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| Appendix B: Programming a New Assay

Sample ANA Screen Enzyme Immunoassay Kit

This sample demonstrates the use of transformations and cutoffs.

Intended Use

This assay is designed for the in vitro

screening of serum for the presence of specific

IgG antinuclear antibodies (ANAs), to aid in diagnosing certain systemic rheumatic
diseases. Sufficient materials are supplied to allow a maximum of 93 samples to be
screened in single, with a positive, cutoff, and negative controls.

Background

Antinuclear antibodies occur in a large number of patients with systemic rheumatic
diseases. These diseases are characterized by the presence of one or more ANAs.
Sera positive on this ANA kit should be tested for the specific autoantibodies
indicative of the various systemic rheumatic diseases.

Principle of the Assay

Microwells are pre-coated with purified antigens. The prediluted controls and diluted
patient samples are added to the wells, and autoantibodies recognizing one or a
combination of antigens bind during the first incubation. After washing the wells to
remove all unbound proteins, IgG conjugate is added. The conjugate binds to the
captured autoantibody, and the excess unbound conjugate is removed by a further
wash step. Substrate is added that causes a blue reaction, thereby exposing the bound
conjugate, and producing an intensity proportional to the concentration of
autoantibody in the sample. Phosphoric acid is added to each well to stop the reaction.
This produces a yellow end-point color, which is read at 450 nm.

Materials Supplied

•

Instruction Leaflet: Giving full assay details.

•

QC Certificate: Indicating the expected performance of the batch.

•

ANA Coated Wells: 12 x 8 well strips coated with purified antigens.

•

Type III Wash Buffer 20x Concentrate: 1 bottle containing 50 mL of a concentrated
buffer for washing the wells.

•

Type III Sample Diluent: 2 bottles containing 50 mL of buffer for sample dilution.
Ready to use.

•

ANA Positive Control: 1 bottle containing 1.8 mL of diluted stabilized serum.
Ready to use.

BioTek Instruments, Inc.

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Summary of Contents for ELx808

Page 1: ...Operator s Manual Absorbance Microplate Reader ELx808 ...

Page 2: ......

Page 3: ...ELx808 Absorbance Microplate Reader All Models Operator s Manual April 2013 2013 Part Number 7341000 Revision P BioTek Instruments Inc ...

Page 4: ...rademark and ELx808 4 Zone and Gen5 are trademarks of BioTek Instruments Inc Microsoft Windows and Excel are either registered trademarks or trademarks of Microsoft Corporation in the United States and or other countries All other trademarks are the property of their respective holders Restrictions and Liabilities Information in this document is subject to change and does not represent a commitmen...

Page 5: ...ark xvi Directive 2004 108 EC Electromagnetic Compatibility xvi Directive 2006 95 EC Low Voltage Safety xvi Directive 2002 96 EC Waste Electrical and Electronic Equipment xvii Directive 98 79 EC In Vitro Diagnostics if labeled for this use xvii Electromagnetic Interference and Susceptibility xvii USA FCC CLASS A xvii Canadian Department of Communications Class A xvii User Safety xviii Safety Symbo...

Page 6: ...t the Reader s Filter Table 17 9 Configure Reader Settings 18 SETUP Options 18 OUTPUT Options 19 REPORT Type 19 READ Options 20 Read Speed 21 10 Install Software Connect to a Computer Optional 21 Attach the Cable 21 Install Gen5 Software on the Host Computer 21 Establish Communication 22 Changing the Baud Rate on the ELx808 22 11 Verify Performance 23 Before Repackaging the Instrument 24 Chapter 3...

Page 7: ...l Location 44 Selecting a Blank Map 44 Blank Map Definitions 45 Constant Blank Value Entry 46 Number of Blanks 46 Selecting a Blank Location 46 Number of Standards 47 Number of Standard Replicates 47 Average Standards 47 Standard Concentration 48 Reuse of Standard Curves 49 Number of Controls 50 Control Type 50 Number of Control Replicates 51 Location of Controls 51 Valid Well Locations 51 Number ...

Page 8: ... Location 72 Beginning the Plate Read 72 Printing Reports and Assay Lists 73 Result 74 Editing Standard Outliers 74 Printing Results 75 Map 75 Assay 76 List 76 Recommendations for Optimum Performance 76 Chapter 4 Instrument Qualification 79 Overview 80 Recommended Qualification Schedule 80 Test Descriptions 81 System Test 81 Incubator Self Test 84 Checksum Test 84 Absorbance Plate Test 85 Empty Ca...

Page 9: ... 101 Recommended Maintenance Schedule 102 Warnings and Precautions 102 Clean Exposed Surfaces 103 Inspect and Clean the Wavelength Filters 104 Optional Lubricate Robotic Components 105 Robotic Motor Adjustment Procedure 107 Replace the Lamp and Clean the Contacts 107 Decontamination 111 Purpose 111 Tools and Supplies 112 Decontamination Procedure 112 Chapter 6 Troubleshooting and Error Codes 115 O...

Page 10: ...71 toll free in the U S 802 655 4740 outside the U S Fax 802 655 7941 E Mail customercare biotek com Service TAC Phone 800 242 4685 toll free in the U S 802 655 4740 outside the U S Fax 802 654 0638 E Mail tac biotek com European Coordination Center Authorized European Representative BioTek Instruments GmbH Kocherwaldstrasse 34 D 74177 Bad Friedrichshall Germany Internet www biotek de Phone 49 0 7...

Page 11: ...tion pages iii 1 8 1 9 2 8 2 20 and 4 13 Added IQ OQ PQ procedures and updated liquid testing information Chapter 4 Revised lamp replacement procedure page 2 15 J 11 03 Preface Updated contact information in Notices page iii Added Document Conventions page vi Updated Warnings section pages vii and viii Updated Electromagnetic Compatibility section pages ix and x Added the following safety symbols ...

Page 12: ...vice section Chapter 2 Added instructions for connecting the external power supply in Connect Power section Moved instructions in Check Adjust the Power Input Voltage Setting section to Appendix F Chapter 4 Changed chapter title from Performance Verification Periodic Maintenance and IQ PQ OQ Tests to Instrument Verification Moved maintenance instructions to new Chapter 5 Preventive Maintenance see...

Page 13: ...er 3 Added Getting Started with Gen5 Gave Baud Rate information for Gen5 Removed references to outdated software Extensions Chapter 4 Removed Installation Qualification Updated Autocal Analysis Updated sample Absorbance Test Plate Results Updated Stock Solution Formulation for Liquid Tests 1 and 2 Removed outdated instructions for creating former Solution A 10x Concentrate PBS from Liquid Test 3 S...

Page 14: ...lished with any laboratory diagnostic assay The user must evaluate this instrument and if used PC based software in conjunction with their specific assay s This evaluation must include the confirmation that performance characteristics for the specific assay s are met If the instrument has an IVD label it may be used for clinical and non clinical purposes including research and development If there...

Page 15: ... Other forms of commercially available packaging are not recommended and can void the warranty If the original packing materials have been damaged or lost contact BioTek for replacement packing Warnings Operate the instrument on a level stable surface away from excessive humidity Bright light or strong incandescent light can reduce the linear performance range of the instrument Measurement values ...

Page 16: ...g liquids on the reader fluid seepage into internal components creates a potential for shock hazard or instrument damage Wipe up all spills immediately Do not operate the instrument if internal components have been exposed to fluid Warning Unspecified Use Failure to operate this equipment according to the guidelines and safeguards specified in this manual could result in a hazardous condition Warn...

Page 17: ...atures fluctuate above or below this range Storage temperature limits are broader Caution Sodium Hypochlorite Do not expose any part of the instrument to the recommended diluted sodium hypochlorite solution bleach for more than 20 minutes Prolonged contact may damage the instrument surfaces Be certain to rinse and thoroughly wipe all surfaces Caution Power Supply Use only the power supply shipped ...

