RSV FIA - Quidel
Contents
1. Fields Virology Fourth Edition Volume 1 Chapter 45 Respiratory Syncytial Virus Lippincot Williams and Wilkins 2001 4 Thompson W et al Mortality Associated With Influenza and Respiratory Syncytial Virus in the United States JAMA 2003 Jan 289 2 184 5 Navas L Wang E et al Improved outcome of respiratory syncytial virus infection in a high risk hospitalized population of Canadian children Pediatric Investigators Collaborative Network on Infections in Canada J Pediatr 1992 Sep 121 3 348 54 Moler F W et al Respiratory syncytial virus morbidity and mortality estimates in congenital heart disease patients a recent experience Crit Care Med 1992 Oct 20 10 1406 13 Biosafety in Microbiological and Biomedical Laboratories 5th Edition U S Department of Health and Human Services CDC NIH Washington DC 2007 Sofia RSV FIA Page 16 of 17 REF 20242 Sofia RSV FIA 25 Test 20260 Sofia RSV FIA 25 Test AL MDSS GmbH Schiffgraben 41 30175 Hannover Germany Quidel Corporation San Diego CA 92121 USA quidel com QUIDEL Authorized Representative in the European Community i 1255200ENO00 08 13 Catalogue number CONTROL Positive control CONTROL Negative control LOT Batch code IVD For In Vitro diagnostic use Consult instructions for use E Manufacturer Sofia RSV FIA Use by a Temperature limitation Page 17 of 172. Sofia RSV FIA Page 12 of 17 Table 2 Sofia RSV FIA Nasopharyngeal Swab Results Versus Culture Culture Sens 126 146 86 Pos Neg 95 C I 80 91 Sofia Pos 126 25 Spec 801 826 97 SofiaNeg 20 801 95 C I 96 98 Total 146 826 PPV 83 126 151 NPV 98 801 821 Table 3 Sofia RSV FIA Nasopharyngeal Aspirate Wash Results Versus Culture Culture Sens 57 64 89 Pos Neg 95 C I 79 95 Sofia Pos 57 12 Spec 688 700 98 SofiaNeg 7 688 95 C I 97 99 Total PPV 83 57 69 NPV 99 688 695 Sofia RSV FIA Performance vs Cell Culture When Testing Specimens Placed into Viral Transport Media The performance of the Sofia RSV FIA when testing specimens placed into VTM was compared to viral cell culture methods followed by DFA in the same multi center clinical field study during February through April of 2012 and October through December of 2012 in the United States This portion of the study was conducted by laboratory personnel at two 2 distinct laboratory sites within the United States A nasopharyngeal swab or nasopharyngeal aspirate wash specimen collected from each of 1 749 patients was placed in viral transport media and then transported cold on ice packs not frozen overnight to the laboratory The Sofia RSV FIA test was performed on a portion of each specimen and the culture was performed using the remainder of the same specimen in VTM Nasophar
3. to re highlight the field Then simply rescan using the correct barcode and the previous one will be overwritten with the correct barcode E 06 01 2011 14 46 Start Test Walk Away Mode User ID Patient ID Order Go to Main Menu to Change Mode Sofia RSV FIA Page 9 of 17 2 Input Patient ID or Order using the handheld barcode scanner or manually enter the data using the key pad e 06 01 2011 14 46 Start Test Walk Away Mode User ID Patient ID l Order l Go to Main Menu to Change Mode 3 Press Start Test and the Sofia Analyzer drawer will automatically open ES 06 01 2011 14 46 RA Supervisor Start Test walk away timing selected Y ua Ta Please insert cassette and close drawer 4 Verify that the correct development mode Walk Away or Read Now has been selected Insert the prepared patient Cassette into the drawer of the Sofia Analyzer and close the drawer 5 The Analyzer will start automatically and display the progress as shown in the example below In Walk Away Mode the test results will be displayed on the screen in approximately fifteen 15 minutes In Read Now Mode the test results will be displayed on the screen within one 1 minute See Interpretation of Results section t 10 28 2010109 43AM if Supervisor Test in Progress Sofia RSV oe For example This display shows RANBNUIDY 2945679901441 that the test in W
