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Truelab Uno micro PCR analyzer manual new version

1. B Verna Industrial Estate Verna Goa 403722 India Tel 91 832 6682000 Fax 91 832 2783139 ll Warranty Warranty Information would be specified in the sales invoice contract Contact your Molbio representative for further information Normally the instrument would be under warranty for a period of twelve 12 months from the date of installation Post warranty services are also available from Molbio Trademarks Truelab Truelab Uno Truepet Trueprep Truenat are registered trademarks of Molbio Diagnostics Pvt Ltd IV IntendedUse The Truelab Uno Real Time micro PCR Analyzer is intended for performing real time PCR as well as real time RTPCR of target nucleic acids and works only with Truenat analyte specific micro PCR chips Itis for In Vitro Diagnostics IVD use only V Preamble Before starting real time PCR testing on the Truelab Uno analyzer it is important to read this USER MANUAL thoroughly and completely All instructions contained in this manual needs to be adhered to and non adherence may lead to erroneous results and possible damage to the analyzer lt The Truelab User s Manual The USER MANUAL provides detailed instructions for the use of all the Truelab Uno s available functions its technical specifications a brief introduction to the concept of PCR and aglossary VII Conventions Used in this Manual This manual uses certain conventions that make it easier for you to dif
2. Truelab Uno Truelab Uno micro PCR Analyzer Truel ve 7 EJ POWER 4 uw Use P A CHAR GIC 4 2 735 72 OW Barry y d 4 603020001 User Manual AN Y DIAGNOSTICS Truelab Uno TABLE OF CONTENTS 7 8 1 Introduction 9 10 1 1 Polymerase Chain Reaction PCR 9 1 2 Real time PCR 9 1 3 Understanding Cycle Threshold Ct Value 9 10 2 1 Box Contents 10 11 2 2 Installation Requirements 11 2 2 1 Installation Precautions 11 2 2 2 Environmental Requirements 11 2 3 Installing the Truelab Uno 11 2 3 1 Power Users 11 2 3 2 Regular Users 12 3 Specifications of the Truelab Uno 12 13 3 1 General Specifications 12 3 2 Shipping 13 4 Using the Truelab Uno micro PCR Analyzer 13 17 4 1 Introduction 13 4 1 1 Interacting with the Truelab Uno 13 14 4 1 2 Checking Battery Status before use 14 15 4 1 3 Charging Using the Truelab Uno with the AC Adaptor 16 17 4 2 Starting the Truelab Uno 17 20 43 Loading the Truenat Chip 20 23 Oe molbio DIAGNOSTICS Truelab Uno 44 Starting the Test 22 24 44 1 Starting the Test 22 23 4 4 2 System Messages 23 24 45 Duringthe Test 24 27 4 5 1 Viewing the Thermal Graph 25 4 5 2 Viewing the Optical Graph 25 4 5 3 Stopping the Test 25 4 5 4 System Messages 26 4 5 5 Test Completion 21 46 Afterthe Test 2 30 4 6 1 Checking the Optical P
3. An Example of Incorrect Chip Placement Note The Tray Pins in the figures above are colored red only for the purpose of illustration Loading the Sample onto the Chip After the Chip has been properly placed onto the Chip Tray Pipette 6 ul elute from ECT tube from the Trueprep MAG Sample Prep Kit into the center of the reaction well Figure 21 Loading the Sample onto the Chip Note A6ulTruepet Precision Micropipette is provided with your Truelab System Important Donottouch the bottom of the reaction well with the pipette tip Donottouch the reaction well with your hand Ensure that the elute has been pipetted out fully into the center of the reaction well Ensure that there is no spillage of the elute from or around the reaction Gently push the Chip Tray back into place Figure 22 below shows a summary of the Truenat loading procedure When the chip has been loaded correctly proceed to section 4 4 AN Y DIAGNOSTICS Truelab Uno Figure 22 A Summary of the Truenat Chip Loading Procedure Figure 23 Incorrect Sample Loading Showing Spillage of the Elute Around the Reaction Well 4 4 Starting the Test 4 4 1 Starting the Test After completing the Truenat chip loading procedure and pushing the chip tray back inside Switch on the Truelab Uno using the B obl bd Power Button Patient ID PN5063 Select Done at the Please Load aid Msi LE Sample promp
4. Check the Bluetooth device you sent the file to verify that it was sent successfully Ifthe file was not sent it will alert you with a pop up If the problem doesn t resolve itself on re trying the procedure or if the Truelab Uno alerts you with a Bluetooth Error message please contact Molbio Support Changing Lab Details The Truelab Uno allows a power user to edit the lab name and location that has been recorded on the system To editthe Lab Name and Lab Location 4 8 5 1 Login as Power User This will open the Profiles Screen Malaria Pf H1N1 Dengue MTB Chikungunya Results Settings Logoff A S molbio DIAGNOSTICS 4 8 5 2 Tap the Settings button in the Profiles Screen This will open the Settings Screen 4 8 5 3 Tap App Settings in the Settings Screen This will open the App Settings Screen 4 8 5 4 Tap on the text boxes next to Lab Name and Lab Location This will display an on screen keyboard which can be used to type in the details Note Do not change any other details in this page as this will affect some features of the Truelab Uno 4 8 5 5 Select Save when you are finished Apop up message confirming that the new Lab name and location have been saved will be displayed Truelab Uno PO 15 13 Settings molbio Profile Settings SE User Settings App Settings Bluetooth Settings 9 gt 0 Lab Na
5. 10 27_12 26 36 4 7 2 2 At the Profiles Screen tap the Results Button at the bottom of the screen MTB_2012 10 27_12 20 12 This will open the Test Results List MTB 2012 10 27 12 16 23 MTB 2012 10 27 12 11 37 MTB 2012 10 26 17 45 06 MTB 2012 08 22 23 18 26 Sort Search Back l Figure 42 Test Results List 4 7 2 3 Tap the Search Button You will be prompted with a pop up Search By display with the following search options Test Name Patient Name Referred By Date Figure 43 Selecting the Parameter to search by AN Y DIAGNOSTICS 4 7 2 4 Tap the field you want search based on In the screenshot the parameter is Name You will be prompted with a text box 4 7 2 5 Fill in the text box with what the information you are searching for 4 7 2 6 Tap the Search button on the pop up to initiate the search When the search is complete a list of previous test results will be displayed 4 7 2 7 Tap the result you want to view to open the Test Results Screen Note Referto section 4 7 1 Viewing Previous Test Results from 4 7 1 3 to 4 7 1 5 for instructions on viewing results Refer to section 4 6 3 Printing the Results if you want to print a particular result from your search 4 7 2 8 Tap Back to go back to the Profiles Screen Note In this section the parameter used to search by is Name The pop up textbox 15 similar for the Referre
6. 4 7 5 Configuring email address and password It has to be a g mail address i e 7 Reason Incorrect device configuration or internet connectivity failure Solution Contact Molbio support along with the details of the error For instance in the screen shot to the right the details of the error are Could not send email Java lO Exception No Content Possible reasons Wi Fi is off or not available Wi Fi was not configured during installation Data connection available Mobile network not available is off or not Solution Check that the Wi Fi is enabled that signal is available and is correctly configured Check that data connection is on and signal is available If still not connecting contact respective network provider If problem persists please contact Molbio Support Truelab Uno Truenat Center moibio Date Fri 24 Aug 2012 11 14 Operator Satheesh Profile MTB Lot 12345 ExpiryDate 09 13 Referred By Thomas Result Control C 320 TestC ND RunStatus Valid MTB NOT DETECTED Print SMS Email Share Back Truenat MTB Center bigtec Date Wed 10 Apr 2013 11 48 Operator Service Profile MTB Lot stg Sample Blood Patient Details Expiry Date Could not send email java lo TOException No content Referred By Result ControlC ND TestC Run Status Invalid Print SMS Email Share Back Internet connection not available Please conne
7. 4 The Graph Screen will be displayed To view the Temperature Profile select Temperature To view the Optical Plot select Optical To view the Test Result select Result Your current selection will be indicated by a green dotto the left of the appropriate title Note The Test Result can be printed by switching on the External Truelab micro PCR Printer and then clicking the Print button onthe Test Results screen 4 7 2 Search Saved Results Truelab Uno 65 Temperature Result 1 9 8 e Fluorescence w d gt Figure 40 The Optical Graph Truenat Center malbio Date Friday 24 August 2012 08 40 16 Operator 5atheesh Profile MTB Lot 12345 ExpiryDate 0912 Sample Sputum Patient Details Name Gopal Mohan ID PN5063 Age 45 Sex Male Referred By Divakar Kohli Result Control C 27 2 TestC 24 0 Run Status Valid MTB DETECTED 5 5110 cee Print SMS Share Back Figure 41 The Saved Result Screen Saved results can also be searched based on the following fields lestName PatientName Referred By Date 32 g w Y DIAGNOSTICS 2 molbio Truelab Uno To search for saved results obit stis 4 7 2 1 Switch on the touchscreen and login See section 4 2 m oan This will open the Profiles Screen bu Dengue we MTB Chikungunya kh Results Setti ngs Logoff Test Results molbio MTB_2012
8. Note The name user typed into the textbox in the figure is just an example You can type in any user name CofmPasmod 1 of your choice Tap Save when you ve entered all the details to create the new user This user will now appear in the User Settings Figure 53 Add User Form Screen and the Truelab Login Screen Save Back DeletingaUser Deleting a particular user name will remove that user name from The drop down menu in the Truelab Login Screen Theuserlistinthe User Settings Page AN Y DIAGNOSTICS Truelab Uno Login as the power user refer to previous section 4 8 1 Logging In as the Power Salmonella User for details This will open the ua Profiles Screen Malaria Pf H1N1 Dengue MTB Chikungunya Results Settings Logoff Figure 54 The Profiles Screen Tap Settings in the Profile Screen This Gp will open the Settings Screen Ak e Profile Settings App Settings 4 User Settings Bluetooth Settings Qo 5 Figure 55 The Settings Screen Me DIAGNOSTICS Truelab Uno the User Settings Icon This will open the User Settings Screen which service A will show a list of all users molbio P Add Remove Reset Back Figure 56 User Settings Screen with the List of Users E 15 28 Select the user you want to delete by tapping on that particular User Name EM Your selection will be ind