Page 18: ...requirements of EN 61326 1 and EN 61326 2 6 for Immunity Verification of compliance was conducted to the limits and methods of the following EN 61000 4 2 Electrostatic Discharge EN 61000 4 3 Radiated EM Fields EN 61000 4 4 Electrical Fast Transient Burst EN 61000 4 5 Surge Immunity EN 61000 4 6 Conducted Disturbances from RFI EN 61000 4 11 Voltage Dips Short Interruptions and Variations Directive ...

Page 19: ...he equipment is operated in a commercial environment Like all similar equipment this equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interference to radio communications Operation of this equipment in a residential area is likely to cause interference in which case the user will be required to...

Page 20: ...riters Laboratories UL 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements Canadian Standards Association CAN CSA C22 2 No 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements EN 61010 Standards see CE Mark starting on page xvi ...

Page 21: ...Arrêt alimentation Aus Trennung vom Netz Desconectado Aperto sconnessione dalla rete di alimentazione Caution refer to accompanying documents Attention voir documents d accompanement Achtung siehe Begleitpapiere Atención vease los documentos incluidos Attenzione consultare la doc annessa Warning risk of electric shock Attention risque de choc électrique Gefährliche elektrische schlag Precaución ri...

Page 22: ...te sélective Getrennte Sammlung von Elektro und Elektronikgeräten Recogida selectiva de aparatos eléctricos y electrónicos Raccolta separata delle apparecchiature elettriche ed elettroniche Consult instructions for use Consulter la notice d emploi Gebrauchsanweisung beachten Consultar las instrucciones de uso Consultare le istruzioni per uso Laser radiation Do not stare into beam Rayonnement laser...

Page 23: ... 7 ELx808 Absorbance Microplate Reader 2 Reader Variations 2 Hardware Features 2 Software Features 3 Package Contents 3 Optional Accessories 3 Specifications 4 Microplates 4 Electrical 4 Physical 4 Environmental 5 Hardware 5 Reading Speeds 5 Standard Model ELx808 5 Incubator Ultraviolet Model ELx808IU 6 Product Support and Service 7 Contacting the Technical Assistance Center 7 Returning Instrument...

Page 24: ...tions Reader Variations ELx808 Absorbance Microplate Reader standard model ELx808IU Reader with incubation and UV capability The ELx808IU has a four zone incubation chamber that controls temperatures up to 50 C and is capable of reading plates between 340 nm and 900 nm wavelengths Hardware Features Eight optics channels with an additional reference channel A wavelength range of 380 900 nm ELx808 3...

Page 25: ...bject to change Please contact BioTek Customer Care with questions ELx808 Absorbance Microplate Reader Power cord PN varies according to country of use Power supply for readers manufactured after December 2005 PN 01281 Filter wheel with four standard filters 405 nm 450 nm 490 nm 630 nm and two blank filters The ELx808IU also includes a 340 nm filter Operator s Manual PN 7341000 Serial cable PN 750...

Page 26: ...s Standard 96 well flat or round bottom plates Electrical Power source and voltage range Readers manufactured after December 2005 24 volt external power supply compatible with 100 240 V 10 50 60 Hz Readers manufactured before December 2005 Internal adjustable power input module with four voltage ranges accommodated by the voltage selection switch Range 1 100 V 90 to 110 V 50 to 60 Hz Range 2 120 V...

Page 27: ...d bottom microplates Wavelength Range 380 to 900 nm Filters 10 nm half bandwidth interference filters User accessible filter wheel Up to 6 filters may be installed on the instrument at one time Filters supplied 405 nm 450 nm 490 nm 630 nm and two blank filters Absorbance Measurement Range 0 000 to 4 000 OD Optical specifications for single wavelength endpoint measurements with a 12 second read nor...

Page 28: ...ers may be installed on the instrument at one time Filters supplied 340 405 450 490 630 nm Absorbance Measurement Range 0 000 to 4 000 OD for 400 to 900 nm range 0 000 to 3 000 OD for 340 to 400 nm range Optical specifications for the 400 to 900 nm range 12 second read in normal regular read mode Accuracy Linearity Repeatability Same as Standard Model Optical specifications for the 340 to 400 nm r...

Page 29: ...side the U S Fax 802 654 0638 E Mail tac biotek com Web www biotek com Please be prepared to provide the following information Your name and company information A daytime phone or fax number and or an e mail address The product name model and serial number The onboard software part number and version available via the keypad by selecting UTIL TESTS CHKSUM Gen5 software version information Help Abo...

Page 30: ...8 Chapter 1 Introduction BioTek Instruments Inc ...

Page 31: ...t Voltage Setting 14 5 Connect Power 14 6 Optional Connect Printer 15 Printers 16 7 Turn on Reader and Run System Test 16 8 Check Adjust the Reader s Filter Table 17 9 Configure Reader Settings 18 SETUP Options 18 OUTPUT Options 19 REPORT Type 19 READ Options 20 Read Speed 21 10 Install Software Connect to Computer Optional 21 Attach the Cable 21 Install Gen5 Software on the Host Computer 21 Estab...

Page 32: ...of this chapter for complete shipping instructions The instrument s packaging is subject to change If the instructions in this section do not apply to the packaging materials you are using please contact BioTek s Technical Assistance Center for guidance The ELx808 and its accessories are securely packaged inside custom designed shipping materials This packaging should protect the instrument from d...

Page 33: ...peration install the reader on a level surface in an area where ambient temperatures between 18 C 64 F and 40 C 104 F can be maintained The reader is sensitive to extreme environmental conditions Conditions to avoid are Excessive humidity Condensation directly on the sensitive electronic circuits can cause the instrument to fail internal self checks The humidity must be in the range of 10 to 85 no...

Page 34: ...roud from the front Note that the shroud is hinged along its back edge Hold the plate access door steady or tape it closed as the shroud is being lifted to prevent the door from moving 4 Ensure that all locations on the filter wheel contain either a filter or a blank Each location on the filter wheel must be occupied for the reader to operate properly Take a moment to record the filter values in e...

Page 35: ... in place if you plan to ship the instrument back to BioTek for service or repair 6 To remove the filter wheel grasp the center hub of the filter wheel and pull it toward the lamp The wheel should easily disconnect from the hub Lift the wheel from the instrument 7 To properly store interference filters for the ELx808 during extended periods of non use package the filters in a light tight envelope ...

Page 36: ...inlet 4 Plug the other end of the power cord into an appropriate power receptacle ELx808 with the internal power input module 1 Locate the power inlet on the right side of the reader 2 Plug the rounded end of the power cord into the power inlet 3 Plug the other end of the cord into an appropriate power receptacle Warning Power Rating The ELx808 or power supply must be connected to a power receptac...

Page 37: ...er and reader are turned OFF before connecting them 1 If the reader and or printer are on turn them off Place the printer in a location adjacent to the reader 2 Attach one end of the parallel cable to the printer s parallel port 3 Attach the other end of the cable to the reader s parallel port located on the instrument s rear panel 4 Make sure the securing screws on both ends of the cable are tigh...

Page 38: ...elength over the specified OD range If a printer is connected to the reader the test results automatically print This test can also be run through Gen5 running on a host PC consult the Gen5 Help system for instructions If the test passes the reader will beep once and the display will show the software s main menu which will resemble one of the following Standard ELx808 R E A D Y 0 1 3 0 P M 1 0 0 ...

Page 39: ...t Utility Option menu select SETUP The EDIT SETUP INFORMATION screen appears E D I T S E T U P I N F O R M A T I O N D A T E T I M E F I L T E R M O R E 4 Select FILTER The wavelength currently defined for Filter 1 appears E N T E R F I L T E R 1 W A V E L E N G T H 4 0 5 If you need to change the filter wavelength number use the numeric keypad to enter a number at the cursor location To save the ...

