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STAT-Dx DiagCORE Respiratory Panel 2 Instructions For Use Manual

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DiagCORE
Respiratory Panel 2
®
Instructions for use
PL-013-05/2018-EN
210002

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Summary of Contents for STAT-Dx DiagCORE Respiratory Panel 2

  • Page 1 DiagCORE Respiratory Panel 2 ® Instructions for use PL-013-05/2018-EN 210002...

  • Page 2: Customer And Technical Support

    STAT-Dx Life, S.L. © Copyright 2018, STAT-Dx Life, S.L. All rights reserved. A printed version of these instructions for use is available upon request.

  • Page 3: Table Of Contents

    6.4 Running a test ....................29 7 Internal control .................... 34 8 Interpretation of results ................35 8.1 Viewing results ....................35 8.2 Result interpretation ..................40 8.3 Internal Control interpretation ................ 41 DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 4 14.2 Declaration of conformity ................64 14.3 Glossary ......................64 14.4 Trademarks and copyright ................65 14.5 Copyright, disclaimer, and warranty ............. 65 14.6 Patent statement ..................... 65 14.7 Software license agreement ................65 DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 5: Table Of Symbols

    Health hazard/hazardous to the ozone layer Expiration date (YYYY MM DD) Batch code Serial number Do not reuse Keep away from sunlight Sufficient for <n> tests Do not use if package is damaged Corrosive DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 6: Information About The Diagcore ® Respiratory Panel 2

    Assay performance characteristics have been established only for individuals who have shown respiratory symptoms. The DiagCORE Respiratory Panel 2 is intended for professional use only and is not intended for self- ® testing. For in vitro diagnostic use. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 7: Package Contents

    ® The expiration date is also included in the cartridge barcode and is read by the DiagCORE ® Analyzer when the cartridge is inserted into the instrument to run a test. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 8: Safety Information

    Observe standard laboratory procedures for keeping the working area clean and contamination- free. Guidelines are outlined in publications like the Biosafety in Microbiological and Biomedical Laboratories from the Centers for Disease Control and Prevention and the National Institutes of Health (www.cdc.gov/od/ohs/biosfty/biosfty.htm). DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 9: General Background

    Transfer of defined aliquots of eluate/master mix to different reaction chambers  Performance of RT-real-time, multiplex PCR testing within each reaction chamber. An increase  in fluorescence, indicating detection of the target analyte, is detected directly within each reaction chamber. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 10: Detected Pathogens

    Pathogens that can be detected and identified with the DiagCORE Respiratory Panel 2 are listed ® in Table 1. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 11 Parvovirus (DNA) Rhinovirus/Enterovirus Picornavirus (RNA) Mycoplasma pneumoniae Bacterium (DNA) Legionella pneumophila Bacterium (DNA) Bordetella pertussis Bacterium (DNA) Note: Enterovirus and rhinovirus are both detected but not differentiated in the DiagCORE ® Respiratory Panel 2. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 12: Description Of The Procedure

    Option 2: Inserting the liquid into the main port using a transfer pipette in the case of transport medium liquid sample type. All of the sample preparation and analysis steps are performed automatically by the DiagCORE ® Analyzer. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 13: Sample Collection And Cartridge Loading

    DiagCORE ® Analyzer. 1. The liquid sample is homogenized, and cells are lysed in the lysis chamber of the DiagCORE ® cartridge, which includes a rotor that turns at high speed. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 14 Analyzer creates the optimal temperature profiles to carry out effective RT-real ® time PCR and performs real-time fluorescence measurements to generate amplification curves. 6. The DiagCORE Analyzer Software interprets the resulting data and process controls and ® delivers a test report. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 15: Required Materials And Equipment That Are Not Provided

    Analyzer (at least one Operational module and one Analytical module) ®  DiagCORE Analyzer User Manual ®  DiagCORE Latest Assay Definition File software for Respiratory Panel 2 installed in the ®  Operational module DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 16: Procedure For Dry Swab Samples

    Respiratory ® Panel 2 cartridge and loaded in the DiagCORE Analyser within 120 minutes. ® 2. Take out the cartridge and position it so that the QR code on the label faces you. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 17 4. Open the sample lid of the swab port on the left side of the cartridge. 5. Insert the swab into the cartridge until the breakpoint is aligned with the access opening (the swab will go no further). DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 18 6. Break the swab shaft at the breakpoint, leaving the rest of the swab in the cartridge. 7. Firmly close the lid of the swab port until it clicks. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 19: Starting The Diagcore ® Analyzer