9. Result Control C 28 0 TestC 24 0 Run Status Valid MTB DETECTED 2 2x1 0 cru m Print SMS Email Share Back Negative valid result Test not detected Control detected Truenat Center molbio Date Fri 24 Aug 2012 11 14 Operator X Evans Profile MTB Lot TBOO1 Expiry Date 09 13 Sample Sputum Patient Details Name Brown ID PN4567 Age 34 Sex Referred By Thomas Result Control C 32 0 TestC ND Run Status Valid MTB NOT DETECTED Print SMS Email Share Back Truelab Uno Positive valid result Test detected Control not detected Truenat MTB Center molbio Date Fri 24 Aug 2012 15 03 Operator Evans Profile MTB Lot TBOO1 Expiry Date 09 13 Sample Sputum Patient Details Name Brown ID PN4567 Age 34 Sex Referred By Thomas Result Control C ND TestC 19 0 Run Status Valid MTB DETECTED 7 3 1008 Print SMS Email Share Back Invalid result Test not detected Control not detected or out of range Truenat MTB Center molbio Date Fri 17 Aug 2012 12 32 Operator Evans Profile MTB Lot TBOO1 Expiry Date 10 13 Sample Sputum Patient Details Name Brown ID PN4567 Age 34 Sex Referred By Thomas Result Control C ND TestC ND RunStatus Invalid Print SMS Email Share Back Figure 34 the Test Results Screen AR S molbio DIAGNOSTICS Truelab Uno Run Status in the Test Results Screen shows the message Valid Printing th
10. Wi Fi GPRS connection because you are not in range of the signal Note GPRS is an optional feature Solution Move the device to within range ofthe Wi Fi signal Initilization incomplete Check analyzer power Used Chip chip loaded is already used Please insert and load a fresh chip to proceed Internet connection mot available Please connect to wifi or enable gprs data Truelab Uno Description Reason for Error and Possible Solution Screenshot of Error System Message Internet connection timed out System Message Could not connect to printer f the problem persists contact Molbio Support Reason The Analyzer could not connect tothe Molbio Support Server Solution Contact Molbio Support Reason The Analyzer was unable to successfully initiate Bluetooth pairing with the printer Solution Always switch the printer and wait at least ten seconds before selecting the print button on the results screen If this does not solve this issue please contact Molbio Support Internet connection timed out Could nat connect to Truelab server http 1115 254 48 101 9080 TrueLabServer Server Truenat MTB Center Date Friday 24 August 2012 08 40 16 Operator Satheesh Profile Lot 12345 ExpiryDate 0912 Sample Sputum Patient Details Name Gopal Mohan ID PN5063 Age 45 Male Refer
11. need to log in to the application using the appropriate user name To log in Tap the User Name Bar in the Login Screen This will open a drop down menu to selectthe User Name Select the user name from the list displayed Note The user name Molbio is just used here as an example The user name is definable by the customer Tap the Password text box You will be prompted with an On screen keyboard Type the password with the on screen keyboard Select the Next button on the on screen keyboard Tap Sign In This will open the Profiles Screen Truelab Uno Truelab Uno Username malbio Password pe ee MAS We molbio Figure 10 The Truelab Application Login Screen Select User Name Service Figure 11 User ID selection Truelab Uno Username molbio 000000000 0000006886 EL Figure 12 The Login Screen with the On screen Keyboard molbio DIAGNOSTICS Truelab Uno Profiles and Sample Details The Profiles Screen will list out all available disease profiles that you can choose from A Salmonella Ve profile contains preset PCR parameters for that particular test Malaria Pf 9 H1N1 Dengue LA Chikungunya SJ Results Settin gs Logoff ff Figure 13 The Profiles Screen To choose a profile Tap on the profile of your choice from the list You will be prompted with a message asking you if you would like to pro
12. range is accurate but extrapolation beyond the dynamic range should be avoided The larger the dynamic range the greater is the ability to detect samples with both high and low copy number in the same run Internal Positive Control IPC An exogenous control that is characterized by spiking DNA at a known concentration into each sample This serves to distinguish between true target negatives from PCR inhibition and also monitor the presence of inhibitors in the template Most commonly IPC is added to the PCR master mix to determine whether inhibitors are present in the master mix Alternatively it can be added at the point of sample collection or prior to sample nucleic acid extraction to monitor sample stability and extraction efficiency in addition to presence of any inhibitors in the master mix Template Thenucleic acid sample used to amplify the target sequence is called the template Threshold Usually 10X the standard deviation of Rn for early PCR cycles background activity The threshold should be set in the region associated with an exponential growth of the PCR product which may be easier in the log view of the amplification plot and not as high as the linear or plateau sections of the curve It should be above the highest baseline signal level It is assigned for each run to calculate the Ct or Cp value for each amplification It may be necessary to have separate different Ct thresholds for each dye usedin the reaction Y Inter
13. to server Update Profiles and the Truelab Software NE Su The Truelab Uno micro PCR Analyzer should be positioned on the workspace tabletop workbench in an upright position The Truelab Uno should not be moved when a test is in progress Attempting to do so may interfere with its functioning and compromise test results At the time of installation service personnel from Molbio will set up a user profile for the laboratory on the Truelab Uno and designate the head of the health center or any other authority assigned for the purpose as the Power User who has access to certain special administrative features on it that regular users do not Oe molbio DIAGNOSTICS Truelab Uno Multiple User ID s can be created by the Power User for Regular Users to log in and run tests on the Truelab Uno These additional users will not have the power user privileges mentioned above 2 3 2 Regular Users Regular users can Runtests Printthe results View previous results of tests run using their User ID Important Regular users do not have access to the administrative features of the Analyzer Since the log files feature is only available to Power Users If you encounter an error and you are not the Power User contact the designated power user in your lab department as soon as possible so he she may log the error on the system 3 Specifications ofthe Truelab Uno The Truelab Uno micro PCR Analyze
14. used to amplify even the smallest trace of an infectious bacterium or virus from a biological specimen The process involves amplifying a specific piece of DNAin a sample using an enzyme called DNA polymerase and periodic cycling of temperature which anneal and split strands respectively With each round of annealing and splitting the amount of nucleic acid doubles leading to an exponential amplification of the starting trace nucleic acid in a short amount of time For instance a typical PCR reaction that runs for thirty five cycles at 100 efficiency will give you 2 34 billion copies The amplified DNAis then analyzed separately so that it can be identified 1 2 Real time PCR Real time PCR is a variant of the regular PCR method It has several advantages over regular PCR that has made it the PCR method of choice A Real time Polymerase Chain Reaction involves simultaneously amplifying and detecting the target DNA during every cycle thus generating accurate information about the presence of the target DNA and its quantity in each reaction thus removing the need to analyze the post PCR product separately The Truelab Uno micro PCR Analyzer is a Real time PCR based system 1 3 Understanding Cycle Threshold Ct Value In any Real time PCR a positive reaction is detected by the accumulation of the amplicon and hence of the fluorescence signal After PCR each amplification curve is defined by its threshold cycle Ct number The Ct ca
15. using your fingers it is recommended that you use the stylus for ease of operation and to keep the screen clean Use only the provided stylus Qe molbio DIAGNOSTICS Truelab Uno The Analyzer and the screen have different battery sources and are operated separately during the procedure so they have to be switched on and off separately The Power Button switches on and switches off the Analyzer The Touchscreen On Off Button is used to switch on and off the screen This is done by inserting the Jack portion of the provided stylus and pressing and holding the button for two seconds The Screen Wake Back Zone is pressed firmly to switch the touchscreen from Sleep Mode to Active mode The Power LED Indicator will glow if the Truelab Uno is switched on The Low Battery LED Indicator Labeled as LOW will glow if the Truelab Uno is low on battery and needs to be charged The Charging LED Indicator will glow if the Truelab Uno micro PCR Analyzer is being charged using the power cable Theln Use LED Indicator will glow ifthe Truelab Uno is currently running a test The Chip Tray holds the disposable analyte specific Truenat chips You can either run the Analyzer using battery power or use it with the power cable plugged in Checking Battery Status before Use Before using the Truelab Uno micro PCR Analyzer on battery you should check if the Analyzer and the Touchscreen
