Page 1 of 15 Sofia Strep A FIA INTENDED USE SUMMARY
Contents
1. Schiffgraben 41 30175 Hannover Germany Quidel Corporation 10165 McKellar Court San Diego CA 92121 USA quidel com Catalogue number 1243801EN00 06 14 CE CE mark of conformity EC REP Authorized Representative in the European Community LOT Batch code z Use by E Manufacturer y Temperature limitation Intended use 2 Consult instructions for use IVD For In Vitro diagnostic use Ws Contains sufficient for XX determinations CONT Contents Contains Positive control Sofia Strep A FIA CONTROL Negative control Page 15 of 152. Group A Streptococcus antibodies m Reagent Tubes 25 m Reagent Solution Bottles 25 4M Sodium Nitrite and 0 2M Acetic Acid inside glass ampoule a Fixed Volume Pipettes 25 m Sterile Rayon Throat Swabs 25 m Positive Control Swab 1 Swab is coated with heat inactivated non infectious Group A Streptococcus m Negative Control Swab 1 Swab is coated with heat inactivated non infectious Group C Streptococcus m Package Insert 1 a Quick Reference Instructions 1 m OC Card located on kit box m Printer Paper 1 MATERIALS NOT SUPPLIED IN KIT m Timer or watch for use in READ NOW Mode m Sofia analyzer m Calibration Cassette supplied with Sofia Installation Pack 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 or Latex or equivalent gloves is recommended when handling patient samples m Dispose of containers and used contents in accordance with Federal State and Local requirements a Do not reuse any used Cassettes Reagent Tubes Fixed Volume Pipettes 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
3. material m The Reagent Solution contains an acidic solution If the solution contacts the skin or eye flush with copious amounts of water m Testing should be performed in an area with adequate ventilation m For more information consult the Safety Data Sheet available on quidel com m The Reagent Solution Bottle contains glass break cautiously m If the Reagent Solution Bottle is missing the glass ampoule or the solution is green prior to the breaking of the ampoule discard and use another Reagent Solution Bottle 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 E f transport media will be used use only the Transport Media and configuration recommended in this Package Insert m Use rayon tipped swabs to collect throat specimens The performance claims in the Performance Characteristics section were obtained with the Swabs provided in the kit Use of the provided Swabs is recommended Do not use calcium alginate cotton tipped or wooden shaft swabs Sofia Strep A FIA Page 2 of 15 m Do not write on the barcode of the Cassette This is used by Sofia to identify the type of test being run and to identify the individual Cassette so as to
4. not rule out possible other infections m Positive test results do not rule out co infections with other pathogens EXPECTED VALUES Group A Streptococcus bacteria are responsible for about 19 of all upper respiratory tract infections Infection is most prevalent in winter and early spring with most cases arising in patients living in highly populated areas Consistent with these figures in the multi center clinical study conducted by Quidel during 2011 and 2012 17 4 128 736 of the patients presenting with pharyngitis were found to be culture positive for Strep A Nearly half of these subjects 46 were male The subjects ages ranged from 3 72 years and 88 647 736 were children 3 17 years of age PERFORMANCE CHARACTERISTICS Sofia Strep A FIA Performance vs Cell Culture The performance of the Sofia Strep A FIA was compared to standard bacterial culture and identification in a multi center clinical field study This study was conducted by health care personnel during 2011 and 2012 at eight 8 distinct sites in various geographical regions within the United States and two 2 sites in Australia In this multi center point of care POC field trial two 2 throat Swabs were collected from 736 patients with symptoms suggestive of bacterial pharyngitis One 1 throat Swab was transported on cold ice packs to a central Reference Laboratory streaked on a sheep blood agar plate SBA and cultured for up to 48 hours Immediately after
