Package Insert EN
Contents
1. Adenovirus type 1 2Xx10 TCIDso mL Negative Negative Adenovirus type 7 2x10 TCIDso mL Negative Negative Human coronavirus 0C43 2x10 TCIDso mL Negative Negative Human coronavirus 229E 2x10 TCIDso mL Negative Negative Human coxsackievirus 2x10 TCIDso mL Negative Negative Cytomegalovirus 2x10 TCIDso mL Negative Negative Epstein Barr Virus 2x10 TCIDso mL Negative Negative Human parainfluenza type 1 2x10 TCIDso mL Negative Negative Human parainfluenza type 2 2x10 TCIDso mL Negative Negative Human parainfluenza type 3 2x10 TCIDso mL Negative Negative Measles 2x10 TCIDso mL Negative Negative Human metapneumovirus 2x10 TCIDso mL Negative Negative Mumps virus 2x10 TCIDso mL Negative Negative Respiratory syncytial virus type A 2x10 TCIDso mL Negative Negative Respiratory syncytial virus type B 2x10 TCIDso mL Negative Negative Rhinovirus type 1B The levels of bacteria were determined by limiting dilution bacterial culture and colony counting to give cfu mL 2x10 TCIDso mL Negative Virus concentrations were determined by standard virology methods Reed Muench Sofia Influenza A B FIA Negative Page 18 of 20 Interfering Substances Whole blood mucin and several over the counter OTC products and2. specimen was negative for Influenza A SD 10 28 2010 09 43AM RA Supervisor Detailed Results Sofia Flu A B and Influenza B Patient ID 2345678904 Date 01 17 2010 10 30AM r i NOTE A negative result does not exclude influenza raer viral infection Negative results should be confirmed i Nega by virus culture or an FDA cleared influenza A and B Flu B Negative Procedural Control valid Start New Test molecular assay Invalid Results For example This result shows that an invalid result had occurred 10 28 2010 09 43AM RA Supervisor Detailed Results Sofia Flu A B Patient ID 2345678904 Invalid Result If the test is invalid a new test should Date 01 17 2010 10 30AM be performed with a new patient sample and a new User ID 00000034 test Cassette Order EGHIJKLMNO Flu A Invalid Flu B Invalid Procedural Control Invalid ae LIMITATIONS m The contents of this kit are to be used for the qualitative detection of influenza type A and B antigens from a nasal swab nasopharyngeal swab and nasopharyngeal aspirate wash specimens m This test detects both viable live and non viable influenza A and B Test performance depends on the amount of virus antigen in the specimen and may or may not correlate with virus culture results performed on the same specimen m The clinical performance of the Sofia Influenza A B FIA for nasopharyngeal aspirate wash samples has no
3. 25 Test Kit m Individually Packaged Cassettes 25 Mouse monoclonal anti influenza A and anti influenza B antibodies m Reagent Tubes 25 Lyophilized buffer with detergents and reducing agents m Reagent Solution 25 Ampoules with salt solution m Sterile Nasal Swabs 25 m Fixed Volume Pipettes 25 m Influenza A and Influenza B Positive Control Swab 1 Swab is coated with non infectious recombinant influenza A and influenza B antigens m Negative Control Swab 1 Swab is coated with heat inactivated non infectious Streptococcus C antigen m Package Insert 1 m Quick Reference Instructions 1 m QC Card located on kit box m Printer Paper 1 MATERIALS NOT SUPPLIED IN KIT m Timer or watch m Sofia Analyzer instrument m Micropipettor m Specimen container m Sterile saline m Equipment used for collection of Nasopharyngeal Aspirate or Nasopharyngeal Wash m Nylon flocked nasopharyngeal swab m Calibration Cassette supplied with the Sofia Analyzer Sofia Influenza A B FIA Page 2 of 20 WARNINGS AND PRECAUTIONS m For in vitro diagnostic use m Do not use the kit contents beyond the expiration date printed on the outside of the box m Use appropriate precautions in the collection handling storage and disposal of patient samples and used kit contents m Use of Nitrile Latex or equivalent gloves is recommended when handling patient samples m Dispose of containers and used contents in accordance with Federal
4. Proceed to the Using the Sofia Analyzer section of this Package Insert Sofia Influenza A B FIA Page 8 of 20 USING THE SOFIA ANALYZER Walk Away Read Now Modes Refer to the Sofia Analyzer User Manual for operating instructions The Sofia Analyzer may be set to two different development timed modes Walk Away and Read Now The procedures for each mode are described below Walk Away Mode Using the barcode reader scan in the user and patient IDs After the user adds the patient sample and inserts the Cassette into the Sofia Analyzer the Analyzer will automatically time the test development scan and display the test result in about fifteen 15 minutes Read Now Mode The Read Now mode provides a convenient way for busy laboratories to conduct batch testing The user adds the patient sample to the Cassette and places the Cassette on the counter or bench top for fifteen 15 minutes outside of the Analyzer The user must carefully and manually time the development step When the development time is approaching completion enter user ID and patient ID with the provided barcode reader Once the development time is complete the user immediately inserts the Cassette into the Sofia Analyzer The Analyzer will scan and display the test result within one 1 minute Note Results will remain stable for an additional fifteen 15 minutes after the recommended development time of fifteen 15 minutes Depending upon the workload several o
