Real-Time PCR Platform Instructions for Use Manual
For Windows® Operating Software
Version 1.0
Страница 1: ...Real Time PCR Platform Instructions for Use Manual For Windows Operating Software Version 1 0...
Страница 2: ...SAFETY AND REGULATORY COMPLIANCE 3 PRODUCT OVERVIEW 5 HARDWARE SET UP GUIDE 9 PLATFORM CLEANING REQUIREMENT 11 WARRANTY 11 STEP BY STEP SOFTWARE GUIDE 12 TROUBLESHOOTING GUIDE 21 APPENDIX A PCR DATA P...
Страница 3: ...CR platform Packaging Storage and Transportation Identification Symbol Description Explanation Places where symbol is located Handle with care Product is a precision instrument and should be handled w...
Страница 4: ...not touch operate the touch screen when the instrument is in operation The instrument must be placed in a clean and ventilated environment to avoid corrosive gas and strong magnetic field interference...
Страница 5: ...netic Compatibility The BioGX pixl Real Time PCR Platform conforms with emission and disturbance immunity requirements specified in EN60601 1 2 It is the manufacturer s responsibility to provide the c...
Страница 6: ...latform is optimally suited for applications where portability and fast time to result is required Applications of pixl are point of care molecular diagnostics test POCT Clinical clearance required fo...
Страница 7: ...or outdoor use and power loss protection Key Parameters Capacity of wells 16 Channels of Fluorophores per well 4 FAM SYBR Green JOE HEX VIC TET ROX Texas Red CY5 LIZ Cy5 5 Multiplex capability Up to 4...
Страница 8: ...ize and weight 247mm L x 188mm W x 133mm H Weight 1350g Power supply DC 16V 90W Adapter provided that accepts 110V 240V AC Wavelength characteristics may be modified by changing filter modules Applica...
Страница 9: ...l Real Time PCR Platform The platform is powered through an external AC DC power adapter The power adapter accepts AC input ranging 110V to 240V and produces DC output of 16V The DC power input connec...
Страница 10: ...ndicate power supply As long as the instrument is powered the green LED indicator will stay on qPCR tube plasticware requirement BioGX pixl Real Time PCR Platform requires the use of transparent 0 2 m...
Страница 11: ...ources devices and cables Do not allow liquid to penetrate instrument openings Reaction well cleaning Clean the reaction wells with lint free wipes or swabs Use of 10 bleach solution to clean and deco...
Страница 12: ...setup exe 2 Installer msi Run setup exe and follow instructions to install the software If the file is one compressed file please decompress it first The installed application file will be in C BioGX...
Страница 13: ...ument When the BioGX pixl software is launched on a PC device the display with options will be presented as shown in Figure 6 Figure 6 Icon for BioGX pixl software initiation screen The numbered highl...
Страница 14: ...REPORT button 2 Name template in Experiment Name section 3 Check box next to Save as template 4 Click Save Experiment Figure 7 BioGX pixl platform real time PCR setup screen for thermocycling program...
Страница 15: ...amic range of the sensors to yield the best signal to noise ratio It is recommended to keep this option checked Figure 7 Figure 8 Screen shot of REPORT section used to save BioGX pixl thermocycling te...
Страница 16: ...ment file then click Next step button to continue setting the thermal cycling program Figure 9 2 Double click the sample grid in the Sample setup window each sample can be identified i e Unknown Negat...
Страница 17: ...eriment proceed to RUN button select the appropriate template name name sample well positions and click Start button Before the instrument starts to execute thermal cycling program it will automatical...
Страница 18: ...he quantity of the DNA RNA targets using standard curve analysis method Amplification analysis This will show the amplification curves for all samples Ct Threshold The threshold for determining Ct is...
Страница 19: ...s used to determine the concentration of an analyte by comparing to a known set of samples with specific concentrations of an analyte Figure 12 We called the samples with known concentration of analyt...
Страница 20: ...From REPORT page open the experiment file to print report and save completed experiment files Figure 13 The experiment file will contain all the settings and experiment results In this page we can al...
Страница 21: ...e power Please note that the power connector at the back of the instrument has an orientation Make sure that the connector is properly aligned with this orientation Do not force the connector in if th...
Страница 22: ...USB connection between PC and instrument cannot be established If the PC USB port is functional properly this can be checked by using it for keyboard mouse or USB disk and the instrument is properly...
Страница 23: ...f the instrument is functioning properly when everything is plugged in In section Launching BioGX pixl Software if it shows My HID Connected it confirms that the software can communicate with the hard...
Страница 24: ...age signal magnitude of the data at the initial cycles and estimate the mean For subsequent processing the algorithm will subtract the mean value to align the initial phase of the data along the x axi...
Страница 25: ...mplification efficiency estimate is provided by examining the fluorescence increase during the initial exponential growth phase DNA amplification Figure A2 Amplification efficiency analysis Additional...
Страница 26: ...purposes It is possible to disable data processing for debug purposes Once all data processing methods are disabled we can view the raw unprocessed fluorescence data in the analysis window As shown b...
Страница 27: ...ositive The algorithm takes into the account of Ct value in that as Ct value increase the signal strength at saturation is expected to be weaker The threshold to trigger a false positive detection bas...
Страница 28: ...ote this analysis is only performed on reaction data that is initially judged as positive The user can adjust the threshold values and save them with the experiment file or template file As shown belo...
Страница 29: ...pixl Real Time PCR Platform Instructions for Use Manual Page 29 of 37 pixl Real Time PCR Instructions for Use Manual Rev 01 28JUL2021 Figure A6 Threshold Values for False Positive Determination...
Страница 30: ...adjust the thresholds it may be helpful to find out the Relative strength Amplification efficiency and Signal to noise ratio of a given reaction data This can be done by floating the mouse curser abo...
Страница 31: ...as illustration The pixl software cross talk suppression parameters and default values are chosen according to empirical data from most common multiplex qPCR reagent products used in factory testing...
Страница 32: ...pixl Real Time PCR Platform Instructions for Use Manual Page 32 of 37 pixl Real Time PCR Instructions for Use Manual Rev 01 28JUL2021 Figure B2 Experimental Data...
Страница 33: ...rve the effect Figure B3 This is done by going to the setting page step 1 and make all crosstalk suppression parameters set to 0 percent then disable the curve fitting functions to view raw data step...
Страница 34: ...Instructions for Use Manual Page 34 of 37 pixl Real Time PCR Instructions for Use Manual Rev 01 28JUL2021 Figure B4 HEX channel late amplification due to cross talk Figure B5 HEX channel late amplific...
Страница 35: ...Time PCR Platform Instructions for Use Manual Page 35 of 37 pixl Real Time PCR Instructions for Use Manual Rev 01 28JUL2021 Revision History Revision Date Description of Change 01 28 JUL 2021 Initial...
Страница 36: ...CE mark On the device s nameplate Use by On the device s nameplate Caution Observe the safety related information warnings and precautionary measures in the instruction manual On the device s namepla...
Страница 37: ...me PCR Platform Instructions for Use Manual Page 37 of 37 pixl Real Time PCR Instructions for Use Manual Rev 01 28JUL2021 Consult instruction for use On the device s nameplate Waste tube On the device...