5. prevent a second read of the Cassette by the same Sofia m Once a Cassette has been successfully scanned by Sofia do not attempt to scan the Cassette again in the same Sofia The barcode on the Cassette contains a unique identifier that will prevent Sofia from performing a second read ona previously scanned Cassette m As the detection reagent is a fluorescent compound no visible results will form on the test strip Sofia must be used for result interpretation KIT STORAGE AND STABILITY Store the kit at room temperature 59 F to 86 F 15 C to 30 C out of direct sunlight Kit contents are stable until the expiration date printed on the outer box Do not freeze QUALITY CONTROL There are three types of Quality Control for Sofia and Strep A FIA Sofia Calibration Check Procedure built in procedural control features and External Controls Sofia Calibration Check Procedure Note This is a Calibration Check procedure The Calibration Check Procedure should be performed every 30 days Sofia is set to remind the user to complete the Calibration Check Procedure The Calibration Check is a required function that checks the Sofia optics and calculation systems using a specific Calibration Cassette This Calibration Cassette is shipped with the Sofia Installation Pack Refer to the Sofia User Manual for details regarding the Calibration Check Procedure Important Ensure that the Calibration Cassette is stored in the provided storag
6. streaking this same Swab was tested in the rapid Sofia Strep A FIA The performance of the Sofia Strep A FIA was determined by comparison of the rapid test result to the corresponding culture result The results from these analyses are presented in Tables 2 3a and 3b Table 2 Sofia Strep A FIA Results Combined Culture Sens 90 6 116 128 Pos Neg Total 95 Cl 84 3 94 6 Sofia Pos 116 24 140 Spec 96 1 584 608 Sofia Neg 12 584 596 95 CI 94 2 97 3 Total 128 608 736 PPV 82 9 116 140 NPV 98 0 584 596 Prev 17 4 128 736 Sofia Strep A FIA Page 10 of 15 Table 3a Sofia Strep A FIA Results READ NOW Mode Culture Sens 89 3 100 112 Pos Neg Total 95 Cl 82 2 93 8 Sofia Pos 100 23 123 Spec 96 0 549 572 Sofia Neg 12 549 561 95 Cl 94 0 97 3 Total 112 572 684 PPV 81 3 100 123 NPV 97 9 549 561 Prev 16 4 112 684 Table 3b Sofia Strep A FIA Results WALK AWAY Mode Sens 100 16 16 95 CI 80 6 100 Spec 97 2 35 36 95 Cl 85 8 99 5 PPV 94 1 16 17 NPV 100 35 35 Prev 30 8 16 52 Culture Pos Neg Total Sofia Pos 16 1 17 SofiaNeg 0 35 35 Total 16 36 52 Reproducibility Studies The reproducibility of the Sofia Strep A FIA was evaluated at three 3 different laboratories Two 2 different oper
7. 1 Sofia Strep A FIA CJ LIE FOR USE WITH SOFIA ONLY iu INTENDED USE The Sofia Strep A FIA employs immunofluorescence technology to detect Group A Streptococcal antigens from throat swabs of symptomatic patients All negative test results should be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used as the sole basis for treatment The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection SUMMARY AND EXPLANATION Group A Streptococcus is one of the most common causes of acute upper respiratory tract infection Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and serious complications such as rheumatic fever and glomerulonephritis Conventional procedures for identification of Group A Streptococcus from throat swabs involve the culture isolation and subsequent identification of viable pathogen at 24 to 48 hours or longer for results 4 PRINCIPLE OF THE TEST The Sofia Strep A FIA employs immunofluorescence technology that is used with the Sofia analyzer Sofia to detect Group A Streptococcal antigen The Sofia Strep A FIA involves the extraction of the antigenic components of the Group A Streptococcus GAS bacteria The patient s Swab specimen is placed in the Reagent Tube containing the Reagent Solution during which time the bacterial
8. 78904 Date User ID Order Strep A 10 28 2010 9 43AM 00000034 EGHIJKLMNO invalid Procedural Control invalid Start New Test For example This result shows that an invalid result was obtained Invalid Result If the test is invalid a new test should be performed with a new patient sample and a new test Cassette Sofia Strep A FIA Page 9 of 15 LIMITATIONS m The contents of this kit are to be used for the qualitative detection of Group A Streptococcal antigens from throat Swab specimens m The test detects both viable and nonviable Group A Streptococcus bacteria and may yield a positive result in the absence of living organisms m Respiratory infections including pharyngitis can be caused by Streptococcus from serogroups other than Group A as well as other pathogens m The Sofia Strep A FIA will not differentiate asymptomatic carriers of Group A Streptococcus from those exhibiting Streptococcal infection 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 transported or stored improperly m Failure to follow the Test Procedure may adversely affect test performance and or invalidate the test result m Patients with symptoms and an antigen negative test should have a follow up culture Test results must be evaluated in conjunction with other clinical data available to the physician m Negative test results do
