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60 DiagCORE Respiratory Panel 2 Instructions for Use

Table 2. Summary of Positive Agreement, Negative Agreement for Reproducibility Testing

Concentration

Pathogen

Expected

Result

Detection

Rate

% Agreement with

Expected Result

3xLoD

Influenza A H1 *

Positive

20/20

100%

Cor HKU1

Positive

20/20

100%

PIV2

Positive

20/20

100%

RSVB

Positive

20/20

100%

1xLoD

Influenza A H1 *

Positive

20/20

100%

Cor HKU1

Positive

19/20

95%

PIV2

Positive

19/20

95%

RSVB

Positive

20/20

100%

Negative

Influenza A H1 *

Negative

80/80

100%

Cor HKU1

Negative

80/80

100%

PIV2

Negative

80/80

100%

RSVB

Negative

80/80

100%

* Note: detection rate applies for both targets, Influenza A and H1.

Concentration

Pathogen

Expected

Result

Detection

Rate

% Agreement with

Expected Result

3xLoD

Influenza B

Positive

20/20

100%

Cor 229E

Positive

20/20

100%

PIV4a

Positive

20/20

100%

Enterovirus D68

Positive

20/20

100%

hMPV B2

Positive

20/20

100%

B. pertussis

Positive

20/20

100%

1xLoD

Influenza B

Positive

19/20

95%

Cor 229E

Positive

20/20

100%

PIV4a

Positive

20/20

100%

Enterovirus D68

Positive

19/20

95%

hMPV B2

Positive

19/20

95%

B. pertussis

Positive

20/20

100%

Negative

Influenza B

Negative

80/80

100%

Cor 229E

Negative

80/80

100%

PIV4a

Negative

80/80

100%

Enterovirus D68

Negative

80/80

100%

hMPV B2

Negative

80/80

100%

B. pertussis

Negative

80/80

100%

Содержание DiagCORE Respiratory Panel 2

Страница 1: ...DiagCORE Respiratory Panel 2 Instructions for use PL 013 05 2018 EN 210002...

Страница 2: ...qiagen com STAT Dx Life S L Baldiri Reixac 4 08028 Barcelona Spain Customer and technical support If assistance is required contact Technical Support using the contact information below Website http...

Страница 3: ...ration nucleic acid amplification and detection 13 4 Required materials and equipment that are not provided 15 5 Procedure for dry swab samples 16 5 1 Sample collection transport and storage 16 5 2 Lo...

Страница 4: ...12 2 Assay Robustness 52 12 3 Exclusivity Analytical Specificity 52 12 4 Inclusivity Analytical Reactivity 54 12 5 Co Infections 57 12 6 Interfering Substances 58 12 7 Carryover 59 12 8 Reproducibili...

Страница 5: ...or use Description Legal manufacturer In vitro diagnostic medical device CE marking for European Conformity Catalog number Storage temperature limitations Consult instructions for use Health hazard ha...

Страница 6: ...with the DiagCORE Respiratory Panel 2 Influenza A Influenza A subtype H1N1 2009 Influenza A subtype H1 Influenza A subtype H3 Influenza B Coronavirus 229E Coronavirus HKU1 Coronavirus NL63 Coronaviru...

Страница 7: ...e propylene glycol triton x 100 and D trehalose dihydrate Transfer pipettes 6 individually packaged transfer pipettes for dispensing liquid sample into the DiagCORE Respiratory Panel 2 Cartridge 1 3 S...

Страница 8: ...trial Hygienists United States of America COSHH Control of Substances Hazardous to Health United Kingdom Follow your institution s safety procedures for handling biological samples Dispose of samples...

Страница 9: ...le of the DiagCORE Analyzer by pneumatically operated microfluidics and make no direct contact with the Analyzer actuators The Analyzer houses air filters for both incoming and outgoing air further sa...

Страница 10: ...decisions regarding treatment hospital admission infection control and return of the patient to work and family It may also greatly support improved antimicrobial stewardship and other important publ...

