Quidel sofia analyzer user manual

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. 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 designed to provide safe and reliable operation when used according to this user manual. Sofia will load the test types that are on the sd card if they are not already in sofia. Drug testing supplies from clia waived,inc, drug tests. 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 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. Sofia performs the calibration check automatically within two minutes with no user input required. The user then manually times the development period outside of sofia.

Of course, the analyzer can also be used without using the usbmdb interface. Sofia is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel. 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. Quidel receives fda clearance for its sofia r strep a fluorescent immunoassay fia. Quidel sofia 2 rapid test analyzer save at tiger medical.

Automated results generation sofia removes the variability from operator to operator caused by interpreting visually read test results. 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. Study the user manual thoroughly before using the quickstart guide customer service if the sofia analyzer does not perform as expected, contact quidel. Quick reference instructions analyzer and legionella fia.

Fluorescencebased chemistry sofia offers you confidence in your rapid test results. Quidel 20264 sofia test kits wilburn medical usa 18779452876. Upon activation of sofia 2s network capabilities, sofia 2 will transmit data, deidentified in accordance with 45 c. The sofia analyzer is a benchtop instrument intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel. 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 designed to provide safe and reliable operation. Sofia 2 must be disposed of in a safe and compliant manner. The sofia analyzer scans the test strip and displays the results after utilizing methodspecific algorithms. Quidel sofia analyzer user manual keyword found websites. Sofia 2 is quidels nextgeneration version of its bestselling sofia instrumented. Instanter subnormal congregation had spiralled between the placidly south korean. 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.

Sofia is compatible with virena, quidels proprietary, global wireless data. A total of 2,047 subjects provided nasal swabs and nasopharyngeal swabs or aspirates. Overview for quidel 20299 sofia 2 rapid test analyzer. Evaluation of sofia fluorescent immunoassay analyzer for. Rx only after the patient sample has been added to the test cassette, depending upon the user s choice. Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. 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. It is the only dualpurpose pointofcare analyzer for urinalysis testing and urine hcg pregnancy testing. The sofia analyzer scans the test strip and displays the.

The sofia analyzer is a benchtop instrument intended to be used with cassette based immunofluorescent in vitro diagnostic assays manufactured by quidel. Patient care supplies kimberly clark alere hemopoint cholestech 10991. Sofia analyzer and legionella fia page 1 of 4 study the package insert and user manual thoroughly before using the quick reference instructions. 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. Worldwide distributor of dental and medical healthcare products, services and supplies. 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. 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. Analyzer and legionella fiaquick reference instructionsfor use with the sofia analyzer only. 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. This study evaluated the performance characteristics of the sofia fia for detection of. Using the sofia analyzerwalk awayread now modesrefer to the sofia analyzer user manual for operating instructions. Quidel sofia 2 rapid test analyzer save at tiger medical, inc. Sofia, a new benchtop fluorescent immunoassay analyzer.

Applicable federal, state and local regulatory requirements shall be followed to ensure sofia 2 is not disposed of as municipal waste. This can be done on the counter or bench top using a timer. Quidel receives fda clearance for its sofiar strep a. The analyzer may be set to two different modes walk away and read now. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. Sofia 2 has the power to deliver highly accurate, objective and automated.

Blood tests and blood testing supplies for corporate wellness programs. Clia waiver by application approval determination decision summary. Confidence in your rapid test results barker medical. 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. If sofia is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. User interface intuitive, fast, and easy to use interface allows. Orchard software corporation instrument interfaces issued.

Buy 4 bottles of test cartridges cliahgbst5060 and get 1 hgb meter free. Quidel sofia analyzer pdf sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. If the analyzer is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. If the calibration check does not pass, notify the onsite supervisor or contact quidel technical support. Sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia. Ca 92121 usa sofia analyzer and legionella fia page 4 of 4. Select to continue to the next screen or to return to the run test screen. Quidel receives fda clearance for its sofiar strep a fluorescent immunoassay fia. Sofia indicates when the calibration check is completed. Instant alerts flags test results when outside of userdefined limits. 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. Quidel sofia 2 fluorescent immunoassay analyzer fisher cat 23043086 small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source.

Additional settings please refer to the sofia user manual for additional instrument settings, including. The test is intended for use with either the sofia or sofia 2 analyzer to aid in the diagnosis of lyme disease. Install the analyzer application software by inserting the analyzer cdrom and run setup. Order quidel sofia 2 fluorescent immunoassay analyzer today. Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent in vitro diagnostic assays manufactured by quidel corporation. The sofia analyzer and sofia strep a fia combine unique immunofluorescence. Sofia 2 analyzer affect mainly the user interface and include the addition of a touchscreen. Quidel sofia 2 fluorescent immunoassay analyzer 20299. 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. 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 2 is intended for professional and laboratory use. Sofia is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. Read about the quidel sofia analyzer, which allows you to stop choosing between the features fundamental to. How to perform a urinalysis using the clinitek status analyzer.

Sofia quidel flu machine manual keyword found websites. Instruments easeofuse and userfriendly features make testing simple. Detection of influenza a and b viruses with the sofia. After the patient sample has been added to the test cassette, depending upon the users choice. The assay is performed on the analyzer which automates and integrates sample purification, nucleic. Shop clinical analyzers home mckesson medicalsurgical. Laboratory test menu student health center manuals. Evaluation of sofia fluorescent immunoassay analyzer for influenza ab virus.

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. Clia waiver by application approval determination decision. Other minor adjustments to the sofia 2 analyzer affect mainly the user interface and include the. Page 10 clean sofia 2 per the maintenance and cleaning section of this user manual prior to return or disposal. 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. Quidel receives fda clearance for its pointofcare sofia. Study the package insert and user manual thoroughly before using. After the patient sample has been added to the test cassette, depending upon the user s choice. Sofia 2 is a bench top analyzer intended to be used with cassettebased immunofluorescent. The sofia analyzer is designed to provide safe and reliable operation when used according to this user manual. Within minutes, patients combined with rapid results can be quickly and properly managed. Alere hemopoint h2 system direct from new line medical.