Page 40: ...ification for more information To select the SETUP OUTPUT and READ user configurable options At the Main Menu screen select UTIL to access the Select Utility Option menu S E L E C T U T I L I T Y O P T I O N T E S T S S E T U P O U T P U T R E A D SETUP Options 1 At the Select Utility Option screen select SETUP E D I T S E T U P I N F O R M A T I O N D A T E T I M E F I L T E R M O R E 2 At the Ed...

Page 41: ... the top line of the display Select the desired option PRINT COMPUTER BOTH to change the output device 3 Press Enter to advance to the Select Printer menu screen If COMPUTER is selected all results will be transferred directly to the computer screen via the RS232 serial port S E L E C T P R I N T E R E P S O N E P S O N H P REPORT Type These selections only apply when the reader is run in standalo...

Page 42: ...s 1 At the Select Utility Option screen press the soft key beneath READ to set up Reader Prompt preferences Select YES to prompt the operator to enter identifications and sample counts before a microplate is read The prompts are shown below 2 Press Enter after each selection to advance the display P R O M P T F O R P L A T E I D N O Y E S N O 3 PROMPT FOR PLATE ID allows the user to enter an alpha...

Page 43: ...re outlined in Chapter 1 10 Install Software Connect to Computer Optional The ELx808 has serial RS232 port located on back of the reader see Figure 3 on page 15 This port allows the reader to communicate with a computer using the BioTek Gen5 software It also allows for upgrades to the ELx808 basecode on board software Attach the Cable Turn off the computer and the reader Connect the supplied seria...

Page 44: ... not successful try the following Is the reader connected to the power supply and turned on Is the communication cable firmly attached to both the reader and the computer Did you select the correct Reader Type in Gen5 Try a different COM port Make sure the reader display is at its Main Menu If you remain unable to get Gen5 and the reader to communicate with each other contact BioTek s Technical As...

Page 45: ... the baud rate currently set S E L E C T B A U D R A T E 9 6 0 0 1 2 0 0 2 4 0 0 9 6 0 0 V I E W 6 To change the Baud rate press the soft key beneath the desired baud rate The display top line automatically updates to reflect the new choice 7 To view the reader s settings for parity stop bits and data bits select VIEW 11 Verify Performance Before using the ELx808 for the first time verify that the...

Page 46: ...sing please contact BioTek s Technical Assistance Center for guidance Warning If the reader has been exposed to potentially hazardous material decontaminate it to minimize the risk to all who come in contact with the reader during shipping handling and servicing Decontamination prior to shipping is required by U S Department of Transportation regulations 1 Decontaminate the reader prior before shi...

Page 47: ...The Startup Screen 30 The Main Menu Screen 30 Quick Read 31 Defining Assays 32 Selecting an Assay 32 Assay Name 32 Defining the Method Map Formula and Curve 33 METHOD 34 MAP 40 FORMULA 53 CURVE 64 Panel Assays 67 Reading a Microplate 70 Select Assay 70 Run Time Prompts 70 Enter Number of Samples 71 Enter Plate ID 71 Enter Sample ID 71 Prompts for Well Location 72 ...

Page 48: ...s for Optimum Performance 76 Some readers have custom programmed assays installed Not all features of the software discussed in this chapter are available on custom instruments Please contact BioTek s Technical Assistance Center TAC if you have any questions about the assays on your reader All users should read Recommendations for Optimum Performance on page 76 BioTek Instruments Inc ...

Page 49: ...cedure dialog will open Go to step 4 For any version 4 Select a Plate Type 5 Click Read to open the Read Step dialog 6 Select a Read Type 7 Select or enter the wavelength s at which the plate will be read 8 Define other reading parameters as desired Click Help for assistance 9 When complete click OK to return to the Procedure dialog 10 Click OK to save and close the Procedure dialog Gen5 version 1...

Page 50: ...line x 24 character LCD display as the user interface see Figure 4 below The reader s bidirectional serial port allows computer control of the instrument and provides the means for downloading additional assay protocols to the instrument Figure 4 ELx808 Front Panel with LCD and Keypad BioTek Instruments Inc ...

Page 51: ... the Shift Options key combination Press the Enter key to select the current option Pressing Enter generally saves the current screen settings and advances to the next screen in a series To move to a previous menu press the Previous Screen key Press Clear to clear reset the current value on the reader s LCD display Press the reverse arrow to move the cursor to the left in the LCD display Press the...

Page 52: ...V X X X I N I T I A L I Z I N G B I O T E K E L X 8 0 8 S E L F T E S T The Main Menu Screen Following successful power up of the ELx808 the Main Menu screen is displayed This screen will vary slightly if the instrument has the Incubation UV option Main Menu screen ELx808 R E A D Y 0 1 3 0 P M 1 0 0 9 0 7 R E A D D E F I N E R E P O R T U T I L Main Menu screen ELx808IU model with incubation UV ca...

Page 53: ...mpted to select a previously run assay with valid data UTIL option Access various onboard utilities used for configuring and testing the reader Quick Read On some readers Assay 01 has been designed to allow for quick and simple assay programming It appears as _Quick Read on the display Most of the options available in Assays 2 through 55 and described in this section are unavailable for programmin...

Page 54: ...IC keys to enter the number of predefined Assay Definition files stored in the reader s memory or use the OPTION key to advance one assay at a time The cursor is positioned at the first editable field and advances automatically The numeric range depends on the number of assays 1 55 or more if custom programmed programmed in the reader s memory 2 The assay s name and number are displayed on the scr...

Page 55: ... to save the contents of the display and return to the previous screen Press Enter to save the contents of the display and advance to the next screen Defining the Method Map Formula and Curve The DEFINE Option screen allows you to edit the Method Map Formula or Curve Fit D E F I N E M E T H O D M A P F O R M U L A C U R V E Press the soft key beneath the displayed option to access the following fu...

Page 56: ... Scan The following keys are active during this screen R E A D T Y P E K I N E T I C E N D P O I N T K I N E T I C S C A N Press SOFT KEY 1 to select Endpoint read mode Press SOFT KEY 2 to select Kinetic read mode Press Enter to save the displayed value and advance to the next screen Delay in First Read Selecting the Delay in First Read option allows you to enter a time delay before the first read...

Page 57: ...ou to select SINGLE or DUAL wavelength for the assay W A V E L E N G T H D U A L S I N G L E D U A L Press SOFT KEY 1 to select SINGLE wavelength The reader will measure the optical density of each well with a single filter Press SOFT KEY 2 to select DUAL wavelength Each well will be read twice each time with a different filter Note The microplate is not removed from the reading chamber between th...

Page 58: ...select the total number of kinetic reads or the length of time the assay will run kinetic duration Any previously defined value is shown on the top line of the display and the options on the second K I N E T I C T O T A L R E A D S T O T A L R E A D S D U R A T I O N Press SOFT KEY 1 to select the total reads option Press SOFT KEY 3 to select the duration option Press Enter to save the selection a...

Page 59: ... C D U R A T I O N 1 1 2 3 4 5 Use the NUMERIC keys to enter the time duration in hours minutes and seconds The maximum duration time is 80 hours Use the LEFT and RIGHT ARROW keys to move between entry fields Press Enter to save the entry and advance to the next screen Shake Mode Selection S H A K E B E F O R E E V E R Y R E A D F I R S T E V E R Y N O N E Press SOFT KEY 1 to select shaking for th...