16. 2 4 7 1 To view previous test results Profiles molblo Salmonella 4 7 1 1 Switch on the touchscreen and login See section 4 2 This will open the Malaria Pf Profiles Screen 4 7 1 2 At the Profiles Screen tap the Results Button at the bottom of the Dangua screen The Test Results List will be displayed MITE Chikungunya Results Settings Logoff 4 7 1 3 Tap the test result you want to view MTB 2012 10 27 12 26 36 Your selection will be indicated by a green dot to the right of the test MTB 2012 10 27 12 20 12 name MTB 2012 10 27 12 16 23 Note To scroll through the list 4 7 1 3 1 Touch and hold down your MTB 2012 10 27 12 11 37 stylus or finger on the touchscreen MTB 2012 10 26 17 45 06 4 7 1 3 2 Swipe upwards or downwards MTB 2012 08 22 23 18 26 on the screen till you see the test result you want to view CEST Figure 39 The Results Lists 2 2 X 37 molbio DIAGNOSTICS Note 2 The results are named automatically by the Analyzer in the format profile date time For example in figure 40 the first result in the list named _2012 10 27_12 26 indicates it was a test using the MTB profile that was performed on the 27 of October 2012 at 12 26PM If you want to search specifically by Patient Name or Test Name use the search function Section 4 7 2 Search Saved Test Results to find what you are looking for 4 7 1
17. 4 7 3 3 Tap the Sort Button options to sort by ByName ByDate 4 7 3 4 Tap your option of choice to select it This action will sort all results based on that field in ascending order Note To view the list in descending order repeat steps 4 7 3 3 to 4 7 3 4 after it has been sorted ascending order and a pop up Will be displayed confirming the action 4 8 Power User Features Important This will prompt you with the following Truelab Uno Figure 48 Test Results Sorting Options Test Results Sorted By Name MTB_2012 10 26_ 17 45 06 2012 10 27 12 11 37 MTB 2012 10 27 12 16 23 MTB 2012 10 27 12 20 12 MIB 2012 10 2 12 26 36 Sorted in ascending order _ Sort Search Back Figure 49 Tests Sorted by Name in Ascending Order The features detailed in this section can only be accessed by power users see Section 2 3 Installing the Truelab Uno for details on power users and regular users If you attempt to access these features as a regular user you will simply receive an error LAW DIAGNOSTICS Truelab Uno message Inorderto use the features this section you must log in to the Truelab using the power user ID You can use the back button to go back to the previous screen or to cancel a pop up or prompt Logging In as the Power User Openthe Truelab Application Click on the User Name box This will open a drop down menu Sel
18. ab Uno Data File LogFle log 15 09 2012 22 52 _ log 15 09 2012 23 45 C W log 16 09 2012 01 06 C CJ log 16 09 2012 22 50 t C7 log 18 10 2012 15 01 7 share send molbio DIAGNOSTICS Truelab Uno 4 8 5 7 Tap Send This will send the file to the Molbio Server A progress bar will be displayed on the screen and the message File Sent will be displayed when the process is complete Uploading Log file Note If the file was not sent it will alert you with a pop up If the problem doesn t resolve itself on re trying the procedure or if the Truelab Uno alerts you with a system error message please contact Molbio Support Sending LogFiles to the Server using Bluetooth If the Truelab Uno is not connected to a Wi Fi Network you can use the Bluetooth functionality to send the log file to the nearest computer or mobile phone with a working Wi Fi connection Once the file is sent you can use that device to send the log file and support request to Molbio Support 4 8 5 1 Login as Power User This will open the Profiles Screen Malaria Pf H1N1 Dengue MTB Chikungunya _ Results Settings Logoff _ 4 8 5 2 Tap the Settings button in the Profiles Screen This will openthe Settings Screen User Settings Bluetooth Settings Qe molbio DIAGNOSTICS Truelab Uno 4 8 5 3 Tap the About Icon in the Settings Screen This
19. are sufficiently charged To do this Press the Power Button to switch on the Analyzer The green Power LED Indicator will glow Ifthe Analyzer battery is low the amber Low Battery LED Indicator will also glow Press and Hold the Touchscreen On Off button for two seconds using the stylus Jack This will open the Lock Screen 10 14 59 Battery Status No service Icon 14 50 Friday October 26 Charged Battery full Please unplug power supply to save energy Figure 4 The Lock Screen with the Battery Status Icon in the Top Right Corner VAA Y DIAGNOSTICS Truelab Uno Check the Battery Status Icon on the Lock Screen Pg Asmall red bar in the icon with whitespace to its left indicates that the touchscreen battery is low rg A green bar in the icon with a little whitespace to its left indicates the touchscreen battery is sufficiently charged M Afully green icon indicates that the Touchscreen Battery is fully charged If the Low Battery LED Indicator and or the Battery Status Icon indicate low battery charge you can either use the Truelab Uno micro PCR Analyzer with the AC Adaptor or you can charge it and wait for it to finish before using it on battery power See the next section 4 1 3 Charging Using the Truelab Uno micro PCR Analyzer with the AC Adaptor Note The Battery Status Icon can also be seen in the Home Screen and Login Screen However it ca
20. back in fully as detailed in Section 4 3 Figure 16 Prompting the User to load the Sample The sample now needs to be loaded onto the Truenat Chip Proceed to the next section for instructions on loading the Truenat chip 4 3 Loadingthe Truenat chip Accessing the Chip Tray Press the Eject button This will eject the Chip Tray The location of the Eject Button is shown in Figure 17 Pulloutthechiptray gently till all six tray pins are exposed ZAR S molbio DIAGNOSTICS Truelab Uno Eject Button Figure 17 Chip Tray with the eject Button to its Left Placing the Chip on the Chip Tray Place a new Truenat chip on to the Chip Tray by lowering the chip onto the chip tray Important Make sure you have placed the chip correctly onto the tray a Thechip s registration holes should be placed properly onto all the tray pins b The reaction well should face upwards Figure 19 below shows the correct placement of the chip with the reaction well facing upwards and to the right side and the chip being placed on the tray pins properly Incorrect placement of the Chip will prevent the tray from being pushed back in fully Registration holes Reaction well Figure 18 The Truenat Chip Figure 19 The Truenat Chip being placed correctly onto the Chip Tray Oe molbio DIAGNOSTICS Truelab Uno L a Figure 20
21. based on the range specified by you and display it with an optical graph Note This option is also available for the optical graphs in saved test results See section 4 7 Viewing Saved Test Results for details on how to view previous test results and their optical graphs The range is reset to the default value every time the result screenor optical graph is closed 4 6 2 Viewing the Test Results After checking the plot for irregularities and setting a custom Ct range if you chose to you can view the Test results by tapping the Result button which will open the results screen The results screen shows you the input details chip details and test results including validity of the test result Invalid tests must be repeated with new sample and or new lot of reagents If still invalid contact Molbio support Important The user should look for irregularities in the Optical plot as indicated in section 4 6 1 even if the Truelab Uno Ct Window ks E EL D ECL A LES Please see Figure 34 overleaf for the Test Results Screen of the four possible result outcomes LOSA molbio DIAGNOSTICS Positive valid result Test detected Control detected Truenat MTB Center molbio Date Fri 24 Aug 2012 08 40 Operator Evans Profile MTB Lot TBOO1 Expiry Date 09 13 Sample Sputum Patient Details Name Brown ID PN4568 Age 34 Sex Referred By Thomas
22. ceed with your choice Note The profile used as an example in this manual is Tap the Proceed Button on this pop up as shownin Figure 14 The Sample Details Form will be displayed Note Selecting the Cancel button Will take you back to the profiles screen Proceed with MTB Figure 14 Profile Confirmation Prompt ZA molbio DIAGNOSTICS Truelab Uno Fill in the Sample Details Form with sample identification details Important Referred By Divakar Kohli Enter the details carefully this screen will not be accessible again once the chip has been loaded Patient Name Mohan The Patient Name is mandatory you will be prompted by the Analyzer if you have not filled it in It is recommended to enter details sample Type Sputum Y Patient ID PN5063 Patient Sex Male 45 Note This data will be saved along with test results when the test has finished and can be viewed whenever you like See section 4 7 Viewing Saved Test Results Start Reaction Back Figure 15 Filling in the Sample Details Form When you have completed the Sample Details Form Press the Start Reaction Buttonatthe bottom of the screen You will be prompted to load the test chip with the message Please load DEI sample Please Load Sample Important Do not select the Done Button in this prompt till you have finished loading the test chip and pushing the chip tray
23. cept Ina standard curve the value of y Ct where the curve crosses the y axis at 1 copy or 3 08 picogram of DNA equivalent template The y intercept value corresponds to the Ct value for a single copy of the target molecule The value of around 40 indicates good sensitivity of the assay Ct values greater than 40 are encountered if PCR efficiency is lower than 100 Glossary adapted from Glossary of real time PCR terms by M Tevfik Dorak MD PhD AN Y DIAGNOSTICS Truelab Uno Addendum 4 7 4 Sending Test Results wirelessly to a Recipient Truenat MTB You can send test results to a phone Center molbio computer or email recipient wirelessly Date Fri 24 Aug 2012 11 14 using the Truelab Uno This feature is accessible from the Test Results Screen both immediately after the test and in all EE LLL saved testresults The SMS option allows you to send the results in plaintext to a recipient mobile phone The e mail allows you to send either the results in plain text Referred By Thomas alone or with raw data of the test as an C 320 Testc attachment Valid MTB NOT DETECTED Note These features can only be used if prem Care VE your Truelab Uno was configured during installation to use A SIM Card with text functionality for sending SMS A SIM Card with data functionality for sending e mail Wi Finetwork for sending e mail Results and Raw data can also be transferr
