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2100 Central Ave, Suite 106, Boulder, CO 80301
www.indevr.com | 303.402.9100 | [email protected]

Imaging and Analysis System

Operation Manual

Summary of Contents for Vaxarray

Page 1: ...2100 Central Ave Suite 106 Boulder CO 80301 www indevr com 303 402 9100 indevr indevr com Imaging and Analysis System Operation Manual Copyright 2014 2018 InDevR Inc All rights reserved ...

Page 2: ...t to make technical changes is reserved Defects caused by unauthorized alterations to the product by the user voids the warranty InDevR shall not be held liable for damages caused by unauthorized modifications This document applies only to the specified product and model number and replaces all previous revisions and publications Copying distribution and utilization without authorization are prohi...

Page 3: ...ectors 11 Imaging Tray Open Button 11 IMAGING TRAY AND SLIDE HOLDER 11 VAXARRAY IMAGING AND ANALYSIS SOFTWARE 12 SOFTWARE OPERATING INSTRUCTIONS 12 SOFTWARE NAVIGATION 12 IMAGING AND ANALYZING A VAXARRAY EXPERIMENT 13 STANDARD WORKFLOW 13 1 START NEW EXPERIMENT 14 2 SETUP EXPERIMENT 15 3 PREVIEW IMAGE 17 4 REVIEW CALIBRATION CURVES 19 5 REVIEW RESULTS SUMMARY 20 6 RESULTS WORKSHEET 22 7 GENERATING...

Page 4: ...g and Analysis System Operation Manual CF 0159 R004 TROUBLESHOOTING CLEANING AND SERVICE 31 FAILURE TO FIND AN ARRAY 31 CLEANING 31 SERVICE 31 SHIPPING 32 PROPER DISPOSAL OF THE INSTRUMENT 32 TRADEMARKS 33 SPECIFICATIONS 33 ...

Page 5: ...xcept as expressly instructed in this manual 7 Always disconnect power before moving or cleaning the instrument Please follow these instructions for your own safety and the proper operation of your instrument 1 Read the user manual fully and completely 2 The main supply source must meet the national regulatory requirements 3 The power cord of the instrument must be connected to a wall outlet with ...

Page 6: ...Array Enabling Compliance with 21 CFR Part 11 and Annex 11 for further details Intended Use of VaxArray Imaging and Analysis System The VaxArray Imaging and Analysis System is intended for imaging and analysis of VaxArray assays www indevr com vaxarray The imaging system delivers images and or calculated information relating to the arrays imaged The VaxArray Imaging and Analysis System is not for ...

Page 7: ...ftware or peripherals may effect system performance Updates to the VaxArray Imaging and Analysis Software will be provided at the discretion of InDevR Inc Package Contents The standard VaxArray Imaging and Analysis System package is supplied with VaxArray instrument with monitor keyboard and mouse Power cord 125 V 15A 2 0m Plastic cap for transportation lock hole 4 Slide Holder VaxArray Imaging an...

Page 8: ...lysis System Operation Manual CF 0159 R004 Installation This section provides a description of the instrument Figure 1 and instructions for installation For a detailed explanation of instrument maintenance and service please refer to ...

Page 9: ...lease refer to Troubleshooting Cleaning and Service for detailed instructions on re installing the lock screws C Connect the USB cables of the mouse and keyboard to the USB outlets on the rear panel Figure 2 D Connect the VGA monitor cable to the VGA connector on the rear panel Figure 2 E Plug power cords for the instrument and monitor into grounded outlets F Turn on the main instrument power sour...

Page 10: ...g the transportation locks see Troubleshooting Cleaning and Service for the proper procedure In case of system failure the imaging tray can be opened without software control via the rear panel See Imaging Imaging Tray Open Button Rear Panel The rear panel is shown in Figure 2 Main Power Switch This switch turns the main power on or off Transportation Lock Placeholders The transportation locks sho...

