Sofia 2 with advance result technology art delivers accurate, objective and automated results in as few as three minutes. 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. Qdel is a major american manufacturer of diagnostic healthcare products that are sold worldwide on may 8, 2020 the u. Cardinal health has a broad portfolio of products to address a variety of needs, including quidel solana, sofia and sofia 2. The sofia analyzer will display the test results positive, negative, or invalid on the screen. From lateral flow to molecular testing, we have a solution for you. This study evaluated the performance characteristics of the. Detection of influenza a and b viruses with the sofia. Confidence in your rapid test results barker medical. Quidel corporation sofia 2 rsv fia starter kit, includes. Feb 16, 2016 one metaanalysis of 159 ridt rapid influenza diagnostic test studies evaluating 26 ridts showed pooled specificities of 98% but pooled sensitivities of only 62. The sofia 2 sars antigen fluorescent immunoassay fia uses advanced immunofluorescencebased lateral flow technology in a sandwich design for qualitative detection of nucleocapsid protein from sarscov2. A and b np5 aspirateswab nasal washswab no no xpet influenza a 4 remel inc. March 2019quidel 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.
The sofia analyzer is a benchtop instrument intended to be used with cassette based immunofluorescent in vitro diagnostic assays manufactured by quidel. The small, clear fixed volume pipette is to be used only for adding patient sample to the test cassette. Product description ordering information product description. These diagnostic tests quickly detect fragments of proteins found on. One metaanalysis of 159 ridt rapid influenza diagnostic test studies evaluating 26 ridts showed pooled specificities of 98% but pooled sensitivities of only 62. March 2019quidel has received the ce mark for its sofia quantitative vitamin d fia for use with the sofia fluorescent immunoassay analyzer for the. These tests are intended for use with the sofia 2 analyzer to aid in the diagnosis of lyme disease in the u.
Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. Sofia analyzer to detect influenza virus nucleoproteins. 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. Quidel sofia hcg fia kinetic check feature provides operator the flexibility of upto 5 minutes before placing test cassette into sofia for analysis manufacturer. 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. Sensitivity and specificity of the quidel sofia influenza. Sensitivity and specificity of the sofia ridt were calculated using rtpcr results as the reference standard. Sensitivity and specificity values percentages of 79. Quidel receives eua for molecular covid19 assay cap today. In 201220, the quidel sofia had higher sensitivity than the quidel quickvue test. One metaanalysis of 159 ridt rapid influenza diagnostic test. Food and drug administration fda to market its sofia 2. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel.
Quidel sofia2 with advance result technology delivering accurate. Quidel, san diego, ca is a novel lateralflow immunoassay that uses specific antibodycoated beads coupled to a heat and lightstable europium. Results specimens were collected from 228 residents mean age 71. This recurring update notification applies to chapter 16, section 70. Clia waiver by application approval determination decision. Our primary objectives for this interim analysis were to evaluate the. Comparison of the sofia and veritor direct antigen detection.
Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Mar 18, 2020 march 2019quidel 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. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. Sofia 2 also integrates wireless connectivity and its barcode scanner within a smaller footprint than the legacy sofia instrument. The sofia analyzer will scan the test strip and measure the fluorescent signal by processing the results using methodspecific algorithms. 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. Quidel receives fda clearance for its sofiar strep a. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give. Sofia, a new benchtop fluorescent immunoassay analyzer.
View and download quidel sofia 2 user manual online. With the sofia analyzer by quidel you no longer have to choose between many of the features that are fundamental to your laboratory. Automated results generation sofia removes the variability from operator to operator caused by interpreting visually read test results. Sofia 2 fluorescent immunoassay analyzer sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. Comparison of the sofia and veritor direct antigen. Quidel sofia analyzer pdf sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.
The sofia analyzer is designed to provide safe and reliable operation. Performance of the quidel sofia rapid influenza diagnostic. Lewandrowski k, tamerius j, menegus m et al detection of influenza a and b viruses with the sofia analyzer. 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. 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.
This study evaluated the performance characteristics of the sofia fia for detection of. The sofia analyzer can be used in the laboratory or pointofcare settings. 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. Performance of the quidel sofia rapid influenza diagnostic test. Pdf sensitivity and specificity of the quidel sofia. The test is intended for use with the sofia analyzer to aid in the assessment of vitamin d. Sofia 2 fluorescent immunoassay analyzer medgizmos pic.
Quidel desires to sell to customer and customer desires to purchase from quidel or its authorized distributor, as designated, distributor certain tests used with the sofia 2 analyzers consumables, as described herein. Waived for nasal and nasopharyngeal swab specimens cpt codes. Quidel s sofia 2 pointofcare immunoassay analyzer receives. Quidel corporation quidel receives emergency authorization.
Sofia is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel. Sofia purchase agreement version2 3142017 exhibit a equipment use and data access pursuant to this agreement, quidel shall provide customer with sofia analyzers, virena use and data access at no charge during the term of this agreement. Pcr ct values for the sofia 202014 influenza a results were not significantly different between the false. 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. The sofia 2 sars antigen fia, with the sofia 2 analyzer, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of. The large, pink fixed volume pipette is to be used only with the aspiratewash or viral transport media test procedure when transferring the patient sample from the collection cup into. Within minutes, patients combined with rapid results can be quickly and properly managed. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. Influenza antigen detection assays sofia fluorescent immunoassay fia and veritor yield objective results, which are potentially useful for pointofcare testing. Evaluation of sofia fluorescent immunoassay analyzer for. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Quidel corporation sofia rsv starter kit 3 pk, 1 leased analyzer, 1 install pack, 3 rsv kits, 25testkt distributor agreement required see manufacturer details page drop ship only.
Sofia rsv fia page 3 of 17 n use the appropriate fixed volume pipette in accordance with test procedures. Medical and scientific recognizes superior examples of good design, a. Respiratory season can be challenging and unpredictable. Sofia uses proprietary algorithms to analyze the data, interpret the signals and. Sofia 2 is a bench top analyzer intended to be used wit h cassettebased immunofluorescent in. 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. Sofia 2 sars antigen fia pointofcare test offers positive results in 15 minutes quidel corporation nasdaq. Rals systems are interfaced to devices you use at the pointofcare every day from market share leaders in glucose, coagulation, blood gaselectrolytes and. 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. If the sofia analyzer does not perform as expected, contact quidel technical support 800 8741517 in the u. Fluorescencebased chemistry sofia offers you confidence in your rapid test results. If sofia, sofia 2 the or do not as perform expected. Shop quidel test kits mckesson medicalsurgical pic.
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