24. components VAA DIAGNOSTICS Caution o 9 Truelab Uno One Truelab Uno Real Time micro PCR Analyzer One AC Adapter to power the Truelab Uno One Stylus One Truelab Uno micro PCR Analyzer User Manual 2 2 Installation Requirements 2 2 1 Installation Precautions Do not install the Truelab Uno micro PCR Analyzer next to instruments that may cause vibrations or electromagnetic interference Do not store the instrument in the path of direct sunlight or use it close to any radiating or heating apparatus such as a conventional oven hot plate or infrared lamp Do not store the Truelab Uno micro PCR Analyzer in an atmosphere of potentially explosive liquids vapors and gas Always place the Truelab Uno on a flat surface in an upright position 2 2 2 Environmental Requirements The Truelab Uno has been designed to operate safely within the following environment specifications Ambientroom temperatures between 15 C to 35 C Relative Humidity RH between 10 80 non condensing 2 3 Installing the Truelab Uno 2 3 1 Power Users There is only one designated Power User for each Analyzer Power users can Edit or change laboratory details such as laboratory name and location View results of tests conducted by any user Generate and send log files Create new user IDs Delete users Reseta user s password Transfer results
25. ct to wifi or enable gprs data i AN Y DIAGNOSTICS ud molbio Molbio Diagnostics Pvt Ltd Tulip House Dr Antonio Do Rego Bagh Alto Santacruz Bambolim Complex P O Bambolim Complex P O Goa 403 202 India www molbiodiagnostics com MB TU 09 13 VER 2
26. d by and Patient searches However if you search by Truelab Uno Set Test Name for Search Figure 44 Searching by name Qe molbio DIAGNOSTICS Truelab Uno date the pop up will be a text box with From and To fields to enter the range of the search Clicking on each of these textboxes will display another pop up to select the date as shown in figure 46 where you use the Thursday October and buttons on the pop up to change each parameter of the date Figure 45 Pop up to enter the Date into each Text Box Set Date for Search 2012 08 18 Figure 46 The From and To Fields filled in 4 7 3 Sorting Test Results On the results screen the list of results can be sorted based on Name Date AN Y DIAGNOSTICS Truelab Uno To sort the list of results 4 7 3 1 Switch on the touchscreen and login See section 4 2 This willopen the Profiles Screen Salmonella Malaria Pf Dengue MTB Chikungunya Results Settings Logo 4 7 3 2 At the Profiles Screen tap the Bound UH Results Button at the bottom of the MTB_2012 10 27_12 26 36 screen This will open the Test Results List 2012 10 27 12 20 12 2012 10 27 12 16 23 2012 10 27 12 11 37 _ 2012 10 26 17 45 06 2012 08 22 23 18 26 _ Sort Search Back Figure 47 Test Results List AN Y DIAGNOSTICS
27. e Results Note An external Bluetooth printer is provided with the Truelab Uno Workstation Results can be sent wirelessly through SMS and or Internet GPRS or Wi Fi to other devices and servers if it was configured to do so during installation For further Figure 35 The External Truelab micro details or activation of this feature PCR Printer contact Molbio Support To print the results of the test Click the Printer Power Button on the left side of Truelab micro PCR E printer Power Printer The amber Power LED will blink this indicates that the Printer is Figure 36 The External Bluetooth Printer and switched on the Power Button on its left side Wait for atleast ten seconds Tap the Print Button in the Results Screen of your Truelab Uno Real Time micro PCR Analyzer The Bluetooth printer will print out the test results Switch off the printer when printing has finished by pressing the Printer Power Button o Please Wait Figure 37 Message displayed before the System begins Printing ZA molbio DIAGNOSTICS Removing the Chip After ensuring that the Analyzer is switched off Truelab Uno Push the Eject Button This will ejectthe Chip Tray Take the Truenat Test Chip off the chip tray Discard the chip into a waste disposal container having freshly prepared 1 sodium hypochlorite solution Push the Chip Tray back into place REA Out S
28. eal Time micro PCR Analyzer ID in use and nature of incident Log files can only be generated by the user of the Analyzer in question ID who has the access to the menu that creates the log file for that unit Creating a log file Salmonella e 4 8 5 1 Login as Power User This will open the Profiles Screen M H1N1 Dengue 2 MTB lt 7 Chikungunya Results Settings Logoff Eu 15 13 Settings molbio Profile Settings 4 8 5 2 Tap the Settings button in the Profiles Screen This will open the Settings Screen AR molbio DIAGNOSTICS Truelab Uno 4 8 5 3 Tap the About Icon in the Settings Screen About This will open the About Screen TruelabUno 1 00 231 OP VOIOKS Log Send Share Update Profiles Back Figure 62 The About Screen 4 8 5 4 Tap the Log icon in the About Screen The Truelab Uno will now aan eie create a log file and prompt you with About a success message when it has SS PST T finished If the log file creation fails please contact Molbio Support Log files are named automatically when they are created in the format log date time For example log 15 09 2012 22 10 was created on the 15 of September 2012 at 10 10 PM Sending Log files to the server using Wi Fi GPRS Ifthe Truelab Uno is connected to a Wi Fi or GPRS network you can send the Log file and Support Requestto Molbio Support directly Note If the Truelab U
29. ectthe power user ID that was created for you at the time of installation Type the password for this ID in the Password text box Tapthe Login Button Note If you have forgotten the password for your power user account please contact Molbio Support Creating aNew User Note You cannot create another Power User New users will only be regular users I Profiles molbio Loginas the power user referto previous section 4 8 1 Logging In as the Power v User for details This will open the Malaria Pf Profiles Screen H1N1 Chikungunya 57 Results Settings Logoff Figure 50 The Profiles Screen Tap Settings in the Profile Screen This inne Will open the Settings Screen Profile Settings App Settings Bluetooth Sett 9 Figure 51 The Settings Screen AN Y DIAGNOSTICS Truelab Uno Tap the User Settings Icon DE Bg um This will open the User Settings Screen which will show a list of all user IDs registered on the Truelab Uno molble P Service A 2 Add Remove Reset Back Figure 52 The User Settings Screen Tap the Add button in the User Settings Screen This will open the Add User Form Fill in the details of the Add User Form You will have to fill in the user name and New UserName user password You will have to re type the same password in the Confirm Password Text Box New Password
30. ed By Thoma Result Control C 32 0 TestC Run Status Valid MTB NOT DETECTED Print SMS Email Share X Back Truenat MTB Center molbio Date Fri 24 Aug 2012 11 14 Operator Satheesh Profile MTB Lot 12345 Expiry Date 09 13 Sample Sputum Patient Details Name Brown ID PD1001 Age 28 Sex Referred By Thomas Result Control C 320 TestC ND RunStatus Valid Print E Figure i Error message for invalid recipient email address en 37 molbio DIAGNOSTICS Truelab Uno the result or Raw Data button to send raw data 4 7 4 2 2 3 Select E mail from the pop up menu 4 7 4 2 2 4 Enter the recipient email Address in to To Address Text Box Note If you are sending it to multiple e mail addresses separate each address with a comma 4 1 4 2 2 5 Press send button 4 7 4 3 Sending Test Results via Bluetooth 4 7 4 3 1 Tap the Share button on the Results Screen 4 7 4 3 2 Tap Result button to send the result or Raw Data button to send the raw data 4 7 4 3 3 Select Bluetooth from the pop up menu 4 7 4 3 4 Select the target bluetooth device to which you wish to send the Result or Raw Data If the device of your choice is not listed tap on Scan for devices and follow on screen instructions De molbio DIAGNOSTICS 4 7 5 1 Configuring Email Address and Password for e mail button option Note Only G mail addresse
31. ed via Bluetooth to a phone or a computer If following error messages are displayed when attempting to use these features contact Molbio Support Generic Failure SMS No Service ERAI E e Radio Of Enter the phone number 4 7 4 1 Sending the Results to a Mobile Phone TE To send the results to a mobile phone via SMS 4 7 4 1 1 Tap the SMS button on the Result Screen 4 7 4 1 2 Enter the recipient phone number in the pop up Tap OK Oe molbio DIAGNOSTICS The results will be sent via SMS to the mobile number you provided and SMS Sent will be displayed on the Screen Sending the Test Results via E Mail sending Results via E Mailbutton you should have a valid G mail account Note This 1 the recommended option as data being sent cannot be edited by the sender 4 7 4 2 1 1 Tap the Email button on the Results Screen 4 7 4 2 1 2 Enter the recipient email Address in to to Address Text Box Note If you are sending it to multiple e mail addresses separate each address with a comma Tap the Result button to send only the result to the email address you entered Tap the Raw Data button to send both results and raw data The results will be sent as body of the mail and raw data as an attachment Note lf the email was sent successfully a pop up with the message Email sent successfully will be displayed If the message Email address i
32. est 5 1 1 1 Switch on the Truelab Real Time micro PCR Analyzer touch screen 5 1 1 2 Select the user enter the password and Log in Blood 5 1 1 3 Select the test profile for the Sputum Truenat chip based test Plasma being run For instance Serum select the TB test profile if Body fluids the control test is being POS control performed on the TB NEG control Truenat chip 5 1 1 4 Select positive control or negative control as the case may be from the menu under sample type in the Sample Details Form 5 1 1 5 Press Start Reaction after which you will be prompted with the Please Load Sample message 9 1 1 6 Press the eject button to open Figure 69 Sample Type Menu the chip tray 5 1 1 7 Open a pouch of Truenat chip based test and retrieve the micro PCR chip 9 1 1 8 Label the chip as per control selected using a marker pen at the space provided on the lower surface of the chip 5 1 1 9 Place the micro PCR chip on the chip tray without touching the reaction well The reaction well should be facing Referred By Patient ID Patient Name Patient Sex Male Patient Age Sample Type NEG Control M Notes Start Reaction Figure 70 Negative Control Selected up and away from the Analyzer Gently press the chip to ensure that it is seated in the chip tray properly Important Touching the reaction well while loading the chip may cause contamination and inva