5. REF 20218 Sofia Influenza A B FIA 25 Test 20254 Sofia Influenza A B FIA 25 Test in MDSS GmbH Schiffgraben 41 30175 Hannover Germany Quidel Corporation Worldwide Headquarters 10165 McKellar Court San Diego CA 92121 USA quidel com L Authorized Representative in the European Community e z CONTROL Positive control LOT Batch code E Consult instructions for use Manufacturer Sofia Influenza A B FIA 1170003ENOO 07 13 Catalogue number CONTROL Negative control IVD For In Vitro diagnostic use EPC Temperature limitation Page 20 of 20
6. State and Local requirements m Do not reuse the used cassette fixed volume pipettes reagent tubes solutions or control swabs m The user should never open the foil pouch of the test Cassette exposing it to the ambient environment until the Cassette is ready for immediate use m Discard and do not use any damaged cassette or material m The Reagent Solution contains a salt solution saline If the solution contacts the skin or eye flush with copious amounts of water m To obtain accurate results the Package Insert instructions must be followed m The Calibration Cassette must be kept in the provided storage pouch between uses m Inadequate or inappropriate specimen collection storage and transport may yield false test results m Specimen collection and handling procedures require specific training and guidance m Use the Viral Transport Media recommended in this Package Insert m When collecting a nasal swab specimen use the nasal swab supplied in the kit m When collecting a nasopharyngeal swab specimen use a nylon flocked nasopharyngeal swab m Do not write on the barcode of the Cassette This is used by the Sofia Analyzer to identify the type of test being run and to identify the individual Cassette so as to prevent a second read of the Cassette by the same Sofia Analyzer m f infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health au
7. a child could sit in the parent s lap facing forward with the child s head against the parent s chest Fill the syringe or aspiration bulb with the minimal volume of saline required per the subject s size and age Instill the saline into one nostril while the head is tilted back Aspirate the wash specimen back into the syringe or bulb The aspirated wash sample will likely be approximately 1 cc in volume Alternatively following instillation of the saline tilt the head forward and let the saline drain out into a clean collection cup SPECIMEN TRANSPORT AND STORAGE Specimens should be tested as soon as possible after collection However if transport of samples is required minimal dilution of the sample is recommended as dilution may result in decreased test sensitivity One 1 milliliter or less is suggested for optimal rapid test performance The following viral transport media listed in Table 1 are compatible with the Sofia Influenza A B FIA Table 1 Recommended Viral Transport Media Recommended Storage Condition Viral Transport Media Copan Universal Transport Media Hank s Balanced Salt Solution M4 M5 v6 Mi a 7ahows TEST PROCEDURES All clinical specimens must be at room temperature before beginning the assay 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 Sw
8. common chemicals were evaluated and did not interfere with the Sofia Influenza A B FIA at the levels tested Table 13 Table 13 Non interfering Substances Substance Concentration _ Homeopathic Alkalol 1 10 dilution Fisherman s Friend Tamiflu Oseltamivir Phosphate Nasal Gel Oxymetazoline 10 v v cl ASSISTANCE If you have any questions regarding the use of this product please call Quidel s Technical Support Number 800 874 1517 toll free in the U S A or 858 552 1100 Monday through Friday between 7 00 a m and 5 00 p m Pacific Time U S A If outside the United States contact your local distributor or technicalsupport quidel com For additional Quick Reference Instructions in your language please see our website quidel com or contact Quidel Technical Support 858 552 1100 or your local distributor for a copy delivered free of charge REFERENCES 1 Murphy B R and Webster R G 1996 Orthomyxoviruses pp 1397 1445 In Fields Virology 3rd edition B N Fields D M Knipe P M Howley et al eds Lippincott Raven Philadelphia 2 CDC Key Facts About Seasonal Influenza www cdc gov flu keyfacts htm accessed 7 2011 3 Biosafety in Microbiological and Biomedical Laboratories 5th Edition U S Department of Health and Human Services CDC NIH Washington DC 2007 4 Bartlett J Management of Respiratory Tract Infections 2nd Ed 1999 149 169 Sofia Influenza A B FIA Page 19 of 20
