The Sofia 2 Instrument implements an industry standard ASTM1 interface for use over Ethernet networks. Sofia 2 will automatically develop the Test Cassette for the required time period (pre-programmed for each test), scan the Test Cassette periodically, and display the test result. Quidel™ Sofia™ 2 Fluorescent Immunoassay Analyzer (Fisher CatSmall bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source. Sofia 2 Fluorescent Immunoassay Analyzer collects hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. Sofia 2 Calibration Check Procedure The Calibration Check Procedure should be performed every 30 days.
Healthcare professionals can purchase the Sofia SARS Antigen FIA through select authorized distributors. What is Sofia 2 calibration? tests can when used on people in the first five. Sofia 2 is designed to provide safe and reliable operation when used according to this User Manual. · Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Quidel Sofia ® 2 analyzers and Sofia SARS Antigen FIA testing kits, with results in as little as 15 minutes, will be provided together. have an interface available for the Sofia. 1517, option 2 (in the U.
Fluorescent immunoassay analyzer (41 pages) Measuring Instruments Quidel Sofia 2 Quick Start Manual. Sofia 2 collects hundreds of data points on the test strip contained inside of a Sofia FIA Test Cassette. com to download and install the latest Software Updates, Assay and testing capabilities for your Sofia 2 Instruments.
1100 (outside the U. Sofia 2 will display the test results. Sofia 2 powers up the network card and joins the network when the instrument powers up.
The User Manual can be accessed online at. Measuring Instruments Quidel Sofia 2 User Manual. 0 CUSTOMER SERVICE If Sofia does not perform as expected, contact Quidel Technical Support 800. Sofia 2 is intended for professional and laboratory use. Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical user interface and optics system to provide an accurate, automated and objective result in as few as 3 minutes. Sofia 2 Instrument Interface Specification – Overview The scope of this document is to provide detail on the capabilities and requirements for implementing a Systems Interface between the Sofia 2 Instrument and the LIS System.
Sofia 2 instrument intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) and nasal (NS) swab specimens directly from individuals quidel who quidel sofia 2 manual are. The Sofia 2 system also comes connected to Virena, quidel sofia 2 manual Quidel’s data management system, which provides aggregated, de-identified testing data in near real-time. Note that User ID can be configured on Sofia 2 to be either required or optional. How to setup and test the Sofia 2 connection Setting up the.
8% of the total number of positives identified! All test results will be captured and deidentified data will transmit to the Centers of Disease Control easily through the Quidel cloud-based Virena ® surveillance system tied to the Sofia 2 analyzers. 7 of the infections that P.
ol ol list-style-type: lower-alpha; Physical Connections to the Sofia The data connection to the Sofia is via the RJ45 connector located on the back side of the Sofia. From the Main menu, tap Run Calibration, Patient Test, or QC to send a result to the Virena cloud and confirm the connection. This Calibration Cassette is supplied with Sofia 2. The Sofia SARS Antigen FIA, with the Sofia 2 and Sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of COVID-19/-nCoV in near-patient testing environments.
ManualsLib. Sofia 2 is now connected to the Virena cloud. How to setup and test the Sofia connection Setting up the Sofia for. Measuring Instruments Quidel Sofia 2 Quick Start Manual 6 pages. 9% of the positives) at 15 minutes. The Sofia 2 SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization. Manuals and User Guides for QUIDEL Sofia. If Sofia 2 is used in a manner not specified in the User Manual, the protection provided by the equipment may be impaired.
· The new approval is specifically for Quidel’s Sofia 2 SARS Antigen FIA. Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet LED energy source. Running Patient Specimens On Your Sofia 2 Get Started. The patient sample sofia is dispensed into the Test Cassette and the Test Cassette is immediately placed in Sofia 2. Refer to the Sofia 2 User Manual for. Sofia 2 can quidel sofia 2 manual be set to remind the user to complete the Calibration Check Procedure. To find out if you can interface the Sofia directly to your systems, the simplest way is to contact your LIS vendor and ask. Page 10 Clean Sofia 2 per the Maintenance and Cleaning section of this User Manual prior to return or disposal.
Summary of Contents for Quidel Sofia Page 1: Customer Service QuickStart Guide Study the User Manual thoroughly before using the QuickStart Guide Software v. The Calibration Check is a required function that checks Sofia 2 optics and calculation systems using a specific Calibration Cassette. If a replacement QC Card is needed, please contact Quidel Technical Support at 800. Introduction The Sofia Analyzer is a benchtop instrument intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays manufactured by Quidel Corporation. Fluorescent immunoassay analyzer. Please refer to Sofia 2 User Manual and assay Package Inserts for specific information Allison Leone, Director New Market Development Cheryl Miller, Vice President New Market Development Quidel’s commitment to this program represents our latest efforts in fulfilling an unwavering commitment to the community.
