Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Database contains 2 quidel sofia 2 manuals available for free online viewing or downloading in pdf. Respiratory season can be challenging and unpredictable. Store 1x pbs in a clean container to prevent contamination. Clia waiver by application approval determination decision summary a. Sensitivity and specificity of the quidel sofia influenza.
The sofia rsv fia test employs immunofluorescence technology that is used with the sofia analyzer for the rapid detection. Quidel receives fda clearance, clia waiver for its pointof. Always operate the sofia analyzer on a surface that is level and dry and not in. Ensure counter top is stable, level, dry and free of obstructions. 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. Small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Upon activation of sofia 2s network capabilities, sofia 2 will transmit data, deidentified in accordance with 45 c.
View and download quidel sofia 2 user manual online. Quidel corporation was formed in 1991 when quidel and monoclonal antibodies merged. Quidel is a leading manufacturer of diagnostic healthcare solutions serving to enhance the. Sofia is the brand name for quidel s nextgeneration, immunoassay system. This study evaluated the performance characteristics of the sofia fia for detection of. The test is intended for use with the sofia analyzer to aid in the assessment of vitamin d. The sofia analyzer can be used in the laboratory or pointofcare settings. 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 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro. Sofia 2 with advance result technology art delivers accurate, objective and automated results in as few as three minutes. This recurring update notification applies to chapter 16, section 70. Used quidel sofia immunoassay analyzer immunology for sale. User manuals, guides and specifications for your quidel sofia 2 measuring instruments.
If it isnt in thepictures and is not specified here don. After the patient sample has been added to the test cassette, depending upon the users choice. For the biopharma industry investment, business development and competitive intelligence professionals who require information to support financing, partnering and licensing activities, bciq provides accurate information and context to support profitable and strategic decision making. The test is intended for use with the sofia analyzer to aid in the. The test is intended for use with the sofia 2 analyzer to aid in the diagnosis of lyme disease. Detection of influenza a and b viruses with the sofia.
Sensitivity of the quidel sofia fluorescent immunoassay. Sofia 2 fluorescent immunoassay analyzer sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. Please follow the below five step process to get your sofia instrument setup. Ricola mountain herb throat dropssugar free menthol. Microbial contamination of the hsv dfa reagent may cause a decrease in sensitivity. On june 18, 1997 quidel settled a lawsuit with becton dickinson. 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.
Flu a test results for the simplexa flu ab and rsv direct rrtpcr assay, viral culture. Quidel sofia 2 fluorescent immunoassay analyzer 20299. The sofia instrument also allows testing in both runnow and walkaway modes, adding an important extra dimension for workflow flexibility. Sofia 2 utilizes the original sofia s fluorescent chemistry. Sensitivity and specificity of the sofia ridt were calculated. Both settings must be set to on to send results to the virena cloud daily.
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. In 1999, quidel acquired metra biosystems, participate in bone health assessment. Evaluation of sofia fluorescent immunoassay analyzer for influenza ab virus. We have 3 quidel sofia manuals available for free pdf download. Rapid diagnostic test kit sofia by quidel corporation. Quidel sofia analyzer small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.
The sofia analyzer and sofia strep a fia combine unique immunofluorescence. Sensitivity of the quidel sofia fluorescent immunoassay compared. Influenza is an acute respiratory illness caused by influenza a or b viruses that occur in outbreaks, mainly during the winter season. Qdel quidel, a provider of rapid diagnostic testing solutions, cellularbased virology assays and molecular diagnostic systems, announced today that it has received 510k clearance and clinical laboratory improvement amendments clia waiver from the united states food and drug administration fda to market its sofia 2 lyme fia to be used. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to give. 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. Sofia, a new benchtop fluorescent immunoassay analyzer. The latest addition is the quidel sofia 2 which we can also connect to your ehr. Quidel had been accused of infringing patents on bectons strep and chlamydia products.
A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates. The sofia analyzer automatically times the test development and. The sofia analyzer scans the test strip and displays the. Quidel corporation quidel receives simultaneous fda. Sofia is the brand name for quidel s flagship product, an instrumented immunoassay system. 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. One metaanalysis of 159 ridt rapid influenza diagnostic test. Industrial equipment quidel lyme fia sofia 2 quick reference instructions 6 pages. Quidel receives fda clearance for its sofiar strep a. This period is the most valuable, given the ability to use antiviral therapy with the most success in shortening duration of symptoms.
