Product Overview
The Respiratory Test Kit Sofia® SARS Antigen FIA 25 Tests CLIA Waived is part of ARG Medical's medical supply catalog, manufactured by QUIDELORTHO SALE.
ARG Medical is a Service-Disabled Veteran-Owned Small Business (SDVOSB) supplying hospitals, VA facilities, and government agencies. Bulk and government pricing available.
Features
- Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration's Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Product ships with minimum 30 days dating
- 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 SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2
- 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 positive results 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
- Rapid results in 15 minutes to support efficient dispositioning of patients
- Objective, accurate results without cross-reactivity to seasonal coronaviruses
Specifications
| Application | Respiratory Test Kit |
| 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, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card |
| For Use With | For use with Sofia / Sofia 2 Instrument |
| Number of Tests | 25 Tests |
| Product Dating | McKesson Acceptable Dating: we will ship >= 30 days |
| Purchase Program Type | Standard Purchase |
| Reading Type | Machine Read |
| Sample Type | Nasal Swab / Nasopharyngeal Swab Sample |
| Specialty | Immunoassay |
| Technology | Immunofluorescent Sandwich Assay |
| Test Format | Cassette Format |
| Test Kit Type | Rapid |
| Test Name | SARS Antigen FIA |
| Test Type | Fluorescence Immunoassay (FIA) |
| Time to Results | 15 Minute Results |
Supplied by the kit (KT).
