FOR USE WIT TH SOFIA ONLY CLIA Comple exity: Waived For in vitro use only A Certificate of Waiver is required to perform p this test in a CLIA A waived settting. This testt may also bee used by laboratories that perform m moderate and high com mplexity testting. To obtain a Certificaate of Waiveer, please nt. Additional CLIA waiveer informatio on is availablle at the Cen nters for contact yourr state health departmen Medicare and d Medicaid website w at ww ww.cms.hhs.
Every year in the United States, on average 5%‐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.
WARNINGS AND PRECAUTIONS For in vitro diagnostic use. Do not use the kit contents beyond the expiration date printed on the outside of the box. Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used kit contents.3 Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.3 Dispose of containers and used contents in accordance with Federal, State, and Local requirements.
QUALITY CONTROL There are three types of Quality Control for Sofia and the Cassette: 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 can be easily set to remind the user to complete the Calibration Check Procedure.
Built‐in Procedural Controls The Sofia Influenza A+B FIA contains a built‐in procedural control feature. Each time a test is run in Sofia, the procedural control zone is scanned by Sofia and the result is displayed on the Sofia 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 Sofia with each test result.
SAMPLE COLLECTION AND HANDLING SAMPLE 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 presents 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.
The followingg viral transpo ort media listted in Table 1 are compati ble with the SSofia Influenzza A+B FIA: Table 1 Recom mmended Viraal Transport M Medium (VTM M) Reco ommended SStorage Cond dition Viral V Transport Medium (V VTM) 2°C to o 8°C 25°C Copan C Univerrsal Transportt Medium 72 hoours 72 hours Hank’s H Balancced Salt Solution 24 hoours Not recomm mended M4 M 72 hoours 72 hours M4‐RT M 72 hoours 72 hours M5 M 72 hoours 72 hours M6 M 72 hoours 72 hours Modified M Liqu uid Stuart
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 120 µL Fixed Volume Pipette with the patient sample from the Reagent Tube. To fill the Fixed Volume Pipette with the patient sample: a. FIRMLY squeeze the top bulb. b. Still squeezing, place the Pipette tip into the patient sample. c. With the Pipette tip still in the patient sample, slowly release pressure on bulb to fill the Pipette. 6.
NOTE: To obtain accurate results, avoid mucoid substances when filling the Large, Pink Fixed Volume Pipette with patient sample from the collection cup. 4. Firmly squeeze the top bulb to empty the contents of the Large, Pink Fixed Volume Pipette into the Reagent Tube. Extra liquid left over in the overflow bulb should be left behind. NOTE: Once the sample is added to the Reagent Tube, vigorously mix prior to adding the sample to the test Cassette.
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 immediately inserts the Cassette into Sofia. The user then returns after 15 minutes to get the test result. In this mode, Sofia will automatically time the test development before scanning and displaying the test result.
2. Input thee Patient ID orr Order # usin ng the barcod de scanner or manually entter the data u using the key pad. 3. Press Staart Test and th he Sofia draw wer will autom matically openn. ALK AWAY or READ 4. Verify that the correct development mode, WA h been selected. Inserrt the prepaared patientt test NOW, has Cassette into the draw wer of Sofia and a close the drawer. 5. Sofia will start autom matically and display the progress, p as sshown w.
INTERPRETATION OF RESULTSS When the test is complette, the resultss will be displayed on thee Sofia screen n. The results can be automatically printed on th he integrated d printer if th his option is selected. s Testt Lines, which are fluoresscent, cannott be seen with the nake ed eye. or the procedural control aas being “valid or invalid,” and will ind dividually The Sofia scrreen will display results fo provide a positive or negaative result fo or both influe enza A and in fluenza B.
Negative Results: For example: This display shows a valid negative result for Influenza A and Influenza B. NOTE: A negative result does not exclude influenza viral infection. Negative results should be confirmed by virus culture or an FDA‐cleared influenza A and B molecular assay. Invalid Results: For example: This display shows an invalid result. Invalid Result: If the test is invalid, a new test should be performed with a new patient sample and a new test Cassette.
Monoclonal antibodies may fail to detect, or detect with less sensitivity, influenza A viruses that have undergone minor amino acid changes in the target epitope region. If differentiation of specific influenza A subtypes and strains is needed, additional testing, in consultation with state or local public health departments, is required. Samples contaminated with whole blood >4% v/v or mucin >0.5% v/v may interfere in the interpretation of the test.