9. in the assay Flow of the sample and appearance of the Control Line were also not affected Table 12 Analytical Specificity and Cross Reactivity Organism Non Influenza Virus Bordetella pertussis Concentration 2x10 cfu mL Flu A Result Negative Flu B Result Negative Canidida albicans 2x10 cfu mL Negative Negative Chlamydia trachomatis 2x10 cfu mL Negative Negative Corynebacterium diphtheriae 2x10 cfu mL Negative Negative Escherichia coli 2x10 cfu mL Negative Negative Haemophilus influenzae 2x10 cfu mL Negative Negative Lactobacillus plantarum 2x10 cfu mL Negative Negative Legionella pneumophila 2x10 cfu mL Negative Negative Moraxella catarrhalis 2x10 cfu mL Negative Negative Mycobacterium tuberculosis avirulent 2x10 cfu mL Negative Negative Mycoplasma pneumoniae 2x10 cfu mL Negative Negative Neisseria meningitidis 2x10 cfu mL Negative Negative Neisseria subflava 2x10 cfu mL Negative Negative Pseudomonas aeruginosa 2x10 cfu mL Negative Negative Staphylococcus epidermidis 2x10 cfu mL Negative Negative Streptococcus pneumoniae 2x10 cfu mL Negative Negative Streptococcus pyogenes 2x10 cfu mL Negative Negative Streptococcus salivarius 2x10 cfu mL Negative Negative
10. minute after the Cassette is inserted into the Analyzer See Interpretation of Results section gt 10 28 2010109 43AM RA Supervisor Test in Progress Sofia Flu A B For example This display shows that the test Patient ID 2345678904444 in Walk Away mode has 12 minutes 13 seconds CSO E remaining The Sofia Analyzer will read and rr display the results after 15 minutes Time remaining 12 13 min Cancel Sofia Influenza A B FIA Page 10 of 20 INTERPRETATION OF RESULTS When the test is complete the results will be displayed on the Sofia Analyzer screen The results can be automatically printed on the integrated printer if this option is selected The Sofia Analyzer detects the test line The test line will not be visible to the user The Sofia Analyzer screen will display results for the procedural control as 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 Positive Results 10 28 2010 09 43AM Supervisor For example This result shows that a valid result had occurred and that the specimen was positive for Influenza A Detailed Results Sofia Flu A B Patient ID 2345678904 e 3 D ia a OoN NOTE A positive result does not rule out co infections User ID 00000034 with other pathogens or identify any specific influenza Order EGHIJKL
11. sample was placed in viral transport media The paired swab samples were randomized with respect to the order of testing in the Sofia Influenza A B FIA versus culture Cell culture was performed either at a local virus laboratory of the test site or transported cold on ice packs not frozen overnight to a central laboratory for culture within 48 hours Results are presented in Tables 2 6 Table 2 Sofia Influenza A B FIA Nasal Swab Results Versus Culture All Age Groups TYPE A TYPE B Culture Sens 124 138 90 Culture Sens 100 112 89 95 C l 84 94 Spec 500 527 95 95 C I 93 96 95 C I 82 94 Spec 530 553 96 95 C I 94 97 z Table 3 Sofia Influenza A B FIA Nasopharyngeal Swab Results Versus Culture All Age Groups TYPE A TYPE B Culture Sens 100 103 97 Culture Sens 101 112 90 95 C I 91 99 Spec 596 630 95 95 C I 93 96 95 C I 83 95 Spec 602 621 97 95 C I 95 98 Pos Neg Pos Neg Sofia Influenza A B FIA Page 13 of 20 Table 4 Sofia Influenza A B FIA Nasopharyngeal Aspirate Wash Results Versus Culture All Age Groups TYPE B Sens 46 52 88 95 C l 77 95 Spec 575 597 96 95 C I 94 98 TYPEA Sens 68 69 99 95 C I 91 100 Spec 554 580 96 95 C I 93 97 Culture Culture Pos Neg sofa Neg 6 575 Table 5 Performance Compared to Culture for Each Specimen Type b
12. 2 95 CI 83 95 87 54 62 95 C1 76 94 94 45 48 95 CI 83 98 100 2 2 95 CI 29 100 97 602 621 95 CI 95 98 97 455 471 95 CI 95 98 98 130 132 95 CI 94 100 94 16 17 95 CI 71 100 100 1 1 95 CI 17 100 88 46 52 95 CI 77 95 87 39 45 95 Cl 73 94 100 7 7 95 CI 60 100 96 575 597 95 CI 94 98 96 572 594 95 CI 94 98 100 3 3 95 CI 38 100 N A 0 0 N A 0 0 A total of 2047 prospective clinical specimens were tested and gave valid results during this clinical study These results were included in Tables 2 6 There were nineteen 19 additional specimens less than 1 of the total collected that gave invalid results The invalid results were excluded from Tables 2 6 because new patient specimens were not collected for re testing Sofia Influenza A B FIA Page 14 of 20 Reproducibility Studies The reproducibility of the Sofia Influenza A B FIA was evaluated at three different laboratories one of which was Quidel Two different operators at each site tested a series of coded contrived samples prepared in negative clinical matrix ranging from low negative to moderate positive influenza A and influenza B Testing occurred on five 5 different days spanning over approximately a two week period The inter laboratory agreement Table 7 for negative samples was 94 100 and 98 100 for positive samples The intra laborato