    2. When prompted, scan the sample ID barcode on the nasopharyngeal swab, or scan the specimen information barcode placed on the top of the DiagCORE ® cartridge, using the front barcode reader that is integrated into the DiagCORE ® Analyzer See figure below). DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 20 3. When prompted, scan the barcode of the DiagCORE Respiratory Panel 2 Cartridge to be used. ® The DiagCORE Analyzer automatically recognizes the assay to be run, based on the cartridge ® barcode. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 21 An error message will be shown in these cases and the cartridge will be rejected. Refer to the DiagCORE Analyzer User Manual for ® further details on how to install assays. 4. Select the appropriate sample type from the list (See image below). DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 22 There is no need to push the cartridge into the DiagCORE Analyzer. Position it correctly into the ® cartridge entrance port, and the DiagCORE Analyzer will automatically move the cartridge ® into the Analytical Module. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 23 If this occurs, repeat the procedure starting with step 5. 9. While the test is running, the time remaining in the run is displayed on the screen. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 24 12. After the cartridge has been ejected, the Results Summary screen will appear. Please refer to section Interpretation of Results for further details. To run another test, press Run Test. NOTE For further information on the use of the instrument, refer to the DiagCORE Analyzer User Manual. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 25: Procedure For Transport Medium Liquid Samples

    Respiratory ® Panel 2 cartridge and loaded in the DiagCORE Analyser within 120 minutes. ® 2. Take out the cartridge and position it so that the QR code on the label faces you. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 26 4. Open the sample lid of the main port on the front of the cartridge. 5. Open the tube with the sample to be tested. Use the supplied transfer pipette to draw up fluid to the third fill line on the pipette (300 µL). DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 27 6. Carefully transfer 300 µL of sample volume into the main port of the DiagCORE Respiratory ® Panel 2 cartridge, using a supplied single-use transfer pipette. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 28: Starting The Diagcore Analyzer

    Respiratory Panel 2 cartridge, cartridge must ® be loaded in the DiagCORE Analyser within 90 minutes. ® 6.3 Starting the DiagCORE Analyzer ® 1. Press the On/Off button on the front of the Analyzer to start the unit. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 29: Running A Test

    DiagCORE Analyzer. ® NOTE It is also possible to enter the sample ID using the virtual keyboard of the touchscreen by pressing on the Sample ID field. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 30 6. Press Confirm when all the displayed data are correct. If needed, press on the appropriate field to edit its content, or press Cancel to cancel the test. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 31 Up to this point, it is possible to cancel the test run by pushing the Cancel button in the bottom right corner of the screen. NOTE Depending on the system configuration, the operator may be required to re-type their user password to start the test run. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 32 12. After the cartridge has been ejected, the Results Summary screen will appear. Please refer to section Interpretation of Results for further details. To run another test, press Run Test. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 33 NOTE For further information on the use of the instrument, refer to the DiagCORE Analyzer User Manual. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 34: Internal Control

    A negative signal of the internal control does not negate any positive results for detected and identified targets, but it does invalidate all negative results in the analysis. Therefore, the test should be repeated if the internal control signal is negative. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 35: Interpretation Of Results

    In case the test failed to complete successfully, a message will indicate “Failed” followed by the specific Error Code. The following Test Data is shown on the left side of the screen: Sample ID  Assay Type  Sample Type  DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 36 Press the Controls tab on the left side to view the controls and select which controls are shown in the amplification plot. Press the circle next to the control name to select or deselect it. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 37 Test Result: Positive (in case at least one respiratory pathogen is detected/identified), negative  (in case no respiratory pathogen is detected) or failed (an error occurred or the test was canceled by the user) DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 38 Example screen showing Test Data on the left panel and Test Details in the main panel. 8.1.3 Browsing results from previous tests To view results from previous tests that are stored in the results repository, press View Results from the Main Menu bar. Example of View Results List. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 39 The list can be sorted according to only one column at a time. The Result column shows the outcome of each test: Name Button Description Positive At least one pathogen is positive. Negative No analytes were detected. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 40: Result Interpretation

    In case seasonal Influenza A H1 strain is detected by the DiagCORE Respiratory Panel 2 ® assay, two signals will be generated, one for Influenza A and a second one for H1 strain and shown on the DiagCORE Analyzer screen. ® DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 41: Internal Control Interpretation

    Failed The internal control failed. Positively detected pathogen(s) are reported, but all negative results (tested but not detected pathogen(s)) are invalid. Repeat testing using DiagCORE Respiratory Panel ® Cartridge. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 42: Installing The Assay Definition File

