Quidel Sofia™ 2 SARS Antigen Fluorescent Immunoassay (FIA)

$875.00

⚕️For Professional Use Only ⚕️

  • Rapid results in 15 minutes to support efficient dispositioning of patients
  • Objective, accurate results without cross-reactivity to seasonal coronaviruses
  • Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode
  • Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays
  • Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping.
  • Fluorescent technology with automated read eliminates the subjectivity of a visual result
  • All necessary components included in kit, ready for use for nasal swab procedure
  • Self-contained Test Cassette that is clean, easy to use and dispose of

 

Quantity: 25 tests per box

Category:

Description

For use with Sofia 2 and Sofia – FDA Emergency Use Authorization

The Sofia SARS Antigen Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from SARS-CoV-2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/2019-nCoV in near-patient testing environments.

Healthcare professionals can purchase the Sofia SARS Antigen FIA through select authorized distributors.

Features & Benefits

Feature Benefit

Results in 15 minutes

Rapid results to support efficient dispositioning of patients.

Objective, accurate results

Reliable results without cross-reactivity to seasonal coronaviruses.

Dual work modes

Adjusts to your volume fluctuations. Allows for significant throughput and batching of samples in READ NOW Mode.

Easy to use

Simple test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays.

Virena connection

Provides automated tracking, data capture, government reporting, and exclusive disease mapping.

Fluorescent technology with automated read

Objective result that eliminates the subjectivity of a visual read.

All necessary components included in kit

Ready for use with Sofia 2 and Sofia for nasal swab procedure.

Self-contained Test Cassette

Clean, easy to use and dispose of.

Product Specifications

Time to results

15 minutes
Sample type

Direct nasal/nasopharyngeal swabs
Kit storage conditions

Room temperature (15°C to 35°C / 59°F to 86°F)
Controls

Positive and negative, included in kit
PPA

96.7%
NPA

100%
CLIA complexity

CLIA waived*
*fda.gov: The settings in which an EUA-authorized test may be used are described in the Letter of Authorization. As discussed in the Guidance for Industry and Other Stakeholders: Emergency Use Authorization of Medical Products and Related Authorities, when the FDA authorizes tests for use at the point of care (including SARS-CoV-2 point of care test systems) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Additional information

Weight .75 kg
Dimensions 8 × 5 × 3 cm

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    $675.00     Add to cart

    ⚕️For Professional Use Only ⚕️

    Rapid results in 2-10 minutes

    Sensitivity of IgM test 1s 87.9% (87/99) and specificity is 100% (14/14) when compared to RT-PCR

    Sensitivity of IgG test is 97.2% 35/36 during the convalescence period, ands specificity is 100% (14/14)

    Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days

    Kit can be stored at room temperature or refrigerated (2-30°C) for up to 24 months from manufacture date

    Disclosure:
    The test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. On 3/23/20, the FDA acknowledged receipt of the necessary intent to launch notices for this testing kit so it may be utilized under the FDA’s Emergency Use Authorization.  For additional information regarding the FDA’s EUA for In Vitro Diagnostic Products, please visit this link.

    Quantity: 25 tests per box

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In accordance with FDA Policy for Diagnostic Tests for Coronavirus Disease-2019, we are not selling tests to the general public at this time. Please review our Terms and Conditions & Privacy Policy at Checkout and confirm you are an eligible purchaser. All orders are being evaluated due to stricter FDA guidelines. If we deem your order is not for professional use then a refund will be given and your order will be cancelled. On 3/23/20, the FDA acknowledged receipt of the necessary intent to launch notices for this testing kit so it may be utilized under the FDA’s Emergency Use Authorization.  For additional information regarding the FDA’s EUA for In Vitro Diagnostic Products, please visit this link. This test’s EUA Submission Number is EUA200056.