Page 60: ...ed 0 021 inch movement from the shake position and back S H A K E S P E E D M E D I U M L O W M E D I U M H I G H V A R I Press SOFT KEY 1 to select low speed shaking Press SOFT KEY 2 to select medium speed shaking Press SOFT KEY 3 to select high speed shaking Press SOFT KEY 4 to select variable speed shaking 1 second of each speed repeated Press Enter to save the entry and advance to the next scr...

Page 61: ...I N T S 3 A L L P O I N T S Use the NUMERIC keys to input the number of points The range is 2 to MAX where max is the total number of reads Press SOFT KEY 1 or 2 to select ALL POINTS Press Enter to save the entry and advance to the next screen Onset OD Selection Use this screen to enter the onset OD time E N T E R O N S E T O D 1 2 3 4 Use NUMERIC keys to enter the onset OD 3 000 OD is the maximum...

Page 62: ...he reader will read the chosen number of points across the well and report the calculated area under the curve MAP The MAP Definition screen allows you to edit or specify the following options in the assay Automatic or Manual Map Generation Mapping Direction Replication Direction Blank Map Selection Blanking Constant Number of Blanks Location of Blanks Number of Standards Number of Standard Replic...

Page 63: ...ected value appears on the top line of the display and the available options appear on the bottom M A P G E N E R A T I O N M A N U A L A U T O M A N U A L Automatic Plate Map Generation Select AUTO to instruct the software to automatically generate a plate map after the blanks controls standards and or samples have been defined Manual Plate Map Generation Select MANUAL to indicate that the well a...

Page 64: ...y how replicates are mapped on the plate The currently selected Replication Direction appears on the top line of the display and the available options appear on the bottom R E P D I R E C T I O N A C R O S S D O W N A C R O S S Press SOFT KEY 1 to map the replicates DOWN the column following the direction of the map listing Press SOFT KEY 2 to map the replicates ACROSS in a paired format As an exa...

Page 65: ... 1 2 3 4 5 6 7 8 9 10 11 12 A STD1 STD1 STD2 STD2 STD3 STD3 STD4 STD4 STD5 STD5 PC PC B NC NC SMP SMP SMP SMP SMP SMP C D E F G H Map Direction DOWN Rep Direction ACROSS 1 2 3 4 5 6 7 8 9 10 11 12 A STD1 STD1 B STD2 STD2 C STD3 STD3 D STD4 STD4 E STD5 STD5 F PC PC G NC NC H SMP SMP Map Direction ACROSS Rep Direction DOWN 1 2 3 4 5 6 7 8 9 10 11 12 A STD1 STD2 STD3 STD4 STD5 PC NC SMP SMP B STD1 ST...

Page 66: ... For all prompts of a well location only the ALPHA keys are active for the first character and NUMERIC for the second and third characters Press ENTER to save the well location and advance to the next screen Selecting a Blank Map This option allows you to select which blanking method to apply to the assay The currently selected Blank Map value appears on the top line of the display and the availab...

Page 67: ...lates ROW enables a single blank well or an average of blank wells to be selected for each row The blank or average will be subtracted from each well in the row Use manual mapping to position blanks controls standards and samples COLUMN enables a single blank well or an average of blank wells to be selected for each column The blank or average will be subtracted from each well in the column Use ma...

Page 68: ...f blank wells in the assay This entry screen is only displayed when Full Column or Row blank map is selected E N T E R N U M B E R O F B L A N K S 0 2 Use the NUMERIC keys to enter the number of blanks The range is 0 to 48 Press the CLEAR key to clear the Number of Blanks value from the display Press the ENTER key to save the value and move to the next screen Selecting a Blank Location The Blank L...

Page 69: ...ne and 2 P 3 for quadratic and 2 for linear and point to point Press CLEAR to clear the value on the display Press ENTER to save the value and move to the next screen Number of Standard Replicates E N T E R N U M B E R O F S T A N D A R D R E P L I C A T E S 0 2 Use the NUMERIC keys to enter the Number of Replicates per Standard The range is 1 to 8 replicates The software will verify that the numb...

Page 70: ...ard group Any previously defined value is displayed If Manual Map Generation is selected the replicate locations must also be defined C O N C N O F L O C A T I O N S T D 1 1 5 0 R E P 1 A 0 1 Use the NUMERIC and ALPHA keys and the DECIMAL POINT key to enter Standard Concentration values The range is 0 00001 to 999999 The entry cannot exceed six characters including the decimal point Valid well loc...

Page 71: ...ed to samples on a plate to be run in assay 51 To reuse a standard curve an assay must first be programmed in positions 31 through 55 and run During the defining process you will be prompted to enter the number of standards the number of standard replicates and the standard concentrations The following screen has been added after these prompts R E U S E S T A N D A R D C U R V E Y E S Y E S N O Af...

Page 72: ...the Starting well in the map usually well A01 If Manual mapping was used to map the plate the map is NOT regenerated the reader will NOT produce results for the well positions that originally were standards Auto mapping is recommended if the standards curves will be routinely reused Number of Controls E N T E R N U M B E R O F C O N T R O L S 0 2 Use the NUMERIC keys to enter the Number of Control...

Page 73: ...does not exceed the number of undefined wells remaining on the plate Press CLEAR to clear the displayed Number of Replicates value Press ENTER to save the displayed value and advance to the next screen Location of Controls The displayed location field can only be edited if manual map generation was selected C O N T R O L 1 L O C A T I O N T Y P E P C R E P 1 A 0 1 Press the CLEAR key to clear the ...

Page 74: ...N U M B E R O F S A M P L E R E P L I C A T E S 0 2 Use the NUMERIC keys to enter the Number of Sample Replicates The range is 1 to 12 replicates The software ensures that the number of replicates multiplied by the number of samples multiplied again by the number of dilutions does not exceed the number of undefined wells remaining on the plate Press the Clear key to clear the value on the display ...

Page 75: ...s that every blank well on a plate should have an OD of less than 0 050 The formula is entered on the reader as a Blank Validation Formula BLK 0 050 Negative Control Validation An assay protocol states that every Negative Control well must have an OD of less than or equal to 0 100 The formula is entered as a Control Validation Formula NC 0 100 Positive Control Validation An assay protocol states t...

Page 76: ...rols are valid In addition Assay Validation formulas can be used to determine whether or not the entire assay should be considered valid The TRANS VAR option allows you to define a variable to be used in transformation formulas Note GENERAL formulas are not used in the ELx808 open assays S E L E C T F O R M U L A T Y P E C U T O F F T R A N S V A L M O R E S E L E C T F O R M U L A T Y P E G E N E...

Page 77: ...he validation type and advance Formula Entry Note In formulas OD is used to represent the optical density value F O R M U L A 1 M A T H O T H E R M A P F U N C T N After a moment the FORMULA 1 prompt disappears and the formula can be entered Each formula can contain a maximum of 24 characters Spaces are unnecessary Use the LEFT and RIGHT ARROW keys to move the cursor to the previous or next editab...

Page 78: ...at the cursor position See the table that follows for the order of items on the OTHER list Left parenthesis Right parenthesis AND Logical AND OR Logical OR Press SOFT KEY 3 to place the next defined item on the plate map list i e STD NC PC BLK at the cursor position Press SOFT KEY 4 to place the next option on the FUNCTION list at the cursor position The available functions are LOG10 Log Base 10 A...

Page 79: ...Previous Screen key to move backward through the menu structure Number of Required Controls Blanks If a control or blank validation formula is entered this screen allows you to enter the number of valid controls blanks for the assay Any previously defined values will appear on the display P C N U M B E R O F V A L I D R E P L I C A T E S R E Q U I R E D 0 2 Use the Numeric keys to enter the Number...

Page 80: ...er PC or PC x to represent the mean or a formula combining the two NC x 0 050 A greyzone around the cutoff value can be defined to indicate equivocal or indeterminate results Do not use the or mathematical symbols in a cutoff formula Tip Choose to print a Column Report to see the greyzone and cutoff values as well as the equations used to assign calls to samples After selecting an assay page 32 de...