9. Isolate 7 0x104 cfu test cfu test colony forming units test The levels of bacteria were determined by limiting dilution bacterial culture and colony counting to give cfu test Sofia Strep A FIA Page 12 of 15 Analytical Specificity Cross Reactivity The cross reactivity of the Sofia Strep A FIA was evaluated with a total of 61 non Group A Streptococcus bacterial and fungal microorganisms and 26 viral isolates None of the organisms or viruses listed below in Table 8 showed any sign of cross reactivity in the assay When the same organisms in Table 8 were pre mixed with Group A Strep and tested in the Sofia Strep A FIA all results were positive also indicating that the potential cross reactants did not interfere with the detection of Strep A Organism Virus lyticum Bacteroides fragilis Bordetella pertussis Candida albicans Corynebacterium diphtheria Corynebacterium pseudodiphtheriticum Enterococcus faecalis Enterococcus faecium Escherichia coli Fusobacterium necrophorum Haemophilus influenzae Haemophilus parahaemolyticus Klebsiella pneumoniae Moraxella catarrhalis Neisseria lactamica Neisseria gonorrhoeae Neisseria meningitidis Neisseria sicca Neisseria subflava Proteus vulgaris Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus intermedius Staphylococcus saprophyticus Streptococcus anginosus Streptococcus gordonii Streptococcu
10. antigens are extracted making them more accessible to the specific antibodies An aliquot of the extracted 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 Group A Streptococcal antigens are present they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia If antigens are not present the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia Note Depending upon the user s choice the Cassette now containing the specimen is either placed directly inside Sofia for automatically timed development WALK AWAY Mode or placed on the counter or bench top for a manually timed development and then placed into Sofia READ NOW Mode Sofia scans measures and interprets the immunofluorescent signal using on board method specific algorithms Sofia will then report the test results to the user Positive Negative or Invalid on its display screen and it can print out the results via an integrated printer or transmit the results via an LIS connection Sofia Strep A FIA Page 1 of 15 REAGENTS AND MATERIALS SUPPLIED 25 Test Kit m Individually Packaged Cassettes 25 Polyclonal rabbit anti
11. ately inserts the Cassette into Sofia The user then returns after 5 minutes to get the test result In this mode Sofia will automatically time the test development before scanning and displaying the test result READ NOW Mode Allow the test to develop for the full 5 minutes BEFORE placing it into Sofia The user must first place the Cassette onto the counter or bench top for 5 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 in less than 1 minute Note Results will remain stable for an additional 10 minutes after the recommended development time of 5 minutes Sofia Strep A FIA Page 7 of 15 Tips for Batch Testing In order to make batch testing easier the user can prepare one or more Reagent Solution Bottles in advance of testing samples The user can break the ampoule inside each Reagent Solution Bottle shake to mix the solutions and then store the capped Bottles on the bench top at room temperature for up to 12 hours without loss of activity before using with Swab sample s Critically important the user should never open the foil pouch thus exposing the test Cassette to the ambient environment until it is ready for immediate use Run Test 1 Input the User ID using the handheld barcode scanner or manually enter the data using the key pad NOTE If you mistakenly scan the wrong barcode use the Arrow Butto
