Respiratory Test Kit Sofia 2 Flu + SARS Antigen FIA 25 Tests CLIA Waived

Key Features

SKU: QDE-20377
Condition: Factory New
Learn more:

Contact The Manufacturer

MFR: Quidel Ships from MFI Medical
MPN: 20377

$7,554.13

Special Order Item

Est. Delivery:

Quantity

<p>Earn%20[points_amount]%20when%20completing%20this%20purchase.</p>

Shop with Confidence

+

Description

For use on Sofia 2 analyzers ONLY - test cannot be run on a Sofia 1 analyzer; reach out to your account manager with any analyzer questions or requests
Sofia 2 Flu + SARS Antigen FIA is for use under an FDA EUA:
Product ships with minimum 60 days dating
Emergency use of this test 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 high, moderate or waived complexity tests
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
The Sofia 2 Flu + SARS FIA is intended to be used with direct nasal or nasopharyngeal swabs and is not validated for use with viral transport media
The test is intended for use in the simultaneous rapid in vitro detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens
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
Laboratories within the United States and its territories are required to report all SARS-CoV-2results to the appropriate public health authorities
Negative results do not rule out COVID-19 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
Negative SARS-CoV-2 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed
The Sofia 2 Flu + SARS Antigen FIA is intended for use on the Sofia 2 only and by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument; the Sofia 2 Flu + SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization
Accurate detection with direct samples
Results in 15 minutes
12-month shelf life from date of manufacture
This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
Room temperature storage

Product Specs

Item Number	1177399
Catalog Number	20377
UOM	CS
Level 1 Family Description	Lab-Waived Lab
Level 2 Category Description	Lab-Respiratory Testing
Level 3 Group Description	Combo Tests
Level 4 Sub-Category Description	Flu-COVID Reader Testing
Application	Respiratory Test Kit
Brand	Sofia 2
Buy American Act (BAA) Compliant	Yes
CLIA Classification	CLIA Waived
CLIA Classified	CLIA Waived
Contents 1	(25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Flu + SARS Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card
Country of Origin	United States
For Use With	For use with Sofia 2 Fluorescent Immunoassay Analyzer
Is_ECAT	N
Is_GSA	Y
Is_VA	N
Manufacturer	Quidel
Manufacturer #	20377
McKesson #	1177399
Number of Tests	25 Tests
Purchase Program Type	Standard Purchase
Reading Type	Machine Read
Sample Type	Nasal Swab Sample
Specialty	Immunoassay
Test Format	Cassette Format
Test Kit Type	Rapid
Test Name	Flu + SARS Antigen FIA
Test Type	Fluorescence Immunoassay (FIA)
Time to Results	15 Minute Results
Trade Agreement Act (TAA) Compliant	Yes
UNSPSC Code	41116144

Frequently asked questions

Does this test detect multiple viruses simultaneously?

Yes, this kit is designed for the simultaneous detection and differentiation of three major respiratory pathogens in a single procedure:

SARS-CoV-2
Influenza A
Influenza B

How quickly can I expect diagnostic results?

The Sofia 2 Flu + SARS Antigen FIA is engineered for efficiency, providing accurate test results in just 15 minutes.

Is this kit suitable for high-precision diagnostic environments?

Absolutely. It utilizes advanced Fluorescence Immunoassay (FIA) technology, which is calibrated specifically for the Sofia 2 platform to ensure high-precision results in professional clinical settings.

Are all necessary components included for quality control?

Yes, the kit is a complete diagnostic package. It includes:

25 individually packaged test cassettes and reagent tubes.
Positive and negative control swabs to ensure accurate quality control and reliable performance.

Are there specific storage requirements for this kit?

The kit is designed for convenience and ease of storage. It is stable at room temperature, eliminating the need for specialized cold-chain refrigeration.

Is this kit compatible with older analyzer systems?

No, this specific test is engineered for use exclusively with the Sofia 2 analyzer. It is not compatible with the older Sofia 1 system.

Does the kit support professional regulatory compliance?

Yes, this is a CLIA-waived kit, making it suitable for diagnostic workflows in both moderate complexity and waived environments. It is also FDA EUA Authorized.

What type of patient samples can be used?

The test is validated for use with direct nasal or nasopharyngeal swabs. Please note that the test is not validated for use with viral transport media.

Is this product manufactured in the United States?

Yes, this product is proudly manufactured in the United States and is fully BAA/TAA compliant.

Is there a recommended shelf life for this product?

The kits have a stable shelf life of 12 months from the date of manufacture, providing flexibility for clinical inventory management.