August 2014 - Roche New Zealand
Contents
1. In this Issue Testing Efficiency Technical Update 7 Service RDNZ Education In this issue RDNZ Education is highlighted with the official grand opening of the Roche Diagnostics AUT Laboratory which was held on the 26th June at the Auckland Uni versity of Technology and was attended by a number of our Auckland customers as well as Roche staff The event was a huge success and in the Education section of this BRocher you will find the AUT University Press Release about the Roche Diagnostics and AUT col laboration and the official opening Another big event on our annual calendar is the NZIMLS Annual Sci entific Meeting which will be held from the 12 15th Aug Onceagain we are proud to continue to be the gold sponsors of this meeting and we look forward to catching up with you at the conference in Dunedin next week Finally the dates for the 2015 Roche User Group Meeting have been confirmed and can be found on the last page of this BRocher cobas Life needs answers cobas 4800 HPV Test Risk matters Deliver 3 results in 1 test for accuracy that your clinical partners expect and that patients deserve http www hpv16and18 com index html Taps Approval No NA 7223 cobas IT Helpline 0800 cobas IT 0800 26 22 748 Testing Efficiency Light Cycler Absolute Quantification Analysis Two main algorithms are used in LightCycler Systems for the cal culation of crossing points Cp The Hi2. Fluorescence 483 533 BJE EAE m E e e E E fa aa EE ett itt ttt a C TT LEE L LY BEDE EERE a BER EE ear Lit ttt tT ty 32 38 Cycle i Sample 2 fies E1 Sample 3 15 20 2 31E4 V Show Fit Points Fit Points 2 y I 24 Sample 1 13 05 9 56E4 E Fi Sample 3 15 11 2 45E4 E OFFS Standard 1 9 5 9 48E5 1 00E6 Standard Curve I F10 Standard 2 13 05 9 56E4 1 00E5 mS T Error 0 0239 22 Replicate Statistics Efficiency 1 940 on Slope 3 476 S 81 Al A13 Ale 13 06 0 03 9 55E4 1 98E3 415 A16 C eee vapabel 0 06 4 76E4 1 74E3 Samples MeanCp STDCp Mean conc STD conc Yintercept 30 37 Pulp kia Ge 15 17 0 06 2 35E4 9 58E2 419 a20 G 16 49 0 04 9 85E3 2 86E2 xl mae 0800 363622 should be restricted to the log linear phase of all PCR curves Threshold Noise Band and threshold are two dif ferent lines The Noise Band defines the cut off meaning which data are used for cal culation Independent from this cut off the threshold line is used to determine the crossing points by the intersection with the virtual regression The posi tion of the threshold can be moved manually The auto function positions the threshold line to minimize the er ror of the standard curve A higher level of threshold moves the Cp val ues towards higher Cps lowering the threshold line results in lower Cp val ues The position of the threshold can be moved manually the auto function pos
3. 12343678901234567 Test 999 abcdefghijkimnopq ABCDEFGHIDK LYNOPO Whitney 2 Press and hold the feed button while you turn the power switch back on 3 Release the feed button when the LED turns RED It will first turn ORANGE The printer will then feed labels and calibrate the sensor LED indication sequence gt orange green orange gt red 5 blinks If the E bar II printer is not printing bar codes or fonts properly or if there are other issues the printer may need to have the DRAM memory cleared and factory de faults restored Note this will not impact on your label templates It just clears the hard memory within the printer To initialize the printer and clear DRAM 1 Turn off the power switch at the rear of the printer cobas IT Helpline 0800 cobas IT 0800 26 22 748 2 Press and hold the feed button while you turn on the power switch 3 Release the feed button when the LED turns GREEN and blinks 5 times LED indication sequence gt orange green orange gt red 5 blinks gt orange 5 blinks gt green 5 blinks Note if you do this you need to follow it with a gap sensor calibration as detailed above If you change a ribbon or label roll don t forget to reset the counter in the software Check your user manual for more informa tion cobas Life needs answers Service Roche Techline Have you ever had a question for Roche but never known who to
4. ability to change a positive call to a negative one and vice versa samples may look similar but receive different calls False Negatives in High Confi dence for early Cp values lt 15 cycles Due to the negative filter algorithm in the High Confidence setting some a sample below the nega 1 tive threshold set to 15 ee Cycles are called nega tive the end of the exponential phase E a a the reaction is more significantly D 8 Some a Te a ee 7 si v Mas Sample 5 26 61 1 05E influenced by limiting parameters ao oe e be v E A8 Sample 8 16 76 1 01E O z2 components aoe oe Son az Samples MeanCp STD Cp Mean conc STD conc Links 1 033 Be E i on v Es J i M e v cote V cobas Life needs answers cobas IT Helpline 0800 cobas IT 0800 26 22 748 RDNZ Education 2 Abs Quant Fit Points Method each data point of the amplification curve In case the cycle range is changed manually the background The Fit Points method requires adjusting comecton automaticaly adapts baseline cycle range setting the noise band and entering the number of data points to be considered in the log linear phase In LightCycler Software default analysis settings are provided for semi au tomated calling However fine tuning ad justments can be made manually by the user The Fit
