QUICK REFERENCE INSTRUCTIONS
Contents
1. a QUICK REFERENCE ofia 1E INSTRUCTIONS COW ILD ELL ce For use with Sofia only Study the Package Insert and User Manual thoroughly CLIA Com plexity Waived before using Quick Reference Instructions This is not a complete Package Insert Test Procedure Note The procedures for testing swab samples versus apirate wash or samples in viral transport media are different Read carefully All clinical samples including samples in VTM must be at room temperature before testing Expiration date Check expiration on each individual test package or outer box before using Do not use any test past the expiration date on the label Swab Test Procedure Nasal Nasopharyngeal 1 B 8 O B O v Verify that Sofia isset Dispense all of the Place the patientswab Roll the swab head Fill the provided Small Clear 120 pL Fixed Volume Firmly squeeze the top bulb to Promptly proceed to the desired mode Reagent Solution into sampleintothe Reagent againstthe inside of Pipette with patient sample from the Reagent Tube empty the contents of the Small to the next section WALK AWAY or READ the Reagent Tube gt Tube Roll the Swab the Reagent Tube Clear 120 pL Fixed Volume Pipette Using Sofia to To fill the Fixed Volume Pipette with the patient NOW See the Using Swirl the Reagent at least 3 times while as you remove it a eae into the Cassette sample well complete the test aaa ae ple pm Sofia2. Fixed Volume Pipette with patient sample from the collection cup or test gt tube To fill the Fixed Volume Pipette with the sample a FIRMLY squeeze the top bulb b Still squeezing place the Pipette tip into the patient sample c With the Pipette tip still in the patient sample slowly release pressure on the bulb to fill the Pipette Note To obtain accurate results avoid mucoid substances when filling the Large Pink Fixed Volume Pipette with patient sample from the collection cup a Squeeze here Overflow 250 uL Pipette Patient Sample Firmly squeeze the top bulb to empty the contents of the Large Pink 250 pL Fixed Volume Pipette into the Reagent Tube Extra liquid be left behind Note Once the sample is added to the Reagent Tube vigorously mix prior to adding the sample to the test Cassette NOTE The Fixed Volume Pipettes are designed to collect and dispense the correct amount of liquid sample Discard the Pipette in your biohazard waste 250 uL Pipette Reagent Tube Fill the provided Small Clear 120 pL Fixed Volume Pipette with patient sample from the Reagent Tube by slowly left over in the overflow bulb should releasing pressure on the bulb Squeeze here 120 ul Pipette Overflow Patient Sample Promptly proceed gt to the next section Using Sofia to gt complete the test Firmly squeeze the top bulb to
3. the Sofia key pad to re highlight the field Then simply rescan using the correct barcode and the previous one will be overwritten with the correct barcode RA Supervisor Start Test WALK AWAY Mode 10 28 2010 09 43AM User ID Patient ID Q Order Q Go to Main Menu to Change Mode Start Test 2 Input the Patient ID or Order using the barcode scanner or manually enter the data using the key pad if Supervisor Start Test WALK AWAY Mode User ID kkkxk Patient ID l Q Order Q 10 28 2010 09 43AM Go to Main Menu to Change Mode Start Test 3 Press Start Test and the Sofia drawer will automatically open 10 28 2010 09 43AM f Supervisor Start Test amp y WALK AWAY Mode selected En AA Please insert cassette and close drawer Cancel 4 Verify that the correct development mode WALK AWAY or READ NOW has been selected Insert the prepared patient test Cassette into the drawer of Sofia and close the drawer 5 Sofia will start automatically and display the progress In WALK AWAY Mode the test results will be displayed on the screen in approximately 15 minutes In READ NOW Mode the test results will be displayed on the screen within 1 minute See Interpretation of Results section Interpretation of Results When the test is complete the results will be displayed on the Sofia screen The results can be automatically printed on the integrated printer
4. 0 2008 Victoria Like were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled Update Influenza Activity United States 2010 2011 Season and Composition of the 2011 2012 Influenza Vaccine Performance characteristics may vary against other emerging influenza viruses If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities soecimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health department for testing Viral culture should not be attempted in these cases unless a BSL 3 facility is available to receive and culture samples Reference the Package Insert for Warnings and Precautions Specimen Collection and Handling and Quality Control CUSTOMER SERVICE If Sofia or the assay do not perform as expected contact Quidel Technical Support 800 874 1517 in the U S 858 552 1100 outside the U S technicalsupport quidel com or your local distributor Study the Package Insert and User Manual thoroughly Quidel Corporation before using Quick Reference Instructions This is not a San Diego CA 92121 USA complete Package Insert quidel com 27411D1014D 10 14 Sofia Influenza A B FIA Page 50f5