4. 0 30 30 30 30 30 30 30 Total 90 90 88 90 88 90 90 90 Overall Agreement 95 Cl 100 98 98 100 95 100 92 100 92 100 95 100 Table 7 Sofia RSV FIA Reproducibility Study Intra laboratory Agreement Overall Agreement 95 Cl 98 30 30 28 30 30 30 30 30 118 120 94 100 98 118 120 94 100 100 120 120 96 100 Low Neg High Negative Low Positive Mod Positive no virus Cs Cos Csx 10D Limit of Detection and Analytical Reactivity The limit of detection LOD for the Sofia RSV FIA was determined using a total of four 4 strains of RSV two 2 isolates of RSV A and two 2 isolates of RSV B Table 8 Table 8 Limit of Detection with Human Isolates of RSV A and B Minimum Detectable Level Viral Strain TCIDso mL RSV A 2 RSV A Long RSV B CH93 18 18 RSV B Washington 18537 62 TCID50 mL 50 tissue culture infectious dose TCIDs levels were determined by the Reed Muench method Analytical reactivity was demonstrated using two 2 additional strains of RSV B West Virginia Strain 14617 85 at 163 TCIDso mL and RSV 9320 at 8 7 TCIDso mL Sofia RSV FIA Page 14 of 17 Analytical Specificity Cross Reactivity The cross reactivity of the Sofia RSV FIA was evaluated with a total of 32 bacterial and fungal microorganisms and 42 non RSV viral isolates None of the organisms or viruses listed below in Tab
5. IMEN COLLECTION Nasopharyngeal Swab Sample Use the nasopharyngeal swab supplied in the kit 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 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 the child should 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
6. Sofia RSV FIA For use with the Sofia Analyzer only INTENDED USE The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus RSV nucleoprotein antigen in 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 diagnosis of acute RSV infections in pediatric patients less than 19 years of age Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions A negative result is presumptive and it is recommended these results be confirmed by virus culture or an FDA cleared RSV molecular assay SUMMARY AND EXPLANATION RSV is a causative agent of highly contagious acute viral infection of the respiratory tract in pediatric and elderly populations Respiratory syncytial virus is a single stranded RNA virus Nearly half of all children become infected by RSV in their first year of life It is also the major viral cause of nosocomial illness in children already hospitalized for other reasons In the United States RSV is estimated to be responsible for 73 400 to 126 300 hospitalizations annually for bronchiolitis and pneumonia alone among children younger than 1 year In an analysis of U S viral surveillance and mortality data respiratory syncytial virus RSV was reported as the most common viral cause of death in children you
7. The Sofia RSV FIA contains a built in procedural control feature Each time a test is run in the Sofia Analyzer the procedural control zone is scanned by the Sofia Analyzer and the result is displayed on the Analyzer screen The manufacturer s recommendation for daily control is to document the results of these built in procedural controls for the first sample tested each day This documentation is automatically logged into the Analyzer with each test result A valid result obtained from the procedural control demonstrates 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 fifteen 15 minutes If the test does not flow correctly the Sofia Analyzer will indicate that the result is invalid Should this occur review the procedure and repeat the test with a new patient sample and a new Cassette 10 28 2010109 43AM _ A Supervisor Detailed Results RSV Patient ID 2345678904 Date 01 17 2010 10 30AM ee UserID 00000034 B Er hia display shows Order EGHIJKLMNO an Invalia result RSV Invalid Procedural Control Invalid Start New Test Sofia RSV FIA Page 4 of 17 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 m once for each untrained oper