5. e QC is displayed in both Radar plots and Levy Jennings LJ charts with a separate tab for each instrument as well as the ability to overlay the QC from each XN on one LJ chart allowing comparison of results between modules e The two XN s can share diluent reagents thus reducing storage requirements below the instrument Shona from Medlab Nelson has the following comments on how they are finding their new XN s Having moved from an XT to an XN feel Sysmex has listened to the feedback from customers and changed most things we felt could be improved on if r g f woua da amp i ay B7 E Patent List Rute 8 4 Ext PU History Precision Check Calibration w d Version Information GP Customize cobas IT Helpline 0800 cobas IT 0800 26 22 748 We like our XN 2000 because e There is no SRV to clean or get blocked We dont have to do a mode to mode calibration e The barcodes dont have to be lined up in the rack There is no start button the racks are loaded and we can walk away e Urgent specimens can be run without interrupting the work flow One module can be down for maintenance etc while still running the other mode e Its so easy to load the new QC values e A precision run Is so simple e Daily maintenance is an automatic shutdown just place the tube of CA clean and the rest is automatic e Reagent replacement is foolproof e Reflex rerun testing is automati
6. ask You may make a note to ask the next Roche representative you see or even mention it when ordering new products We have had the 0800 363 622 Roche Tech line in place for over 10 years now and all our customers use this when they have urgent issues and require assistance from our technical support team of Service Engi neers and Product Specialists What we are now introducing is the Roche Techline email address nz rdnztechline roche com This email account will be monitored by our technical support team to ensure the gen eral questions for non urgent support are directed to the correct person s in Roche and ensure a timely response to all our cus tomers with the relevant information and answers you require Our 0800 number should still be used for urgent issues where you need to speak to someone quickly for advice or to report an issue or incident a bit like the 111 number with urgent issues requiring an ambulance police or fire services If there are general questions that you need help with or follow up answers and want to ask them by using the convenience of email then this will now be available via the RDNZ Techline email service This adds to our communication pathways for our friends and customers outside NZ in the Pacific Islands and French Territories where the 0800 number is not available Of course our office number in Auckland will always direct the overseas callers to the internal Techline number ser
7. Points method has no positive negative filter all thresholds like noise band and cycle range can be adjusted by the user Noise Band The software performs an automat ic noise band setting In some cas es an additional manual adjustment to an optimal position i e as low as possible and as high as neces sary might be required For the analysis only the fluorescence data above the noise band will be used Analysis The software calculates a virtual re gression line through all selected fit points in the log linear phase data points above the noise band of each amplification curve The intersection of this line with the horizontal threshold line determines the crossing point of the sample The number of fit points Background Adjustment The software automatically adjusts the background fluorescence for all samples to a uniform level by us ing an arithmetic background cor rection the mean value of the data points of the cycle range 2 to 6 of each PCR reaction is subtracted from Window Demo Abs Quant with SYBR Green I User System Admin Analyses bs Quant Fit Points gt SAA Information Program Amplification Color Compensation Off Subset Standards and Unknowns BAe Cycle Range Noise Band Eo M an C 213 tats Te 17 Ta To honhnii hennan 20121122 23 24 ES e E Amplification Curves m 7 a E E E 5 5 E E E E a E 7 5 a J J 5 E 7 E 3 KI
8. c in closed mode rules can be set up so anything can be rerun e And it s really really fast Pil bone cobas Life needs answers Technical Update Accu Chek Inform Il Meter Laser scanner for linear barcodes will be replaced by a photographic scanner capable of scanning 2 dimensional codes as well as linear 1D barcodes for operator and patient IDs New Battery Pack the first step to unified platform battery pack Same battery pack for all platform devices CoaguChek XS Pro and cobas h 232 to follow Both battery and cover included in meter kit Separate battery cover WLAN chip on board no removable RF card anymore The new software version 03 05 00 features an improved Wait Screen and new reset procedure No reset button anymore in the When running a test during the strip quality check an hour glass icon battery pack another hole removed from the meter The will be shown instead of an inserted strip icon This means clearer on new reset procedure is a controlled shutdown triggered by screen instructions for sample applications and less wastage of strips pressing the ON OFF button for more than 12 seconds and releasing the button again Patient Test Patient 123456789 StripyLot 545794 ro 9 Patient Test 12 48 pm 12 48 pm Patient 123456789 Patient 123456789 Strip Lot 545794 Strip Lot 545794 No RF Card anymore Reset Button a 12 48 pm d