33. f Check with a fresh vial of negative control If not corrected decontaminate work area the chip tray of Truelab analyzer and pipette using a wipe wetted with 0 5 sodium hypochlorite and subsequently with clean water wipe and check with negative control Repeat this procedure till problem is resolved If problem persists then contact Molbio support Caution Sodium hypochlorite can cause PCR reactions to fail Confirm with positive control after every cleaning routine to ensure that the work area surfaces and equipment are free of sodium hypochlorite or its vapor before proceeding with another test 5 2 Maintenance The Truelab Uno will prompt you in case of hardware malfunction or errors encountered when performing a test Refer to the System Messages and Troubleshooting section on how to EJ IM a e De molbio DIAGNOSTICS Truelab Uno resolve common errors or contact support 5 3 Cleaning instructions Wipe the exterior of the Truelab micro PCR Analyzer with a dry lint free cloth ensuring that no fibrous material adheres to the surface of the Analyzer Donotspill water or any other solution on the surface of the Analyzer 5 4 Disposal of Consumables All laboratory hardware used for a PCR assay including Truenat micro PCR chips micropipette tips etc are to be safely disposed of by using the following method 1 Submerge all of the materials in a freshly prepared 1 solution of sodium hyp
34. ferentiate types of instructions Text Conventions Text Convention Usage Numbered Lists Numbered Lists indicate that the steps need to be performed according to the numbering Bold Text When found within a numbered list or explanatory section Bold Text is used to indicate an object that the user interacts with AN Y DIAGNOSTICS Truelab Uno which can be a physical object or an object on the software interface For instance Touchscreen Power Button and AC Adapter are references to physical objects Send and OK are references to objects on the software interface Note Conventions You will see three types of notes in this manual Each has a symbol and a particular type of textual formatting to indicate what type of note it is The table below details their use along with the associated symbol Symbol Text Formatting and Usage This is a note A note communicates information that cannot be included as part of a procedural list but is useful for the user to understand what he is doing in a certain section or to understand the relevance of a particular section or instruction Important This is an Important Note An important note communicates important information that cannot be included as part of a procedural list but is integral for the user to read and understand Caution This is a Cautionary Note A cautionary note is placed before or after any instruction or secti
35. ght for long Truelab Uno Started On 12 10 12 17 50 By molbio Pa ie 1 PBA Current Cycle Temperature 95 PLOT STOP Started On 12 10 12 17 50 By molbio Pa ip n M p periods of time Solution Switch off the Analyzer using the Power Button Eject the chip tray and discard the chip Please repeat the test using a fresh chip Current Cycle Temperature 95 PLOT STOP 4 5 5 TestCompletion The test stops automatically when itis complete When the test is done the red In use LED indicator on the Truelab Uno will go off and you will hear a beep Note At this point switch off the Truelab Analyzer using the power button the results can still be viewed on the touchscreen 4 6 Afterthe Test Caution It is necessary that you verify the optical plot of your test for irregularities before you view the test results screen even though these irregularities happen only in rare circumstances Section 4 6 1 Checking the Optical plot for Irregularities AN Y DIAGNOSTICS 4 6 1 Checking the Optical Plot for Irregularities Truelab Uno Description Cause of Error and Possible Solution Errors in the reported Ct This can be detected by looking at the optical plot and observing visually if the Ct reported does not coincide with the cycle at which the exponential phase of the amplification curve begins For example in the plot on the left the red amplification curve has
36. icated by a green molbio P dotto the rightofthe user name user U Add Remove Reset Back Figure 57 Green Dot to the Right of the User Name to Indicate Selection MAS We DIAGNOSTICS Truelab Uno Tap the Remove Button You will be prompted to confirm that you want to delete the user Tap the Yes Button on this prompt to delete the user you selected Are you sure you want to delete user user Figure 58 User Deletion Conformation Prompt Resetting the Password ey Login as the Power User This will open xd the Profiles Screen HINI Dengue MTB Chikungunya Results Settings Logoff Figure 59 The Profiles Screen 15 13 Settings molbio Tap Settings in the Profile Screen This will open the Settings Screen Profile Settings App Settings 8 User Settings Bluetooth Settings 9 About Back VAN Y DIAGNOSTICS Truelab Uno User Settings Tap the User Settings Icon This will open the User Settings Screen Service A molbio P Addi abemove Reset Figure 60 User Settings Screen User Settings Tap on the User Name whose password you would like to change Your selection will be indicated by a green dot to the right molbio P of the user name Service A user U Tap Reset This will open the Password Reset Form Add Remove Reset Back Fill in the New password in the appropriate text b
37. ient Arc sample Type Blood motes System Message Read Error Reason The Analyzer was unable to read chip memory Solution Chip Alert 1 Turn off the Truelab micro i E PCRAnalyzer main power leac 2 Tap on the Read Error Prompt 3 Check if chip was loaded properly into the tray If so remove the chip and select the profile from Profile screen and repeatthe steps 4 Load a different chip or the same chip in case not loaded before If the same message reappears please contact Molbio s support team VAN Y DIAGNOSTICS Truelab Uno Description Reason for Error and Possible Solution Screenshot of Error System Message Initilization incomplete System Message Used Chip after completing Truenat chip loading procedure System Message Internet connection not available Reason The system was unable to establish an internal connection Solution Check that the Truelab micro PCR Analyzer main power is on The green indicator should glow if it is powered on Contact Molbio s support team ifthe problem persists Reason You have loaded a used chip in the Chip Tray Solution Please switch off the Analyzer using the Power Button Pressing OK on the pop up takes you back to the Profiles Screen Choose the desired profile and continue as if beginning a new test Reason You are not connected to a
38. le MTB 12345 txpryDate 09 14 POS Control 29 0 RunStatus Valid MTB DETECTED Print SMS Share Back Truenat Center bigtec Date Fri 04 Jan 2013 09 21 Operator MCVR Profile MTB Truelab Uno Truenat MTB Center bigtec Date Fri 04 Jan 2013 09 21 Operator MCVR Profile MTB BAO01 Expiry Date 10 14 POS Control ND Run Status Invalid Print SMS Share Back Truenat Center molbio Date Fri 04 Jan 2013 06 29 Operator User Profile MTB 001 Expiry Date Lot 12345 Expiry Date 09 14 NEG Control Sample NEG Control Result ND Test C 29 0 RunStatus Va RunStatus Invalid lid MTB NOT DETECTED Print SMS Share Print SMS Share Valid Results Invalid Results Interpretation of the Results The Test Result Screen shows details of the test along with the result and the validity of the test performed Both positive and negative control must show Valid result to confirm proper working of the Truelab analyzer and the Truenat chip Invalid tests have to be repeated with fresh control and if still invalid for positive control this indicates either that the lot of Truenat test is not working or that there is a problem with the Truelab analyzer Check again with a new lot of Truenat If problem persists then contact Molbio support Repeated invalid for negative control indicates contamination of the work area the chip tray of Truelab analyzer pipettes or the negative control itsel
39. lidate the control test 5 1 1 10 Using the filter barrier tip provided in the pouch pipette six 6 uL of the control solution into the centre of the white reaction well Take care not to scratch the internal well surface and not to spill on the outside of the well Slide the chip tray back into the Truelab Uno Real Time micro PCRAnalyzer Press the power button on the Analyzer to turn it on The green LED should glow Press Done on the Please Load Sample Alert message Read and interpret the results See section 5 1 2 below for details Press the power button on the Analyzer to switch it off The green Power LED Indicator should stop glowing Remove the micro PCR chip at end of the test and dispose it as per the section on Disposal and Destruction Section 15 of Universal Control Testing Package Insert If you want a hard copy of Truelab Uno Referred By Patient ID Patient Name Patient Sex Male Patient Age Sample Type POS Control M Notes Start Reaction Figure 73 Positive Control Selected E ILISSSQ De molbio DIAGNOSTICS 9 1 2 the results switch on Truelab micro PCR printer and select print on the screen Test results are automatically stored and can be retrieved later if required Switch off the Truelab Uno Real Time micro PCR Analyzer touch screen Truenat MTB Center molbio Date Fri 04 Jan 2013 06 29 Operator User Profi
40. lot for Irregularities 28 4 6 2 Viewing the Test Results 28a 4 6 3 Printing the Results 29 30 4 7 Viewing Saved Test Results 31 37 48 Power User Features 37 58 Maintaining the Truelab Uno 58 62 5 1 Running Controls 58 61 5 2 61 62 5 3 Cleaning Instructions 62 5 4 Disposal of Consumables 62 6 Troubleshooting 62 65 7 Glossary 65 66 AN Y se DIAGNOSTICS lab 10 13 13 14 16 16 17 17 18 18 18 19 19 20 20 21 21 21 22 22 23 molbio DIAGNOSTICS lab M 23 28 24 24 24 28 25 26 26 27 27 31 32 32 32 33 34 48 35 36 36 37 38 38 28 molbio DIAGNOSTICS lab 40 40 43 45 46 46 47 47 48 48 49 49 50 50 51 51 53 90 60 63 65 66 66 67 67 68 molbio DIAGNOSTICS Truelab Uno Contact Addresses Molbio Diagnostics Pvt Ltd Corporate Office Tulip House Dr Rego Bagh Alto Santa Cruz Bambolim Complex P O Goa 403202 India Tel 91 832 2458546 51 Fax 91 832 2458544 Manufacturing M46 47 Phase