8. alk Away mode has Test Development Scan 12 minutes 13 seconds remaining eS The Sofia Analyzer will read and eT A display the results after 15 minutes Time remaining 12 13 min Sofia RSV FIA Page 10 of 17 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 Test Lines which are fluorescent cannot be seen with the naked eye The Sofia Analyzer screen will display results for the procedural control as being valid or invalid and will provide a positive or negative result for RSV If the procedural control is invalid retest with a new patient sample and a new Cassette Positive Results he 10 28 2010109 43AM MA Supervisor Detailed Results RSV Patient ID 2345678904 ik Sees 10 30AM For example This display shows a valid Order EGHIJKLMNO positive result for RSV RSV Positive Procedural Control valid Start New Test NOTE A positive result does not rule out co infections with other pathogens Negative Results i 10 28 2010109 43AM_ RA Supervisor Detailed Results RSV Patient ID 2345678904 Date 01 17 2010 10 30AM a User ID 00000034 For example This display shows a valid Order EGHIJKLMNO negative result for RSV RSV Negative Procedural Control valid Start New Test NOTE A negative result does not exclude RSV viral infection Neg
9. ative results should be confirmed by viral culture Invalid Results 10 28 2010109 43AM RA Supervisor Detailed Results RSV Patient ID 2345678904 Date 01 17 2010 10 30AM cigs User ID 00000034 For example This display shows an Order EGHIJKLMNO invalid result RSV Invalid Procedural Control Invalid Start New Test Invalid Result If the test is invalid a new test should be performed with a new patient sample and a new Cassette Sofia RSV FIA Page 11 of 17 LIMITATIONS m This test is suitable for the pediatric population less than 19 years of age only Performance characteristics have not been established for use with patients older than 19 years of age and for immunocompromised patients m The contents of this kit are to be used for the qualitative detection of RSV antigen from nasopharyngeal swab and nasopharyngeal aspirate wash specimens m This test detects both viable live and non viable RSV Test performance depends on the amount of virus antigen in the specimen and may or may not correlate with viral culture results performed on the same specimen 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 avai
10. ator m once for each new shipment of kits provided that each different lot received in the shipment is tested m 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 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 Swab Test Procedure provided in this Package Insert or in the Quick Reference Instructions 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 either of the QC tests do 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 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 SPEC
11. e 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 patient sample Discard the pipette in your biohazard waste 7 Proceed to the next section Using the Sofia Analyzer to complete the test Nasopharyngeal Aspirate Wash or Specimens in Viral Transport Media Test Procedure Slowly 1 Verify that the Sofia Analyzer is set to the desired Analyzer Mode Walk Away or Dispense Read Now See the Using the Sofia Analyzer section for more information Twist off 2 Prepare Reagent a Flick or shake the Reagent Solution vial down so that all fluid is in the bulb ae b Twist off the tab c Slowly dispense all of the Reagent Solution into the Reagent Tube Pl al d Gently swirl the Reagent Tube to dissolve its contents in Bulb Sofia RSV FIA Page 7 of 17 Squeeze 3 Fill the provided large pink fixed volume pipette with patient sample from the a Squeeze collection cup 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 patient sample c With the pipette tip still in the liquid sample release pressure on bulb to fill the pipette Patient Sample 4 Firmly squeeze the top bulb to empty the contents of the large pink fixed volume pipette into the Reagent Tube Extra liquid in the overfl