12. ators at each site tested a series of coded contrived samples prepared in negative clinical matrix ranging from low negative to moderate positive Group A Streptococcus The inter laboratory agreement Table 4 for negative samples was 96 7 100 and 96 7 100 for positive samples The intra laboratory agreement Table 5 for all samples ranged from 97 5 99 2 Table 4 Sofia Strep A FIA Reproducibility Study Inter laboratory Agreement Low Negative no bacteria 0 cfu test 30 30 High Negative Cs 1 5x10 cfu test Low Positive Css 3 0x10 cfu test Mod Positive Cx 2 8x10 cfu test 30 30 30 30 30 30 30 30 30 30 Total 90 90 90 90 Overall Agreement 95 CI 100 90 90 95 9 100 96 7 87 90 90 7 98 9 Table 5 96 7 87 90 90 7 98 9 100 90 90 95 9 100 Sofia Strep A FIA Reproducibility Study Intra laboratory Agreement Low Negative no bacteria 0 cfu test High Negative Cs 1 5x10 cfu test Low Positive Css 3 0x10 cfu test Mod Positive Csx 2 8x10 cfu test Overall Agreement 95 Cl 30 30 30 30 28 30 30 30 98 3 118 120 94 1 99 5 99 2 119 120 95 4 99 9 97 5 117 120 92 9 99 1 Sofia Strep A FIA Page 11 of 15 Limit of Detection The limit of detection LOD for the Sofia Strep A FIA was determined using three 3 strains of Group A Strept
13. cus sp Group G strain 1 Streptococcus sp Group G strain 3 Coronavirus 229E Cytomegalovirus 3x108 ClDso test 3x10 TCDso test Influenza A H1N1 Influenza B Panama 1 5x104 TCIDs0 test 1 2 TODso test Parainfluenza virus 2 Rhinovirus Type 15 3x104 ClDs0 test Rhinovirus Type 1B 3x10 TCIDso test pO cfu test colony forming units test TCIDso test 50 tissue culture infectious dose The levels of bacteria were determined by limiting dilution bacterial culture and colony counting to give cfu test Virus concentrations were determined by standard virology methods Reed Muench Sofia Strep A FIA Page 13 of 15 Interfering Substances Several over the counter OTC products whole blood and blood agar were evaluated and did not interfere with the Sofia Strep A FIA at the levels tested Table 9 Table 9 Non interfering Substances Substance Crest Pro Health Night Mint Cetylpyridnium chloride 25 v v Listerine Antiseptic Eucalyptol Menthol Methyl salicylate and Thymol 25 v v Listerine Cool Mint Eucalyptol Menthol Methyl salicylate and Thymol 25 v v Cepacol Dual Relief Spray Benzocaine and Menthol 25 v v Chloraseptic Max Sore Throat Relief Phenol and Glycerin 25 v v Children s Dimetapp DM Cold amp Cough Elixir Brompheniramine maleate Dextromethorphan HBr and o l 25 v v Phenylephrine HCI Children s Wal Tap Elixir Cold amp Allergy Brompheniramine maleate and P
14. e pouch between uses to protect it from exposure to light 1 To check the calibration of Sofia select Calibration from the m Main Menu e 10 28 2010 09 43AM RA Supervisor Main Menu Run Test Run QC Review Data gt Calibration q Supervisor Menu Change Mode 2 Following the prompts insert the Calibration Cassette into Sofia e and gently close the drawer Sofia performs the Calibration Check automatically with no user input required Start Calibration Sofia indicates when the Calibration Check is completed Select OK to return to the Main Menu NOTE If the Calibration Check does not pass notify the on site Supervisor or contact Quidel Technical Support for assistance from h a 7 00 a m to 5 00 p m Pacific Time at 800 874 1517 in the U S rr 858 552 1100 outside the U S Fax 858 455 4960 custserv quidel com Customer Service technicalsupport quidel com Technical Support Please insert calibration cassette and close drawer or contact your local distributor Sofia Strep A FIA Page 3 of 15 Built in Procedural Controls The Sofia Strep A FIA contains two built in procedural control features The manufacturer s recommendation for daily control is to document these built in procedural controls for the first sample tested each day A control of the extraction procedure is provided by a color change from clear to green as the Reagent Solution is mixed The color change is an indication of Reagent Solution in
15. en The results can be automatically printed on the integrated printer if this option is selected Test Lines which are fluorescent will never be visible to the naked eye For example This display shows that the test in WALK AWAY mode has 4 minutes 13 seconds remaining Sofia will read and display the results in about 5 minutes The Sofia screen will display results for the procedural control as being valid or invalid and will provide a positive or negative result for Strep A If the procedural control is invalid retest with a new patient sample and a new test Cassette Positive Result i 10 28 2010109 483AM RA Supervisor Detailed Results SirepA Patient ID 2345678904 Date 10 28 2010 9 43AM User ID 00000034 Order EGHIJKLMNO StrepA positive Procedural Control valid Start New Test For example This display shows a valid positive result for Strep A NOTE A positive result does not rule out co infections with other pathogens Negative Result ES 10 28 2010109 43AM_ MA Supervisor Detailed Results Strep A Patient ID 2345678904 Date 10 28 2010 9 43AM User ID 00000034 Order EGHIJKLMNO StrepA negative Procedural Control valid For example This display shows a valid negative result for Strep A NOTE A negative result does not rule out possible other infections Invalid Result el 10 28 2010109 43AM_ MA Supervisor Detailed Results Strep A Patient ID 23456