13. MNO A virus subtype Flu A Positive Flu B Negative Procedural Control valid anatra TESS NC pre For example This result shows that a valid result had occurred and that the specimen was positive for Influenza B Detailed Results Sofia Flu A B Patient ID 2345678904 i A da 01 17 2010 10 30AM NOTE A positive result does not rule out co infections User ID 00000034 with other pathogens Order EGHIJKLMNO Flu A Negative Flu B Positive Procedural Control valid art mme 10 28 2010 109 43AM_ RA Supervisor For example This result shows that a valid result had occurred and that the specimen was positive for both Detailed Results Sofia Flu A B Influenza A and Influenza B Patient ID 2345678904 e UuU ee gt Date 01 17 2010 10 30AM ZST IDT 90000024 NOTE A positive result does not rule out co infections Order EGHIJKLMNO with other pathogens Flu A Positive FluB Positive NOTE Co infection with influenza A and B is rare Sofia Influenza A B FIA dual positive clinical Main Menu Start New Test specimens influenza A and influenza B positive should be re tested Repeatable influenza A and B dual positive results should be confirmed by virus culture or an FDA cleared influenza A and B molecular assay before reporting results Sofia Influenza A B FIA Page 11 of 20 Negative Results For example This result shows that a valid result had occurred and that the
14. Sofia Influenza A B Fia For use with the Sofia Analyzer only CLIA Complexity MODERATE 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 virus 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 management decisions The test is intended for professional and laboratory use 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 60 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 wit
15. a Influenza A B FIA Page 1 of 20 PRINCIPLE OF THE TEST The Sofia Influenza A B FIA employs immunofluorescence technology that is used with the Sofia Analyzer to detect influenza virus nucleoproteins This test allows for the differential detection of influenza A and influenza B antigens The Sofia Influenza A B FIA involves the disruption of influenza A and B viral antigens The patient specimen is placed in the Reagent Tube during which time the virus particles in the specimen are disrupted exposing internal viral nucleoproteins After disruption the specimen is dispensed into the Cassette sample well From the sample well the specimen migrates through a test strip containing various unique chemical environments If influenza viral antigen is present they will be trapped in a specific location Note Depending upon the user s 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 the Sofia Analyzer to be scanned Read Now Mode The Sofia Analyzer will scan the test strip and measure the fluorescent signal by processing the results using method specific algorithms The Sofia Analyzer will display the test results Positive Negative or Invalid on the screen The results can also be automatically printed on an integrated printer if this option is selected REAGENTS AND MATERIALS SUPPLIED
16. ab Reagent 1 Add the Reagent Solution to the Reagent Tube Gently swirl the Reagent Tube to dissolve its contents Solution Reagent Tube Sofia Influenza A B FIA Page 6 of 20 2 Immediately place the patient swab sample into the Reagent Tube Roll the swab a minimum of three 3 3x times while pressing the head against the bottom and side of the Reagent Tube Leave the swab in the Reagent Tube for one 1 minute 3 Express all liquid from the swab head by rolling it against the inside of the Reagent Tube as the swab is 3x being removed Discard the swab in accordance with your biohazard waste disposal protocol 4 Fill the provided fixed volume pipette 120 uL or a micropipettor with 120 pL of the s p i queeze patient sample from the Reagent Tube here Overflow To fill the fixed volume pipette with the patient sample a ipette a FIRMLY squeeze the top bulb di b Still squeezing place the pipette tip into the liquid sample OR c With the pipette tip still in the liquid sample release pressure on bulb to fill the pipette Patient Patient Sample Sample 5 Dispense the patient sample into the Cassette sample well Firmly squeeze the top P bulb to empty the contents of the fixed volume pipette into the Cassette sample well extra liquid in the overflow bulb is OK NOTE The fixed volume pipette is designed to collect and dispense the correct amount of liquid sample Discard the pipette in accordance with your biohazard waste disp
17. esents the most secretion under visual inspection Using gentle rotation push the swab until resistance is met at the level of the turbinates less than one inch into the nostril Rotate the swab several times against the nasal wall then remove it from the nostril Nasopharyngeal Swab Sample Use a nylon flocked nasopharyngeal swab not supplied To collect a nasopharyngeal swab sample carefully insert the swab into the nostril that presents the most secretion under visual inspection Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx Rotate the swab several times then remove it from the nasopharynx Nasopharyngeal Aspirate Wash Sample Follow your institution s protocol for obtaining nasopharyngeal aspirate wash specimens Use the minimal amount of saline that your procedure allows Alternatively if your institution does not provide a protocol then consider the following procedures that are used by clinicians Sofia Influenza A B FIA Page 5 of 20 To collect a nasopharyngeal aspirate sample instill a few drops of sterile saline into the nostril to be suctioned Insert the flexible plastic tubing along the nostril floor parallel to the palate After entering the nasopharynx aspirate the secretions while removing the tubing The procedure should be repeated for the other nostril if inadequate secretions were obtained from the first nostril To collect a nasopharyngeal wash sample