Page 11: ...he Imaging Tray Open button on the rear panel while pressing the power button on the front panel The imaging door will open and the imaging tray will extend Imaging Tray and Slide Holder The four slide holder should be placed into the imaging tray with the A1 engraved on the slide holder positioned toward the top left near the A1 of the imaging tray The slide s are to be placed in the 4 slide hold...

Page 12: ...ns audit trails and electronic signatures maintain data integrity and support laboratories that are compliant with FDA 21 CFR Part 11 and Annex 11 Software Operating Instructions Software Navigation In every software view icons for action items are displayed across the bottom of the page or view Figure 4 In sequence from left to right these icons are a Home Page Return to the home page b Open Clos...

Page 13: ... commercially available VaxArray assays This manual will use the VaxArray Influenza Seasonal Hemagglutinin Potency Assay v1 2 to illustrate the use of the system Standard Workflow Execute Assay According to Assay Operation Manual Click New Experiment and select assay Enter experiment information Preview to adjust optimize exposure time Image Slide s Review Calibration Curves View Results ...

Page 14: ... along with the imaging tray open close button Select New Experiment on the home screen A pop up will appear that allows the user to select the VaxArray assay to be analyzed Figure 6 Additionally the user may select to analyze the assay in Raw Analysis Mode which provides results as RFU relative fluorescent unit values instead of determining protein concentrations Standards used to construct a cal...

Page 15: ...commended Edits to these variables are restricted to users with sufficient permissions a Analysis Methodology Analysis with the VaxArray Imaging and Analysis Software can be performed using either a sequence of four point linear fits or a sequence of five point linear fits The selection is made via a dropdown menu b R2 Cutoff This variable is the minimum value for a given linear range which must b...

Page 16: ...eactive Selecting only the appropriate antibodies can simplify the appearance of the user interface and eliminate visualizing extraneous data but all antibodies will be analyzed regardless of the selection and a deselected antibody may be reselected later D Fill in Sample info Click on each slide to fill in reagent lot information slide IDs sample IDs and dilution factors Figure 9 The slide s must...

Page 17: ...nd the autopopulate feature of the table automatically fills in the remaining standard concentrations For example entering a concentration value into Std 1 High cell of H1 i autofills the same concentration in all H1 Std 1 High cells In addition the lower concentrations are autofilled following the fractional dilution series recommended by InDevR 0 8 0 6 0 4 0 2 0 1 and 0 05 multipliers Any value ...

Page 18: ... the highest concentration standard and is therefore likely to be the highest concentration sample on the entire slide The exposure time should be adjusted to provide large but not saturated signals in well A1 Signals in the range of 30 000 to 55 000 RFUs are ideal The exposure time should be decreased if any signals are above 65 000 RFU saturated After each change in exposure time re click the ca...

Page 19: ...ages button in the Preview Image view Figure 10 allows the user to save TIFF format images of every array The TIFF format images are the original 16 bit images In addition the user is allowed to export a PNG image of each array that appears as a 24 bit RGB or false color image of each array A false color montage of 16 array images is also available for export as a PNG file E Select the Right Arrow...

Page 20: ...al value RFU for each individual data point c The signals corresponding to the quantitation limit QL for each antibody are shown in a table at the bottom left B Standards and Samples The calibration curves plot the signals from the standards as black crosses plus signs and the signals from the samples are superimposed on the calibration curves as colored circles When sample signals are near the qu...

Page 21: ...ble The term OQR Out of Quantitation Range is displayed when the calculated concentration is less than the quantitation limit QL QL is based on the standard deviation of the median signals for the blank analysis multiplied by the QL multiplier in the Analysis Variables view Figure 8 A value of 5 is the recommended QL multiplier OQR is also displayed when the sample signal falls in a section of the...

Page 22: ...alysis Mode reports the RFU signals measured by the instrument for the different antibodies These are reported in a table of results titled Sample Signal Values Relative Fluorescent Units RFUs In addition to RFUs a corresponding table of results is presented that normalizes the RFU signals by the maximum fluorescence value 65535 then multiplies by the dilution factor associated with each sample Di...