Table 2 Sofia Influenza A+B FIA Nasal Swab Results Versus Culture (All Age Groups) TYPE A Culture Pos Neg Sofia Pos 124 27 Sofia Neg 14 500 TYPE B Sens = 124/138 = 90% (95% C.I. 84%‐94%) Culture Spec = 500/527 = 95% (95% C.I. 93%‐96%) Pos Neg Sofia Pos 100 23 Sofia Neg 12 530 Sens = 100/112 = 89% (95% C.I. 82%‐94%) Spec = 530/553 = 96% (95% C.I.
Table 6 Performance Compared to Culture for Each Sample Type by Age Group for Influenza B Nasal Swabs Nasopharyngeal Swabs Nasopharyngeal Aspirate/Wash Sensitivity Specificity Sensitivity Specificity Sensitivity Specificity All Ages 89% (100/112) (95%CI=82%‐94%) 96% (530/553) (95%CI=94%‐97%) 90% (101/112) (95%CI=83%‐95%) 97% (602/621) (95%CI=95%‐98%) 88% (46/52) (95%CI=77%‐95%) 96% (575/597) (95%CI=94%‐98%) <6 years 90% (35/39) (95%CI=76%‐97%) 96% (238/247) (95%CI=93%‐98%) 87% (54/62) (95
Table 8 Sofia Influenza A+B Reproducibility Study Intra‐Laboratory Agreement Flu A Lab.
Table 10 Analytical Reactivity with Human Isolates of Influenza A and B Viral Strain A/Fort Monmouth/1/47 A/New Caledonia/20/1999 A/New Jersey/8/76 A/NWS/33 A/Puerto Rico/8/34 A/Solomon Islands/3/06 A/Taiwan/42/06 A/WI/629‐9/2008 A1/Denver/1/57 Influenza/Mexico/4108/2009 A/WI/629(D02312)/2009 A/WI/629(D02473)/2009 A/Port Chalmers/1/73 A/Victoria/3/75 A/WI/629‐2/2008 Viral Strain A/Anhui/1/2013* Viral Type Sub‐Type A H1N1 A H1N1 A H1N1 A H1N1 A H1N1 A H1N1 A H1N1 A H1N1 A H1N1 A 2009 H1N1 A 2009 H1N1 A 20
Analytical reactivity was further evaluated using a total of 12 influenza A viruses isolated from birds. The Sofia Influenza A+B FIA detected all of the strains examined (Table 11).
Table 12 Analytical Specificity and Cross Reactivity Organism/Non‐Influenza Virus Bordetella pertussis Canidida albicans Chlamydia trachomatis Corynebacterium diphtheriae Escherichia coli Haemophilus influenzae Lactobacillus plantarum Legionella pneumophila Moraxella catarrhalis Mycobacterium tuberculosis (avirulent) Mycoplasma pneumoniae Neisseria meningitidis Neisseria subflava Pseudomonas aeruginosa Staphylococcus epidermidis Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius Adenov
Interfering Substances Whole blood, mucin, and several over‐the‐counter (OTC) products and 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 Whole Blood Mucin Concentration 4% 0.5% Ricola (Menthol) 1.5 mg/mL Sucrets (Dyclonin/Menthol) 1.5 mg/mL Chloraseptic (Menthol/Benzocaine) 1.
Table 14 Sofia Influenza A+B FIA Versus Culture (Nasal/Nasopharyngeal Swabs) TYPE A Culture Sens = Pos Neg Sofia Pos 219 58 Sofia Neg 16 1014 Spec = TYPE B 219/235 = 93% (95% C.I. 89%‐96%) Culture 1014/1072 = 95% (95% C.I. 93%‐96%) Pos Neg Sofia Pos 188 40 Sofia Neg 21 1058 Sens = 188/209 = 90% (95% C.I. 85%‐93%) Spec = 1058/1098 = 96% (95% C.I.
Table 17 So ofia Influenzaa A+B FIA Perrformance Neear the Cutofff—Study B Untrained Intended Ussers Sam mple Level Percent Agreement A with Expeccted Results* 95% Conffidence Intervval Flu A Weak Negative N (C5) 95% (57/60) ( 866%‐99% Flu A Weak Positive P (C95) 97% (58/60) ( 888%‐>99% Flu B Weak Negative N (C5) 80% (48/60) ( 688%‐88% Flu B Weak Positive P (C95) 97% (58/60) ( 888%‐>99% *The expe ected results for “Weak Positive e” samples are ““Positive,” whilee the expected rresults for “We
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