9. gh Confidence algorithm is opti 1 mized to find highly reliable Cps i e in general Cps are called for samples with a Make a plausibility check when the curves are looking positive in the graph but are called negative or 1 Abs Quant 2nd Derivative Maximum Method e Fully automated calculation of Crossing Points Cp with no user input based solely on the shape of the curve The Cp value can be vi sualized by identifying the first max imum of the second derivative of the amplification curve Sorting into positive negative and uncertain curves is performed by the SW auto matically and does not allow any us er influence This method offers the advantages of speed and simplicity especially for highly reproducible analysis of data coming from differ ent runs or different users e The 2nd derivative maximum point represents the maximum accelera tion of the curve This is exactly the region where an exponential ampli fication takes place The seemingly lower fluorescence increase per cy cle is influenced by the background fluorescence of the system The ob served fluorescence increase does not represent the real amplification rate At the 1st derivative maximum point the PCR begins to leave the exponential phase e We decided to measure the Cp in the middle of the exponential phase instead of measuring at the end of the exponential phase because at prominent rise and a high signal to noise ratio The risk
10. ic aa P Friday 27 June 2014 10 52 am AUT University Press Release Tags Science Medical Newsworthy Press Release AUT University is proud to announce the opening of the AUT Roche Diagnostics Laboratory The laboratory collaboration is the first of its kind in New Zealand and will provide undergraduate and postgrad uate students access to the latest scientific evaluations in chemistry immunology and haematology The new laboratory will also be used for re search and development of new molecular tests for the detection of pathogens and their emerging variants such as the flu vi rus AUT Vice Chancellor Derek McCormack says The University s collaboration with Roche is further demonstration that AUT provides our students with a real world learning experience as this laboratory has state of the art facilities which are used in industry This collaborative relationship be tween AUT and Roche Diagnostics is an excellent example of a productive research partnership and industry investment At RochesDiagnostics we are eager to be involved in helping the future of the medi vane 0800 363622 cal laboratory science community to be as well equipped as possible when entering the workforce We also believe that the re search that will be done in the new labo ratory will be world leading in the area of pathogen detection says Dr Lara Hashi moto General Manager of Roche Diagnos tics The project ha
11. ing with Roche Product Specialists and engineers training students on how to use and maintain the instruments cobas Life needs answers RDNZ Education Courses Team Talk Welcome Michael Horsburgh to the RDNZ team VWchline 0800 363622 We are pleased to announce that Michael is the new Field Service Engineer and will be based in Palmerston North He previously worked at Enatel in Christchurch and was primarily involved with fault finding and repair work so he is looking forward to the new challenge with Roche Michael will be working alongside Bill and Gary in the Wellington region until his training program is complete and will be primarily responsible for the territory in and around Palmerston North Contact Michael Email michael horsburgh roche com Mobile 021 841 397 cobas IT Helpline 0800 cobas IT 0800 26 22 748 cobas Life needs answers Roche User Group Meeting 2015 22 28 March Millennium Manuels Taupo Meeting dates for each discipline will be communicated to you over the next few weeks Start thinking about your Presentations Posters For further information contact your Roche Diagnostics Sales Account Manager www roche co nz a cobas Life needs answers
12. itions the threshold line to mini mize the error cobas cobas IT Helpline 0800 cobas IT 0800 26 22 748 Life nec alsiieis Testing Efficiency amp amp First XN 2000 for NZ arrives in Nelson The first XN 2000 for NZ was installed in MedLab South Nelson Hospital in May 2014 bringing the total of XN instruments in our territory to 12 since Jan 2012 A second XN 2000 will be installed in SCL Invercargill in August Having moved from an XT to an XN I feel Sysmex has listened to the feed back from customers and changed most things we felt could be improved on Shona Brougham The XN 2000 is a dual unit with two XN 10 or XN 20 or a combination of both sharing a specialised sampler unit The instruments work together to analyse a rack of 10 samples utilising smart logic to share the load between the two giving a throughput of 200 samples hour CBC Diff NRBC The instruments can also operate independently with one taking the load when the other is being utilised for Manual sample analysis or temporarily off line for maintenance procedures RDNZ Education Other features unique to the XN 2000 include e A single IPU is shared between the two instruments with a separate maintenance tab for each XN labelled Left amp Right e A shared database with all results displayed on one explorer screen The database has a capacity for 100 000 samples after which a FIFO process is utilised
