Quidel sofia analyzer user manual

Sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia. Laboratory test menu student health center manuals. Clia waiver by application approval determination decision. Automated results generation sofia removes the variability from operator to operator caused by interpreting visually read test results. How to perform a urinalysis using the clinitek status analyzer. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Sofia 2 analyzer affect mainly the user interface and include the addition of a touchscreen. 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. User interface intuitive, fast, and easy to use interface allows.

If sofia is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. Select to continue to the next screen or to return to the run test screen. Sofia 2 is intended for professional and laboratory use. Of course, the analyzer can also be used without using the usbmdb interface. Study the package insert and user manual thoroughly before using.

The sofia analyzer is designed to provide safe and reliable operation when used according to this user manual. It is the only dualpurpose pointofcare analyzer for urinalysis testing and urine hcg pregnancy testing. Quidel sofia analyzer pdf sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Sofia is compatible with virena, quidels proprietary, global wireless data. Quidel receives fda clearance for its pointofcare sofia. This study evaluated the performance characteristics of the sofia fia for detection of. Quidel receives fda clearance for its sofiar strep a fluorescent immunoassay fia. Depending upon the users choice, the cassette is either placed inside of the sofia analyzer for automatically timed development walk away mode or placed on the counter or bench top for a manually timed development and then placed into. Evaluation of sofia fluorescent immunoassay analyzer for. Quidel sofia 2 rapid test analyzer save at tiger medical, inc.

Quidel sofia 2 rapid test analyzer save at tiger medical. Quidel sofia analyzer user manual keyword found websites. Clia waiver by application approval determination decision summary. Sofia is designed to provide safe and reliable operation when used according to this user manual. Sofia indicates when the calibration check is completed. Sofia 2 is quidels nextgeneration version of its bestselling sofia instrumented. Evaluation of sofia fluorescent immunoassay analyzer for influenza ab virus. Orchard software corporation instrument interfaces issued. Quick reference instructions analyzer and legionella fia. 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 receives fda clearance for its sofiar strep a. Sofia is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel.

Rx only after the patient sample has been added to the test cassette, depending upon the user s choice. Analyzer and legionella fiaquick reference instructionsfor use with the sofia analyzer only. This can be done on the counter or bench top using a timer. The analyzer receives orders through the load list by order choice that is uploaded into the middleware and sends results back as a comma separated value csv file.

Worldwide distributor of dental and medical healthcare products, services and supplies. Sofia performs the calibration check automatically within two minutes with no user input required. 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. Blood tests and blood testing supplies for corporate wellness programs. Quidel sofia 2 fluorescent immunoassay analyzer 20299. The sofia analyzer scans the test strip and displays the. Statistics view analyzer info the first screen of view analyzer info displays the firmware version, hardware version, no. Quidel corporation san diego, ca received fda clearance for its new benchtop fluorescent immunoassay analyzer, the sofia, a device designed for rapid diagnoses of. Quidel receives fda clearance for its sofia r strep a fluorescent immunoassay fia. The user then manually times the development period outside of sofia. Confidence in your rapid test results barker medical. Sofia 2 fluorescent immunoassay analyzer sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette.

Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source results are reported automatically on the screen and can be stored in sofia, on the sd card provided in the install pack, printed using the integrated printer, or sent to the lis. The quidel sofia 2 rapid test analyzer is an easytouse small benchtop analyzer designed to quickly and accurately measure different chemicals and properties found in patient biological samples. The test is intended for use with either the sofia or sofia 2 analyzer to aid in the diagnosis of lyme disease. Low maintenance requires no extra servicing to function as designed hematocrit result is calculated when hemoglobin result is within 1218 gdl hemopoint h2 analyzer brochure hemopointh2brochure. Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent. Instant alerts flags test results when outside of userdefined limits. Sofia 2 must be disposed of in a safe and compliant manner.

Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. After the patient sample has been added to the test cassette, depending upon the users choice. Patient care supplies kimberly clark alere hemopoint cholestech 10991. Study the user manual thoroughly before using the quickstart guide customer service if the sofia analyzer does not perform as expected, contact quidel. Shop clinical analyzers home mckesson medicalsurgical. 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. Sofia will display the test types that are newly installed. 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 is designed to provide safe and reliable operation. Quidel sofia analyzer small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.

Quidel sofia 2 fluorescent immunoassay analyzer 20299, 20314. If the calibration check does not pass, notify the onsite supervisor or contact quidel technical support. Additional settings please refer to the sofia user manual for additional instrument settings, including. Upon activation of sofia 2s network capabilities, sofia 2 will transmit data, deidentified in accordance with 45 c. The sofia analyzer scans the test strip and displays the results after utilizing methodspecific algorithms. Drug testing supplies from clia waived,inc, drug tests. The sofia analyzer and sofia strep a fia combine unique immunofluorescence. 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 sofia roche elecsys system siemens acs 180 siemens advia centaur siemens advia centaur cp siemens dade behring bn prospec nephlometer siemens immulite siemens versacell system sigma aptus singulex erenna skylab 752 technicon immunoone tosoh aia600 ii tosoh nexia triage census connect triage meterpro trinity trinblot triturus. Sofia 2 fluorescent immunoassay analyzer collects hundreds of data points on the test strip contained inside of a sofia fia test cassette. If the analyzer is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. Instanter subnormal congregation had spiralled between the placidly south korean. The assay is performed on the analyzer which automates and integrates sample purification, nucleic.

Read about the quidel sofia analyzer, which allows you to stop choosing between the features fundamental to. The analyzer may be set to two different modes walk away and read now. A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates. Fluorescencebased chemistry sofia offers you confidence in your rapid test results.

Within minutes, patients combined with rapid results can be quickly and properly managed. The cliawaived, inc hemoglobin hb testing system is for the quantitative determination of hemoglobin in nonanticoagulated capillary whole blood or anticoagulated venous whole blood in edta k2, k3, na2 or sodium heparin. Quidel 20264 sofia test kits wilburn medical usa 18779452876. The sofia analyzer is a benchtop instrument intended to be used with cassette based immunofluorescent in vitro diagnostic assays manufactured by quidel. Order quidel sofia 2 fluorescent immunoassay analyzer today. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel. Ca 92121 usa sofia analyzer and legionella fia page 4 of 4. After the patient sample has been added to the test cassette, depending upon the user s choice. Sofia, a new benchtop fluorescent immunoassay analyzer.

Both cardinal health strep a rapid tests are cliawaived rapid chromatographic immunoassays for the qualitative detection of strep a antigen from throat swab specimens to aid in the diagnosis of group a streptococcal infection. Sofia 2 has the power to deliver highly accurate, objective and automated. Applicable federal, state and local regulatory requirements shall be followed to ensure sofia 2 is not disposed of as municipal waste. Overview for quidel 20299 sofia 2 rapid test analyzer.

Detection of influenza a and b viruses with the sofia. Sofia will load the test types that are on the sd card if they are not already in sofia. 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. Buy 4 bottles of test cartridges cliahgbst5060 and get 1 hgb meter free. Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Other minor adjustments to the sofia 2 analyzer affect mainly the user interface and include the.