5. box Main Menu Run Test gt Runac lt 3 Sofia will prompt the user to select the desired mode WALK AWAY or READ NOW Review Data and then to run the External Control Swabs Calibration Supervisor Menu Change Mode 4 Follow the Swab Test procedure of this Quick Reference Instructions to test each P Select Control Swab first the Positive Control followed by the Negative Control After both the Positive and Negative Swabs have been run the results will be displayed as Passed or Failed INTENDED USE The Sofia Influenza A B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab nasopharyngeal swab and nasopharyngeal aspirate wash specimens taken directly from symptomatic patients This qualitative test is intended for use as an aid in the rapid differential diagnosis of acute influenza A and influenza B viral infections The test is not intended to detect influenza C antigens A negative test is presumptive and it is recommended these results be confirmed by viral culture or an FDA cleared influenza A and B molecular assay Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions Performance characteristics for influenza A and B were established during February through March 2011 when influenza viruses A California 7 2009 2009 H1N1 A Perth 16 2009 H3N2 and B Brisbane 6
6. empty the contents of the Small Clear Fixed Volume Pipette into the Cassette sample well Note Extra liquid left over in the overflow bulb should be left behind Discard the Pipette in your biohazard waste Page 2 of 5 Using Sofia WALK AWAY READ NOW Modes Refer to the Sofia User Manual for operating instructions Sofia may be set to two different modes WALK AWAY and READ NOW The procedures for each mode are described below WALK AWAY MODE READ NOW MODE In WALK AWAY Mode the user immediately inserts the Cassette into Sofia The user then returns after 15 minutes to get the test result In this mode Sofia will automatically time the test development before scanning and displaying the test result Critically important Allow the test to develop for the full 15 minutes BEFORE placing it into Sofia The user must first place the Cassette onto the counter or bench top for 15 minutes outside of Sofia and manually time this development step Then the user inserts the Cassette into Sofia In READ NOW Mode Sofia will scan and display the test result within 1 minute Note Results will remain stable for an additional 15 minutes after the recommended development time of 15 Minutes Sofia Influenza A B FIA Page 3 of 5 Using Sofia cont RUN TEST 1 Input the User ID using the barcode scanner or manually enter the data using the key pad NOTE If you mistakenly scan the incorrect barcode use the Arrow Buttons on
7. if this option is selected Test Lines which are fluorescent cannot be seen with the naked eye The Sofia screen will display results for the procedural control being valid or invalid and will individually provide a positive or negative result for both influenza A and influenza B If the procedural control is invalid retest with a new patient sample and a new Cassette Sofia Influenza A B FIA Reader Display Flu A Positive Flu B Negative Flu A Positive Flu B Positive Flu A Negative Flu B Negative Flu A Invalid Flu B Invalid Procedural Control Invalid Positive Test for Flu A Positive Test for both Flu A and Flu B no antigen detected Result Invalid Fusnes Ni Flu A Negative Positive Test for Flu B Flu B Positive influenza B antigen present Ave Poe Co infection with influenza A and B is rare Sofia Influenza A B FIA dual positive clinical specimens influenza A and influenza B positive should be re tested with a new patient sample and a new test Cassette Repeatable influenza A and B dual positive results should be confirmed by viral culture or an FDA cleared influenza A and B molecular assay before reporting results Page 4of5 External Quality Control External Positive and Negative Swabs are supplied in the kit 1 From the main menu select Run QC C fe 10 26 20101 08 43AM RIA Supervisor 2 Following the prompt on the screen scan the QC Card located on the kit
8. section for more Tube to dissolve its pressing the head Dispose of the Extra liquid left over in the overflow information gt contents againstthe bottom and usedswabinyour a FIRMLY squeeze the top bulb gt bulb should be left behind side of the Reagent biohazard waste b Still squeezing place the Pipette tip into the NOTE The Fixed Volume Pipettes Tube patient sample are designed to collect and c With the Pipette tip still in the patient sample dispense the correct amount of slowly release pressure on bulb to fill the Pipette liquid sample Discard the Pipette in your biohazard waste Slowly 3 pqueeze Dispense 3k Twist Leave the Swab inthe Reagent Tube Reagent for 1 minute z 120 uL Pipette Overflow Tube o Solution in Bulb Patient Sample Sofia Influenza A B FIA Page 1 of 5 Nasopharyngeal Aspirate Wash or Samples in Viral Transport Media Test Procedure Verity that Sofia is set tothe desired mode WALK AWAY or READ NOW See the Using Sofia section for more information Also ensure that the liquid sample is at room temperature before proceeding into the Reag contents Slo Dispense all of the Reagent Solution ent Tube Swirl the Reagent Tube to dissolve its wly Dispense Twist Tube baa Solution in Bulb Sofia Influenza A B FIA off Reagent iS Fill the provided Large Pink 250 pL
Download Pdf Manuals
Related Search