Page 81: ...d Press the Clear key to clear the displayed value Press the Enter key to save the displayed value and advance Positive Negative Calls for Cutoff After the greyzone is defined calls for the sample wells POSitive NEGative EQUIVocal must be defined S A M P L E C U T O F F 0 5 P O S P O S N E G Select POS or NEG to select the call that will be assigned to samples greater than the cutoff value plus th...

Page 82: ... than 1 500 NEG if the sample is less than 1 500 2 For a quantitative assay samples with OD values greater than the STD2 mean plus a 10 greyzone should be labeled as positive samples with OD values less than the STD2 mean minus the 10 greyzone should be labeled as negative All other samples should be considered equivocal For this example STD2 x the mean of the STD2 wells equals 2 000 OD The cutoff...

Page 83: ... T H O D M A P F O R M U L A C U R V E Ï This will bring you to a screen asking to Select Formula Type At this screen select TRANS and then enter the formula using the Math Other Map and Function keys S E L E C T F O R M U L A T Y P E C U T O F F T R A N S V A L M O R E Ï Example Divide all ODs on the plate by 2 and multiply by 100 Enter the formula OD 2 100 This formula will be applied to the ODs...

Page 84: ... R M U L A T Y P E C U T O F F T R A N S V A L M O R E Ï The options displayed now include TRANS VAR Press VAR at this screen S E L E C T F O R M U L A T Y P E G E N E R A L T R A N S V A R M O R E Ï The following screen will appear asking you to choose the scope of this transformation S C O P E V A R I A B L E O D S M P O D If SMP is chosen the transformation formula will be applied only to the s...

Page 85: ...rols and samples on the plate At the SCOPE VARIABLE screen choose OD and press Enter Now enter the formula NC x CTL1 x by using the MATH OTHER MAP and FUNCTION keys Press the ENTER key The formula definition screen is displayed Choose TRANS Enter the following formula OD TVar TVar 100 using the MATH OTHER MAP and FUNCTION keys TVar is included in Map options on the formula entry screen The transfo...

Page 86: ...t fit straight line is plotted using the values of the standards Quadratic or Quad curve fit A curve fit which uses the Quadratic equation ax2 bx c y to plot the standard s values Utilizing this curve any data point for a standard that deviates from the ideal value will not affect the entire curve Cubic curve fit A curve fit that uses the equation ax3 bx2 cx d y to plot the standard s values This ...

Page 87: ... KEYS 1 2 3 or 4 to select the curve fit type that is displayed above the soft key Select the soft key below the menu option MORE to display additional options The top line of the display updates to reflect this selection Press ENTER to save the selection and advance to the next screen or use the MAIN MENU and PREVIOUS SCREEN keys to move backward through the menu structure Edit Standard Outliers ...

Page 88: ...een appears only if Manual Map Generation has been selected X Y A X I S T Y P E L I N L I N L I N L O G L O G L O G L I N Press SOFT KEY 1 2 3 or 4 to select the method by which the X and Y axes will be scaled The top line of the display updates to reflect the selection This option is not available for the 2 P and 4 P curve fit types The X Y scaling for these curves is always LIN LIN Press ENTER t...

Page 89: ...efined in any of the assay positions 1 55 The assays specified within the Panel must all use the Endpoint read method The assays specified within the Panel must all read at the same wavelength s Any curve fit type formulas or standard concentrations previously defined for each assay will be used when the assay is selected for a Panel Panel assays cannot reuse standard curves Only an Auto map is re...

Page 90: ...selecting the mapping direction of the assays choose which assays to include in the panel S E L E C T A S S A Y N U M B E R 2 2 N A M E H B S A G 1 Press the Options key to cycle through the assay numbers and names or use the numeric keys to enter an assay number Press Enter to make a selection After an assay is selected its starting location must be defined S T A R T M A P P I N G A T W E L L L O...

Page 91: ...The mapping for Assay 8 can begin in well B04 or any well other than A01 to B03 The reader will beep if you try to map into a well that is already assigned for use with the Panel The mapping for Assay 22 may begin at the next available well location after Assay 8 mapping is complete The Panel Assay results are sorted by Sample unless a custom assay has been programmed by BioTek Note The Interpreta...

Page 92: ...e assay s name and number are displayed on the screen S E L E C T A S S A Y N U M B E R 2 5 N A M E H B S A G Press Enter to advance to the Run Time prompts MAIN MENU Returns the display to the Main Menu screen Run Time Prompts After the assay is selected one or more informational prompts may be presented depending on preferences selected in UTIL READ whether or not the assay specifies manual mapp...

Page 93: ...se caution when creating multiple Plate IDs The reader does not warn you that you are about to exceed the maximum of 10 plate IDs stored in memory If an eleventh Plate ID is added it will overwrite the first Plate ID stored in memory Note If the internal bar code scanner option is installed the reader will automatically scan the plate bar code label and use this as the Plate ID P L A T E I D S P A...

Page 94: ...ation using the SHIFT LETTER sequence to key in letters and press Enter to specify the desired location Beginning the Plate Read When the following screen appears on the display the reader is ready to read a plate P L A C E P L A T E I N C A R R I E R A N D P R E S S R E A D K E Y Place the plate in the carrier and press the READ key to initiate the plate read After the plate has been read all req...

Page 95: ... Assay and Assay List reports See Appendix A for sample reports R E A D Y 9 4 5 P M 0 5 0 9 0 7 R E A D D E F I N E R E P O R T U T I L P R I N T R E P O R T R E S U L T M A P A S S A Y L I S T The eight most recent sets of plate data are stored in memory see next page Select REPORT RESULT to print an exact copy of results from the plate reading The form in which the results are presented is deter...

Page 96: ...o edit outliers is presented E D I T S T D O U T L I E R S Y E S N O Select NO to include all standards in the curve fit calculations Select YES to indicate that one or more standard replicates or groups should be temporarily excluded from curve fit calculations If AVERAGE STANDARDS was set to NO in the assay definition one or more standard replicates can be chosen for exclusion E D I T S T D 1 R ...

Page 97: ...assay is left with insufficient standards the curve fit will fail Printing Results After the assay is selected and standard outliers are edited if necessary the results report can be printed P R I N T R E S U L T S Y E S N O Ensure that the printer is connected turned on and filled with paper Press YES to print reports or NO to return to the Main Menu Map Select REPORT at the Main Menu and then se...

Page 98: ... V bottom 96 well microplates the reader achieves optimum performance with optically clear flat bottomed wells Non uniformity in the optical density of the well bottoms can cause loss of accuracy especially with U and V bottom polyvinyl microplates Check for this by reading an empty microplate Dual wavelength readings can eliminate this problem or bring the variation in density readings within acc...

Page 99: ...rference from ambient light is suspected read a microplate of high density solutions under the suspect conditions and again with all ambient light blocked in a dark room for example then compare results The blocked results will appear as an increase in optical density readings if light is influencing the readings Because of the mathematical correction this difference under normal conditions should...

Page 100: ...78 Chapter 3 Operation BioTek Instruments Inc ...

Page 101: ...formance initially and on an ongoing basis Overview 80 Recommended Qualification Schedule 80 Test Descriptions 81 System Test 81 Checksum Test 84 Absorbance Plate Test 85 Empty Carrier Test 88 Liquid Tests 88 Perform the Tests 89 System Test 89 Checksum Test 89 Absorbance Plate Test 89 Empty Carrier Test 91 Liquid Tests 92 ...

Page 102: ...intenance with spreadsheets for analyzing results and checklists and logbooks Contact your BioTek dealer for more information Recommended Qualification Schedule The schedule below defines the factory recommended intervals for qualifying an ELx808 reader used two to five days a week The actual frequency however may be adjusted depending on your usage of the instrument This schedule assumes the read...