18. function that checks the Sofia Analyzer optics and calculation systems using a specific Calibration Cassette This Calibration Cassette is shipped with the Sofia Analyzer Refer to the Sofia Analyzer User Manual for details regarding the Calibration Check Procedure Important Ensure that the Calibration Cassette is stored in the provided storage pouch between uses to protect from exposure to light 1 To checkthe calibration of the Sofia Analyzer select Calibration from the Main Menu 06 01 2011 14 46 Main Menu Run Test Run QC Review Data gt Calibration lt j Supervisor Menu Change Mode 2 Following the prompts insert the Calibration Cassette into the Sofia Analyzer and close the drawer The Analyzer performs the calibration check automatically with no user Start Calibration input required The Sofia Analyzer indicates when the Calibration Check is completed Select OK to return to the Main Menu NOTE If calibration cannot be completed successfully notify the on site Supervisor or contact Quidel Technical Support for assistance from 7 00 a m 5 00 p m PST at 800 874 1517 within the USA 858 552 1100 outside the USA Fax Please insert cassette and close drawer 858 455 4960 custserv quidel com Customer Service Cancel technicalsupport quidel com Technical Support or contact your local distributor a A Sofia Influenza A B FIA Page 4 of 20 Built in Procedural Control The Sofia Infl
19. h 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 Virus culture should not be attempted in these cases unless a BSL 3 facility is available to receive and culture specimens SUMMARY AND EXPLANATION Influenza viruses are causative agents of highly contagious acute viral infections of the respiratory tract Influenza viruses are immunologically diverse single stranded RNA viruses There are three types of influenza viruses A B and C Type A viruses are the most prevalent and are associated with most serious epidemics Type B viruses produce a disease that is generally milder than that caused by type A Type C viruses have never been associated with a large epidemic of human disease Both Type A and B viruses can circulate simultaneously but usually one type is dominant during a given season Every year in the United States on average 5 to 20 of the population contract influenza more than 200 000 people are hospitalized from influenza complications and about 36 000 people die from influenza related causes Some people such as adults 65 years of age and older young children and people with certain health conditions are at high risk for serious influenza complications Sofi
20. ment of kits provided that each different lot received in the shipment is tested and as deemed additionally necessary by your internal quality control procedures and in accordance with local state and federal regulations or accreditation requirements The user must first select Run QC on the main Menu of the Sofia Analyzer and then when prompted scan the QC Card located on kit box This card provides information specific to the kit lot including lot number and expiration date The Analyzer will then prompt the user to run the External Control swabs External Positive and Negative Control swabs are supplied in the kit and should be tested using the Swab Test Procedure provided in this Package Insert or in the Quick Reference Instructions Note the Influenza Positive Control Swab should give a positive result for both influenza A and influenza B Do not perform patient tests or report patient test results if the control tests do not produce the expected results Repeat the test or contact Quidel Technical Support before testing patient specimens Additional External Control swabs may be obtained separately by contacting Quidel s Customer Support Services at 800 874 1517 toll free in the U S A or 858 552 1100 SPECIMEN COLLECTION AND HANDLING SPECIMEN COLLECTION Nasal Swab Sample Use the nasal swab supplied in the kit To collect a nasal swab sample carefully insert the swab provided in the kit into the nostril that pr
21. n respiratory specimen the performance characteristics of this device with clinical specimens that are positive for H7N9 influenza virus have not been established The Sofia Influenza A B FIA can distinguish between influenza A and B viruses but it cannot differentiate influenza subtypes Sofia Influenza A B FIA Page 16 of 20 Table 11 Analytical Reactivity with Different Isolates of Avian Influenza A Minimum Detectable Level Viral Strain Viral Type Sub Type TCID50 mL A Mallard NY6750 78 A Mallard OH 338 86 A Mallard Wl 34 75 A Chicken CA 431 00 A Chicken NJ 15086 3 94 A Blue Winged Teal LA B174 86 A Chicken NJ 122210 97 A Chicken NJ 15906 9 96 A Duck LA 188D 87 A Gull MD 704 77 A Mallard GurjevRussia 262 82 A Shorebird DE 172 2006 The performance characteristics for influenza A virus subtypes emerging as human pathogens have not been established dP JdiP JiP JP dP J4P 40 40 40 402 gt Sofia Influenza A B FIA Page 17 of 20 Analytical Specificity Cross Reactivity The Sofia Influenza A B FIA was evaluated with a total of eighteen 18 bacterial and fungal microorganisms and sixteen 16 non influenza viral isolates Bacterial and fungal isolates were evaluated at a concentration of 2x10 cfu mL Viral isolates were evaluated at a concentration of 2x10 TCIDso mL None of the organisms or non influenza viruses listed below in Table 12 showed any sign of cross reactivity
