The sofia analyzer can be used in the laboratory or pointofcare settings. Sofia 2 sars antigen fia pointofcare test offers positive results in 15 minutes quidel corporation nasdaq. Quidel, adenoplus test, adeno detector, detecor plus tear fluid quidel corporation 87809qw quidel corporation, quickvue adenoviral conjunctivitis test tear. Proven lateralflow technology and proprietary advanced fluorescence chemistry and assay development techniques are all integrated into two small bench top analyzers that can be used near patient and in laboratory settings. The sofia analyzer scans the test strip and displays the. Influenza antigen detection assays sofia fluorescent immunoassay fia and veritor yield objective results, which are potentially useful for pointofcare testing. The sofia analyzer will then read the cassette and determine if there is a fluorescent signal in the rsv a or rsv b location on the nitrocellulose strip. Quidel sofia analyzer small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Qdel is a major american manufacturer of diagnostic healthcare products that are sold worldwide on may 8, 2020 the u. Quidel corporation san diego, ca received fda clearance for its new benchtop fluorescent immunoassay analyzer, the sofia, a device designed for rapid diagnoses of infectious diseases using.
The assays were evaluated with reverse transcriptase pcr rtpcr using 411 nasopharyngeal swab specimens. This test uses a lateral flow design with locationdependent lines and zones. Path path to directoryfiles to be scanned optional arguments. Qdel is a major american manufacturer of diagnostic healthcare products that are sold worldwide.
Plug the barcode scanner into the ps2 port in the back of the analyzer. Sensitivity and specificity values percentages of 79. Quidel corporation quidel receives emergency authorization. Most logical call points hospital and physician office labs, urgent care. Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic. Food and drug administration fda to market its sofia 2. The cassette houses the lateral flow strip and has a laser printed 2d barcode label containing lot and.
Detection of influenza a and b viruses with the sofia analyzer. See the using the sofia a firmly squeeze the top bulb. Analyzer section for more information b still squeezing, place the pipette tip into the patient sample. This will be compared to a background fluorescence reading based on the negative control line and result will be reported on the sofia analyzer display screen.
Respiratory season can be challenging and unpredictable. After your sofia 2 has been setup register your sofia 2 instrument at to download and install the latest software updates, assay and testing capabilities for your sofia. If the sofia analyzer does not perform as expected, contact quidel technical support 800 8741517 in the u. It integrates bestofbreed tools with a java framework to provide an endtoend solution for developing high quality database driven web applications. Jan 15, 2015 download pdfanalyzer this lightweight, useful application enables users to quickly scan through the metadata hidden inside pdf files such as the number of form fields or embedded fonts. Quick reference instructions analyzer and legionella fia. Download pdfanalyzer this lightweight, useful application enables users to quickly scan through the metadata hidden inside pdf files such as the number of form fields or embedded fonts.
Quidel sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level utilizing proprietary. This fact sheet contains information to help you understand the risks and benefits of using this test for. Sofia is a bench top analyzer intended to be used with cassettebased. Sofia 2 sars antigen fia quidel corporation may 8, 2020 disease 2019 covid19 1 you are being given this fact sheet because your samples was tested for the coronavirus disease 2019 covid19 using the sofia 2 sars antigen fia. Quidel rapid lateral flow assays thermo fisher scientific australia. Sofia 2 sars antigen fia quidel corporation may 8, 2020 coronavirus disease 2019 covid19 1. From lateral flow to molecular testing, we have a solution for you.
The sofia analyzer scans the test strip and displays the results after utilizing methodspecific algorithms. 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. Pdf background influenza is a significant pathogen for longterm care facility ltcf residents. Clia waiver by application approval determination decision. Sofia, a new benchtop fluorescent immunoassay analyzer. Dbsophic qure analyzer free download windows version. After the sample was prepared and added to the cassette, it was incubated for 15 minutes, either on the bench top or in the sofia analyzer, before being analyzed. Author links open overlay panel chang kyu lee a 1 chi hyun cho a 1 mi kyung woo a 2 agnes e. You are being given this fact sheet because your sampleswas tested for the coronavirus disease 2019 covid19 using the sofia 2 sars antigen fia.
Our primary objectives for this interim analysis were to evaluate the sensitivity and specificity of the quidel sofia. View and download quidel sofia 2 quick start manual online. Comparison of the sofia and veritor direct antigen. The interface is designed to reduce user the prototype sofia rsv fia. Sofia 2 fluorescent immunoassay analyzer collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel. It detects the nucleoprotein of the influenza virus and can discriminate strain a from b in nasal swabs, aspirates, and nasopharyngeal swab specimens. For analysis by rtpcr, viral rna was extracted using the nuclisens. Google scholar see all references the sofia fia reader can store, print, and send results directly to laboratory information systems to be used for influenza surveillance data. Quidel sofia analyzer user manual keyword found websites.