41. me abc Lab Location bangalore TruelabID dev Numerator 23 9016 Denominator 18 4739 Flash On Chip DISABLED IP Address http 115 254 48 1 Save Figure 64 The App Settings Screen zo T Settings malbio Lab Name abc Lab Location bangalore Tru lab ID dev Numerator 23 9016 Flash On Chip DISABLED IP Address http 115 254 48 1 Save Back O molbio DIAGNOSTICS Truelab Uno Sending the Data File You can send data files test data to an external agency or server using a Wi Fi or GPRS connection if this feature was configured during installation To send the Data File 4 8 5 1 Login as Power User This will open the Profiles Screen Salmonella Malaria Pf H1N1 Chikungunya Results Settings he 4 8 5 2 the Settings button in the Profiles Screen This will open the Settings Screen Profile Settings App Settings 8 User Settings Bluetooth Settings 5 About Back Settings molbio 0 15 11 4 8 5 3 Tap the About Icon in the Settings Settings malbio Screen About This will open the About Screen ana lah Oe molbio DIAGNOSTICS Truelab Uno 4 8 5 4 Tap the Send Share Button This will display a pop up with the options Log File and Data File Data File Log File e 4 8 5 5 Tap Data File The Truelab Uno will display an upload status bar and display a pop up confirma
42. mple Details Screen Press Start Reaction You will be prompted with a Please Load Sample alert message Press Done If the Chip Alert message appears again it is possible that the wrong Truenat chip was loaded for e g the user has loaded a Truenat Dengue chip but actually wishes to run the profile Please look at the chip packaging to confirm if you have placed the right chip in the chip tray If the chip does not match the analyte you want to test please switch off the Analyzer using the Power Button Eject the chip tray and discard the incorrect chip Truelab Uno Figure 25 The Red In Use LED Indicator glowing Chip Alert Chip loaded does not match the selected profile Figure 26 Error in Matching Truenat Chip to chosen Test Profile Low Battery The battery 15 low 30 or less remaining Please recharge b Continue Figure 27 Low Battery Alert SOE molbio DIAGNOSTICS Truelab Uno Press OK on the pop up message This will take you back to the profiles screen Proceed as if beginning a new test LowBattery Alert Please Connect Charger If the touchscreen battery is low you will be alerted with a message asking you to The battery is critically low 2096 or less remaining recharge the touchscreen Press the Please connect charger to Continue button in the pop up to avoid shutdown continue with thetest Ho
43. n thus be defined as the number of cycles required for the fluorescence signal to cross the threshold exceeding the background signal of the system Ct levels are inversely proportional to the amount of target DNA or cDNA in the sample So lower AN Y DIAGNOSTICS Truelab Uno the Ctlevel greater is the amount of target nucleic acids in the sample Plateau Exponential Phase Fluorescence Threshold Ct i 20 40 PCR cycle number Figure 1 Model ofa real time PCR amplification plot Definitions 1 Baseline defined as the first few cycles of the PCR reaction where the fluorescent signal is almost unchanged 2 Threshold used to determine the Ct value in a real time guantitative analysis is a value of the fluorescence that is significantly higher than the baseline falling in the region of the exponential amplification B Ct cycle threshold is defined as the number of cycles required for the fluorescent signal to cross the threshold Note Cycle threshold Ct is a relative measure of the concentration of the target in the PCR reaction Many factors besides the concentration of the target impact the value of the Ct Therefore Ct values from PCR reactions run under different conditions or obtained using different PCR machines and or reagents cannot and should not be compared 2 Setting Up the Truelab Uno 2 1 Box Contents The standard Truelab Uno package contains the following
44. nnot be seen once logged in If the battery charge is too low to perform a test the Analyzer will alert you with a system message before the test begins Use only the provided AC Adaptor to charge or power to Truelab Uno Power LED Indicator Low Battery LED Indicator Figure 5 The Amber Low Battery Indicator Glowing AN Y DIAGNOSTICS Truelab Uno Charging Using the Truelab Uno micro PCR Analyzer with the AC Adaptor Switch off the Analyzer by pressing the Power Button if itisn t already switched The Green Power LED Indicator will stop glowing Plugin the Truelab AC Adaptor to the Charging Port of the Truelab Analyzer A U N O Charging Port LAM Figure 6 The Charging Port on the Left Panel of the Analyzer Plugin the other end of the AC Adaptor to a wall socket Switch on the wall socket When the Truelab Uno is charging the blue Charging LED Indicator will glow and the Low Battery LED Indicator will go off if it was glowing Charging LED Indicator Figure 7 The Blue Charging LED Indicator glowing You can now use the Truelab Uno micro PCR Analyzer with the AC Adaptor Proceed to Section 4 2 Charging the Analyzer will take 4 hours When the charging is complete the Charging LED Indicator will stop glowing AN Y DIAGNOSTICS Truelab Uno Note Remember to Switch off the Anal
45. no is not configured to work with Wi Fi GPRS or if a Wi Fi GPRS network is unavailable see section 4 8 5 3 Sending Log Files to the Server using Bluetooth AN Y DIAGNOSTICS Truelab Uno Profiles molbia To send log files using Wi Fi GPRS 4 8 5 1 Login as Power User This will open Salmonella the Profiles Screen Malaria Pf H1N1 Dengue MTB Chikungunya Results Settings Logoff 4 8 5 2 Tap the Settings button in the Profiles Screen This will open the Settings Screen Profile Settings App Settings SP User Settings Blue both Seming About Settings melbio About TruelabUno 1 00 231 4 8 5 3 Tap the About Icon in the Settings Screen This will open the About Screen Oe molbio DIAGNOSTICS 4 8 5 4 Tap the Send Share Button This will display a pop up with the options Log File and Data File 4 8 5 5 Tap Log File A list of available log files will be displayed Note Select the correct log file to send Log files are named automatically when they are created in the format log date time For example log 15 09 2012 22 52 was created on the 15 of September 2012 at 10 52 PM 4 8 5 6 Tap the log file you want to send from the list to select it Your selection will be indicated by a green dot next to the log file name This will display a pop up with the options Send and Share Data File Log File AES Select one log file Truel
46. ochlorite for 30 minutes 2 Dispose as biological waste as per the applicable laws in your region 6 Troubleshooting The following section details some errors you may encounter while using the Truelab Uno micro PCR Analyzer and provides you with the reason for the error and possible solutions to it lf the error you encounter is not mentioned in this section please contact Molbio support Description Reason ior ang Screenshot of Error Possible Solution Login attempt failure with Reason system message Login Invalid The password you entered was Incorrect Password incorrect Solution Tap the OK Button Login Invalid This will take you back to the Incorrect Password login screen Re enter the correct password password is case sensitive Note If you have been using your fingers to type you may find it easier to use the provided stylus to type out the password on the on screen keyboard Oe molbio DIAGNOSTICS Truelab Uno Reason for Error and Description Screenshot of Error Possible Solution System message Invalid Reason Patient in Sample The Patient field in the Details Screen Sample Details Form is blank This field is mandatory Solution Patient Sex Male T You need to fill in mandatory information to continue with the test Invalid Patient Name Pat
47. on that may cause damage to the device or invalidate the test results if performed or if performed incorrectly It is also used to communicate general precautions and things to avoid AN Y DIAGNOSTICS Truelab Uno 1 Introduction Thank you for your purchase of the Truelab Uno micro PCR Analyzer The Truelab Uno micro PCR Analyzer is a revolutionary portable and battery operated real time PCR analyzer and works with Truenat analyte specific micro PCR chips It enables fast accurate and reliable near care testing is easy to use and requires minimal training This is the User Guide for the Truelab Uno micro PCR Analyzer Please read through this manual before beginning to use the Truelab Uno and always keep it handy for reference and trouble shooting The latest updated versions of the manual can also be found at www molbiodiagnostics com 1 1 Polymerase Chain Reaction PCR The Polymerase Chain Reaction invented in 1983 by Kary Mullis is a technique of amplifying DNA that has found widespread use among professionals and researchers involved with analysis of nucleic acids due to its high reliability soeed and sensitivity Since Deoxyribonucleic Acid DNA is unique to each species and individual it is currently the most reliable identifier for any living organism from microbes to humans Using the PCR method even the smallest amounts of DNAcan be amplified in order to analyze it For example it can be
48. ox Reset Password Retype the new password in the Confirm Password Text Box Tap the Reset Button to reset the password to the new one you just typed Figure 61 Password Reset Form L X LTS molbio DIAGNOSTICS Truelab Uno Generating and Transmitting Log Files The Truelab Uno Real Time micro PCR Analyzer automatically records data within the system whenever it encounters an error A log file which is file containing information about the error can be generated by the user so that it can be sent to Molbio Support for troubleshooting All support requests from the user to Molbio Support should be accompanied by the log file generated after the incident has been reported to occur It is strongly suggested that the user generates a log file immediately every time there is any undesirable behavior or event during the working with the Truelab Uno micro PCR Analyzer Important If a test is in progress when the error occurs create the log file before beginning the next test Log files can be sent to Molbio support using one of the following methods Thelnternet The Truelab Uno Real Time micro PCR Analyzer is capable of connecting to Wi Fi GPRS network Note GPRS is an optional feature The Wi Fi feature is configured during installation Via Bluetooth to the nearest computer mobile phone The log file should be sent to Molbio support with the Truelab Uno R
