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IMMULITE/Dimension/Stratus CS Control Migration
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Overview
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IMMULITE/RIA Info
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Dimension/Stratus Info
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FAQ
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Siemens Healthcare Diagnostics and Bio-Rad Laboratories, Inc. have expanded their global ADVIA® Chemistry and ADVIA Centaur® Immunoassay Systems joint marketing agreement. Bio-Rad will now offer their quality control products and Unity™ Quality Control (QC) data management solutions to Siemens IMMULITE® Immunoassay Systems, RIA, Dimension® Integrated Chemistry Systems, Dimension Vista® Intelligent Lab Systems, and Stratus® CS Systems customers. The combination of quality control products and data management solutions will assist Siemens customers in the tracking and reporting of the analytical performance of their laboratory systems.
Through this agreement, all Siemens Immunoassay and Chemistry systems can now use the same portfolio of Bio-Rad and Siemens controls. This reduces the number of controls that your laboratory must manage. In conjunction with this, three IMMULITE and RIA controls, CON6, Tumor Marker, and Cardiac will be discontinued and inventory is expected to be depleted by April 1, 2012 (see Table 1 in the IMMULITE Control Info tab).
Siemens Portfolio Controls and Data Management Solutions
Bio-Rad’s Unity software products offer varying levels of functionality ranging from basic Internet-based data submission to advanced real-time QC data management, rules evaluation, and analysis, providing laboratories with increased confidence in their test systems and proficiency survey outcomes.
Now, for the first time, you will be able to report QC results for both Bio-Rad and Siemens labeled controls using Bio-Rad’s Unity™ Quality Control (QC) program – Siemens Portfolio Data Management Solution. This program is a better overall productivity solution providing access to quality control data of thousands of laboratories worldwide for peer group InterLaboratory comparison.
What does this mean for you?
Starting today:
Your clinical laboratory can use the same Bio-Rad control materials for all your systems in the Siemens Immunoassay and Chemistry portfolio.
Starting January 2012:
Laboratories already subscribing and reporting into Bio-Rad’s Unity Quality Control program will be able to start reporting their Siemens labeled control results for all the systems in the Siemens Immunoassay and Chemistry portfolios.
You should expect to see a reduction in assay management activities.
Thank you for your continued support of Siemens products and solutions.
Table 1
The following Siemens IMMULITE and RIA controls will be discontinued and migrated to Bio-Rad controls:
| Discontinued Siemens IMMULITE and RIA controls | Siemens Part Number | Bio-Rad Equivalent Control | Bio-Rad Part Number | Expected Depletion Date |
|---|---|---|---|---|
| Con 6 | 10385346 10385347 |
Lyphocheck Immunoassay Plus Level 1, 2, 3 | 371, 372, 373 | March 2012 |
| Cardiac Marker | 10385345 | Liquichek Card Marker Plus LT Level 1, 2, 3 | 145, 147, 148 | March 2012 |
| TMCO (Tumor Marker) | 10385590 10385591 |
Liquicheck Tumor Marker Level 1, 2, 3 | 547, 548, 549 | March 2012 |
Table 2
The following Siemens IMMULITE controls will continue to be available from Siemens:
| IMMULITE Controls Still Available from Siemens | Siemens Part Number | Control Code | Available as Module or Kit | Comment |
|---|---|---|---|---|
| 3gAllergyTM Specific IgE Positive Control for D2 | 10485101 | DC2LCM | Module | |
| IMMULITE Ferritin Control | 10385378 | FECM | Module | Available ex-US only |
| Total IgE Control | 10385349 | IEACM | Module | Available ex-US only |
| Cytokine Control | 10385389 10385291 |
ILCM ILCM(D) |
Module | Available ex-US and US (D) |
| Canine Control | 10385584 | K9CON | Module | |
| Canine Thyroid Control | 10385585 | K9TCM | Module | |
| IMMULITE Specific IgE Negative Control | 10485107 | L2SNCCM | Module | |
| IMMULITE Thyroid Autoantibody Control | 10385381 | LAACM | Module | |
| IMMULITE ACTH Control | 10385382 | LACCM | Module | |
| IMMULITE Anti-Hepititis B Surface Antigen Controls | LAHC1-3 | Kit | ||
| IMMULITE AlaTop Control | LATC1-2 | Kit | Available ex-US only | |
| IMMULITE Total Anti-HAV Control | LAVC1-3 | Kit | Available ex-US only | |
| IMMULITE Beta 2 Microglobulin Control | 10385587 | LBMCM | Module | |
| IMMULITE HCG Control | 10385358 | LCGCM | Module | |
| IMMULITE Calcitonin Control | 10385383 | LCLCM | Module | |
| IMMULITE CMV IgM Control | LCMC1-2 | Kit | ||
| IMMULITE CRP Control | 10385316 | LCRCM | Module | |
| IMMULIITE CMV IgG | 10469595 | LCVGCM | Module | |
| IMMULITE D-Dimer Control | 10385330 | LDDCM | Module | Available ex-US only |
| IMMULITE EBNA IgG Control | LEBC1-2 | Kit | Available ex-US only | |
| IMMULITE EBNA IgM control | LEMC1-2 | Kit | Available ex-US only | |
| IMMULITE ECP Control | LEOCM | Kit | Available ex-US only | |
| IMMULITE EPO Control | 10385384 | LEPCM | Module | |
| IMMULITE Free-Beta HCG Control | 10385385 | LFBCM | Module | Available ex-US only |
| IMMULITE Allergen Specific IgG4 Control | LG4C1-2 | Kit | Available ex-US only | |
| IMMULITE Gastrin Control | 10385331 | LGACM | Module | |
| IMMULITE Immulite Allergen Specific IgG Conrol | LGGC1-2 | Kit | Available ex-US only | |
| IGF Control Module | 10385387 | LGCOCM | Module | |
| IMMULITE Albumin Control | 10385388 | LHACM | Module | |
| IMMULITE Hepatitis B Surface Antigen Controls | LHBC1-2 | Kit | ||
| IMMULITE Anti- Hepatitis B Core Total Controls | LHCC1-2 | Kit | ||
| IMMULITE H. pylori Controls | 10469596 | LHPGC1-3 | Module, Kit | |
| IMMULITE Herpes Controls | LHVGC1-2 | Kit | ||
| IMMULITE Insulin Controls | 10286614 | LINCM | Module, Kit | |
| IMMULITE LBP Controls | 10385337 | LLBCM | Module | |
| IMMULITE Canine TLI Controls | 10385338 | LLICM | Module | |
| IMMULITE Anti-Hepatitis B Core IgM Controls | LMCC1-3 | Kit | ||
| iMMULITE NT-proBNP Controls | 10385339 | LNTCM | Module | Available ex-US only |
| IMMULITE Osteocalcin Controls | 10385415 | LONCM | Module | Available ex-US only |
| IMMULITE PAP Control | 10360480 | LPACM | Module | |
| IMMULITE PAPP-A Control | 10385317 | LPCCM | Module | Available ex-US only |
| IMMULITE Pyrilinks-D Control | 10385243 | LPDCM | Module | |
| IMMULITE Rubella IgM Controls | 10469597 | LRMCM | Module, Kit | |
| IMMULITE Rubella IgG Controls | 10469599 | LRUBCM | Module, Kit | |
| IMMULITE SHBG Controls | 10285226 | LSHCM | Module, Kit | |
| iMMULITE Syphilis Screen Controls | 10469593 | LSYCM | Module, Kit | |
| IMMULITE TBG Controls | 10385244 | LTBCM | Module | |
| IMMULITE 3rd Generation TSH Control | 10385395 | LTGCM | Module | |
| IMMULITE Toxoplasm IgM Controls | LTMC1-2 | Kit | Available ex-US only | |