Page 103: ...s and if equipped proper function of the incubator The testing is designed to verify that the ELx808 will give in specification performance for each set wavelength over the specified OD range Autocal is run only at the factory or by an authorized service engineer to calibrate the carrier axis of the instrument The results of this test are included in the System Test Report In the field the alignme...

Page 104: ...46672 Filter 490 Gain 16 00 Channel Ref 1 2 3 4 5 6 7 8 Air 29585 40785 53183 50389 42324 46927 45225 51112 48181 Dark 1806 1981 1927 2187 2121 2172 2369 2182 2247 Delta 27779 38804 51256 48202 40203 44755 42856 48930 45934 Filter 620 Gain 8 26 Channel Ref 1 2 3 4 5 6 7 8 Air 28973 40210 53315 49573 42596 47522 46312 50677 49083 Dark 922 1012 983 1116 1084 1111 1211 1114 1150 Delta 28051 39198 523...

Page 105: ...6 9680 Fax 802 655 3399 Fax 49 0 7136 968 111 All Others Tel 802 655 4040 Fax 802 655 3399 email TAC biotek com Product support center www biotek com service The INCUBATOR SELF TEST shows the PASS or FAIL condition of the four heating zones in the incubator if equipped See Incubator Self Test on the next page AUTOCAL ANALYSIS provides coordinates of the last Autocal performed on the instrument AUT...

Page 106: ... Zone 4 36 9 Min 36 9 Max 37 0 Range PASS Thermistor PASS Zone Reports the average temperature of the zone at the time the test is run Each zone is evaluated independently Min The minimum temperature recorded during the time that the system test is run Max Maximum temperature recorded during the time that the system test is run There is no range checking between Min and Max temperatures Range This...

Page 107: ... and mechanical alignment to NIST traceable values To run the test you will need a BioTek Absorbance Test Plate with its accompanying data sheet The BioTek PN 7260522 Test Plate has a glass filter in location C6 which is used to check the wavelength accuracy of a monochromator Although the ELx808 does not have a monochromator you must enter values for the peak wavelength when defining the 7 filter...

Page 108: ...86 Chapter 4 Instrument Qualification Figure 6 Sample Absorbance Plate Test Report The report varies slightly depending on how it was run via the keypad or Gen5 BioTek Instruments Inc ...

Page 109: ...te carrier Check the Test Plate s alignment holes to ensure they are clear of debris Accuracy Linearity The Test Plate contains neutral density glass filters of known OD values at several wavelengths Actual measurements are compared against the expected values provided in the Test Plate s data sheet Since there are several filters with differing OD values the accuracy across a range of ODs can be ...

Page 110: ... neutral density filters do not The optics characteristics may differ in these two cases alerting you to different types of problems The Absorbance Test Plate will indicate the absolute amount of light absorbed which will effectively test the linearity of the electronics The liquid tests will help detect optical defects such as dirt on the lenses or other contamination that can contribute to erran...

Page 111: ...on select Help About Gen5 Using the instrument keypad From the main menu select UTIL TESTS CHKSUM The initial checksum test display will show the onboard base code software part number version number and checksum After a few moments a second screen will show the assay configuration software part number and version number Absorbance Plate Test Define the Test Plate Parameters Using Gen5 click Help ...

Page 112: ...nu and select UTIL TESTS CALPLATE The Calibration Filter screen will appear 2 Select the appropriate wavelength and press Enter 3 When prompted insert the Test Plate into the plate carrier and press the READ key to begin the test The Test Plate Analysis Report sample on page 86 will be sent to a printer when the test is complete Gen5 version 1 07 and earlier users Gen5 s Reader Diagnostics Utility...

Page 113: ...elength Check the microplate carrier to ensure that it is clear of debris Verify that the lamp is properly aligned and then run the test again If the lamp has been in use for approximately 600 hours it may need to be replaced and the contacts in the lamp socket may need to be cleaned Refer to Replace the Lamp and Clean the Contacts in Chapter 5 Follow the steps in Inspect and Clean the Wavelength ...

Page 114: ...e Phosphate o nitrophenyl phosphate 3N sodium hydroxide beta Galactosidase o nitrophenyl beta D galactopyranoside 1M sodium carbonate Peroxidase 2 2 Azino di ethylbenzothiazoline sulfonic acid ABTS citrate phosphate buffer pH 2 8 Peroxidase o phenylenediamine 0 03N sulfuric acid Stock Solution Formulation The stock solution for Liquid Tests 1 and 2 may be formulated using the materials listed belo...

Page 115: ...h boat 1 liter volumetric flask Prepare Stock Solution 1 Weigh out 0 092 gram of FD C No 5 yellow dye powder into a weigh boat 2 Rinse the contents into a 1 liter volumetric flask 3 Add 0 5 mL of Tween 20 or 5 mL of BioTek s wetting agent 4 Make up to 1 liter with DI water cap and shake well 96 well flat bottom microplates are required for the liquid tests Corning Costar 3590 is recommended Use ne...

Page 116: ...l A1 is now in the H12 position Read the plate five more times Turnaround plate position 6 Print the ten sets of raw data or export the data to an Excel spreadsheet using Gen5 The mathematical computations described below may then be performed and the template kept for future tests Calculations 7 Calculate the mean OD value for each well location in columns 1 and 2 for the five plates read in the ...

Page 117: ...recommended method of testing the instrument performance is to use the Absorbance Test Plate to confirm alignment repeatability and accuracy which will also confirm linearity If a Test Plate is not available Liquid Test 2 can be used for these tests Required Materials A new 96 well flat bottom microplate Corning Costar 3590 is recommended Ten test tubes numbered consecutively stored in a rack Cali...

Page 118: ...e choice of dilutions and the absorbance of the original solution can be varied Use the table on the previous page as a model for calculating the expected absorbances of a series of dilutions given a different absorbance of the original solution After pipetting the diluted test solution into the microplate and before reading the plate we strongly recommend shaking the plate for four minutes This w...

Page 119: ...rd deviation of 0 0026 The mean 1 951 multiplied by 0 5 1 951 0 005 0 0098 which when added to the 0 005 0 0098 0 005 0 0148 OD which is the allowable deviation Since the standard deviation is less than this value the reader meets the test criteria Repeatability Specification 0 5 0 005 OD from 0 000 OD to 2 500 OD at 405 nm Channel to Channel Variation and Alignment Test C 1 Using the plate prepar...

Page 120: ...the lenses If the four corner wells are within the repeatability range the reader is also in alignment Perform Liquid Test 3 UV Models Only Liquid Test 3 is an optional test offered for sites that must have proof of linearity at wavelengths lower than those attainable with the Absorbance Test Plate This test verifies operation of the ELx808 at 340 nm and is optional because the reader has good fro...

Page 121: ...umns 3 and 4 150 µL of the 50 Test Solution into all wells of columns 5 and 6 After pipetting the diluted test solution into the microplate and before reading the plate we strongly recommend shaking the plate for four minutes This will allow any air bubbles in the solution to settle and the meniscus to stabilize If a plate shaker is not available wait 20 minutes after pipetting the diluted test so...

Page 122: ...he mean by 1 0 and add 0 005 0 8004 0 010 0 005 to get 0 013 Since the standard deviation for well A1 is less than 0 013 the well meets the test criteria Repeatability Specification 1 0 0 005 OD from 0 000 to 2 000 OD at 340 nm Calculate Linearity 1 For each of the three Test Solutions calculate the mean absorbance for the wells containing that solution mean of wells A1 to H2 A3 to H4 and A5 to H6...

