Sofia 2 is quidel s nextgeneration version of its bestselling sofia instrumented system. Sofia 2 is a bench top analyzer intended to be used wit h cassettebased immunofluorescent in. Sofia 2 fluorescent immunoassay analyzer sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Quidel sofia analyzer pdf sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Qdel quidel, a provider of rapid diagnostic testing. The test is intended for use with the sofia analyzer to aid in the assessment of vitamin d sufficiency and is the first quantitative assay on sofia.
Qdel quidel, the company, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, today filed the companys required report on form 8ka with the securities and exchange commission the commission after market close. Product description ordering information product description. User history, lot status, qc and test data will not transfer over. The sofia hcg fia is an immunofluorescencebased lateral flow test for use with the sofia analyzer sofia. Patient management should follow current cdc guidelines. Quidel s sofia 2 immunoassay analyzer received three separate awards. Once complete, it is safe to remove the usb flash drive. Detection of influenza a and b viruses with the sofia analyzer. However, in the event of a false positive result, risks to. The sofia analyzer and sofia lyme fia combine unique immunofluorescence chemistry, advanced lateral flow technology, and failure alert and failsafe systems designed to ensure reliable, objective, diagnostic results within 10 minutes of application of the patients specimen. Place sofia 2 on the counter top within reach of an electrical outlet.
This safety information sheet has been created on a voluntary basis. Quidel receives eua for molecular covid19 assay cap today. Quidel s sofia tests offer results between 315 minutes. 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. Sofia 2 is intended for professional and laboratory use. Qdel, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, announced today it has received ce mark for its sofia quantitative vitamin d fia for use with the sofia fluorescent immunoassay analyzer for the quantitative determination of total 25oh vitamin d from serum samples. The risks described in reports and registration statements that we file with the securities and. Fia employs immunofluorescence technology that is used with the sofia analyzer sofia to detect. Refer to the sofia user manual for operating instructions.
The sofia analyzer is designed to provide safe and reliable operation when used according to this user manual. Sensitivity and specificity of the quidel sofia influenza. If any item is missing or damaged, please contact quidel technical support at 800. Sofia rapid test kits are easy to use, which means sofia can be adapted to. Sofia 2 is quidel s nextgeneration version of its bestselling sofia instrumented.
March 2019 quidel has received the ce mark for its sofia quantitative vitamin d fia for use with the sofia fluorescent immunoassay analyzer for the quantitative determination of total 25oh vitamin d from serum samples. For those that need it, the file copier instructions guide provides detailed instructions on how instrument updates are copied from your pc after you download them from to your portable drive. When cloning sofia 2, all settings including test type files will transfer over. Language files yellow may not be provided in the installation pack. Follow the instructions per the sofia user manual and the external control set. One metaanalysis of 159 ridt rapid influenza diagnostic test studies evaluating 26 ridts showed pooled specificities of 98% but pooled sensitivities of only 62. Expands the pointofcare market opportunity to include freestanding eds, micro hospitals. Qdel, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, announced today that its sofia 2 pointofcare immunoassay analyzer has received special recognition from good design australia, an international design promotion organization responsible for managing australias annual good. Sofia analyzer to detect influenza virus nucleoproteins. The form 8ka amends quidel s prior report on form 8k. Quidel sofia hcg fia kinetic check feature provides operator the flexibility of upto 5 minutes before placing test cassette into sofia for analysis manufacturer. Study the package insert and user manual thoroughly before using.
Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. Update settings in order to download test type files, language files or firmware via the cloud, sofia must be set up to a specific ip address and port number. After the patient sample has been added to the test cassette. Installing test type files test files must be loaded prior to performing testing. Always operate the sofia analyzer on a surface that is level and dry and not. Quidel receives fda clearance and clia waiver for its. Page 1 of 15 sofia strep a fia intended use summary. User manual, quick start manual quidel sofia user manual 58 pages. The file copier app is part of the guided service helping you to update your quidel instrument software. Quidel sofia 2 measuring instruments quick start manual. Plug the barcode scanner into the ps2 port in the back of the analyzer. The unit is portable and can be moved to a suitable location for testing.
Sofia fluorescent immunoassay analyzer, generation 1 and 2 safety data sheet a safety data sheet is not required for this product. Plug the power adapter into the power port on the rear panel of sofia 2 and appropriate electrical outlet. With sofia 2s proprietary advance result technology art, sofia 2 can produce and store results in as few as 3 minutes, giving you, your providers and your patients an accurate result, faster than ever before. Installation instructions power supply adapters for international power supply installation instructions note. The sofia strep a fia employs immunofluorescence technology to detect group a. Sofia 2 sars antigen fia quidel corporation may 8, 2020 coronavirus disease 2019 covid19 patient management decisions. Sofia fluorescent immunoassay analyzer, generation 1 and 2. Quidel receives ce mark for its new sofiar fluorescent.
The assays were evaluated with reverse transcriptase pcr rtpcr using 411 nasopharyngeal swab specimens. The test is intended for use with the sofia analyzer to aid in the assessment of vitamin d. Sensitivity and specificity values percentages of 79. Quickstart guide study the user manual thoroughly before using the quickstart guide customer service if the sofia analyzer does not perform as expected, contact quidel technical support 800 8741517 in the u. Sd cards test type files blue, language files yellow, and blank sd card. The easytouse firstgeneration sofia analyzer and its companion assays combine unique software and fluorescent chemistry to yield an automatic, objective result that is readily available on the. Comparison of the sofia and veritor direct antigen. Pdf sensitivity and specificity of the quidel sofia. If the analyzer is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. View and download quidel sofia quick start manual online. The sofia 2 sars antigen fia has been designed to minimize the likelihood of false positive test results. Test files must be loaded prior to performing testing. Sofia 2 utilizes the original sofia s fluorescent chemistry. Place the sofia analyzer on the counter top within reach of an electrical outlet.
These diagnostic tests quickly detect fragments of proteins found on. Food and drug administration fda has issued the first emergency use authorization eua for a covid19 antigen test, a new category of tests for use in the ongoing pandemic. Quidel receives fda clearance for its pointofcare sofia. Quidel receives pmda approval for its pointofcare sofia.
Sofia is the brand name for quidel s flagship product, an instrumented immunoassay system. Sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. Turn sofia2 2 on using the power switch located on the rear panel. Sensitivity and specificity of the sofia ridt were calculated using rtpcr results as the reference standard. Qdel is a major american manufacturer of diagnostic healthcare products that are sold worldwide on may 8, 2020 the u. View online or download quidel lyme fia sofia 2 user manual. Sofia is a bench top analyzer intended to be used with cassettebased. Influenza antigen detection assays sofia fluorescent immunoassay fia and veritor yield objective results, which are potentially useful for pointofcare testing. Expands pointofcare testing opportunity into alternate site segment. Sofia s default ip address and port number figure 17 are set up to be compatible with the virena router when the router is wired directly to sofia. Qdel quidel, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, announced today that quidel has received emergency use authorization eua from the u. We have 3 quidel sofia manuals available for free pdf download. The test is intended for use with the sofia analyzer to aid in the assessment of. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy sofia instrument.1235 330 552 856 697 562 294 514 1335 7 1492 755 33 1248 1259 1520 1095 1481 522 706 505 1118 82 415 1270 118 997 1139 191 1469 106 1060 285 513