| IMMUILITE TPS Control | LTPC1-2 | Kit | ||
| IMMULITE Toxoplasm IgG Control | 10469600 | LTXPCM | Module, Kit | |
| IMMULITE Thyroglubulin Control | 10385246 10385247 |
LTYCM LTYCM(D) |
Module | Available ex-US and US (D) |
| IMMULITE Toxoplasma IgM (µ-capture) Control | LTZC1-2 | Kit | Available ex-US only | |
| 3gAllergyTM Specific IgE Universal Kit Controls | LUNC1-2 | Kit | ||
| IMMULITE 3rd Generation PSA Control | 10385396 | LUPC | Module | |
| IMMULITE EBV-VCA IgG Controls | LVGC1-2 | KIt | Available ex-US only | |
| IMMULITE Anti-HAV IgM Controls | LVMC1-3 | Kit | Available ex-US only | |
| IMMULITE IL-10 Controls | 10385248 | LXPCM | Module | Available ex-US only |
| 3gAllergyTM Specific IgE Positive Control for M6 | 10485106 | MC6LCM | Module | |
| C-peptide Control | 10385589 | PECM | Module | |
| IMMULITE Intact PTH Control | 10385354 | PHCM | Module | |
| Serum Drug Control | 10385397 | SDC | Module | |
| Estradiol Control | 10389765 | E2TC1 | Module |
Table 3
The following RIA controls will continue to be available from Siemens:
| IMMULITE RIA Controls Still Available from Siemens | Siemens Part Number | Control Code | Available as Module or Kit | Comment |
|---|---|---|---|---|
| Anti-DNA Control - RIA | ADCO1-2 | Kit | ||
| Anemia Control - RIA | ANC | Kit | ||
| C-peptide Control | 10385589 | PECM | Module | |
| Canine Control | 10385584 | K9CON | Module | |
| Canine Thyroid Control | 10385585 | K9TCM | Module | |
| Gastrin Control - RIA | 10385461 | GACM | Module | |
| Glucagon Control - RIA | GNCO1-2 | Kit | ||
| IF bAb Positive Control -RIA | ISP5 | Kit | ||
| SHBG Controls - RIA | SHCO1-2 | Kit | ||
| Direct Androstenedione Control - RIA | TANC1-2 | Kit | ||
| Canine TLI Controls - RIA | TLCO1-3 | Kit | ||
| T3 Uptake Controls - RIA | TTU4-5 | Kit | ||
| Estradiol Control | 10389765 | E2TC1 | Module | |
| Serum Drug Control | 10385397 | SDC | Module |
Table 1
The following Siemens Dimension controls will continue to be available from Siemens:
| Siemens Dimension Controls Still Available | Siemens Part Number | Comment |
|---|---|---|
| Dimension Drugs of Abuse Negative Control | 10445032 | DC44A |
| Dimension Drugs of Abuse Positive Control | 10445033 | DC43A |
| MPO Control (Myeloperoxidase) | 10464334 | RC426 |
Table 2
The following Siemens Dimension Vista controls will continue to be available from Siemens:
| Siemens Dimension Vista Controls Still Available | Siemens Part Number | Comment |
|---|---|---|
| Vista DAT Positive Control | 10445198 | KC515 |
| Vista DAT Negative Control | 10445199 | KC715 |
| Protein 1 Control L (Low) | 10445919 | KC715 |
| Protein 1 Control M (Medium) | 10445920 | KC716 |
| Protein 1 Control H (High) | 10445921 | KC717 |
| APO Control | 10445923 | KC725 |
| Cystatin C Control L (Low) | 10445924 | KC735 |
| Cystatin C Control L (High) | 10445925 | KC737 |
| C1IN Control | 10445927 | KC745 |
| High Sensitivity CRP Control Low | 10445929 | KC755 |
| High Sensitivity CRP Control High | 10445930 | KC757 |
| Protein 3 Control | 10445933 | KC775 |
| Protein 2 Control L (Low) | 19445936 | KC785 |
| Protein 3 Control (High) | 10445937 | KC787 |
| Protein 3 Control (USA) | 10465668 | KC775U |
Table 3
The following Siemens Stratus CS control will continue to be available:
| Siemens Stratus CS Controls Still Available | Siemens Part Number | Comment |
|---|---|---|
| Innovance D-Dimer Controls | 10446006 | OPDY09 |
What is the Siemens Quality Control Material Migration project?