Страница 11: ...irus NL63 Coronavirus RNA Coronavirus OC43 Coronavirus RNA Parainfluenza Virus 1 Paramyxovirus RNA Parainfluenza Virus 2 Paramyxovirus RNA Parainfluenza Virus 3 Paramyxovirus RNA Parainfluenza Virus 4...

Страница 12: ...Samples are collected and loaded manually into the DiagCORE cartridge Option 1 Inserting the swab into the swab port in the case of dry swab sample type Option 2 Inserting the liquid into the main por...

Страница 13: ...inserted into the swab port of the DiagCORE cartridge Transport medium liquid sample type 300 L of the sample is transferred into the DiagCORE cartridge using a transfer pipette In the case of transp...

Страница 14: ...h the lyophilized PCR chemistry in the dried chemistry chamber of the DiagCORE cartridge 4 The mixture of sample and PCR reagents is dispensed into the DiagCORE cartridge PCR chambers which contain ly...

Страница 15: ...ry Panel 2 is designed for use with the DiagCORE Analyzer Before beginning a test make sure the following are available DiagCORE Analyzer at least one Operational module and one Analytical module Diag...

Страница 16: ...5 2 Loading a sample into the DiagCORE Respiratory Panel 2 Cartridge 1 Open the package of a DiagCORE Respiratory Panel 2 Cartridge using the tear notches on the sides of the packaging After the packa...

Страница 17: ...n label on the top of the DiagCORE cartridge Make sure that the label is properly positioned and does not block the lid opening 4 Open the sample lid of the swab port on the left side of the cartridge...

Страница 18: ...18 DiagCORE Respiratory Panel 2 Instructions for Use 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...

Страница 19: ...CORE Analyzer by entering the user name and password NOTE The Login screen will appear if User Access Control is activated If the User Access Control is disabled no user name password will be required...

Страница 20: ...ng on the chosen system configuration entering the patient ID may also be required at this point NOTE Instructions from the DiagCORE Analyzer appear in the Instructions Bar at the bottom of the touchs...

Страница 21: ...ate previously used cartridges or cartridges for assays that have not been installed on the unit An error message will be shown in these cases and the cartridge will be rejected Refer to the DiagCORE...

Страница 22: ...to edit its content or press Cancel to cancel the test 7 Ensure that both sample lids of the cartridge are firmly closed When the cartridge entrance port on the top of the DiagCORE Analyzer automatica...

Страница 23: ...is inserted an error will be generated and the cartridge will be automatically ejected NOTE Up to this point it is possible to cancel the test run by pushing the Cancel button in the bottom right cor...

Страница 24: ...e cartridge should be removed when the cartridge entrance port opens and ejects the cartridge If the cartridge is not removed after 30 seconds it will be automatically moved back into the Analyzer and...

Страница 25: ...into Universal Transport Medium 6 2 Loading a sample into the DiagCORE Respiratory Panel 2 Cartridge 1 Open the package of a DiagCORE Respiratory Panel 2 Cartridge using the tear notches on the sides...

Страница 26: ...on the top of the DiagCORE cartridge Make sure that the label is properly positioned and does not block the lid opening 4 Open the sample lid of the main port on the front of the cartridge 5 Open the...

Страница 27: ...care not to aspirate any of the beads present in the tube If air or beads are drawn into the pipette carefully expel the sample fluid in the pipette back into the sample tube and draw up fluid again 6...

Страница 28: ...as been loaded by checking the sample inspection window in the cartridge see the image below After sample is introduced inside the DiagCORE Respiratory Panel 2 cartridge cartridge must be loaded in th...

Страница 29: ...be required and the Main screen will appear 4 In case the Assay Definition File software has not been installed in the Analyzer follow the instructions prior to running the test See Section 9 of this...

Страница 30: ...gCORE Analyzer will not accept cartridges with elapsed expiration date previously used cartridges or cartridges for assays that are not installed on the unit An error message will be shown in these ca...