    ® assay is released. NOTE Assay Definition Files are available on the STAT-Dx web site and also through the STAT-Dx sellers/distributors. The Assay Definition File (extension.asy) must be saved into a USB Drive previously to the installation on the DiagCORE Analyzer.
  • Page 43 A dialog will appear to confirm upload of the file. A dialog may appear to override current version by a new one. Press yes to override. The assay becomes active by pressing the ‘Assay Active’ button (See screenshot below). DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 44: Limitations Of The Procedure

    Detection of viral and material nucleic acids depends on proper sample collection, handling,  transportation, storage, and loading into the DiagCORE Respiratory Panel 2 Cartridge. ® Improper operations for any of the aforementioned can cause incorrect results, including false- positive or false-negative results. DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 45 Please note that a higher prevalence favors the positive predictive value of a test results, while a lower prevalence favors the negative predictive value of a test result. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 46: Performance Characteristics. Clinical Performance

    Performance characteristics. Clinical Performance The performance characteristics of the DiagCORE Respiratory Panel 2 assay were assessed in a multicenter clinical trial. Both the performance of the universal transport medium of nasopharyngeal swab specimen (´UTM´), and of a dry nasopharyngeal swab specimen (FLOQSwabs, Copan ref 503CS01) (´SWAB´) were assessed.
  • Page 47 475 results. The overall Clinical Specificity or NPA was calculated from 190 full negative samples. In total 462 true positive and 204 true negative DiagCORE Respiratory Panel 2 results were found, as well as 13 false negative and 17 false positive results.
  • Page 48 698 results used to calculate the specificity performance for the remaining (DiagCORE Respiratory Panel 2 assay pathogens. The DiagCORE Respiratory Panel 2 assay detected multiple organisms in 101 samples, for a total of 228 organism results. This represents 26.3 % of the total positive specimens (101/ 385). Eighty-two samples were double infections, 15 were triple infections, and the remaining coinfection samples had 4 (3) or more pathogens (1 sample had 7 pathogens).
  • Page 49 159 results . In total 177 true positive and 156 true negative dipped swab results were found, as well as 1 false negative and 3 false positive dipped swab results. Table 3. DiagCORE Respiratory Panel 2 Sensitivity and Specificity characteristics with 95% Confidence Intervals for dry swab specimen...
  • Page 50 Respiratory Panel 2 cartridges as dry swabs. The dry swab specimen was found to show excellent concordance with the UTM specimen, as best demonstrated by the overall agreement between the UTM specimen and dipped swabs, which was 98.5% (95% confidence interval 97%-99.5 %). DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 51: Performance Characteristics. Analytical Performance

    Parainfluenza Virus Greer ATCC VR-92 5.0 TCID 19/20 Parainfluenza Virus C 243 ATCC VR-93 15.8 TCID 20/20 Parainfluenza Virus M-25 ATCC VR-1378 2.8 TCID 20/20 Respiratory ATCC VR-1540 2.8 TCID 20/20 Syncytial Virus A DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 52: Assay Robustness

    Respiratory Panel 2 for respiratory or non-respiratory organisms which ® are not covered by the panel. These organisms included specimens which are related to, but distinct from, respiratory panel organisms, or that could be present in specimens collected from the DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 53 Pseudomonas aeruginosa Serratia marcescens Staphylococcus aureus Staphylococcus epidermidis Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarus Cytomegalovirus Epstein-Barr Virus Herpes Simplex Virus 1 Viruses Herpes Simplex Virus 2 Measles Virus Mumps DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 54: Inclusivity (Analytical Reactivity)

    (pan) Zeptometrix 0810249CFHI A/SwineNY/03/2009 H1N1/NY/02/09 Zeptometrix NATRVP-IDI B/Virginia/ATCC5/2012 ATCC VR-1807 B/FL/04/06 ATCC VR-1804 B/Taiwan/2/62 ATCC VR-295 Influenza B B/Panama/45/90 Zeptometrix NATFLUB-ERCM B/Florida/02/06 Zeptometrix 810037CFHI B/Maryland/1/59 ATCC VR-296 ATCC VR-740 Coronavirus 229E Zeptometrix NATRVP-IDI DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 55 Gomen ATCC VR-7 Adenovirus B ATCC VR-3 Zeptometrix NATADV3-ST ATCC VR-1 Adenoid 71 ATCC VR-846 Adenovirus C ATCC VR-5 Adenoid 75 ATCC VR-6 Adenovirus E ATCC VR-1572 RI-67 Zeptometrix 0601178NTS Bocavirus Zeptometrix MB-004 DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 56 L. pneumophila 169-MN-H Zeptometrix 0601645NTS subsp. Pneumophila / ATCC 33152 Philadelphia-1 I028 ATCC BAA-2707 B. pertussis A639 Zeptometrix NATRVP-IDI 18323 [NCTC 10739] ATCC 9797 All pathogens tested showed positive results at the concentration tested. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 57: Co-Infections