Siemens Healthcare Diagnostics and Bio-Rad Laboratories, Inc. have expanded their global joint marketing agreement under which Bio-Rad will sell its quality control products and Unity™ Quality Control (QC) data management solutions to Siemens IMMULITE® Immunoassay Systems, RIA, Dimension® Integrated Chemistry Systems, and Dimension Vista® Intelligent Lab Systems. This move extends clinical laboratorians access to consistent control materials and data management tools within the Siemens laboratory systems portfolio which, until today, only included the ADVIA® Chemistry and ADVIA Centaur® Immunoassay systems.
Through this agreement, laboratories using Bio-Rad controls and Siemens proprietary labeled controls on Siemens Immunoassay and Chemistry systems will be able to participate in Bio-Rad’s comprehensive Unity™ InterLaboratory Program. Bio-Rad’s Unity software products offer varying levels of functionality ranging from basic internet-based data submission to advanced real-time QC data management, rules evaluation, and analysis, thus creating Portfolio Controls and Portfolio Data Management Solutions.
What is Siemens partnership history with Bio-Rad?
The Siemens/Bio-Rad partnership was a first in which an instrument manufacturer and a third party control manufacturer were working together for the benefit of the customer. Traditionally, instrument manufacturers have their own controls for internal processes and external assay qualifications. While customers understand the benefits of third party controls, they frequently have to utilize the instrument manufacturer’s controls when validating and troubleshooting assays and instrumentation. Customers are forced to choose between a Quality Control system which is not connected to the assay calibrators, and a control system which has been validated by the instrument manufacturer.
The Siemens/Bio-Rad expanded partnership continues to overcome this traditional and cumbersome paradigm. During 2011, Siemens will be validating Bio-Rad labeled controls on our IMMULITE and RIA systems and incorporating them into our manufacturing, installation, and troubleshooting processes.. Siemens customers will be able to purchase controls from a company which specializes in controls and InterLaboratory Quality Control (ILQC) solutions, and which the instrument manufacturer uses for validating and troubleshooting.
Through this unique partnership, Siemens is recommending that customers partner with a company whose quality control products are used in 70% of the marketplace and who has the world’s largest quality control comparison groups.
Siemens customers are able to join with a quality control manufacturer who is truly best in class, and who is committed to expanding their options for quality products and management.
Will all Siemens IMMULITE and RIA Quality Control Materials be migrated to Bio-Rad Commercially Available Controls?
Three IMMULITE and RIA Controls: CON6, Tumor Maker (TMCO) and Cardiac Marker (CC) controls, will be migrated. Siemens Proprietary controls will still be manufactured and sold by Siemens.
The IMMULITE Control Info tab above provides lists of IMMULITE and RIA discontinued controls and those that will continue to be available.
What about Siemens Dimension, Dimension Vista, and Stratus CS Customers using Dade® Controls?
Siemens U.S. Dimension, Dimension Vista, and Stratus CS customers have been primarily using 3rd party control materials and Siemens labeled controls for which there is not a 3rd party control available or where a Siemens labeled control is required for regulatory reasons. This will continue.
However, the majority of Siemens Dimension, Dimension Vista, and Stratus CS customers outside of the US have either All Inclusive (consumables supplied by Siemens at a fixed price) or Cost Per Result (CPR, a fixed price for each reported result) contracts in which control materials are provided. Bio-Rad controls will be substituted for the DADE® controls or the Thermo-Fisher (MAS) controls in these contracts.
The Dimension/Stratus Control info tab provides lists of the Dimension, Dimension Vista, and Stratus CS controls that will continue to be available.
