PRINCIPLE OF THE TEST The Silaris Influenza A&B Test is a point of care Nucleic Acid Amplification Test (NAAT) for detection of influenza A virus and/or influenza B virus in patients with flu-like symptoms in approximately 30 minutes. To perform the test, nasal swab specimens are added to the Nasal Swab Buffer to solubilize the sample. An aliquot of the Nasal Swab Buffer is then dispensed into an Silaris Influenza A&B Test Cassette.
MATERIALS PROVIDED SEPARATELY Silaris Dock (Catalog # 1026) Silaris Influenza A&B Control Kit (Catalog # 1024) STORAGE AND HANDLING • Store reagents at room temperature (15°C - 30°C, 59°F - 86°F). Do not refrigerate or freeze. • Do not reuse kit contents: Rayon Swabs, Test Cassettes, Transfer Pipettes, Control Swabs, or Nasal Swab Buffer. • Do not remove the Test Cassette from the foil pouch until immediately before use. • Do not use kit or reagents past the expiration date.
Do not open the foil pouch until the sample is ready for testing. The Test must be initiated within 30 minutes of opening the foil package. Remove the patient nasal swab from the Nasal Swab Buffer vial and discard it into a biohazardous waste container. Remove a Test Cassette and Transfer Pipette from the foil package (these items are packaged together). Replace the cap on the Nasal Swab Buffer vial.
Firmly squeeze the TOP bulb of the pipette. While continuing to squeeze the top bulb firmly, place the pipette tip well below the surface of the liquid in the Nasal Swab Buffer vial. Dispose of the Pipette in a biohazardous waste container. Squeeze The Dock screen will then read SAMPLE LOADED CLOSE LID “SAMPLE LOADED CLOSE LID”. Pipette Stem Overflow Chamber DO NOT SQUEEZE Close the lid of the Dock immediately to automatically begin the test program.
INTERPRETATION OF RESULTS Note: The appearance of any shade of Blue Test Line at the FLU A and/or FLU B positions is a valid result that is interpreted as positive for the influenza A and/or influenza B viral RNA target. A negative result will only contain a Blue Test Line at the C position. Open the lid of the Dock. Window Remove the Test Cassette and interpret the results according to the Interpretation of Results section below.
DOCK CLEANING Sekisui Diagnostics recommends cleaning the Dock each day it is used. Procedure: Clean the Silaris Dock and surrounding area according to the instructions provided in the cleaning section of the Silaris Dock Operator's Guide. LIMITATIONS EXPECTED VALUES The prevalence of influenza varies from year to year, with outbreaks occurring during the fall and winter months.
PERFORMANCE CHARACTERISTICS Reproducibility Studies Silaris Influenza A&B Test vs. Molecular Influenza Assay: Prospective Clinical Study The Reproducibility study was performed to demonstrate the reproducibility of the Silaris Influenza A&B Test with contrived nasal swabs at three CLIA-waived sites and one moderately complex site based in the United States.
Agreement of actual results with expected results was 100%. There were no significant differences observed within run (replicates tested by one operator), between run (five different days), between sites (four sites), or between operators (eight operators). Limit of Detection Multiple analyte levels were tested in 20 replicates until the LoD was determined (the level at which at least 19/20 results are positive). Four (4) influenza strains were run in replicates of twenty (20) for each concentration.
The Analytical Specificity (Cross-Reactivity) Interfering Substances The analytical specificity was evaluated with a panel of common organisms when tested on the Silaris Influenza A&B Test. Thirty-three (33) organisms were obtained from Zeptometrix Corporation except for Chlamydia pneumonia and Corynebacterium glycinophilum (were obtained from ATCC). These potentially cross-reacting non-influenza organisms were tested in replicates of three (3) in this study.
Interfering Substances: Agreement of Observed/Expected Interferent Description, Concentration Mucin, 20 µg Mucin/mL Blood (Human) 1% (v/v) Neo-Synephrine (phenylephrine nasal spray) Afrin (Oxymetazoline nasal spray) Nasacort (Triamcinolone, nasal corticosteroid No Interferent Zicam (Nasal gel, homeopathic allergy relief medicine) Cepacol (throat lozenge) Zanamivir (anti-viral drug) 10mg/mL Mupirocin (antibiotic) 12 mg/mL Tobramycin (antibacterial) 2.
ASSISTANCE AND CONTACT INFORMATION For technical questions or assistance, or if the Silaris Dock and/or Silaris Influenza A&B Test is not performing as expected, please contact Sekisui Diagnostics Technical Support at (800)-332-1042. (U.S. Only) or 1-781-652-7800 (Outside U.S.) REFERENCES 1. Cheung M, Lieberman JM. Influenza: update on strategies for management. Contemporary Pediatrics. October 2002; 19:82. 2. Iha Y, Kinjo T, Parrott G, Higa F, Mori H, Fujita J.