13. n removed ese 123456789 A trip Lot 545794 S v gt S j uu T Mons r 5 LI a Aa _ amp 09 18 13 l Oe am 09 18 13 P Sea amp 09 18 13 BAT cobas IT Hel i cobas nlina NAANA nnhac IT NANN AQC d9 FAQ p ine VoUU CO b as U OUU ZO ZZ 40 Life needs answers Technical Update The E bar Il printer is a very robust print er which works on thermal transfer tech nology This technology has been around for many years and is generally the print mode of choice for production of high qual ity labels as is required for the barcode scanning technology central to the Roche Ventana systems Although these printers are robust and rarely give any issues they do require the occasional bit of maintenance and calibra tion It is a good idea to clean the print heads every time you change a printer ribbon This will help to ensure trouble free clear print ing To do this 1 Let the printer cool down for 1 minute 2 Wipe the printer element with a clean ing swab 3 Rotate the roller while wiping it with 70 alcohol 4 Leave to dry and re install the ribbon The printer has gap sensors which may need to be recalibrated if the printing posi tion begins to drift If you change a ribbon or roll of labels you should perform a recali bration of the gap sensor To calibrate the gap sensor 1 Turn off the power switch at the rear of the printer ie ue 0800 363622
14. of false positive Cp calling is therefore drastically reduced The High Confidence algorithm should be used for all experiments that require Color Com pensation The High Sensitivity algorithm detects crossing points even for data curves with a weak rise in fluorescence and thus a low signal to noise ratio It is therefore suitable for all assays requiring very high sensitivity like detection of low to single copy targets The drawback of this algo rithm is a certain risk of false positive Cp calling The result of a High Sensitivity analysis should thus always be examined in detall Limitations of Cp calling Too much noise may lead to false negative callings This is especially true for samples with a steep decrease in fluorescence sig nal during the first cycles of measure ment The suggested workaround for customers affected by this problem is indow Test group1 121005 ad i ive Max for test groupi uncertain by the software 2 Switch from High Confidence to High Sensitivity mode and vice versa or use Fit Points to set the threshold line accordingly 3 Improve the overall performance of the assay to achieve higher signal intensities and or lower noise Samples might fail in High Sen sitivity because they amplify very slowly A failure can be caused by a growth of nearly zero e g curves amplifying over 30 cycles and still do not reach saturation Slight variations have the
15. s been led by AUT Immu nology Senior Lecturer Dr Fabrice Merien School of Applied Sciences and his work has been instrumental in the success of the partnership This collaboration has been in the works for more than a year and we have already seen amazing results from the partnership The feedback from industry regarding our graduates that have trained in the labora tory has been universally positive says Dr Merien Scientific and medical education is an im portantpart of this partnership An example of this is the educational forum organised by Roche Diagnostics NZ and AUT which was held earlier in the year on A local and global perspective on cervical screening with HPV Two prestigious guest speakers were invited Thomas Wright Professor of Pathology at Columbia University Medical Centre New York and Dr Marion Saville from the Victorian Cytology Service Mel bourne This forum provided a great op cobas IT Helpline 0800 cobas IT 0800 26 22 748 AUT University partnering with leading portunity for AUT and Roche Diagnostics NZ to show their professional commitment towards better health for women in New Zealand The collaboration agreement extends be yond the laboratory to academic collab oration including the judging of scientific posters at the Roche Diagnostics New Zea land Annual Scientific Meeting co spon soring the New Zealand Institute of Med ical Laboratory Science poster session and teach
16. vice as usual RDNZ Techline l 0800 363 622 A number of our technical support staff are away from their desks during a working day and instant email access is not always pos sible when they are conducting site visits training courses and other service related activities so this generic email address will ensure the message is passed to an avail able support person in the Roche team It will definitely help those operators in the laboratory who are less familiar with our support team personnel and their individ ual email addresses If you dont know who can answer your question or enquiry then please use this new service and encourage your local staff members to also use it It may be great for out of hour staff members who can have an answer back to them in their inbox when they are next on their shift and not rely on internal communication channels to filter and request the questions on their behalf w RDNZ main office 09 2764157 or 0800 652 634 Techline email i _ nz rdnztechline roche com We welcome any feedback about the new service and will be asking you what you think of the new service in the coming months If you wish to discuss the email service or anything related to after sales Technical support at RDNZ then please contact the Service Manager Craig Martin at craig martin roche com cobas Life needs answers cobas IT Helpline 0800 cobas IT 0800 26 22 748 RDNZ Education diagnost
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