QUIDEL Rapid Test Kit Sofia® Strep A+ FIA Fluorescence Immunoassay (FIA) Strep A Test Throat Swab Sample(POC) 25 Tests/Kit

Product Features & Benefits:

• Results in 5 minutes:Fast time to results for truly rapid strep testing.
• Self-contained test cassette.
• Clean, easy to use and dispose of.
• Fixed-volume pipette.
• Collects and dispenses correct amount of sample needed for testing.
• Objective result.
• Eliminates the subjectivity of a visual result.
• All components included in kit.
• Ready to use with Sofia or Sofia 2, no need for additional equipment.
• Room temperature storage.
• No refrigerator space needed. No need to wait for reagents to warm up. Rapid strep tests can be run immediately as needed.

Product Specifications:

• Sample type: Throat swab
• Time to results: 5 minutes
• Kit storage conditions: Room temperature (15°C to 30°C / 59°F to 86°F)
• Controls: Positive and negative
• Sensitivity*: 93.7%
• Specificity*: 94.4%
• Shelf life: 24 months from date of manufacture
• CLIA complexity: Waived

SKU: QUI 20274

Below is a link to Package Insert

https://www.quidel.com/sites/default/files/product/documents/EF1347101EN00.pdf

Please refer to CLI below:

https://www.quidel.com/sites/default/files/product/documents/CL1347100EN01.pdf

Below is a link to Instruction for Use "IFU"  and Quick Reference Guide.

https://www.quidel.com/sites/default/files/product/documents/EF1347200EN00.pdf

Please refer to FAQs

https://www.quidel.com/sites/default/files/product/documents/FQ2027404EN00.pdf

Below is a link to Safety Data Sheet

Warnings and Precautions:

• For in vitro diagnostic use only.
• For prescription use only.
• This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.§263a, to perform moderate, high or waived complexity tests. This product 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.
• Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
• This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens.
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
• Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories.
• Do not use kit past its expiration date.
• Do not store or test specimens in viral transport media, as it may result in false positive or false negative results.
• It is recommended that personal protection equipment and gloves (not provided) be worn when running each test and handling patient specimens.
• The Extraction Solution in this kit contains a detergent and a preservative that will inactivate cells and virus particles. Samples eluted in this solution are not suitable for culture.
• Test Devices are single use only and should be discarded after use. Do not re-use the Test Device.
• Proper sample collection, storage and transport are essential for correct results. Specimens should be prepared in accordance with the instructions provided in the "Specimen Collection and Storage" section.
• Excess blood or mucus on the swab specimen may interfere with test performance, potentially yielding an inaccurate result. Avoid touching any bleeding areas of the nasopharynx when collecting specimens.
• Users should test specimens as quickly as possible after specimen collection