Store it in the opaque sleeve whenever it is not being used. Its the latest pandemic move for quidel, which tripled third-quarter sales thanks to its sofia-2 antigen test. Assays manufactured by quidel corporation and software quidel app residing on an apple iphone manufactured by apple. Quidel sofia influenza ab fia, reference instructions, 121205, 06/17 using. This document is a supplement to the manufacturers instructions and is. Refer to the sofia 2 user manual for details regarding the calibration check procedure. Rechargeable battery; power adapter; calibration cassette; user manual. Rice lake digi di-80 operation manual operation manual 40 pages idexx vettest operators manual operators manual 132 pages tramex me5 quick start manual quick start manual 4 pages geomax zoom20 pro series user manual. For qualitative detection of group a ?- hemolytic streptococcus. Figure 1 touchscreen display barcode scanner cassette drawer installation, setup and operation sofia 2 setup place sofia 2 on the bench top. Sofia 2 is designed to provide safe and reliable operation when used according to this user manual. Get connected: visit connectm for help connecting your quidel instruments to lis or the cloud, including how to get started and use the virena test results surveillance system. If the sofia, sofia 2 or the assay do not perform as expected, contact quidel technical. 626 User manual quick start guide warranty card barcode scanner barcode scanner stand. Sofia 2 training please refer to sofia 2 user manual and assay package inserts for specific information allison leone, director new market development. Quidel recommends that positive and negative external controls be run. The calibration check is a required function that checks sofia 2 optics and calculation systems using a specific calibration cassette.
Heyl testomat 808 replacing instructions replacing instructions 2 pages vwr international 8231-656 user manual operation. The sofias instruction manual claims that the product can detect 6. Quidel sofia 2 flu ab starter kit sofia 2 instrument with 3 sofia flu kits fisher cat 23-043-070. Refer to the sofia 2 user manual for operating instructions. 607 User manuals, guides and specifications for your quidel sofia 2 measuring instruments. No expiration date on the sofia 2 warranty quidel warrants that the equipment will be materially free from defects in materials and workmanship for a. At present, diagnosis of active severe acute respiratory syndrome coronavirus 2 sars-cov-2 infection relies primarily on the use of molecular. We have 1 quidel lyme fia sofia 2 manual available for free pdf download: user manual. Wipe the external surfaces and cassette drawer only. Sofia 2 collects hundreds of data points on the test strip contained inside of a sofia fia test cassette.
Start by watching the below six video modules - or - read each modules instruction. Quidel claims its sofia 2 covid-1 rapid antigen test is. Important: ensure that the calibration cassette is stored in the. Sofia 2 uses proprietary algorithms to analyze the data, interpret the signals and determine the results automatically to. Quidel sofia 2: user manual brand: quidel category: measuring instruments size: 2. Users manual 16 pages hach quikchem 8500 2 series operations operations 54 pages ge d60 instruction manual. Laid out in this document and provided in the quidel sofia2 fda. View and download quidel sofia 2 user manual online. Diagnostic assays manufactured by quidel corporation. And quidel is now shipping the product to its customer. ? External quality controls: refer to assay-specific package insert for details on specific tests. Study the user manual thoroughly before using the quickstart guide. Sofia, the next generation in diagnostic testing, takes rapid testing to a whole new level. These tests may be performed in facilities with a clinical. Module 1: unpacking module 2: calibrating module 3: configuring sofia 2 and virena module 4: performing quality control. The user then manually times the development period outside of sofia 2. Database contains 2 quidel sofia 2 manuals available for free online viewing or downloading in pdf: quick start manual, operation. 1023
Schedule using labfinder and access your results online. As shown in figure 24, there is a v shaped slot on the underside of the drawer. If sofia 2 does not perform as expected, contact quidel technical support 800. 78 Sofia 2 utilizes the original sofia fluorescent chemistry design while improving upon the graphical user interface and optics system to. If sofia 2 is used in a manner not specified in the user manual, the protection provided. Proven lateral-flow 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. Be prepared to setup your sofia 2 instrument, run quality control checks and perform testing including coronavirus covid-1. Upon activation of sofia 2s network capabilities, sofia 2 will transmit data, de-identified in accordance with 45 c. The 16 mainstreet clinics statewide are using the quidel sofia 2 sars antigen test, approved by the fda. This calibration cassette is supplied with sofia 2. Module 5: performing testing; nasal swab collection run patient tests maintenance; certification printer. If sofia 2 does not perform as expected, contact quidel technical support. Specifics quidel sofia 2 fluorescent immunoassay triage analyzer new old stock dom: 3/2018 ref: 202 serial no: 2010148 user manual 44 pg photocopy. Furthermore, sofia 2 instrument can offer two distinct workflows, depending on the users choice.
Measuring instruments quidel sofia 2 quick start manual 6 pages. Speakers: allison leone, new market development director, quidel corporation. If sofia 2 is used in a manner not specified in the user manual, the protection provided by the equipment may be impaired. 533 Kit, please refer to the safety data sheet sds located at. Rapid coronavirus tests like quidels, they said, should be. The user will manually perform the timing on the bench top, outside of sofia 2. Physician offices, hospitals and reference laboratories can run this assay using the sofia 2 immunofluorescence system as described below. Quidel sofia antigen test conducted within 5 days of symptom. Healthcare professionals can purchase the sofia sars antigen fia through select authorized distributors. Get the latest updates: after your sofia 2 has been setup register your sofia 2 instrument at myq to download and install the latest software updates, assay and testing capabilities for your sofia. The sofia 2 instrument also offers two distinct workflows: depending upon the users choice, the sofia 2 sars antigen fia cartridge is placed. Sofia 2 analyzer and influenza ab fia startup kit promotion 25 tests clia waived. Sofia 2 is quidels best-selling cartridge-based rapid. Click here to fill out this form in order to fulfill this order. The test is the first rapid antigen, point-of-care test for all three viruses to receive eua. Sofia 2 sars antigen fia page 1 of 1 for use under the emergency use authorization eua only. The qc results will show a skipped control test as on sofia 2. Sofia 2 has the power to deliver highly accurate, objective and automated. Sofia 2 is intended for professional and laboratory use.
Place in a narrow vessel approximately 4 inches high supplied in the. Time is complete, the user will insert the test cassette into sofia 2. The sofia analyzer can be used in the laboratory or point-of-care settings. The sofia sars antigen fia, with the sofia 2 and sofia analyzers, provides automated and objective results in 15 minutes, allowing for testing of patients suspected of covid-1/201-ncov in near-patient testing environments. Please, tick the box below to get your link: print manual. Two distinct workflows: depending upon the users choice, the sofia 2 sars. Quidel corporations san diego, ca, usa sofia 2 sars antigen fia has become the. Sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. After the patient sample has been added to the test cassette, depending upon the assay and/or the users choice, the cassette is either. The quidel sofia 2 is a small bench top analyzer that uses advanced fluorescence detection with an ultraviolet led energy source. 237 The sofia 2 instrument offers 2 workflows depending upon the users choice: the sofia 2 sars antigen fia cartridge is placed inside sofia 2. Additional external control swabs may be obtained separately by contacting quidel customer. ? The sofia 2 calibration cassette is sensitive to light. Learn about documentation capabilities using the sofia2. The instructions provided in this document are for the quidel sofia 2 machine. Quidels sofia 2 instrument also delivers two specific workflows based on the users choice.