22. nfluenza A B FIA was 15 for influenza A and 13 for influenza B PERFORMANCE CHARACTERISTICS Sofia Influenza A B FIA Performance vs Cell Culture The performance of the Sofia Influenza A B FIA was compared to viral cell culture methods followed by DFA in a multi center clinical field study during February through March 2011 in the United States This study was conducted by health care personnel at seventeen 17 distinct sites in various geographical regions within the United States In this multi center point of care POC field trial two 2 nasal or two 2 nasopharyngeal swabs or nasopharyngeal aspirate wash specimens were collected from each of two thousand forty seven 2047 patients Six hundred sixty five 665 provided a nasal swab specimen seven hundred thirty three 733 provided a nasopharyngeal swab specimen and six hundred forty nine 649 provided a nasopharyngeal aspirate wash specimen All clinical samples were collected from symptomatic patients Seventy one percent 71 of the population tested were lt 6 years of age 22 6 21 years of age 6 22 59 years of age and 1 gt 60 years of age Fifty three percent 53 were male and forty seven percent 47 were female On site testing of one nasal swab or nasopharyngeal swab or a portion of nasopharyngeal aspirate wash specimen in the Sofia Influenza A B FIA test was performed on the fresh specimen by medical personnel in the physician s office or hospital facility The remaining
23. ng Kong 8 G8 on BiAllen 4 ce T Maey 8 26 TCIDso mL levels were determined by either the Reed Muench method or Rowe ELISA Sofia Influenza A B FIA Page 15 of 20 Analytical Reactivity Analytical reactivity was demonstrated using a total of twenty nine 29 strains of human influenza viruses comprised of twenty 20 Influenza A and nine 9 influenza B viruses Table 10 Table 10 Analytical Reactivity with Human Isolates of Influenza A and B Minimum Minimum Detectable Detectable i Level Viral Level Viral Strain Type Sub Type TCID50 mL A New Jersey 8 7 H1N1 100 A Shearwater Australia A H15N9 10 A Solomon Islands 3 06 031 2576 79 200 Sersan 8 10 200 e Florida o zoo6 B l o At Denver 5 20 e Fiorida ori200a 8 500 Influenza Mexico 4108 2009 2009 HINT 200 B GL 1739 54 B 000 A WV629 002312 2009 A_ 2009HINI so B MongKongis2 B 20 A A 00 100 200 200 20 200 50 25 A WI 629 D02473 2009 A 2009HINI 25 B Lee 40 OB 5 A Port Chalmers 1 73 A H3N2 B Maryland 1 59 Bl 50 Avinors a Hna 20 eronionvzios Je 50 mwez a nna O 20 erwan 8 50 Minimum Detectable Viral Level Viral Strain Type Sub Type EID50 mL TCIDso mL 50 tissue culture infectious dose ElDso mL 50 egg infective dose TCIDso and ElDso levels were determined by the Reed Muench method Although this test has been shown to detect H7N9 virus cultured from a positive huma
24. osal protocol 6 Proceed to the Using the Sofia Analyzer section of this Package Insert Sofia Influenza A B FIA Page 7 of 20 Nasopharyngeal Aspirate Wash or Specimens in Viral Transport Media Test Procedure 1 Add the Reagent Solution to the Reagent Tube Gently swirl the Reagent Tube to dissolve its Q contents Reagent Solution Reagent Tube Reagent Tube 2 Fill a micropipettor with 260 uL of the patient s liquid sample Dispense the contents M of the micropipettor into the Reagent Tube Gently swirl the Reagent Tube to mix its A contents ft Patient Sample 3 Fill the provided fixed volume pipette 120 uL or a micropipettor with 120 pL of the s p l queeze patient sample from the Reagent Tube here Overflow To fill the fixed volume pipette with the patient sample n ipette a FIRMLY squeeze the top bulb i b Still squeezing place the pipette tip into the liquid sample OR c With the pipette tip still in the liquid sample release pressure on bulb to fill the pipette Patient Patient Sample Sample 4 Dispense the patient sample into the Cassette sample well Firmly squeeze the P top bulb to empty the contents of the fixed volume pipette into the Cassette sample well extra liquid in the overflow bulb is OK NOTE The fixed volume pipette is designed to collect and dispense the correct amount of liquid sample Discard the pipette in accordance with your biohazard waste disposal protocol OR 5