Страница 31: ...Module 8 Upon detecting the cartridge the DiagCORE Analyzer will automatically close the lid of the cartridge entrance port and start the test run No further action from the operator is required to st...

Страница 32: ...on how to proceed 11 Press Eject to remove the cartridge and dispose of it as biohazardous waste in accordance with all national state and local health and safety regulations and laws The cartridge sh...

Страница 33: ...DiagCORE Respiratory Panel 2 Instructions for Use 33 NOTE For further information on the use of the instrument refer to the DiagCORE Analyzer User Manual...

Страница 34: ...al verifies all steps of the analysis process including sample resuspension homogenization lysis nucleic acid purification reverse transcription and PCR A positive signal for the internal control indi...

Страница 35: ...ts The first list includes all pathogens detected and identified in the sample preceded by a sign and are colored red The second list includes all pathogens tested in the sample Pathogens detected and...

Страница 36: ...Pathogens Details about the tested pathogens and controls are shown on the left and the amplification curves are shown in the center NOTE If User Access Control is enabled on the DiagCORE Analyzer th...

Страница 37: ...rigin to return to the default values 8 1 2 Viewing test details Press Test Details in the Tab Menu Bar at the bottom of the touchscreen to review the results in more detail Scroll down to see the com...

Страница 38: ...tive signal Internal Control with CT and endpoint fluorescence 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...

Страница 39: ...y pressing the circle to left of the sample ID A checkmark will appear next to selected results Unselect test results by pressing this checkmark The entire list of results can be selected by pressing...

Страница 40: ...r other parameters such as Assay a dialog will open with a list of assays stored in the repository Select one or more assays to filter only the tests that were performed with the selected assays The s...

Страница 41: ...pathogen that can be detected with the DiagCORE Respiratory Panel 2 only one signal will be generated if the pathogen is present in the sample 8 3 Internal Control interpretation Controls result Expl...

Страница 42: ...vailable 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...

Страница 43: ...reen 4 Select the file from the USB drive corresponding to the assay to be imported 5 A dialog will appear to confirm upload of the file 6 A dialog may appear to override current version by a new one...

Страница 44: ...ed for testing of samples other than those described in these instructions for use Test performance characteristics have been established only with nasopharyngeal swab samples collected in transport m...

Страница 45: ...ance parameters of a given assay and do not vary depending on prevalence In contrast both the negative and positive predictive values of a test result are dependent on the disease organism prevalence...

Страница 46: ...ry Panel 1 7 2 and the Allplex Respiratory Panel assay A total of 578 clinical UTM patient samples were enrolled into the study One 1 sample was excluded from the analysis due to the sample being misp...

Страница 47: ...5 659 662 99 50 98 7 99 8 Bocavirus 4 4 100 00 51 0 100 0 693 694 99 90 99 2 100 0 Coronavirus 229E 4 5 80 00 37 6 96 4 693 693 100 00 99 4 100 0 Coronavirus HKU1 8 8 100 00 67 6 100 0 690 690 100 00...

Страница 48: ...aining 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 to...

Страница 49: ...ed to be most relevant with regard to assessing equivalency of the dry swab with the UTM specimen performance Testing of the dry swab involves taking 2 samples from the same patient and although paire...

Страница 50: ...ab specimen was 98 1 95 confidence interval 94 6 99 4 The dry swab study results supported the ability to test swabs entered directly in the DiagCORE Respiratory Panel 2 cartridges as dry swabs The dr...

Страница 51: ...Brisbane 59 07 Zeptometrix 0810244CFHI 0 04 TCID50 mL 19 20 A New Caledonia 20 99 Zeptometrix 0810036CFHI 4 6 TCID50 mL 19 20 Influenza A H3N2 A Virginia ATCC6 2012 ATCC VR 1811 0 4 PFU mL 19 20 A Wi...