16. henylephrine HCI 25 v v Children s Wal Tap DM Elixir Cold amp Cough Brompheniramine maleate Dextromethorphan HBr and 25 v v Phenylephrine HCI Rite Aid Tussin CF Dextromethorphan HBr Guaifenesin and Phenylephrine HCI 25 v v Robitussin Cough amp Cold CF Max Dextromethorphan HBr Guaifenesin and Phenylephrine HCI 25 v v Robitussin Nighttime Cough Cold amp Flu Acetaminophen Diphenhydramine HCI and Phenylephrine HCI 25 v v Cepacol Sore Throat Cherry Flavor Benzocaine and Menthol 25 w v Halls Cherry Mentholyptus Menthol 25 w v Halls Mentholyptus Menthol Ricola Mountain Herb Throat Drops Sugar Free Menthol 25 w v Sucrets Complete Vapor Cherry Dyclonine Hydrochloride and Menthol Sucrets Complete Cool Citrus Dyclonine Hydrochloride and Menthol 25 w v Chlorasceptic Throat Drops Cherry Phenol and Glycerin BreathSavers 3 Hour Mint Spearmint Cetylpyridnium chloride 25 w v Tic Tac Freshmints Eucalyptol Menthol Methylsalicylate and Thymol Whole Blood 5 v v Sheep Blood Agar 5 Sheep Blood 2 16 mg mL Horse Blood Agar 5 Horse Blood 1 67 mg mL ASSISTANCE If you have any questions regarding the use of this product or if you want to report a test system problem please call Quidel s Technical Support Number 800 874 1517 in the U S or 858 552 1100 Monday through Friday from 7 00 a m to 5 00 p m Pacific Time If outside the U S contact you
17. itation requirements The user must first select Run QC on the Main Menu of Sofia and then when prompted scan the QC Card located on the kit box This card provides information specific to the kit lot including lot number and expiration date Sofia will prompt the user to select the desired mode WALK AWAY or READ NOW and then to run the External Control Swabs External Positive and Negative Control Swabs are supplied in the kit and should be tested using the Test Procedure provided in this Package Insert or in the Quick Reference Instructions Additional External Control Swabs may be obtained separately by contacting Quidel s Customer Support Services at 800 874 1517 in the U S or 858 552 1100 outside the U S When the QC test is complete each result will be displayed as Passed or Failed for the Positive Control and the Negative Control Do not perform patient tests or report patient test results if the QC test does not produce the expected results Repeat the test or contact Quidel Technical Support before testing patient specimens if a Failed result is obtained with the External Controls Sofia Strep A FIA Page 4 of 15 SPECIMEN COLLECTION AND HANDLING SPECIMEN COLLECTION Use the Rayon tipped Swabs provided in the kit to collect throat specimens The performance claims listed in the Performance Characteristics section were obtained with the Swabs provided in the kit Do not use calcium alginate cotton tipped
18. ns on 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 iy 10 28 2010109 43AM RA Supervisor Start Test WALK AWAY Mode User ID Patient ID Q Order Q Go to Main Menu to Change Mode e 10 28 2010109 43AM_ RA Supervisor Start Test WALK AWAY Mode UserID Patient ID Qq Order Qq Go to Main Menu to Change Mode 3 Press Start Test and the Sofia drawer will automatically open iy 10 28 2010 09 43AM Supervisor Start Test WALK AWAY Mode selected 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 Sofia Strep A FIA Page 8 of 15 5 Sofia 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 5 minutes In the READ NOW Mode the test results will be displayed on the screen in less than 1 minute See Interpretation of Results section e 10 28 2010109 43AM_ MA Supervisor Test in Progress Sofia Strep A Patient ID 2345678904444 Test Development Scan ST Time remaining 4 13 min Cancel i INTERPRETATION OF RESULTS When the test is complete the results will be displayed on the Sofia scre