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. Measuring instruments quidel sofia user manual 58 pages. Quidel receives eua for molecular covid19 assay cap today. Quidel recommends that positive and negative external controls be run. Clia waiver by application approval determination decision. Quidels sofia 2 immunoassay analyzer received three. The sofia analyzer is designed to provide safe and reliable operation when used according to this user manual. Quidel sofia 2 fluorescent immunoassay analyzer sofia 2.
Clinical sensitivities and specificities of the rapid influenza diagnostic tests have varied considerably in the literature. Cascade healthcare solutions has quidel corporation rapid diagnostic test kit sofia 20253kt. During 2011, the us food and drug administration fda and the european conformity mark provided quidel with 510k clearance for selling sofia analyzer, and another 510k clearance for the quidel molecular hmpv assay. 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. 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. Comparison of the sofia and veritor direct antigen detection. Quidel sofia 2 fluorescent immunoassay analyzer 20299, 20314. Download this press release pdf format opens in new window pdf.
Results are reported automatically on the screen and can be stored in sofia 2, optionally printed on an external printer, or sent to virena. Ready to use with sofia analyzer, no need for additional equipment. Power up power port sofia 2 will display the power on progress screen and complete a power on selftest. Sofia 2 fluorescent immunoassay analyzer sofia 2 is a small benchtop analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. A simple extraction procedure requires the addition of only two reagents. Sofia 2 has the power to deliver highly accurate, objective and automated. Albeit statistically nonsignificant, the sofia system demonstrated higher sensitivity values percentages for influenza a and b than the veritor system 79. Quidel, san diego, ca is a novel lateralflow immunoassay that uses specific antibodycoated beads coupled to a heat and lightstable europium. Pdf sensitivity and specificity of the quidel sofia. We have 1 quidel lyme fia sofia 2 manual available for free pdf download. 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. Aug 01, 2015 the fluorescence is measured by the sofia influenza analyzer, which displays the test results as positive, negative, or invalid. Need quidel corporation rapid diagnostic test kit sofia.
Performance of the quidel sofia rapid influenza diagnostic. Sofia 2 is quidel s nextgeneration version of its bestselling sofia instrumented system. Quidel corporation quidel receives fda clearance and. Quidels sofia 2 pointofcare immunoassay analyzer receives. Quidel sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level.
Sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia. The sofia strep a fia employs immunofluorescence technology to detect group a. Evaluation of sofia fluorescent immunoassay analyzer for. Rinsefree perineal cleanser rinsefree perineal and skin cleanser skin care basics skin. Sofia 2 is a small 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 is a bench top analyzer intended to be used with cassettebased immunofluorescent. Quidel agreed to buy a product license and pay royalties on its product sales. Quidel sofia 2 measuring instruments quick start manual. Sofia 2 is intended for professional and laboratory use. Quidel sofia 2 fluorescent immunoassay analyzer fisher cat 23043086 small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Quidel quickvueinfluenza test 20226 wilburn medical usa 1. Patient care supplies kimberly clark alere hemopoint cholestech 10991.
Quidel corporation quidel receives fda clearance, clia. Fda cleared and clia classified moderately complex. 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. Page 1 of 15 sofia strep a fia intended use summary. The sofia analyzer is designed to provide safe and reliable operation.
View online or download quidel lyme fia sofia 2 user manual. Jun 22, 2017 quidels sofia 2 pointofcare immunoassay analyzer receives multiple awards from good design australias 2017 good design awards. Refer to the sofia user manual for operating instructions. Pdf background influenza is a significant pathogen for longterm care. Unlike other intelligence solutions, bciq exclusively supports the unique needs of the biopharma industry and. Download quick start manual of quidel sofia 2 measuring instruments for free or view it online on. The sofia strep a fia employs immunofluorescence technology that is used with the sofia analyzer sofia to detect. Quidel receives fda clearance for its sofia r strep a fluorescent immunoassay fia. Sofia 2 is a bench top analyzer intended to be used wit h cassettebased immunofluorescent in. From lateral flow to molecular testing, we have a solution for you. K946276 the quickvue chlamydia test detects chlamydia directly from endocervical swab and. Sofia strep tests by quidel medline industries, inc. Rapid laboratory diagnosis of influenza can help guide the clinical management of suspected patients effectively.
Reusable glassware must be cleaned and thoroughly rinsed free of all detergents. Sofia and virena surveillance installation overview there are a few simple steps required in order to set up your virena router and sofia. Measuring instruments quidel sofia 2 quick start manual 6 pages. Proven lateralflow technology, proprietary advanced fluorescence chemistry and assay development techniques are all integrated into this small bench top analyzer that can be used near patient and in laboratory settings. To learn more about the quidel sofia analyzer, visit their website here. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. Quidel sofia analyzer pdf sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.
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