49. r is a portable battery operated Real time PCR Analyzer It houses a touchscreen for user interaction a sliding chip tray for the Truenat microchip optical detection systems and electronic components that control all aspects of the system 3 1 General Specifications Principe Interface Wi Fi GPRS Bluetooth Operating environment Display Capacitive 3 2 Touch Screen Printer External 2 Bluetooth Thermal Printer Power Rechargeable Lithium lon Battery Pack 7 5V 2200 mAh Input to AC DC adaptor Single Phase 100 240V 50 60Hz 1500 mA Output from AC DC adaptor 10 V 4500mA 45VA If the input specifications in your country do not meet the above requirements please contact your local Molbio representative 0 9 kgs 210mmX140mmXx109 mm AR S molbio DIAGNOSTICS Truelab Uno 3 2 Shipping The Truelab Uno is shipped as part of the Truelab micro PCR Workstation Cat no 603010001 oras a standalone system Cat no 603020001 4 Using the Truelab Uno micro PCR Analyzer 4 1 Introduction 4 1 1 Interacting with the Truelab Uno Truenat Chip Touchscreen Chip Tray On Off Button Power Button Touchscreen LED Indicators Touchscreen Wake Back Zone Figure 2 The Truelab Uno micro PCR Analyzer The Truelab Uno is operated using the touch sensitive screen You can use your fingers or the provided stylus to operate it Note While the touchscreen can be operated
50. red By Divakar Result Control C 27 2 TestC 24 0 Status Valid Absolute quantification Amplicon Amplification Plot 7 Glossary An assay used to quantitate unknown samples by interpolating their quantity from a standard curve as in the determination of the viral copy number The amplified sequence of DNA obtained by the PCR process This is also called the PCR product The plot of cycle number versus fluorescence signals which correlates with the initial amount of nucleic acid during the exponential phase ofthe PCR 2 molbio 65 g w Y DIAGNOSTICS Truelab Uno Baseline The initial cycles of the PCR during which there is little change in fluorescence signal usually cycles 3 to 15 Ct threshold cycle Threshold cycle reflects the the cycle number at which the fluorescence signal generated within the reaction crosses the threshold It is inversely correlated to the logarithm of the initial copy number The Ctassigned to a particular sample thus reflects the point during the reaction at which a sufficient number of amplicons have accumulated It is also sometimes called the crossing over Cp point Dynamic Range The range of initial template concentrations over which accurate Ct values are obtained If endogenous control is used for ACt quantitation method dynamic ranges for sample and control should be comparable In absolute quantitation interpolation within this
51. s will function properly Log in to the Truelab Application to access the Home Screen If you are at the Results Screen Select the Back button to display the Home Screen Select Settings Select App Settings in the Settings Screen Fill in or edit the E mail and Password Text Boxes Select Save Logout and Log back in to the Truelab application for the changes to take effect Note The Email ID can be changed at any time from this screen Every time the ID is changed you need to save the settings and then log out of the Truelab application and log in again for the changes to take effect Configuring Email Address and Password for share button option Request during installation to use this feature Lab Name Lab Location bangalore TruelabID dev 23 61658 Numerator Denominator 19 68746 Flash On Chip ENABLED IP Address Email Password Save Truelab Uno molbio http 202 83 29 10 Figure ii The App Settings Screen with E mail configuration options A S molbio DIAGNOSTICS Troubleshooting system Message Authentication Failure System Message Could not send email error message System Message Internet Connection Not Available Reason The email ID and password is configured incorrectly in the device settings Solution Re type the email address and password in the app settings screen and Save the settings See section
52. s invalid is displayed the recipient email address must have been typed Truelab Uno Truenat Center molbio Date Fri 24 Aug 2012 11 14 Operator Satheesh Profile MTB Lot 12345 Expiry Date 09 13 Sample Sputum Patient Details Name Brown ID 01001 Age 28 Sex Referred By Thomas Result Control C 320 TestC ND Run Status Valid MTB NOT DETECTED Print SMS Email Share Back Enter email id seperated with comma 10 adros Text Box Result Raw Data Cancel molbio DIAGNOSTICS incorrectly Enter it again and retry If you received the error message Authentication Failure it may be because your email settings aren t correctly configured See section 4 7 5 for details on configuring e mail If you received any other error message refer to the troubleshooting section at the end for details on what might have caused the errors If error messages recur even on retrial or troubleshooting contact Molbio support 4 7 4 2 2 Sending Results via E Mail option from Share menu works with all E mail accounts Caution The results attached to the e mail can be edited in this option by the sender 4 7 4 2 2 1 Tap the Share button on the Results Screen 4 7 4 2 2 2 Tap the Result button to send Truelab Uno Truenat MTB Center molbio Date Fri 24 Aug 2012 11 14 Operator Satheesh Profile Lot 12345 ExpiryDate 09 13 Sample Sputum Referr
53. t You will be prompted Sample Type Sputum with the message Please Wait Wait for System Health OK the Analyzer to finish initializing When it has finished initializing the In use LED Indicator on the Truelab micro PCR Analyzer will glow red and the Test Status Screen will appear This indicates that the test has started Current Cycle Temperature 95 FLOT STOP Figure 24 The Test Status Screen AN Y DIAGNOSTICS Caution Do not attempt to eject the chip tray or switch off the Analyzer once the chip has been loaded and the test has started 4 4 2 System Messages Before the test begins the Analyzer will check all system parameters including the Truenat chip Touchscreen battery status and Analyzer battery Status If there are any errors the Analyzer willalert you with a pop up message The alerts you may receive are as follows Loaded Truenat Chip and Selected Test Profile do not match If you loaded the wrong Truenat analyte specific chip for the profile you selected or accidentally chosen wrong profile an error message will be displayed and the test will not be started Figure 27 shows this error message Pressing the OK button in the pop up error message will take you back to the Profiles Screen Select the correct profile for e g if you loaded a Truenat MTB chip please select the profile Press Proceed on the pop up This will take you to the Sa
54. t of the total number of 40 cycles The Test Details including patient details sample type system health battery level and current cycle temperature are detailed in the Test Details Bar Thered Test Completion Indicator on the Test Status Screen will turn green when the test is complete You can also view the Thermal and Optical graphs during the test Note The screen will go blank stand by mode after every minute of inactivity This is done to conserve battery If you want to see the screen after it has gone blank press the Screen Wake Zone situated below the screen Refrain from waking up the screen unnecessarily as this will drain the battery 4 5 1 Viewing the Thermal Graph Tap the Plot Button on the Test screen Select Temperature to view the thermal graph Figure 30 The Temperature Graph Viewing the Optical Graph optical Tap the Plot Button on the Test Screen Select Optical to view the Optical Graph Note The fluorescence measure in the optical graph is in arbitrary units 4l Cycles BACK Figure 31 The Optical Graph 4 5 3 Stopping the Test Caution Stopping the test will make the current chip unusable To do the test again you will have to use a new chip and start the process from the beginning If you want to stop the test Tap the Stop Button at the bottom of the Test Status Screen A pop up will be displayed asking molbio DIAGNOSTICS Truelab Uno
55. tarting a New Test Tapping the Back button in the Test Results Screen will re open the Profiles Screen At this point you can begin a new test by choosing a new profile You can also logout of the Truelab Uno Real Time micro PCR Analyzer by Tapping the Logoff button in the Profiles Screen and switch off the Touchscreen by using the Touchscreen On Off Button on the Analyzer Note KOE XXXI If you leave the touchscreen switched on without using it it will automatically switch to Sleep Mode after a minute When you want to perform another test use the Screen Wake Zone to switch it on again If you had logged off before leaving the screen idle you will have to login again Ensure that the touchscreen is switched off at the end of the working day Salmonella Malaria Pf ay H1N1 vr Dengue MTB e Chikungunya i uu esti i Figure 38 The Profiles Screen A S molbio DIAGNOSTICS Truelab Uno 4 7 Viewing Saved Test Results Results and details of previously performed tests can be viewed at any time You cannot browse saved test results when a test is currently in progress Note Unless you are a Power User see Section 2 3 Installation of the Truelab Uno for details you will only be able to view tests that were performed using your designated user ID Only the last 30 days of results are displayed for results older than that use the search function See Section 4 7