Sofia 2 must be disposed of in a safe and compliant manner. Published on, 10:23 AM EDT. Quidel Sofia 2 Manuals & User Guides. If the connection is unsuccessful, contact Technical Support. Study the User Manual thoroughly before using the QuickStart Guide. View online Operation & user’s manual for Quidel Sofia 2 Measuring Instruments or simply click Download button to examine the Quidel Sofia 2 guidelines offline on your desktop or laptop computer. We have 3 QUIDEL Sofia manuals available for free PDF download: User Manual, Quick Start Manual Quidel Sofia User Manual (58 pages).
Sofia 2 with specific information including kit lot and expiration date. The Sofia Analyzer can be used in the laboratory or point-of-care settings. Use the Barcode Scanner to scan the barcode from a User&39;s ID Card or tap User ID field to manually enter the data using the onscreen keyboard on Sofia 2. Quidel designed the Sofia 2 for easy replacement of the Sofia and therefore include the standard “ASTM interface” in quidel sofia 2 manual the Sofia 2. Quidel Sofia®2 with advance result technology delivering accurate, objective and automated results in as few as three minutes. — With assistance by Katerina Petroff. What is Sofia 2 test cassette? Enter the Patient ID.
1%), and 50 more (only 6. ol ol list-style-type: lower-alpha; Physical Connections to the Sofia 2 The data connection to the Sofia 2 is via the RJ45 connector located on the back side of the Sofia 2. Quidel Corporation - Sofia 2 Influenza A+B FIA Starter Kit, Includes: (1) Leased Sofia, (1) Install Pack and (1) Flu Kit, 25 tests/kt (Distributor Agreement Required - (See Manufacturer Details Page) (US Only) (DROP SHIP ONLY) Consult your Quidel representative for a listing of approved Sofia assays. Quidel Lyme FIA Sofia 2 Pdf User Manuals. Most of the popular LIS vendors in the U. The Sofia’s instruction manual claims that the product can detect 96.
Sofia 2 utilizes the original Sofia’s fluorescent chemistry design while improving upon the graphical. · Quidel’s Sofia rapid coronavirus test. Sofia 2 is designed to provide safe and reliable operation when used according to this User Manual. 0%), 645 by 8 minutes (88.
Sofia powers up the network card only when testing the connection or sending results. View online or download Quidel Lyme FIA Sofia 2 User Manual. The Sofia 2 "Home" screen is the "Run Test" screen.
As shown in the last two columns in Table 1, a total of 574 positive results had been identified by 5 minutes (79. Sofia 2 is a bench top analyzer intended to be used with Cassette-based immunofluorescent in vitro diagnostic assays manufactured by Quidel Corporation. Industrial Equipment. The Sofia 2 SARS Antigen FIA is intended for use by medical professionals or trained operators who are proficient in performing tests using the Sofia 2 Instrument. User Manuals, Guides and Specifications for your Quidel Sofia 2 Measuring Instruments. View online Quick start manual for Quidel Sofia 2 Measuring Instruments or simply click Download button to examine the Quidel Sofia 2 guidelines offline on your desktop or laptop computer.
Applicable Federal, State and Local regulatory requirements shall be followed to ensure Sofia 2 is not disposed of as municipal waste. If Sofia 2 does not perform as expected, contact Quidel Technical Support 800. In this mode, the User dispenses the patient sample into the Test Cassette and then immediately inserts the Test Cassette into Sofia 2. 7%), 677 within 10 minutes (93. Page 11: Introduction. Get the latest updates: After your Sofia 2 has been setup register your Sofia 2 instrument at MyQuidel.
· Of 727 positive test results, 326 were reported by Sofia 2 in 3 minutes—44. Use a standard Ethernet cable to connect the Sofia 2 to your LAN. The Sofia 2 SARS Antigen FIA should be used with Sofia 2. How to scan barcodes on Sofia 2?
· Sofia 2 is Quidel’s next-generation version of its best-selling Sofia instrumented system. Use a standard Ethernet cable to connect the Sofia to your LAN. The assay is currently available for sale in the United States under EUA, and Quidel is now shipping the product to its customers.
Sofia 2 will read the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. How does Sofia 2 work? How to buy Reach out to our team for ordering information. ), com or your local distributor.
Database contains 2 Quidel Sofia 2 Manuals (available for free online viewing or downloading in PDF): Quick start manual, Operation & user’s manual.
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