Страница 52: ...L 20 20 Type 1A ATCC VR 1559 5 0 TCID50 mL 20 20 Mycoplasma pneumoniae M129 B7 ATCC 29342 0 1 CFU mL 20 20 Legionella pneumophila CA1 ATCC 700711 0 01 CFU mL 20 20 Bordetella pertussis I028 ATCC BAA 2...

Страница 53: ...chiseptica and Bordetella parapertussis at high concentrations Target gene used for Bordetella pertussis detection insertion element IS481 is a transposon also present in other Bordetella species Tabl...

Страница 54: ...enza A strains isolated from different geogracphical areas and in different calendar years were included Next table below shows the list of respiratory pathogens tested in this study Table 1 List of A...

Страница 55: ...VR 1377 B n a Zeptometrix NATRVP IDI RSV A n a A2 ATCC VR 1540 Long ATCC VR 26 n a Zeptometrix NATRVP IDI RSV B n a 9320 ATCC VR 955 18537 ATCC VR 1580 WV 14617 85 ATCC VR 1400 n a Zeptometrix NATRSVB...

Страница 56: ...14 18947 ATCC VR 1823 Rhinovirus A A1 n a Zeptometrix NATRVP IDI 1A n a ATCC VR 1559 A2 HGP ATCC VR 482 A16 11757 ATCC VR 283 HRV 1B B632 ATCC VR 1645 HRV A39 209 ATCC VR 340 Rhinovirus B B14 1059 AT...

Страница 57: ...influenza 3 C243 50xLoD Influenza A H1N1 2009 NY 03 09 5xLoD Parainfluenza 3 Influenza A H1N1 2009 C243 NY 03 09 5xLoD 50xLoD Respiratory Syncytial Virus A A2 50xLoD Influenza B B FL 04 06 5xLoD Respi...

Страница 58: ...an authentic nasopharyngeal swab specimen The selected samples were tested with and without addition of the potential inhibitory substance for direct sample to sample comparison Additionally pathogen...

Страница 59: ...ve samples were tested Samples were tested in replicates using different lots of DiagCORE Respiratory Panel 2 cartridges and tests were executed on different DiagCORE Analyzers by different operators...

Страница 60: ...ve 80 80 100 RSVB Negative 80 80 100 Note detection rate applies for both targets Influenza A and H1 Concentration Pathogen Expected Result Detection Rate Agreement with Expected Result 3xLoD Influenz...

Страница 61: ...ected Result Detection Rate Agreement with Expected Result 3xLoD Influenza A H3 Positive 20 20 100 Cor NL63 Positive 20 20 100 PIV1 Positive 20 20 100 Adenovirus E4 Positive 20 20 100 L pneumophila Po...

Страница 62: ...study was executed to analyze storage conditions for clinical samples to be tested with the DiagCORE Respiratory Panel 2 Simulated NPS sample matrix cultured human cells in Copan UTM was spiked with...

Страница 63: ...Control and Prevention CDC Diseases Conditions Adenoviruses https www cdc gov adenovirus index html 7 Centers for Disease Control and Prevention CDC Diseases Conditions Non polio Enterovirus https ww...

Страница 64: ...e includes elements that provide connectivity to the Analytical Module and enable user interaction with the DiagCORE Analyzer The Analytical Module contains the hardware and software for sample testin...

Страница 65: ...RODUCT Purchase of the DiagCORE Analyzer and or associated DiagCORE Respiratory Panel 2 cartridges does not grant any rights under patents owned or controlled now or later by STAT Dx Life except to th...

Страница 66: ...OR ANY OTHER COMMERCIAL DAMAGES OR LOSSES ARISING OUT OF OR RELATED TO YOUR USE OF OR INABILITY TO USE THE SOFTWARE HOWEVER CAUSED REGARDLESS OF THE THEORY OF LIABILITY CONTRACT TORT OR OTHERWISE AND...

Страница 67: ...E 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 DiagCORE Respiratory...

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