25. ptions exist to make batch testing easier The user can add the Reagent Solution to one or more Reagent Tubes recap them and store them on the bench at RT for up to 12 hours without loss of activity before adding the sample s Alternatively after addition of the Reagent Solution the user can process the swab or liquid specimens in the Reagent Tube then after removing the swab recap the tube and let them stand at RT for up to 12 hours without loss of activity before testing Critically important the user should never open the foil pouch thus exposing the test Cassette to the ambient environment until they are ready for immediate use Run Test When placing the Cassette into the Sofia Analyzer the user ID patient ID and order can be entered via a handheld barcode scanner or by manually entering the information onto the keypad of the Sofia Analyzer The test ID test type lot Cassette serial and test expiration date on the Cassette is scanned automatically into the Sofia Analyzer with an internal barcode reader The test is automatically interpreted at fifteen 15 minutes when the Analyzer is set to the Walk Away Mode and will give the result within one 1 minute after inserting the Cassette when the Analyzer is set to the Read Now Mode NOTE If you mistakenly scan the incorrect barcode simply rescan using the correct barcode and the previous one will be overwritten with the correct barcode 1 Highlight User ID field using the A
26. rrow Buttons on the Sofia Analyzer key pad Input the user ID using the barcode scanner or manually enter the data using the key pad 06 01 2011 14 46 RA Supervisor Start Test Walk Away Mode User ID l Patient ID Order Go to Main Menu to Change Mode Mein Menu Star Test Sofia Influenza A B FIA Page 9 of 20 2 Press the Down Arrow on the Sofia Analyzer keypad to go to the Patient ID or Order field Input patient ID or Order using the barcode scanner or manually enter the data using the key pad a 06 01 2011 14 46 RA Supervisor Start Test Walk Away Mode User ID Patient ID Order Go to Main Menu to Change Mode 3 Press Start Test and the Sofia Analyzer drawer will automatically open 06 01 2011 14 46 RA Supervisor Start Test Walk away timing selected Please insert cassette and close drawer 4 Verify that the correct development mode Walk Away or Read Now has been selected Immediately insert the prepared patient test Cassette into the drawer of the Sofia Analyzer and close the drawer 5 Upon closing the drawer the Sofia Analyzer will start automatically and display the progress as shown in example below In the Walk Away Mode the test results will be displayed on the screen in approximately fifteen 15 minutes after the Cassette is inserted into the Sofia Analyzer In the Read Now Mode the test results will be displayed on the screen within one 1
27. ry agreement Table 8 for all samples ranged from 98 99 Table 7 Sofia Influenza A B Reproducibility Study Inter Laboratory Agreement Laboratory Site Neg Flu A Flu A Flu A Flu B Flu B Flu B y virus Neg Cs Low Pos Mod Pos da Sa Neg Cs Low Pos Mod Pos DO 30 30 29730 3030 3030 28730 29 30 3030 30 30 29 30 30 30 30 30 30 30 29 30 30 30 30 30 30 30 30 30 30 30 27 30 30 30 30 30 90 90 88 90 90 90 90 90 85 90 88 90 90 90 Overall Agreement with 100 98 100 100 94 98 100 Expected Result 95 100 92 100 95 100 95 100 87 98 92 100 95 100 95 CI Table 8 Sofia Influenza A B Reproducibility Study Intra Laboratory Agreement Overall Neg Pia Mia Agreement with no virus ganeg Low Pos Css Mod Pos Cx 91 9 Low Pos Css Mod Pos Gx Expected Result G Cs 95 CI 98 1 30 30 29 30 30 30 30 30 28 30 29 30 30 30 206 210 95 100 99 2 30 30 29 30 30 30 30 30 30 30 29 30 30 30 208 210 96 100 99 3 30 30 30 30 30 30 30 30 27 30 30 30 30 30 207 210 96 100 Limit of Detection The limit of detection LoD for the Sofia Influenza A B FIA was determined using a total of four 4 strains of human influenza viruses two 2 influenza A and two 2 influenza B viruses Table 9 Table 9 Limit of Detection with Human Isolates of Influenza A and B Minimum Detectable Viral Type Sub Type Level TCID 0 mL A California 07 2009 2009 H1N1 AlHo
28. t been established in patients 60 years of age and older and may not be consistent with the clinical performance obtained with younger patients m A negative test result may occur if the level of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly m Failure to follow the Test Procedure may adversely affect test performance and or invalidate the test result m Test results must be evaluated in conjunction with other clinical data available to the physician m Positive test results do not rule out co infections with other pathogens m Positive test results do not identify specific influenza A virus subtypes m Negative test results are not intended to rule in other non influenza viral or bacterial infections m Children tend to shed virus more abundantly and for longer periods of time than adults Therefore testing specimens from adults will often yield lower sensitivity than testing specimens from children m Positive and negative predictive values are highly dependent on prevalence False negative test results are more likely during peak activity when prevalence of disease is high False positive test results are more likely during periods of low influenza or activity when prevalence is moderate to low m Individuals who received nasally administered influenza A vaccine may have positive test results for up to three days after vaccination m Monoclonal antibodies may fail to de