19. ococcus pyogenes The LOD ranged from 9x103 2x104 colony forming units cfu test Table 6 Table 6 Sofia Strep A FIA Limits of Detection for Three Streptococcus pyogenes Strains Minimum Detectable Level Bruno CIP 104226 1 86x10 cfu test CDC SS 1402 9 24x10 cfu test CDC SS 1460 2 34x10 cfu test cfu test colony forming units test The levels of bacteria were determined by limiting dilution bacterial culture and colony counting to give cfu test Analytical Reactivity Analytical reactivity for the Sofia Strep A FIA was determined using 15 strains of Streptococcus pyogenes Each strain listed below in Table 7 produced positive results in the assay Table 7 Analytical Reactivity Streptococcus pyogenes Strain Test Quantity Strain 1 ATCC 19615 6 5x10 cfu test Strain 2 ATCC 700942 7 4x104 cfu test Strain 3 ATCC 700952 8 3x10 cfu test Strain 4 Field Clinical Iso 3 1x10 cfu test Strain 5 Field Clinical Iso 7 6x104 cfu test Strai d Clinical Iso 7 1x10 cfu test Strain 7 Field Clinical Iso 6 3x10 cfu test Strain 8 Field Clinical Iso 6 3x10 cfu test Strain 9 Field Clinical Iso 5 3x10 cfu test Strain 10 ATCC 700482 6 5x104 cfu test Strain 11 ATCC BAA 1315 7 2x104 cfu test Strain 12 ATCC 700459 5 4x10 cfu test Strain 13 ATCC 12203 6 9x104 cfu test Strain 14 ATCC 700944 5 3x104 cfu test Strain 15 Field Clinical
20. or wooden shaft swabs Collect throat specimens by standard clinical methods Depress the tongue with a tongue blade or spoon Rub the Swab on the back of the throat both of the tonsils the uvula and the posterior pharynx Be careful not to touch the tongue sides or top of the mouth with the Swab Consult standard reference procedures such as the collection method described by Facklam SPECIMEN TRANSPORT AND STORAGE It is recommended that Swab specimens be processed as soon as possible after collection Swabs can be held in any clean dry plastic tube or sleeve up to 24 hours at room temperature 15 C to 30 C or refrigerated 2 C to 8 C up to 48 hours The following transport media and storage conditions have been tested and are also acceptable Table 1 Table 1 Recommended Transport Media Recommended Storage Condition Transport Media 2 C to 8 C Ambient Temperature BD BBL CultureSwab with Liquid Stuarts Media 220109 48 hours 24 hours Remel BactiSwab with Liquid Amies Media R723095 48 hours 24 hours These transport media systems preserve the sample on the Swab tip via contact with a media moistened sponge If a culture is desired lightly streak the Swab on a 5 sheep blood agar plate before using the Swab in the Sofia Strep A FIA Do not perform the Strep A FIA before streaking the Swab as the Reagent Solution will destroy the bacteria on the Swab thereby rendering the organism incapable of successful cul
21. r local distributor or technicalsupport quidel com REFERENCES 1 American Academy of Pediatrics Group Streptococcal Infection In Pickering L K Baker C J Kimberlin D W Long S S eds Red Book 2009 Report of the Committee on Infectious Diseases 28th ed Elk Grove Village IL America Academy of Pediatrics 2009 pp 616 628 2 Youmans G P Paterson PY and Sommer H M Upper Respiratory Tract Infection General Considerations in the Biological and Clinical Basis of Infectious Disease W B Saunders Co Philadelphia 1980 pp 177 183 3 Versalovic J Carroll K C Jorgensen J H Funke G Landry M L Warnock D W eds Manual of Clinical Microbiology 10 ed ASM Press Washington DC Chapter 20 Streptococcus 2011 pp 331 349 4 Youmans G P Paterson PY and Sommers H M The Biological and Clinical Basis of Infectious Disease 1975 pp 172 185 N Biosafety in Microbiological and Biomedical Laboratories 5th Edition U S Department of Health and Human Services CDC NIH Washington DC 2007 Facklam R R and Washington J A Manual of Clinical Microbiology 5 Edition 1991 p 241 Rammelkamp C H Jr Principles of Internal Medicine 8th Edition 1977 pp 814 820 8 Lauer B A Reller L D and Mirrett S Journal of Clinical Microbiology 17 338 340 1983 Sofia Strep A FIA Page 14 of 15 20231 Sofia Strep A FIA 25 Tests multi language 20253 Sofia Strep A FIA 25 Tests CE MDSS GmbH