    Coronavirus 229E 50xLoD Respiratory Syncytial Virus A 5xLoD Coronavirus 229E 5xLoD Respiratory Syncytial Virus A 50xLoD Respiratory Syncytial Virus B 9320 50xLoD Coronavirus NL63 5xLoD Respiratory Syncytial Virus B 9320 5xLoD Coronavirus NL63 50xLoD DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 58: Interfering Substances

    (ATCC VR-1789) Human Cytomegalovirus 2.0E+04 TCID (ATCC NATCMV-0005) Exogenous substances Concentration tested Utabon 10% v/v ® Nasal spray (decongestant) RHINOmer ® 10% v/v Nasal spray (salt water solutions) Tobramycin 6 mg/mL Mupirocin 2.5% w/v DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 59: Carryover

    M-25 Rhinovirus Enterovirus /US/IL/14-18952 (enterovirus D68) Adenovirus RI-67 (adenovirus E4) RSV B 9320 hMPV Peru6-2003 (type B2) Bocavirus Clinical sample Mycoplasma pneumoniae M129-B7 (type 1) Clamydophila pneumoniae TW183 Legionella pneumophila Bordetella pertussis I028 DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 60 Positive 20/20 100% Influenza B Negative 80/80 100% Cor 229E Negative 80/80 100% PIV4a Negative 80/80 100% Negative Enterovirus D68 Negative 80/80 100% hMPV B2 Negative 80/80 100% B. pertussis Negative 80/80 100% DiagCORE Respiratory Panel 2 Instructions for Use...
  • Page 61 Bocavirus Positive 20/20 100% 1xLoD Bocavirus Positive 20/20 100% Negative Bocavirus Negative 80/80 100% All samples tested generated the expected result (95-100% agreement) showing reproducible performance of the DiagCORE ® Respiratory Panel 2. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 62: Sample Stability

     -70 ˚C to -80 ˚C for 30 days All pathogens were successfully detected at the different storage temperatures and durations concluding that samples were stable at the indicated storage conditions and durations. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 63: References

    11. BLAST: Basic Local Alignment Search Tool. https://blast.ncbi.nlm.nih.gov/Blast.cgi 12. Schreckenberger PC and McAdam AJ, Point-Counterpoint: Large Multiplex PCR Panels Should be First-Line Tests for Detection of Respiratory and Intestinal Pathogens. J Clin Microbiol, 2015 Oct; 53(10):3110-5. DiagCORE Respiratory Panel 2 Instructions for Use...

  • Page 64: Appendices

    STAT-Dx Life, S.L. Baldiri Reixac 4-8 08028 Barcelona, Spain An up-to-date Declaration of Conformity can be requested from STAT-Dx Life, S.L. 14.3 Glossary Amplification curve: Graphical representation of the RT-real time PCR amplification data Analytical Module (AM): The main DiagCORE Analyzer hardware module, in charge of executing ®...

  • Page 65: Trademarks And Copyright

    Respiratory Panel 2 cartridge Instructions for Use. 14.7 Software license agreement Stat-Dx Life, S.L. is the owner, or licensee with right to sublicense, of all rights necessary to provide to the Purchaser of the DiagCORE Analyzer and associated DiagCORE cartridges, a license to the...
  • Page 66 LIABILITY FOR PERSONAL INJURY, OR OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THIS LIMITATION MAY NOT APPLY TO YOU. In no event shall STAT-Dx Life S.L.’s total liability to you for all damages (other than as may be required by applicable law in cases involving personal injury) exceed the purchase price of the DiagCORE Analyzer.
  • Page 67 DiagCORE ® Respiratory Panel 2 DiagCORE Respiratory Panel 2 Instructions for Use, Revision 1.0 ® © 2018 STAT-Dx Life S.L. All rights reserved. STAT-Dx · Baldiri Reixac 4, Barcelona, Spain +34 93 448 51 24 · http.support.qiagen.com...

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