12. he expiration date on the label Nasopharyngeal Swab Test Procedure 1 Verify that the Sofia Analyzer is set to the desired Analyzer Mode Walk Away or Read Now See the Using the Sofia Analyzer section for more information 2 Prepare Reagent a Flick or shake the Reagent Solution vial down so that all fluid is in the bulb b Twist off the tab c Slowly dispense all of the Reagent Solution into the Reagent Tube d Gently swirl the Reagent Tube to dissolve its contents 3 Place the patient swab sample into the Reagent Tube Roll the swab at least three 3 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 Sofia RSV FIA Slowly Dispense Reagent Tube Reagent Solution in Bulb 3x Twist off Page 6 of 17 4 Roll the swab head against the inside of the Reagent Tube as you remove it Dispose of the used swab in your biohazard waste 5 Fill the provided small clear fixed volume pipette with the patient sample from the Reagent Tube here To fill the fixed volume pipette with the patient sample a FIRMLY squeeze the top bulb Pipette Overflow b Still squeezing place the pipette tip into the patient sample c With the pipette tip still in the patient sample release pressure on bulb to fill the pipette Patient Sample 6 Firmly squeeze the top bulb to empty the contents of the small clear fixed volum
13. hen transferring the patient sample from the collection cup into the Reagent Tube 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 Do not attempt to scan a Cassette more than one time The barcode on the Cassette contains a unique identifier that will prevent the Sofia Analyzer from performing a second read on a previously scanned Cassette An error message will be displayed if a Cassette is scanned more than once 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 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 the Sofia Analyzer and Cassette Sofia Analyzer Calibration Check 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 Chec
14. ing it into the Analyzer The user must first place the Cassette onto the counter or bench top for fifteen 15 minutes outside of the Analyzer and manually time this development step Less than fifteen 15 minutes may result in false negative results Then the user inserts the Cassette into the Analyzer In Read Now Mode 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 Tips for Batch Testing Depending on the workload several options 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 room temperature for up to 4 hours without loss of activity before adding the sample s Alternatively after addition of the Reagent Solution the user can process swab or liquid specimens in the Reagent Tube then after removing the swab if applicable recap the tube and let them stand at room temperature for up to 4 hours without loss of activity before testing Critically important the user should never open the foil pouch exposing the Cassette to ambient environment until 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 Buttons on the Sofia Analyzer key pad
15. k is a required function that checks the Sofia Analyzer optics and calculation systems using a specific Calibration Cassette This Calibration Cassette is shipped with the Sofia Installation Pack 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 check the calibration of the Sofia Analyzer select Calibration from the Main Menu 06 01 2011 1 14 46 Main Menu Run Test Run QC Review Data Calibration lt Supervisor Menu Change Mode Sofia RSV FIA Page 3 of 17 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 input required 06 01 2011 1 14 46 Start Calibration a 7 Please insert cassette and close drawer Cancel The Sofia Analyzer 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 7 00 a m 5 00 p m PST at 800 874 1517 within the USA 858 552 1100 outside the USA Fax 858 455 4960 custserv quidel com Customer Service technicalsupport quidel com Technical Support or contact your local distributor Built in Procedural Controls
16. lable to the physician m Positive test results do not rule out co infections with other pathogens m Negative test results are not intended to rule in other non RSV viral or bacterial infections 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 RSV activity when prevalence is moderate to low m Monoclonal antibodies may fail to detect or detect with less sensitivity RSV viruses that have undergone minor amino acid changes in the target epitope region m Samples contaminated with whole blood gt 1 may interfere in the interpretation of the test Visually bloody samples should not be used m Mycoplasma pneumoniae at levels greater than 1x10 cfu mL may cross react or interfere with the performance of the test m The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection EXPECTED VALUES The rate of positivity observed in RSV testing will vary depending on the method of specimen collection handling transport system employed detection method utilized time of year age of the patient and disease prevalence The prevalence observed with culture during the clinical study was 12 211 1755 PERFORMANCE CHARACTERISTICS Sofia RSV FIA Performance vs Cell Culture The performance of