Page 123: ...form to specification Recommended Maintenance Schedule 102 Warnings and Precautions 102 Clean Exposed Surfaces 103 Inspect and Clean the Wavelength Filters 104 Optional Lubricate Robotic Components 105 Robotic Motor Adjustment Procedure 107 Replace the Lamp and Clean the Contacts 107 Decontamination 111 Purpose 111 Tools and Supplies 112 Decontamination Procedure 112 ...

Page 124: ...an shown below Task Frequency Every three months Every six months As needed Before storage or shipment Clean Exposed Surfaces p 103 9 Inspect Clean Wavelength Filters p 104 9 Optional Lubricate Robotic Components p 105 9 Replace Lamp and Clean Contacts p 107 after 500 hours Decontamination p 111 9 Warnings and Precautions Please read the following before performing any maintenance procedures Warni...

Page 125: ... BioTek s Technical Assistance Center Important Do not soak the keypad this will cause damage Moisten a clean cloth with deionized or distilled water and wipe the keypad Dry immediately with a clean dry cloth Clean Exposed Surfaces Important Turn off and unplug the ELx808 for the cleaning procedure Exposed surfaces may be cleaned not decontaminated with a cloth moistened not soaked with water or w...

Page 126: ... Isopropyl ethyl or methyl alcohol Lens cleaning tissue To inspect and clean the wavelength filters 1 If you have not already done so turn off and unplug the reader 2 Temporarily tape the reader s plate access door shut 3 Using your fingertips locate the seven perimeter screws around the sides and front where the reader s top shroud meets the base Remove the screws using a screwdriver Tip Bring th...

Page 127: ...contact your BioTek Representative or BioTek Optional Lubricate Robotic Components This section applies to ELx808 robotic models only You will need lubricant BioTek PN 66039 1 Remove the top shroud of the instrument see instructions in Chapter 2 2 Lubricate the components as shown in Figure 8a and Figure 8b every six months or after 10 000 cycles according to the instructions in the table below Co...

Page 128: ...106 Chapter 5 Preventive Maintenance Figure 8a Location of bracket motor shaft and main PCB motor assembly Figure 8b Roller surface and hook in bracket BioTek Instruments Inc ...

Page 129: ...oor to the desired height Press the DOWN soft key if you want to adjust the door downward Important Do not open the door to its maximum open position 8 Press the Main Menu key 9 Press the CLOSE soft key This will close the door The door should rest closed on the top cover Replace the Lamp and Clean the Contacts There are two types of lamp assemblies Steps 7 and 8 only pertain to the newer assembly...

Page 130: ...hut 3 Using your fingertips locate the seven securing perimeter screws around the sides and front where the reader s top shroud meets the base Remove the screws using a screwdriver Tip Bring the reader to the edge of the work surface to access the screws without having to turn the reader upside down 4 Carefully raise the front of the shroud and tip it toward the back of the instrument 5 The lamp i...

Page 131: ...d rotating the socket counterclockwise 10 Clean the two contacts in the socket using a cotton swab moistened with isopropyl alcohol and allow them to dry for a few minutes An alternative cleaning technique would be to rub the contacts with a pencil eraser To install the lamp reverse steps 1 through 9 Keep your fingers out of the reflector interior and away from the bulb Ensure that the bulb is set...

Page 132: ...110 Chapter 5 Preventive Maintenance Figure 10 New lamp hardware for the ELx808 assembled Lamp Assembly 1 Figure 11 Location of the lamp in the ELx808 Lamp Assembly 2 BioTek Instruments Inc ...

Page 133: ...ek nor the CDC assumes any liability for the adequacy of these solutions and methods Each laboratory must ensure that decontamination procedures are adequate for the Biohazard s they handle Warning Internal Voltage Turn off and unplug the instrument for the decontamination procedure Warning Wear prophylactic gloves when handling contaminated instruments Gloved hands should be considered contaminat...

Page 134: ...he interior of the instrument If this happens contact the BioTek Service Department Do not soak the keypad this will cause damage Important Turn off and unplug the instrument for all decontamination and cleaning operations 1 Turn off and unplug the instrument 2 Prepare an aqueous solution of 0 5 sodium hypochlorite bleach As an alternative 70 isopropyl alcohol may be used if the effects of bleach ...

Page 135: ...y with a clean dry cloth Wipe the plate carrier the inside of the carrier door and all exposed surfaces of the instrument 4 Wait 20 minutes Moisten a cloth with deionized or distilled water and wipe all surfaces of the instrument that have been cleaned with the bleach solution or alcohol 5 Use a clean dry lint free cloth to dry all wet surfaces 6 Reassemble the instrument as necessary 7 Discard th...

Page 136: ...114 Chapter 5 Preventive Maintenance BioTek Instruments Inc ...

Page 137: ...or Codes This chapter provides a list of Error Codes that may appear on the ELx808 or in Gen5 and their probable causes Overview 116 Diagnostics 116 Terms Used in the Error Codes Tables 116 Error Codes General 117 Error Codes Fatal 121 ...

Page 138: ... should be conducted for diagnostic purposes Refer to the following brief instructions for performing the Self Test From the Main Menu screen on the ELx808 display select UTIL TESTS SYSTEM In Gen5 access the System menu and select Diagnostics Run System Test Terms Used in the Error Codes Tables Air Blank A full light reading through a filter with no plate in the light path Dark Current A reading t...

Page 139: ... where the light beam from the optics is no longer detectable by the measurement electronics This error is usually only seen during the service Auto Cal sequence Probable causes Carrier Lamp may be out or blocked by a faulty filter wheel A loose belt or a loose motor pulley may cause the carrier to ignore movement instructions Filter Wheel Motor The filter wheel is missing or loose or a loose filt...

Page 140: ...ations in background electronic noise were detected when blocking the light and increasing the Gain to maximum Probable causes Electrical noise penetrating the measurement chamber The bottom and top shrouds are part of the electrical shielding Check that the shrouds are installed and properly fastened Ambient light leak Check that the plate chamber door is closed to keep out ambient light Missing ...

Page 141: ...e same reading taken during the power up self check Probable cause Lamp has failed since power up Check that the lamp is lit and replace if necessary Analog PCB failure 0C00 Printer time out error Error 0C00 indicates that the time allotted for the instrument to make a valid connection to a printer has expired Probable cause Printer out of paper not connected or not on line 0D00 Reader failed cali...

Page 142: ... last digit indicates the filter wheel position If a 23xx error is displayed during a read the last digit indicates the filter number in the list of filters used for the read Probable causes Defective or old lamp replace the lamp Lamp not sitting correctly in lamp holder always remove the holder to install the lamp then insert the holder with the lamp back into the reader Lamp contacts dirty Clean...

Page 143: ...ervice section in Chapter 1 Code Description A100 Task control block not available A200 Read already in progress A300 Device not available A400 Failed code checksum test on powerup A500 DR steps alloc free error assay num A600 Data flash write timed out A700 Data flash readback did not match write test chip A800 Code flash write timed out A900 Memory Manager corruption detected Power instrument of...

Page 144: ...122 Chapter 6 Error Codes BioTek Instruments Inc ...

Page 145: ...RT from the Main Menu screen L Important The OUT indication on reports means the OD for an individual well or the average OD for a group of wells falls outside the minimum maximum OD range defined for the assay For the Quick Read assay on the ELx808 this range is 3 0 OD to 3 0 OD For assays defined onboard by a user Assay02 Assay55 it is 4 0 OD to 4 0 OD Samples with Calls on Matrix Report 124 Cur...

Page 146: ...124 Appendix A Sample Reports Samples with Calls on Matrix Report BioTek Instruments Inc ...

Page 147: ...Curve Fit Report 125 Curve Fit Report ELx808 Operator s Manual ...

Page 148: ...126 Appendix A Sample Reports BioTek Instruments Inc Samples with Calls on Column Report ...