What are Portfolio Quality Control Materials?
For the first time, with the new Bio-Rad partnership, Siemens is able to recommend the same commercially available quality control materials for our portfolio of ADVIA, Dimension, Dimension Vista, IMMULITE, and Stratus CS instrument platforms.
What are the Siemens Labeled Controls that will still be manufactured and sold by Siemens?
For the most up-to-date list of Siemens IMMULITE, RIA, Dimension, Dimension Vista, and Stratus CS labeled controls - see tabs above.
What are Portfolio Data Management Solutions?
By partnering with Bio-Rad, Siemens customers will be offered the same QC data management services for our portfolio of ADVIA, IMMULITE, Dimension, Dimension Vista, and Stratus CS instrument platforms. The Bio-Rad QC management services will incorporate not only Bio-Rad controls but also Siemens Labeled Controls, enabling customers to further consolidate their QC reporting.
What is Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program?
Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program is a database in which participating quality control users world wide (over 15,000 Siemens customers) can report and compare QC results. This helps to increase confidence in proficiency results by identifying trends or shifts that may occur between proficiency surveys, and reduce costs.
Will the Siemens Labeled Controls be available on the Bio-Rad Unity Reporting Program (InterLaboratory QC)?
Yes. In another first for this partnership, Siemens customers will now be able to report their peer data for Siemens labeled controls into Bio-Rad Unity.
How does a Siemens customer enroll in Bio-Rad's Unity™ InterLaboratory Peer Data Management Reporting Program?
A Siemens customer can contact the local Bio-Rad representative or go to Bio-Rad's internet site www.QCNet.com for additional information.
How soon will Siemens customers be expected to migrate to the Bio-Rad Controls?
Customers can start migrating to Bio-Rad controls immediately.
CON6, TMCO, and CC will be discontinued and inventory is expected to be depleted by April 1, 2012.
Is there a plan to convert the “All Inclusive” and “CPR” contracts?
Yes, each Siemens Country Commercial Organization will manage the conversion of their All Inclusive and CPR contract customers. This will be completed by March 2012.
What about new All Inclusive and CPR contracts?
Effective immediately, every new “All Inclusive” and “CPR” contract will be written to designate Bio-Rad controls instead of IMMULITE and RIA CON6, Tumor Maker (TMCO) and Cardiac Marker (CC) controls or DADE controls or the Thermo-Fisher (MAS) controls
Who will investigate control complaints?
The Siemens Bio-Rad partnership will ensure Siemens customers are fully supported by either Siemens, Bio-Rad, or both to address customers' needs.
Why is Siemens doing this change?
Based on extensive customer research, Siemens identified that customers want to use the same quality control materials and data management solutions across multiple Siemens platforms to improve workflow in the laboratory. The Bio-Rad partnership achieves this goal by leveraging the expertise of a company whose quality control products are used in 70% of the marketplace and who has the world's largest quality control comparison groups.
If Bio-Rad does not have a specific representative in a/my country how can they be contacted?
The information can be found on Bio-Rad's website:
www.bio-rad.com/qualitycontrol
How do I convert to Bio-Rad Controls?
To proceed with your control conversion, please contact your local Bio-Rad representative or Bio-Rad distributor. Siemens recommends that you allow sufficient time for the conversion.
How will I troubleshoot my QC, when the Siemens Controls are no longer available?
Your local Bio-Rad Customer Service Center will assist you. Additionally, through participation in Bio-Rad’s Unity InterLaboratory Program, you may access the Bio-Rad website at www.qcnet.com to locate the data appropriate for your lot of Bio-Rad control. In addition, you can continue to contact Siemens for questions related to Siemens products and services.
To view the Siemens/Bio-Rad brochure, worldwide Bio-Rad contact information, as well as information on equivalent Bio-Rad controls, go to: www.siemens.com/diagnostics-controlbrochure
I have more questions on the migration, who can I contact?
Contact your local Siemens or Bio-Rad representative, who will be happy to help you.