Quidel wins the covid19 antigen test race evaluate. These diagnostic tests quickly detect fragments of proteins found on. Quidel sofia 2 fluorescent immunoassay analyzer 20299. After your sofia has been setup register your sofia instrument at to download and install the latest software updates.
Rals systems are interfaced to devices you use at the pointofcare every day from market share leaders in glucose, coagulation, blood gaselectrolytes and. Prompt detection of influenza a and b viruses using the bd veritor. Quidel sofia 2 fluorescent immunoassay analyzer 20299, 20314. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give you an objective result you can rely on. Quidel receives fda clearance for its sofiar strep a. The sofia analyzer is a fluorescence detection instrument. Detection of influenza a and b viruses with the sofia. 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. Quidel sofia strep a fia cliawaived print share quidel sofia strep a fia cliawaived. Evaluation of sofia fluorescent immunoassay analyzer for. If sofia 2 is used in a manner not specified in the user manual, the protection provided. Quidel sofia fia system required an extra step of addition of reagent buffer to dissolve the contents of the reagent tube and the protocol required incubation of the sample cassette for 15 min prior to the instrument read. Sofia 2 is intended for professional and laboratory use.
Of the sofia rsv fia was compared to that of quidels visuallyinterpreted. In addition, the quidel sofia fia analyzer requires 50 s to process the test results. The unit is portable and can be moved to a suitable location for testing. The salmon open framework for internet applications sofia is a rad tool set for the j2ee. The sofia analyzer is a benchtop instrument intended to be used with cassette based immunofluorescent in vitro diagnostic assays manufactured by quidel. Analyzer brugermanual af indhold quidel corporation globalt hovedkvarter mckellar court san diego, ca generel information korte advarsler, forholdsregler. Sensitivity and specificity of the quidel sofia influenza. What are the brand names of your readerbased technologies for influenza. Rals systems are interfaced to devices you use at the pointofcare every day from market share leaders in glucose, coagulation, blood gaselectrolytes and cardiac markers, and more. After the patient sample has been added to the test cassette, depending upon the users choice. Place the sofia analyzer on the counter top within reach of an electrical outlet. Qure analyzers intuitive graphical interface helps you quickly identify and analyze performance bottlenecks. Qdel quidel, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, announced today th. After your sofia 2 has been setup register your sofia 2 instrument at to download and install the latest software updates.
Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. For rapid qualitative detection of group a streptococcal antigens from throat swabs of symptomatic patients. Quidel sofia 2 measuring instruments quick start manual. Quidel rapid lateral flow assays thermo fisher scientific new. Antigen testing is the third type of test to gain the fdas authorisation, after viral rna tests and assays that identify former covid patients by detecting antibodies to the virus in their blood. 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. The sofia analyzer is a fluorescence detection instrument designed to be portable and simple to use. Quidel sofia flu package insert keyword found websites. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.
Autoimmune disease diagnostics market growth, trends. Headtohead comparison of the diagnostic accuracies of bd. The quidel sofia influenza ab fluorescence immunoassay fia employs immunofluorescence technology that is used with the sofia analyzer to detect. Sofia 2 fluorescent immunoassay analyzer sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give. Evaluation of sofia fluorescent immunoassay analyzer for influenza ab virus. The sofia 2 sars antigen fia assay can provide results in 15 minutes, according to its manufacturer, quidel. Analyzer brugermanual af indhold quidel corporation globalt hovedkvarter mckellar court san diego, ca quidel. A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates.
Fact sheet for patients coronavirus disease 2019 sofia 2. It has a graphical user interface and is powered by either electrical outlet or battery. Quidel, san diego, ca is a novel lateralflow immunoassay that uses specific antibodycoated beads coupled to a heat and lightstable europium. Evaluation of rapid influenza diagnostic tests for influenza a h3n2v virus and updated case count united states, 2012. Abaxis piccolo blood chem analyzer wb chem, cmp, renal abaxis, inc 82040qw. Sofia fluorescent immunoassay analyzer the optical sensor inside of sofia scans and collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. Antigen testing is the third type of test to gain the fdas authorisation, after viral rna tests and assays that identify former covid patients by detecting antibodies to the virus in. Comparison of the sofia and veritor direct antigen detection. Evaluation of rapid influenza diagnostic tests for. Pdf sensitivity and specificity of the quidel sofia. Quidel sofia2 with advance result technology delivering accurate. The test was designed to be compatible with nasopharyngeal swabs, nasal washes and aspirates.
Dbsophic qure analyzer allows you to compare and analyze sql server trace files workloads. Quidel sofia 2 measuring instruments quick start manual pdf. Cardinal health has a broad portfolio of products to address a variety of needs, including quidel solana, sofia and sofia 2. And thanks to multidimensional grouping, sorting and filtering you can easily isolate the most resourceconsuming sql statements, applications, users, hosts and more. View and download quidel sofia 2 user manual online. Quidel offers a continuum of diagnostic immunoassays including fluorescent immunoassays that are. Sofia uses proprietary algorithms to analyze the data, interpret the signals and determine the results.
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