29. tect or detect with less sensitivity influenza A viruses that have undergone minor amino acid changes in the target epitope region Sofia Influenza A B FIA Page 12 of 20 m f differentiation of specific influenza A subtypes and strains is needed additional testing in consultation with state or local public health departments is required m Samples contaminated with whole blood gt 4 v v or mucin gt 0 5 v v may interfere in the interpretation of the test Visually bloody or overly viscous samples should not be used m The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection EXPECTED VALUES Seasonal outbreaks of influenza occur worldwide in both the northern and southern hemispheres causing widespread illness each winter The average attack rate of influenza is 26 33 cases per 100 people per year The risk of hospitalization is roughly 1 300 of those infected among the very young and elderly Over a period of 30 years between 1976 and 2006 estimates of flu associated deaths in the United States ranged from a low of about 3 000 to a high of about 49 000 people Ninety percent 90 of deaths occur in those 65 years of age and older Influenza pandemics occurred in 1978 1957 1968 and 2009 In the 1918 pandemic an estimated 40 50 million deaths resulted worldwide The prevalence observed with the reference test virus culture during the 2011 clinical study for Sofia I
30. thorities soecimens should be collected with appropriate infection control precautions for novel virulent influenza viruses and sent to state or local health departments for testing Viral culture should not be attempted in these cases unless a BSL 3 facility is available to receive and culture specimens m Although this test has been shown to detect cultured avian influenza viruses including avian Influenza A subtype H5N1 virus the performance characteristics of this test with specimens from humans infected with H5N1 or other avian influenza viruses are unknown m As the detection reagent is a fluorescent compound no visible results will form on the test strip The Sofia Analyzer must be used for result interpretation KIT STORAGE AND STABILITY Store the kit at room temperature 59 86 F 15 30 C out of direct sunlight Kit contents are stable until the expiration date printed on the outer box Do not freeze Sofia Influenza A B FIA Page 3 of 20 QUALITY CONTROL There are three types of Quality Control for the Sofia Analyzer and Cassette Sofia Analyzer calibration procedure built in procedural control features and External Controls Sofia Analyzer Calibration Check Procedure Note This is a Calibration Check procedure The Calibration Check Procedure should be performed every thirty 30 days The Sofia Analyzer can be set to remind the user to complete the calibration check procedure The Calibration Check is a required
31. uenza A B FIA contains a built in procedural control feature Each time a test is run in the Sofia Analyzer the i RAI OOR procedural control zone is scanned by the Sofia Analyzer and the Detailed Results result is displayed on the Analyzer screen Sofia Flu A B The manufacturer s recommendation for daily control is to Patient ID 2345678904 document the results of these built in procedural controls for the Date 01 17 2010 10 30AM User ID 00000034 first sample tested each day This documentation is automatically Order EGHIJKLMNO logged in the Analyzer with each test result I Flu A Invalid A valid result obtained from the procedural control demonstrates e j that the test flowed correctly and the functional integrity of the Cassette was maintained The procedural control is interpreted by the Sofia Analyzer after the Cassette has developed for Main Menu Start New Test fifteen 15 minutes If the test does not flow correctly the Sofia Analyzer will indicate that the result is invalid Should For example This result shows that an this occur review the procedure and repeat the test with a new invalid result had occurred patient sample and a new test Cassette External Quality Control External Controls may also be used to demonstrate that the reagents and assay procedure perform properly Quidel recommends that Positive and Negative External Controls be run once for each untrained operator once for each new ship
32. y Age Group for Influenza A Nasal Swabs Nasopharyngeal Swabs Nasopharyngeal Aspirate Wash All aaes 20 124 138 95 500 527 97 100 103 95 596 630 99 68 69 96 554 580 9 95 1 84 94 95 CI 93 96 95 CI 91 99 9596CI 93 96 95 CI 91 100 05 CI 93 97 PRA 95 62 65 y 95 CI 87 99 95 210 221 97 61 63 94 444 470 99 68 69 95 544 570 6 to 21 87 46 53 years 95 CI 75 94 95 CI 91 97 95 CI 86 100 95 CI 92 96 95 CI 91 100 95 CI 93 97 22 to 59 78 14 18 years 95 CI 54 92 88 15 17 100 1 1 95 CI 64 98 N A 0 0 95 CI 17 100 95 193 204 97 35 36 94 136 144 N A 0 0 100 10 10 95 CI 91 97 95 CI 85 100 95 CI 89 97 95 CI 68 100 96 82 85 100 4 4 100 15 15 95 CI 90 99 95 CI 45 100 95 CI 76 100 N A 0 0 N A 0 0 60 Years 100 2 2 on wa on vao Table 6 Performance Compared to Culture for Each Specimen Type by Age Group for Influenza B Nasal Swabs Nasopharyngeal Swabs Nasopharyngeal Aspirate Wash All Ages lt 6 years 6 to 21 years 22 to 59 years 60 Years and up 89 100 112 95 CI 82 94 90 35 39 95 CI 76 97 92 56 61 95 CI 82 97 73 8 11 95 CI 43 91 100 1 1 95 CI 17 100 96 530 553 95 CI 94 97 96 238 247 95 CI 93 98 95 187 196 95 CI 91 98 97 89 92 95 CI 90 99 89 16 18 95 CIl 66 98 90 101 11
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