Page 149: ...Column Report without Samples 127 Column Report without Samples ELx808 Operator s Manual ...

Page 150: ...128 Appendix A Sample Reports Panel Report BioTek Instruments Inc ...

Page 151: ...Assay Detail Report 129 Assay Detail Report ELx808 Operator s Manual ...

Page 152: ... 03 4 ASSAY 04 5 ASSAY 05 6 ASSAY 06 7 ASSAY 07 8 ASSAY 08 9 ASSAY 09 10 ASSAY 10 11 ASSAY 11 12 ASSAY 12 13 ASSAY 13 14 ASSAY 14 15 ASSAY 15 16 ASSAY 16 17 ASSAY 17 18 ASSAY 18 19 ASSAY 19 20 ASSAY 20 21 ASSAY 21 22 ASSAY 22 23 ASSAY 23 24 ASSAY 24 25 ASSAY 25 26 ASSAY 26 27 ASSAY 27 28 ASSAY 28 29 ASSAY 29 30 ASSAY 30 ...

Page 153: ...ot been verified on any clinical kits The kit instructions are provided so that users can see how it is possible to translate the kit wording into an ELx808 assay program For clarity only the user menu choices from the reader screens are shown See Chapter 3 for details Important The user is responsible for programming the reader properly according to their specific kit instructions and for verifyi...

Page 154: ...to the wells and autoantibodies recognizing one or a combination of antigens bind during the first incubation After washing the wells to remove all unbound proteins IgG conjugate is added The conjugate binds to the captured autoantibody and the excess unbound conjugate is removed by a further wash step Substrate is added that causes a blue reaction thereby exposing the bound conjugate and producin...

Page 155: ...ighest quality available Calibrated Micropipettes For dispensing 1000 100 and 10 µL Multichannel Pipette Recommended for dispensing 100 µL volumes of conjugate substrate and stop solution Glass Plastic Tubes For sample dilution Quality Control For an assay to be valid all the following criteria must be met Cutoff as well as Positive and Negative controls must be included in each run The OD of the ...

Page 156: ...n Menu press DEFINE Enter the assay number and edit the name if desired At the DEFINE menu STEP COMMENTS To program the reading method press METHOD READ TYPE Endpoint Kinetic or Scan Endpoint DELAY FIRST READ If incubator model INCUBATION TEMP Ambient or Temperature WAVELENGTH Single or Dual Single MEASURE Wavelength s to use 450 SHAKE First Every or None To program the plate map press MAP AUTO Au...

Page 157: ... REPLICATES 01 When defining control validation formulas use PC to indicate the criterion for each of the PC replicates and PC x to indicate the average of the Positive Control replicates To create the plate transformation for CALC divide the ANA result by a cutoff standard FORMULA MORE TRANS VAR SCOPE VARIABLE SMP or OD Select OD to advance to the formula definition screen and define the transfor...

Page 158: ... Assay Microwells are pre coated with cardiolipin and cofactor Standards controls and patient samples are added to the wells and autoantibodies recognizing cardiolipin bind during the first incubation After washing the wells to remove all unbound proteins conjugate is added The conjugate binds to the captured antibody and the excess unbound conjugate is removed by a further wash step Substrate is ...

Page 159: ...containing 14 mL TMB substrate Ready to use Stop Solution 1 bottle containing 14 mL of 3M phosphoric acid Ready to use Additional Materials and Equipment Not Supplied Automatic Microplate Plate Washer This is recommended however plate washing can be performed manually Microplate Reader Capable of measuring optical densities at 450 nm referenced on air Distilled or Deionized Water This should be of...

Page 160: ...emoved If the absence of this point means that the curve has a shape dissimilar to that of the sample calibration curve or more than one point appears to be anomalous then the assay should be repeated Calculation of Autoantibody Levels in Controls and Samples Read the level of the anticardiolipin autoantibody in the controls and diluted samples directly from the calibration curve The control value...

Page 161: ... serum from 102 normal adult blood donors The ranges below are provided as a guide only ELISA assays are very sensitive and capable of detecting small differences in sample populations It is recommended that each laboratory determine its own normal range based on the population techniques and equipment employed lgG Anticardiolipin 11 GPL U mL Negative result 11 GPL U mL Positive result Programming...

Page 162: ... for Positive and Negative calls Note Kit instructions specify that samples with concentration values greater than 11 should appear as positive The ELx808 software calculates the cutoff based on absorbance value or transformed value see the previous example and cannot calculate based on concentration The technician must make the positive or negative determination visually based on the calculated c...

Page 163: ...usting the power input voltage setting in ELx808 instruments that are equipped with an internal four voltage range power input module Identifying the Reader s Power Input Module 142 Newer Style Module 143 Adjust the Power Input Voltage Setting 143 Reconfigure or Replace Fuses 145 Older Style Module 147 Adjust the Power Input Voltage Setting 147 Reconfigure or Replace the Fuses 148 ...

Page 164: ...ow to make sure the setting is appropriate for your location If you need to adjust the setting first determine which type of power input module is installed in the reader The newer style module has a cover that can swing back toward the reader when opened with small needle nose pliers If your reader has this module follow the instructions starting on page 143 for adjusting the power input voltage ...

Page 165: ...eedle nose pliers into the two holes on the cover of the power input module Lift the cover open and swing it back toward the power cord socket see Figure 12 below 3 As shown below a small voltage selector card is located to the right of the fuse holder Using the pliers carefully pull this card straight out of the compartment Figure 12 Power input module accessing the voltage selector card and fuse...

Page 166: ...t the bottom of the card as shown below Figure 13 Voltage selector card input range positions 5 Reinsert the voltage selector card into the power input module so that the text side faces the ON OFF switch and the desired voltage range is on the bottom of the card see above 6 Reconfigure or replace fuses as needed see next page 7 Replace the cover and verify that the white peg lines up with the cor...

Page 167: ...Center if the fuse replacement fails to resolve the problem See Chapter 1 for contact information The fuse holder can have either one of two fuse configurations 100 120 V USA A fused hot AG 1 5 A 250 V Slo Blow PN 46024 or 230 240 V International Both hot and neutral fused with a 5 x 20 mm 0 63 A 250 V Slo Blow PN 46038 To reconfigure fuses 1 Turn off and unplug the reader 2 Insert the needle nose...

Page 168: ...he fuse holder with the fuses toward the back of the power input module Replace the cover and verify that the white plastic indicator peg lines up with the correct voltage indicator hole To replace defective fuses 1 Follow steps 1 through 3 on the previous page to access the fuse holder 2 Remove the defective fuse and replace it with the correct new one 3 Reinstall the fuse holder with the fuse to...

Page 169: ...ht out of the module 4 Text printed on the card identifies the four different voltage positions Each voltage number has an arrow printed next to it Rotate the white plastic indicator peg so that it fits into the groove on the card that represents the desired voltage the peg should point in the opposite direction from the arrow printed on the board 5 Orient the card so that the peg is facing out an...

Page 170: ...ortant Turn off and unplug the reader before reconfiguring or replacing the fuses Both USA and International style fuses are installed in the fuse holder that is attached to the inside of the power input module s cover The reader s fuses are configured at the factory prior to shipping Use the procedure below if you need to reconfigure or replace fuses BioTek Instruments Inc ...

Page 171: ...at blade screwdriver into the access hole between the power cord inlet and the power input module cover Carefully pry the cover off the module 3 Use the screwdriver to remove the Phillips head screw that anchors the fuse holder to the inside of the cover See Figure 14 4 Turn the fuse holder over 5 Reattach the fuse holder to the cover with the screw 6 Replace the cover and verify that the white pl...

Page 172: ...150 Appendix C Adjusting the Power Input Voltage Setting BioTek Instruments Inc ...

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