17. le 9 showed any sign of cross reactivity in the assay When the same organisms in Table 9 were pre mixed with RSV and tested in the Sofia RSV FIA all results were positive indicating that the potential cross reactants did not interfere with the detection of RSV Organism Non RSV Virus Concentration Acinetobacter baumannii Table 9 Analytical Specificity and Cross Reactivity Organism Non RSV Virus Concentration 2 32x10 cfu mL Coranavirus 229E 2 32x10 TCIDso mL Bacteroides fragilis 2 32x10 cfu mL Coxsackievirus B5 Faulkner 2 32x10 TCIDso mL Bordetella pertussis 2 32x10 cfu mL Cytomegalovirus AD 169 2 32x10 TCIDso mL Candida albicans yeast 2 32x10 cfu mL Cytomegalovirus Towne 2 32x10 TCIDso mL Corynebacterium diptheriae 2 32x10 cfu mL Echovirus Type 3 2 32x10 TCIDso mL Escherichia coli 2 32x10 cfu mL Herpes Simplex virus 1 2 32x10 TCIDso mL Haemophilus influenzae 2 32x10 cfu mL Herpes Simplex virus 2 2 32x10 TCIDso mL Klebsiella pneumoniae 2 32x10 cfu mL Human Metapneumovirus A1 2 32x10 TCIDso mL Lactobacillus plantarum 2 32x10 cfu mL Human Metapneumovirus A2 2 32x10 TCIDso mL Legionella pneumophila 2 32x10 cfu mL Human Metapneumovirus B1 2 32x10 TCIDso mL Moraxella catarrhalis 2 32x10 cfu mL Human Metapneumovirus B2 2 32x10 TCIDso mL Mycobacterium a
18. nfluenza A H3N2 2 32x10 TCIDso mL Influenza B Hong Kong 2 32x10 TCIDso mL Influenza B Panama 2 32x10 TCIDs0 mL Influenza C Taylor 1233 47 2 32x10 TCIDso mL Measles Edmonston 2 32x10 TCIDso mL Metapneumovirus VR 03 00181 UIHC 2 32x10 TCIDso mL Mumps Enders 2 32x10 TCIDso mL Parainfluenza virus 1 2 32x10 TCIDso mL Parainfluenza virus 2 2 32x10 TCIDso mL Parainfluenza virus 3 2 32x10 TCIDso mL Parainfluenza virus 4A 2 32x10 TCIDso mL Parainfluenza virus 4B 2 32x10 TCIDso mL Rhinovirus Type 1B 2 32x10 TCIDso mL Rhinovirus Type 2 2 32x10 TCIDso mL Rhinovirus Type 3 2 32x10 TCIDso mL Rhinovirus Type 7 2 32x10 TCIDso mL Rhinovirus Type 15 2 32x10 TCIDso mL Adenovirus 11 2 32x10 TCIDso mL Rhinovirus Type 18 2 32x10 TCIDso mL Coranavirus OC43 2 32x10 TCIDs0 mL Rhinovirus Type 37 2 32x10 TCIDso mL Varicella Zoster Virus 3 55x10 TCIDso mL The levels of bacteria were determined by limiting dilution bacterial culture and colony counting to give cfu mL cfu colony forming unit Virus concentrations were determined by standard virology methods Reed Muench Sofia RSV FIA Page 15 of 17 Interfering Substances Whole blood mucin and several over the counter OTC products and common chemicals were evaluated and did not interfe
19. nger than 5 years when compared to influenza A H1N1 influenza A H3N2 and influenza B Among children hospitalized with RSV infection the mortality rate is estimated to be as low as 0 3 to 1 0 gt and in the range of 2 5 to 4 0 for children with underlying cardiac or pulmonary disease PRINCIPLE OF THE TEST The Sofia RSV FIA test employs immunofluorescence technology that is used with the Sofia Analyzer for the rapid detection of RSV antigens The Sofia RSV FIA test involves the disruption of RSV 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 RSV viral antigens are 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 In
