The Sofia Strep A FIA uses immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients. This test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection. It is important to note that all negative test results should be confirmed by bacterial culture, as negative results do not rule out Group A Strep infection and should not be the sole basis for treatment.

Group A Streptococcus is a common cause of acute upper respiratory tract infections. Early diagnosis and treatment of Group A Streptococcal pharyngitis are crucial in reducing the severity of symptoms and preventing serious complications like rheumatic fever and glomerulonephritis. Conventional identification methods typically require 24 to 48 hours for results.

The Sofia Strep A FIA employs immunofluorescence technology used with the Sofia analyzer (Sofia) to detect Group A Streptococcal antigen. The process involves extracting the antigenic components of the Group A Streptococcus (GAS) bacteria from the patient's swab specimen. The specimen is placed in the Reagent Tube containing the Reagent Solution, allowing the bacterial antigens to be extracted. An aliquot of the extracted specimen is then dispensed into the Cassette sample well, where it migrates through a test strip containing specific chemical environments. If Group A Streptococcal antigens are present, they are bound by antibodies coupled to fluorescent microparticles that migrate through the test strip and are detected by Sofia.

Features:

• Results in 5 minutes for truly rapid testing.
• Self-contained test cassette for easy use and disposal.
• Fixed-voume pipette ensures the correct amount of sample is collected and dispensed.

Kit Includes:

• (25) Individually Packaged Cassettes
• (25) Reagent Tubes
• (25) Reagent Solution
• (25) Fixed Volume Pipettes
• (1) Positive Control Swab
• (1) Negative Control Swab
• (1) Printer Paper
• (1) Package Insert
• (1) Quick Reference Instructions
• (1) QC Card

Warnings and Precautions:

• For in vitro diagnostic use.
• Do not use the kit contents beyond the expiration date printed on the outside of the box.
• Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.
• Use of Nitrile or Latex (or equivalent) gloves is recommended when handling patient samples.
• Dispose of containers and used contents in accordance with Federal, State and Local requirements.
• Do not reuse any used Cassettes, Reagent Tubes, Fixed Volume Pipettes, solutions, or Control Swabs.
• The user should never open the Foil Pouch of the test Cassette exposing it to the ambient environment until the Cassette is ready for immediate use.
• Discard and do not use any damaged Cassette or material.
• The Reagent Solution contains an acidic solution. If the solution contacts the skin or eye, flush with copious amounts of water.
• Testing should be performed in an area with adequate ventilation.
• The Reagent Solution Bottle contains glass, break cautiously.
• If the Reagent Solution Bottle is missing the glass ampoule or the solution is green prior to the breaking of the ampoule, discard and use another Reagent Solution Bottle.
• To obtain accurate results, the Package Insert instructions must be followed.
• The Calibration Cassette must be kept in the provided storage pouch between uses.
• Inadequate or inappropriate specimen collection, storage, and transport may yield false test results.
• Specimen collection and handling procedures require specific training and guidance.
• If transport media will be used, use only the Transport Media and configuration recommended in this Package Insert.
• Use rayon-tipped swabs to collect throat specimens. The performance claims in the Performance Characteristics section were obtained with the Swabs provided in the kit. Use of the provided Swabs is recommended. Do not use calcium alginate, cotton-tipped or wooden shaft swabs.
• Do not write on the barcode of the Cassette. This is used by Sofia to identify the type of test being run and to identify the individual Cassette so as to prevent a second read of the Cassette by the same Sofia.
• Once a Cassette has been successfully scanned by Sofia, do not attempt to scan the Cassette again in the same Sofia. The barcode on the Cassette contains a unique identifier that will prevent Sofia from performing a second read on a previously scanned Cassette.
• As the detection reagent is a fluorescent compound, no visible results will form on the test strip. Sofia must be used for result interpretation.

Storage:

Store the kit at room temperature, 59°F to 86°F (15°C to 30°C), out of direct sunlight. Kit contents are stable until the expiration date printed on the outer box. Do not freeze.

• The product warranty is applicable as per the terms and conditions provided by the product manufacturer.

Please call us for specific details.

• No returns will be accepted after 30 days from the date of shipment.
• All returns are subject to a restocking fee as per manufacturers terms and conditions.
• All returns must have an RGA number (Returned Goods Authorization), unauthorized returns will not be accepted.
• We do not guarantee fulfillment of any desired purpose or product suitability to the user and this will not be considered as a valid reason for return.
• The products must be new, unused condition, not tampered with, in original packaging and returned at the customers expense in the original packaging.
• If your return is not due to any manufacturing defect then the original shipping cost will be deducted from the total refund.
• Hygiene, bath and toilet items cannot be returned once opened or used.
• Standard manufacturer terms and conditions apply for return policy of this product.

Please call us for specific details.