- A significant test that gained prominence during the COVID-19 pandemic because it allows for the simultaneous detection and differentiation of three important respiratory viruses from a single patient sample:
- Influenza A
- Influenza B
- SARS-CoV-2 (the virus that causes COVID-19)
Key Features:
- Triple Threat Detection:
- Primary purpose is to help healthcare providers quickly distinguish between influenza A, influenza B, and COVID-19 infections, especially during flu season when symptoms can overlap
- This allows for more targeted treatment and infection control measures
- Fluorescent Immunoassay (FIA):
- Similar to other Sofia tests, it utilizes advanced immunofluorescence-based lateral flow technology
- This means the test results are read and interpreted by a dedicated instrument, the Sofia 2 Analyzer, providing objective and automated results
- This generally offers higher sensitivity and accuracy than visually-read rapid tests
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Rapid Results:
- Results are typically available in 15 minutes
- For SARS-CoV-2, positive results can sometimes appear even faster, as quickly as 3 minutes on the Sofia 2 Analyzer (though the official time to result is 15 minutes for confirmation)
- CLIA Waived:
- This designation makes the test suitable for use in a wide range of point-of-care (POC) settings, such as physician's offices, urgent care clinics, and other facilities with a CLIA Certificate of Waiver
- Sample Type:
- It is authorized for use with direct nasal swab and nasopharyngeal swab specimens
- Emergency Use Authorization (EUA):
- At the time of the COVID-19 pandemic, this test was authorized by the FDA under an Emergency Use Authorization (EUA)
- While some aspects of the EUA framework have evolved, many of these tests continue to be vital tools for diagnostics
- Objective and Accurate:
- The instrument-read fluorescent technology removes subjective interpretation, leading to more consistent and reliable results
- It is designed to have good sensitivity and specificity for each of the target viruses
- Convenient Storage:
- The kits can typically be stored at room temperature (15°C to 35°C / 59°F to 86°F), making them easy to store in clinical environments
- Complete Kit:
- A single kit contains all the necessary components for 25 tests, including test cassettes, reagent tubes, reagent solution, sterile nasal swabs, fixed-volume pipettes, and control swabs (positive Flu A+B+SARS, negative)