Page 23: ...Page 23 VaxArray Imaging and Analysis System Operation Manual CF 0159 R004 Figure 16 Generate a Report ...

Page 24: ...imental Records After opening a record the user can click the left arrow to navigate back to the Preview Imaging view where the Export Images button is available C Delete Experiment A user with the appropriate permissions can delete a record from the database by right clicking on the record to be deleted and then clicking Delete Experiment A dialogue box prompting the user to confirm their decisio...

Page 25: ...gue box will be displayed prompting the user to confirm their decision clicking the green check will permanently delete the images F Experiment Log On the right side of the screen in the Experimental Records view there will be a list of events that have occurred for the selected experiment This record shows times and data as well as user names for specific events corresponding to that experiment I...

Page 26: ...e focus position of the VaxArray Imaging and Analysis System is stable during routine use but periodic focus checks should be included as part of standard laboratory operations a Instrument focus is based on optimizing the focus at wells positions A1 A2 and H2 To set the instrument focus see Figure 19 i Open the tray and insert a previously processed VaxArray slide in the left most position in the...

Page 27: ...ptimal focus can be obtained by a combination of the visual appearance and the first derivative value xi The exposure time may also be adjusted within the focus window This may be necessary to create sufficiently bright spots for visual focus optimization xii Repeat the process for all three arrays A1 H1 H2 After all three arrays have been imaged the Green Check will be displayed xiii During focus...

Page 28: ...he Windows search field type lusrmgr msc and select Enter 3 Double click on the Users folder 4 Right click on the user to be deleted 5 Select Remove 6 Select Yes in the prompted dialog Adding a User to a Specific User Group 1 Log in to the computer with an Administrator account 2 Within the Windows search field type lusrmgr msc and select Enter 3 Double click on the Groups folder 4 Double click th...

Page 29: ...ed to enter experimental variables unless also added to VaxArraySetupExperiment group To perform all functions of the software a user would need to be added to all groups Note Windows security groups and users are organized in a hierarchical manner In order to make administration of VaxArray permissions easier you can alternatively create your own groups that batch several types of VaxArray groups...

Page 30: ...re only recommendations and the exact details of which user permissions are assigned to each user will be dependent on the individual requirements of each customer Basic user This user will be able to open the software setup and run an experiment generate results and modify experiments that have been setup but not yet run and add notes to experiments Add these users to the following groups VaxArra...

Page 31: ...s can cause spots within an array to not be found Some examples are The fiducial spots may be inadequate or non existent due to o Insufficient amount of fiducial label in the label mix o Short exposure times resulting in low fiducial signals o Array printing errors o Pipette tip or other damage to the microarray surface in the area s of the fiducial spots Image artifacts due to o Large numbers of ...

Page 32: ...in the correct position to insert the lock screws E Remove the two lock screws from their placeholders on the rear of the instrument F Lock the motorized stage by tightly screwing the two knurled screws into the openings on the right and rear side of the housing G Repack the instrument into the original packaging in the same way it was delivered H If returning the instrument to InDevR fill out the...

Page 33: ... mm Height 200 mm Weight without monitor 15 kg An additional 4 inches 100 mm of space must be provided in front and back of the instrument and an additional 2 inches 50 mm on the left for cables and ventilation Ambient conditions Pollution degree 2 Operation Environmental conditions Indoor use only Temperature 15 C to 35 C Relative humidity 10 to 75 non condensing Altitude Operating at max 2000 m ...

Page 34: ... Result data Image storage format 16 bit TIFF grayscale Results storage format CSV spreadsheet pdf files xml spreadsheet Internal PC specifications Embedded PC miniITX PC Operating system Windows 7 embedded pre installed Processor Intel Celeron Dual Core T3100 1 9 GHz or higher RAM 2 x 2 GByte DDR3 Hard Disk 250 GByte or larger Interfaces 4x USB2 4 internal VGA Monitor output PS 2 for keyboard and...

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