20. ow bulb is OK Gently swirl the Reagent hae Tube to mix NOTE The fixed volume pipette is designed to collect and dispense the correct amount of patient sample Discard the pipette in your biohazard waste Reagent Tube 5 Fill the provided small clear fixed volume pipette with patient sample from the Reagent Tube N here Pipette Overflow Patient Sample 6 Firmly squeeze the top bulb to empty the contents of the small clear fixed volume pipette into the Cassette sample well Extra liquid in the overflow bulb is OK Discard the pipette in your biohazard waste NOTE The fixed volume pipette is designed to collect and dispense the correct amount of patient sample Discard the pipette in your biohazard waste 7 Proceed to the next section Using the Sofia Analyzer to complete the test Sofia RSV FIA Page 8 of 17 USING THE SOFIA ANALYZER Walk Away Read Now Modes Refer to the Sofia Analyzer User Manual for operating instructions The Analyzer 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 immediately inserts the Cassette into the Analyzer The user then returns after fifteen 15 minutes to get the test result In this mode the Analyzer will automatically time the test development before scanning and displaying the test result Read Now Mode Allow the test to develop for the FULL fifteen 15 minutes BEFORE plac
21. re with the Sofia RSV FIA at the levels indicated below Table 10 Table 10 Non interfering Substances Substance Active Ingredient Concentration OTC Mouthwash 1 Listerine OTC Mouthwash 2 Crest Pro Health OTC Mouthwash 3 Scope OTC Cough Drop 1 CVS OTC Cough Drop 2 Ricola OTC Cough Drop 3 Halls Nasal Spray 1 Vick s Nasal Spray 2 4 Way 23 Nasal Spray 3 Equate 23 Whole Blood 1 Acetamidophenol 23 mg mL Acetylsalicylic acid 23 mg mL Chlorpheniramine 4 mg mL Dextromethorphan 4 mg mL Diphenhydramine 3 mg mL Mucin 9 mg mL Guaiacol 46 mg mL Phenylephrine 11 mg mL Rimantadine 116 ug mL Albuterol 26 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 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 REFERENCES 1 Red Book American Academy of Pediatrics 28th edition 2009 pp 560 569 2 Macartney K et al Nosocomial Respiratory Syncytial Virus Infections The Cost Effectiveness and Cost Benefit of Infection Control Pediatrics 2000 Sep 106 3 520 526 http pediatrics aappublications org cgi content full 106 3 520 3 Collins P Chanock R Murphy B
22. the Sofia RSV FIA was compared to viral cell culture methods followed by DFA in a multi center clinical field study during February through April of 2012 and October through December of 2012 in the United States This study was conducted by health care personnel at 17 distinct sites in various geographical regions within the United States In this multi center point of care POC field trial two 2 nasopharyngeal swabs or nasopharyngeal aspirate wash specimens were collected from each of 1 736 patients A pair of nasopharyngeal swab specimens was provided by 972 patients and a nasopharyngeal aspirate wash specimen was provided by 764 patients All clinical samples were collected from symptomatic patients less than 19 years of age 55 were male and 45 were female On site testing of one nasopharyngeal swab specimen or a portion of nasopharyngeal aspirate wash specimen was performed by medical personnel in the physician s office or hospital facility with the Sofia RSV FIA The samples were freshly collected and tested The remaining sample was placed in viral transport media for culturing The paired swab samples were randomized with respect to the order of testing in the Sofia RSV FIA versus culture Viral cell culture was performed either at a local clinical laboratory at the test site or the samples were transported cold on ice packs not frozen overnight to a central laboratory for culture within 48 hours Results are presented in Tables 2 and 3
23. valid on the screen The results can also be automatically printed on an integrated printer if this option is selected Sofia RSV FIA Page 1 of 17 REAGENTS AND MATERIALS SUPPLIED 25 Test Kit m Individually Packaged Cassettes 25 Mouse monoclonal anti RSV antibodies m Reagent Tubes 25 Lyophilized buffer with detergents and reducing agents m Reagent Solution 25 Vials with salt solution m Sterile Nasopharyngeal Swabs 25 m Large Pink Fixed Volume Pipettes 25 m Small Clear Fixed Volume Pipettes 25 m RSV Positive Control Swab 1 Swab is coated with non infectious RSV antigen 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 for use in Read Now Mode m Sofia Analyzer instrument Sterile saline for the collection of Nasopharyngeal Aspirate or Wash Specimens m Equipment used for collection of Nasopharyngeal Aspirate or Wash Specimens m Calibration Cassette supplied with the Sofia Analyzer 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 glo