56. the Application Installed confirmation screen This will take you back to the Home Screen You will have to log in again to use the Analyzer Application installed Note If the application did not install properly the system will display the message Application not installed If this procedure fails again on retrial contact Molbio Support Figure 68 Update Confirmation Screen Maintaining the Truelab Uno 5 1 Running Controls Itis important to run controls periodically in order to make sure the Truelab Uno and Truenat chips are functioning properly It is also advisable to run control tests under the following circumstances Whenever anew shipment of test kits is received When opening a new test kit lot Ifthe temperature of the storage area falls outside of 2 30 C AN Y DIAGNOSTICS Truelab Uno By each new user prior to performing testing on clinical specimen Truenat Universal Control Kit REF601100008 consisting of a calibrated positive control and a negative control is used for the purpose Please refer to the Truenat Universal Control kit Pack Insert for details Running controls generally follows the same procedure as running patient samples as detailed in Section 4 0 of this Manual with some differences in the selection of parameters and interpretation of test results These differences are highlighted in the procedures below 5 1 1 Performing the T
57. the exponential phase beginning at 25 cycles but the Ct displayed on the screen is 17 5 A drift noise in the signal has caused the Ct to be erroneously detected Elute evaporation This can be observed visually by looking at the optical plot The signal will appear to be dropping continuously for either of the curves Cause of Error Noise drift in the signal causes errors in the calculation of the Ct This could happen in either of the two amplification curves Solution Repeat the test with a fresh chip If the problem persists contact support Cause of Error This could be indicative of elute evaporation from the chip Solution Repeat the test with a fresh chip If the problem persists contact support Ch B Ct 29 6 Ch A Ct 17 5 BACK Temperature e Optical W Result Calculating Ct Based on a User Defined Range The Truelab Uno allows you to calculate the Ct value from the optical plot based on a range defined by you This feature is optional but useful in some specific cases such as for instance in an optical graph with spikes in the signal Oe molbio DIAGNOSTICS To define a custom range and calculate the Ct value Tap anywhere on the optical graph This will open the Custom Ct Window Enter the desired ranges for Ch A IPC Control and Ch B Target Select Done on the Custom Ct Window The Truelab Uno will calculate the Ct value
58. tion message when itis finished Upload Status Total Files 4 Uploaded 4 4 8 5 6 Tap OK in the pop up message Not Found 0 Updating Disease Profiles 4 8 5 1 Loginas Power User This will open the Profiles Screen Salmonella 2 Malaria Pf H1N1 Dengue MTB Chikungunya ww Results Settings Logoff ZA S molbio DIAGNOSTICS Truelab Uno 4 8 5 2 Tap the Settings button in the Settings molbie Profiles Screen This will open the Settings Screen 6 Profile Settings App Settings 48 User Settings Bluetooth Settings 9 gt About U 4 8 5 3 Tap the About Icon in the Settings Settings molbio Screen About This will open the About Screen TruelabUno 1 00 231 4 8 5 4 Tap Profiles in the About Screen settings malbi This will begin the update process A About confirmation message will be TruelabUno 1 00 231 displayed when the update process is complete Note The message Latest Version Installed will be displayed if the profiles are already up to date shown in figure 66 OFF VOIOKNS Log Send Share Update Profiles Figure 65 The system message if there are no profile updates available Oe molbio DIAGNOSTICS Truelab Uno Updating the Truelab Uno 4 8 5 1 Login as Power User This will open the Profiles Screen Salmonella Malaria Pf H1N1 Dengue MTB Chikungunya Results Settings Logoff 4 8 5 2 Tap the Se
59. ttings button in the gt Profiles Screen This will open the Settings Screen a Profile Settings App Settings 5e User Settings Bluetooth Settings 4 8 5 3 Tap the About Icon in the Settings Screen TruelabUno 1 00 231 This willopen the About Screen molbio DIAGNOSTICS Truelab Uno 4 8 5 4 Tap Update The Truelab Uno will connect to the server and automatically check for new versions of the software If it finds a new version it will prompt you to install it Checking for latest version Note The following message will be displayed if the system software is already up to date Latest Version Installed No Update available 4 8 5 5 You will be asked to confirm whether you want to Replace Application Click OK to open the install prompt Replace application 4 8 5 6 Select Install in the install prompt The application you are installing will replace another This will display an update progress application bar When the update has completed All previous user data will be a confirmation screen will be m displayed Do you want to install this application Allow this application to Network communication Your personal information Storage Dhnno ralle Cancel Figure 66 Software Update Installation Prompt AR S molbio DIAGNOSTICS Truelab Uno Installing Figure 67 Installation Progress Bar 4 8 5 7 Click Done at
60. wever it is recommended that you charge use the Analyzer with the AC Adaptor before you continue with the test Figure 28 shows this error message Critically Low Battery Alert If the touchscreen battery is very low you will be alerted with a message asking you Figure 28 Critically Low Battery Alert to connect the charger If you get this error it is strongly recommended that you need to use the Analyzer with the AC Adaptor immediately otherwise it may shut down in the middle of the test Figure 29 shows this error message 4 5 During the Test Test Completion Indicator mm Cycle Progress Test Progress Bar Bar 2 40 Started On 12 10 12 17 50 By molbio Patient ID PN5063 Patient Name Gopal Mohan Test Details Patient Age 45 Sample Type Sputum System Health OK Battery 55 Current Cycle Temperature 95 Plot Button lt stoe gt Stop Button Figure 29 The Test Status Screen The Test Status Screen lets you monitor the progress of your current test The yellow Cycle Progress Bar is the topmost bar on the Test Status Screen and indicates the progress of the current cycle The Green Test Progress Bar at the top of the Test Status Screen indicates the total progress AN Y DIAGNOSTICS Truelab Uno of the test along with the current cycle number For instance in the Screen shot above the current cycle is 2 ou
61. willopen the About Screen Anouk TruelabUno 1 00 231 4 8 5 4 Tap the Send Share Button This will display a pop up with the options Log File and Data File Data File Log File U 15 20 4 8 5 5 Tap Log File A list of available log files will be Select one log file displayed log 15 09 2012 22 52 CJ log 15 09 2012 23 45 C log 16 09 2012 01 06 log 16 09 2012 22 50 log 18 10 2012 15 01 C5 AN Y DIAGNOSTICS 4 8 5 6 Tap the log file you want to send from the list to select it Your selection will be indicated by a green dot next to the log file name This will display a pop up with the options Send and Share 4 8 5 7 TapSharein the Pop up Message This will display a list of options to choose from 4 8 5 8 Select Bluetooth in the Pop upmessage This will display the Bluetooth Devices List which is a list of all available Bluetooth devices that the Truelab Uno can connectto Truelab Uno Share Send Share Send Bluetooth GP E mail Gmail e Messaging Bluetooth device picker Bluetooth Scan for devices Bluetooth devices ANTHERMAL FireFly 8E88 FireFly 8EA7 FireFly B2F0 Figure 65 Bluetooth Devices List AN Y DIAGNOSTICS Truelab Uno 4 8 5 9 Tap on the name of the device you want to send the file to This will send the file to the device and display the message File Sent when complete Note
62. you to confirm that you want to stop the test Are you sure you want to stop reaction i mmm umm Figure 32 Test Stop Confirmation Tap Yes in the confirmation pop up to stop the test The Test Status screen will be displayed Started On 27 10 12 17 56 By molbio Patient ID PN5063 Patient Name Gopal Mohan Patient Age 47 Sample Type Sputum System Health OK Battery 079 Current Cycle Tem perature BACK RESULT Figure 33 The Test Status Screen after Stopping the Test Inthe Test Status Screen to view the results screen for test results Tap Result To go back to the Profiles Screen Tap Back 4 5 4 System Messages In rare circumstances the following errors may occur during the test When one of these errors occurs you will be prompted by the Analyzer with a pop up message AN Y DIAGNOSTICS System Message Incorrect Thermal Cycling When it Occurs During the test System message Incorrect loading low amplification When it Occurs During the test Reason Cycle temperature out of range from normal operation range Solution Switch off the Analyzer using the Power Button Eject the chip tray and discard the chip Please repeat the test using a fresh chip If the problem persists please contact support Reason Low high volume loaded in reaction well liquid spilled outside reaction well or chip exposed to li
63. yzer using the power button before proceeding with Section 4 2 4 2 Starting the Truelab Uno Important Thissection only requires you to switch on the touchscreen See Section 4 1 for details Keep the Truelab Uno switched off until you have loaded the chip and pushed the chip tray back into the Analyzer Switching on the Analyzer before finishing the chip loading procedure may make the chip unusable Ensure that all installation requirements met before using the Truelab Uno micro PCR Analyzer Note An on screen keyboard will appear every time you click on a text box requiring text input This is operated using fingers or the provided stylus Switching on the Touchscreen Press and hold the Touchscreen On Off Button for two seconds using the stylus Jack riday October 26 This will switch on the touchscreen and Charged display the Lock Screen Slide the Lock Icon on the Lock Screen sideways to the right to open the Home Screen Lock Icon Note Battery full Please unplug powe A Stylus is provided with the Truelab supply to save energy package See Section 4 1 1 Interacting with the Truelab Uno Figure 8 The Lock Screen with the green Lock Icon in the bottom left corner T9 0 22 58 molbio DIAGNOSTICS Starting the Truelab Application Tap the Truelab Uno Application Icon this will open the Truelab Login Screen Logging In You will

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