- Condition: Factory New
- Weight: 12.88 lb
- Rapid results in 15 minutes to support efficient dispositioning of patients
- Dual work modes adjust to your volume fluctuations and allows for significant throughput and batching of samples in Read Now mode.
- Kit includes 25 individually packaged test cassettes; 25 reagent tubes; 25 ampules of reagent solution; 25 sterile nasal swabs; 25 120-µl fixed volume pipettes; positive control swab; negative control swab; package insert; quick reference instructions and QC card.
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Learn more:
- MFR: Quidel Ships from MFI Medical
- MPN: 20374
Frequently asked questions
Does this test eliminate subjective interpretation errors?
Yes. The Sofia SARS Antigen FIA utilizes automated fluorescent technology on the Sofia or Sofia 2 instrument, which removes the subjectivity inherent in visual test reading to provide consistent, objective results.
How quickly can I obtain diagnostic results?
This system is designed for high-efficiency environments, delivering accurate and objective test results in just 15 minutes.
Can this handle high testing volumes effectively?
Absolutely. The system features a versatile dual-work mode that allows clinical staff to switch between individual testing and high-throughput batching using the “READ NOW” functionality to accommodate fluctuating sample volumes.
Are all necessary consumables included in the kit?
Yes, each kit is comprehensive and includes everything needed for 25 tests, such as:
- 25 Individually packaged test cassettes
- 25 Reagent tubes and ampoules of reagent solution
- 25 Sterile nasal swabs
- 25 Fixed volume pipettes
- Positive and negative control swabs
Is this kit compatible with electronic data reporting?
Yes, the system is fully compatible with Virena, an automated data integration platform that facilitates efficient data capture, governmental reporting, and disease mapping.
What type of clinical settings can use this?
This kit is intended for professional use in environments certified under CLIA for moderate, high, or waived complexity tests, making it ideal for point-of-care clinical settings.
Which sample types are accepted for this assay?
The assay is validated for the detection of SARS viral antigens using either nasal swabs or nasopharyngeal swabs.
Does this product meet high manufacturing standards?
Yes, this product is proudly manufactured in the United States and is both BAA (Buy American Act) and TAA (Trade Agreements Act) compliant.
Is there a storage requirement I should know about?
The product is shipped with a guaranteed minimum of 60 days of dating on the shelf life to ensure optimal performance upon delivery.
Are there specific requirements for interpreting the results?
Yes. As this is an RX-only, in vitro diagnostic product, all test results must be interpreted by trained healthcare professionals in the context of the patient’s specific clinical history and symptomatic presentation.