22. s mitis Streptococcus mutans Streptococcus oralis Streptococcus parasanquis Streptococcus pneumoniae Streptococcus salivarius Streptococcus sanguinis Streptococcus sp Group B strain 1 Streptococcus sp Group B strain 2 Streptococcus sp Group B strain 3 Streptococcus sp Group B strain 4 Streptococcus sp Group B strain 5 Streptococcus sp Group C strain 1 Streptococcus sp Group C strain 2 Streptococcus sp Group C strain 3 Test Quantity 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x104 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 1 5x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x104 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test Table 8 Analytical Specificity and Cross Reactivity 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x10 cfu test 3x104 TCIDs0 test Streptococcus sp Group C strain 5 Streptococcus sp Group D strain 3 Streptococcus sp Group F strain 3 Streptococ
23. t Tube for 1 minute Leave for 1 minute 7 Vigorously mix the solution again by plunging the Swab 5 times in an up and down motion in the Tube I Vigorously plunge up and down 5x Sofia Strep A FIA Page 6 of 15 8 Express as much liquid as possible from the Swab by squeezing the sides of the Tube as the Swab is withdrawn Discard the Swab in accordance with your biohazard waste disposal protocol 9 Fillthe provided Yellow 100 uL Fixed Volume Pipette with the sample Squeeze here To fill the Fixed Volume Pipette with the sample a FIRMLY squeeze the top bulb Overflow Pipette b Still squeezing place the Pipette tip into the sample c With the Pipette tip still in the sample release pressure on the bulb to fill the Pipette Sample 10 Firmly squeeze the top bulb to empty the contents of the Fixed Volume Pipette into the Squeeze Cassette sample well Extra liquid in the overflow bulb is OK here NOTE The Fixed Volume Pipette is designed to collect and dispense the correct amount of patient sample Discard the Pipette in your biohazard waste 11 Proceed to the next section Using Sofia to complete the test A Sample Well 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 In WALK AWAY Mode the user immedi
24. tegrity and is also an indication that the extraction procedure was performed correctly Each time a test is run in Sofia a procedural control is interpreted by Sofia and the result is displayed on the Sofia screen This information Oe een stn is automatically logged in Sofia with each test result A valid result Detailed Results obtained with the procedural control demonstrates that the extracted Strep A specimen flowed correctly and the functional integrity of the Cassette Batien D 2346678904 was maintained This procedural control is interpreted by Sofia after Date 10 28 2010 9 43AM the Cassette has developed for 5 minutes If the specimen has not User ID 00000034 flowed correctly Sofia will indicate that the result is invalid Should Order EGHIJKLMNO this occur review the procedure and repeat the test with a new patient Ema sample and a new test Cassette Start New Test For example This result shows that an invalid result had occurred 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 Controls be run m once for each untrained operator m once for each new shipment of kits provided that each different lot received in the shipment is tested and m as deemed additionally necessary by your internal quality control procedures and in accordance with Local State and Federal regulations or accred
25. turing Alternatively two throat Swab specimens can be obtained in this case one can be used separately for culture and the other for the Sofia Strep A FIA TEST PROCEDURE Important E All specimens must be at room temperature 15 C to 30 C before beginning the test m Gloves should be worn when handling human samples E Do not use the Reagent Solution if it is green prior to breaking the ampoule E Do not open the foil pouch of the test Cassette until it is ready for immediate use Expiration date Check expiration on outer box before using Do not use any test Cassette past the expiration date on the label 1 Verify that Sofia is set to the desired Mode WALK AWAY or READ NOW See the Using Sofia section for more information 2 Squeeze ONCE to break the glass ampoule inside the Reagent Solution Bottle prior to running the assay Sofia Strep A FIA Page 5 of 15 3 Vigorously shake the Bottle 5 times to mix the Solutions Solution should turn green after the ampoule is broken 4 Remove the cap Holding Bottle vertically fill the Reagent Tube to the line approximately 6 drops 5 Immediately add the patient Swab sample to the Reagent Tube Vigorously mix the solutions by plunging the Swab 5 times in an up and down motion in the Tube NOTE Best results are obtained when the specimen is vigorously extracted in the solution D Vigorously plunge up and down 5x 6 Leave the Swab in the Reagen
Download Pdf Manuals
Related Search