24. ves is recommended when handling patient samples m Dispose of containers and used contents in accordance with Federal 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 nasopharyngeal swab specimen use the nasopharyngeal swab supplied in the kit Sofia RSV FIA Page 2 of 17 m Use the appropriate fixed volume pipette in accordance with test procedures gt The small clear fixed volume pipette is to be used ONLY for adding patient sample to the test cassette gt The large pink fixed volume pipette is to be used ONLY with the aspirate wash or viral transport media test procedure w
25. vium 2 32x10 cfu mL Mycobacterium intracellulare 2 32x10 cfu mL Mycobacterium tuberculosis 2 32x10 cfu mL Mycoplasma pneumoniae 1x10 cfu mL Neisseria meningitides 2 32x10 cfu mL Neisseria mucosa 2 32x10 cfu mL Neisseria sicca 2 32x10 cfu mL Neisseria subflava 2 32x10 cfu mL Pseudomanas aeruginosa 2 32x10 cfu mL Serratia marcescens 2 32x10 cfu mL Staphylococcus aureus 2 32x10 cfu mL Staphylococcus aureus Cowen 1 2 32x10 cfu mL Staphylococcus epidermidis 2 32x10 cfu mL Str eptococcus mutans 2 32x10 cfu mL Streptococcus pneumoniae 2 32x10 cfu mL Streptococcus pyogenes Group A 2 32x10 cfu mL Streptococcus sanguis 2 32x10 cfu mL Streptococcus sp Group B 2 32x10 cfu mL Streptococcus sp Group C 2 32x10 cfu mL Streptococcus sp Group F 2 32x10 cfu mL Streptococcus sp Group G 2 32x10 cfu mL Adenovirus 3 2 32x10 TCIDso mL Adenovirus 4 2 64x104 TCI Dso m L Adenovirus 5 8 98x10 TCIDso mL Adenovirus 7A 2 32x10 TCIDso mL Influenza A H1N1 Mexico 4108 2009 2 32x10 TCIDso mL Influenza A H1N1 Denver 1 57 2 32x10 TCIDso mL Influenza A H1N1 FM 1 47 2 32x10 TCIDso mL Influenza A H1N1 New Jersey 8 76 2 32x10 TCIDso mL Influenza A H1N1 PR 8 34 2 32x10 TCIDso mL I
26. 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 Sofia RSV FIA Page 5 of 17 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 RSV FIA TEST PROCEDURE All clinical specimens must be at room temperature before beginning the assay Viral Transport Media Copan Universal Transport Media Hank s Balanced Salt Solution Table 1 Recommended Viral Transport Media Recommended Storage Condition 2 C to 8 C 24 hours 24 hours 25 C 24 hours 24 hours Liquid Amies Media 24 hours 24 hours 24 hours 24 hours 24 hours 24 hours 24 hours 24 hours Modified Liquid Stuarts Media 24 hours 24 hours Saline 24 hours 24 hours Starplex Multitrans Phosphate Buffered Saline 24 hours 24 hours 24 hours 24 hours Expiration date Check expiration date on each individual test package or outer box before using Do not use any test past t
27. yngeal swab specimens were provided by 968 patients and nasopharyngeal aspirate wash specimens were provided by 781 patients Results are presented in Tables 4 and 5 Table 4 Sofia RSV FIA Nasopharyngeal Swab in VTM Results Versus Culture Culture Sens 125 143 87 Pos Neg 95 C I 81 92 Sofia Pos 125 26 Spec 799 825 97 SofiaNeg 18 799 95 C I 95 98 Total 143 825 PPV 83 125 151 NPV 98 799 817 Table 5 Sofia RSV FIA Nasopharyngeal Aspirate Wash in VTM Results Versus Culture Culture Sens 59 67 88 Pos Neg 95 C I 78 94 Sofia Pos 59 12 Spec 702 714 98 SofiaNeg 8 702 95 C I 97 99 Total 67 714 PPV 83 59 71 Sofia RSV FIA NPV 99 702 710 Page 13 of 17 Reproducibility Studies The reproducibility of the Sofia RSV FIA was evaluated at three 3 different laboratories Two 2 different operators at each site tested a series of coded contrived samples prepared in negative clinical matrix ranging from low negative to moderate positive RSV The inter laboratory agreement Table 6 for negative samples was 98 100 and 98 100 for positive samples The intra laboratory agreement Table 7 for all samples ranged from 98 100 Table 6 Sofia RSV FIA Reproducibility Study Inter laboratory Agreement Low Neg High Negative Low Positive Mod Positive no virus Cs Cos Csx Lop 30 30 28 30 30 30 30 30 30 30 30 30 28 30 30 30 3
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