WARNINGS AND PRECAUTIONS ◼ For in vitro diagnostic use. ◼ For prescription use only ◼ This product has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests.
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KIT STORAGE AND STABILITY Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable until the expiration date printed on the outer box. Do not freeze. QUALITY CONTROL There are three types of Quality Control for Sofia and Sofia 2 and the Test Cassette: Sofia Calibration Check procedure, built-in procedural control features, and External Controls. Sofia Calibration Check Procedure NOTE: This is a “Calibration Check” procedure.
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The Calibration Check is a required function that checks Sofia 2 optics and calculation systems using a specific Calibration Cassette. This Calibration Cassette is supplied with Sofia 2. Refer to the Sofia 2 User Manual for details regarding the Calibration Check Procedure. Important: Ensure that the Calibration Cassette is stored in the provided storage pouch between uses to protect from exposure to light. 1. To check the calibration of Sofia 2, select “Run Calibration” from the Main Menu. 2.
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For example: This display shows an invalid result on Sofia. For example: This display shows an invalid result on Sofia 2. External Quality Control External Controls may also be used to demonstrate that the reagents and assay procedure perform properly.
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If both the Positive and Negative Controls fail, repeat testing with new Positive and Negative Controls a second time. If only a single Control fails, the user has the option of repeating both the Positive and Negative Controls OR to repeat only the Control that failed. The user may select “Skip” on the Sofia display or on the Sofia 2 display to skip the Control test that previously passed. The QC Results will show a skipped Control test as “unknown” or on Sofia 2.
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4. Roll the swab head against the inside of the Reagent Tube as you remove it. Dispose of the used swab in your biohazard waste. 5. Fill the provided Small, Clear 120 µL Fixed Volume Pipette with the 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 patient sample. c) With the Pipette tip still in the patient sample, slowly release pressure on bulb to fill the Pipette. 6.
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Warning: Results must not be interpreted past 30 minutes after inoculation. Using the Sofia or Sofia 2 past this time may result in false results. Tips for Batch Testing Depending on the workload, several options exist to make batch testing easier. The user can add the Reagent Solution to one or more Reagent Tubes, recap them, and store them on the bench at room temperature (RT) for up to 6 hours without loss of activity before adding the sample(s).
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3. Press Start Test and the Sofia drawer will automatically open. 4. Verify that the correct development mode, WALK AWAY or READ NOW, has been selected. Insert the prepared patient Test Cassette into the drawer of Sofia and close the drawer. 5. Sofia will start automatically and display the progress, as shown in the example below. In WALK AWAY Mode, the test results will be displayed on the screen in approximately 15 minutes.
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Positive Results: For example: This display shows a valid positive result for SARS. NOTE: A positive result does not rule out co-infections with other pathogens. Negative Results: For example: This display shows a valid negative result for SARS. Note: Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
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RUN TEST WITH SOFIA 2 1. Input the User ID using the integrated barcode scanner or manually enter the data using the on-screen key pad. NOTE: If you mistakenly scan the incorrect barcode, select the field again to re-highlight it. Then simply rescan using the correct barcode, and the previous one will be overwritten with the correct barcode. 2. Input the Patient ID and Order #, if applicable, using the barcode scanner or manually enter the data using the on-screen key pad. 3.
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4. Insert the prepared Test Cassette into the drawer of Sofia 2 and close the drawer. 5. Sofia 2 will start automatically and display the progress, as shown in the example below. In WALK AWAY Mode, the test results will be displayed on the screen in 15 minutes. In READ NOW Mode, the test results will be displayed on the screen within 1 minute. See Sofia 2 Interpretation of Results section. For example: This display shows that the test in WALK AWAY Mode has 12 minutes, 34 seconds remaining.
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Negative Results: For example: This display shows a valid negative result for SARS. NOTE: Negative results should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed.
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◼ Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result. ◼ Test results must be evaluated in conjunction with other clinical data available to the physician. ◼ Positive test results do not rule out co-infections with other pathogens. ◼ Positive test results do not differentiate between SARS-CoV and SARS-CoV-2. ◼ Negative test results are not intended to rule in other non-SARS viral or bacterial infections.
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1 The letter of authorization refers to “authorized laboratories” as: “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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Sofia SARS Antigen FIA Assay Reference Extracted RT-PCR assay POS NEG Total POS 29 0 29 NEG 1 179 180 Total 30 179 209 PPA NPA PPV NPV Prevalence 96.7% 100.0% 100.0% 99.4% 14.4% 95% CI 83.3% 99.4% 97.9% 100.0% 88.3% 100.0% 96.9% 99.9% 10.2% 19.8% The performance of this test has not yet been clinically validated for use in patients without signs and symptoms of respiratory infection or for serial screening applications, and performance may differ in these populations.
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4. LoD Comparison between Sofia and Sofia 2 Instruments To compare the LoD between the Sofia and Sofia 2 a study was performed using concurrent testing of 1x and 2x LoD concentrations (1.13 x102 and 2.26 x102, respectively) of heatinactivated SARS-CoV-2. The two instruments generated matching LoDs of TCID50 2.26 x102 in this study.
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Cross-Reactivity: Sofia SARS Antigen FIA – Wet testing Source/ Cross-Reactive Interference Strain Concentration Virus/Bacteria/Parasite* Sample type Results** Results** 6 Streptococcus 2.26 x 10 Z022; 19f Isolate Negative Positive pneumoniae cfu/mL 6.37 x 106 Bordetella pertussis A639 Isolate Negative Positive cfu/mL Pneumocystis jirovecii-S. 1.56 x 106 W303-Pji Isolate Negative Positive cerevisiae Recombinant cfu/mL *Coronavirus HKU1 was not tested for cross-reactivity due to lack of availability.
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ASSISTANCE If you have any questions regarding the use of this product or if you want to report a test system problem, please call Quidel Technical Support at 800.874.1517 (in the U.S.) or 858.552.1100, Monday through Friday, from 7:00 a.m. to 5:00 p.m., Pacific Time. If outside the U.S. contact your local distributor or technicalsupport@quidel.com. Test system problems may also be reported to the FDA through the MedWatch medical products reporting program (phone: 800.FDA.1088; fax: 800.FDA.
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GLOSSARY _________________________________________________________________________________ Sofia SARS Antigen FIA Page 21 of 22
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REFERENCES 1 2 3 4 Baker, S., Frias, L., and Bendix, A. Coronavirus live updates: More than 92,000 people have been infected and at least 3,100 have died. The US has reported 6 deaths. Here's everything we know. Business Insider. March 03, 2020. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/events-as-they-happen Clinical and Laboratory Standards Institute. Viral Culture; Approved Guidelines.