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Biotest Blood Bank Solutions March 5 th , 2009
Presentation Overview ,[object Object],[object Object],[object Object],[object Object],[object Object]
Biotest – 60+ years of  Transfusion Diagnostics ,[object Object],[object Object],[object Object],[object Object],1948 Introduced World’s First  Anti-D test serum 1983 Seraclone, Monoclonal Antibodies for Blood Grouping developed 1985 Erytype introduced, Ready to Use Microplates for  Blood Grouping 1946 Founded as Biotest Serum-Institut GmbH
Biotest Diagnostics Corporation USA ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Biotest Diagnostics Corporation   ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
New Biotest Diagnostics Headquarters ,[object Object],[object Object],[object Object],[object Object],[object Object]
BDC Transfusion Management ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Traditional Blood Bank Reagents ,[object Object],[object Object],[object Object]
Traditional Blood Bank Reagents ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Rh Antisera ,[object Object],[object Object],[object Object],[object Object],[object Object],BS226 MS24 MS33 MS12/MS260 MS16/MS21 /MS63 Seraclone ®  Anti-D (RH1) Seraclone ®  Anti-C (RH2) Seraclone ®  Anti-c (RH4) Seraclone ®  (2) Anti-E (RH3) Seraclone ®  (3) Anti-e (RH5) ,[object Object],[object Object],BS242/ BS221/ H411B7   Seraclone ®  Anti-D (RH1) Blend   Features Clones Product
Rare Antisera ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],MS56 (IgM) Lk1 (IgM) MS15 (IgM) MS8 (IgM) LeA2 (IgM) BS57 (IgM) BS41 (IgM) MS94 (IgM) P3YAN3 (IgG) DG-FYA-02 (IgG) 650 (IgM) Seraclone® Anti-K (KEL1) Seraclone® Anti-k (KEL2) Seraclone® Anti-Jka (JK1) Seraclone® Anti-Jkb (JK2 Seraclone® Anti-Lea (LE1) Seraclone® Anti-M (MNS1) Seraclone® Anti-N (MNS2) Seraclone® Anti-S (MNS3)  Seraclone® Anti-s (MNS4)  Seraclone® Anti-Fya (FY1)  Seraclone® Anti-P1 (P1)   Test Method Clones Product
Reagent Red Cell Products ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Additional Manual Reagents ,[object Object],[object Object],[object Object],[object Object],[object Object]
Traditional Reagents:  The Biotest Advantage ,[object Object],[object Object],[object Object],[object Object]
Traditional Reagent Evaluation   ,[object Object],[object Object],[object Object]
Results of Rh Antisera Evaluation Biotest Significantly Outperforms 61 4 96 Anti-e 108 110 110 97 Number of samples tested Roughly Equivalent 10 14 Anti-c Roughly Equivalent 5 3 Anti-E Roughly Equivalent 29 14 Anti-C Roughly Equivalent 18 14 Anti-D Blend Conclusion # Stronger with Biotest Rgts # Stronger  with Reference Rgts Antisera
Rare Antisera Evaluation Biotest Outperforms 17 2 31 Anti-s Biotest Outperforms 10 0 31 Anti-S Roughly Equivalent 6 2 30 Anti-N Roughly Equivalent 0 1 11 Anti-k Equivalent 0 0 41 Anti-K Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera
Rare Antisera Evaluation Roughly Equivalent 4 0 30 Anti-Lea Biotest Outperforms 10 0 18 Anti-P1 Roughly Equivalent 2 2 31 Anti-Jkb  Roughly Equivalent 3 8 31 Anti-Jka Biotest Outperforms 11 0 31 Anti-Fya Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera
Rare Antisera Evaluation Conclusions ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Traditional Reagents:  The Biotest Advantage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
Features ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Erytype and Solidscreen  Platform ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Superior Reagent Stability ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ABO/Rh Methodology  Erytype S ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
ABO/Rh Method ,[object Object],[object Object],[object Object],[object Object],[object Object]
TANGO ABO/Rh Results ,[object Object],[object Object],[object Object],[object Object]
Field Trial ABO/Rh  NTD Rates ,[object Object],[object Object],[object Object],[object Object],0.1% Rh 0.03% Rh ABO ABO 0.7% Donor Samples n = 3,208 1.8% Patient Samples n = 3,449 NTD Rate after repeat testing
Antiglobulin Test Methodology Solidscreen II ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object]
[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object]
Solidscreen II Reaction Patterns Positive Antibody Screen Negative Antibody Screen
Field Trial Sensitivity by Method
Antibodies Not Detected ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Linauts S, Lammers C,  Transfusion,  Vol. 44, No. 9S, 2004, p. 123A .  ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],59 50 9 Total 16 16 0 2 to 3+ 30 25 5 w to 1+ 13 9 4 Neg Total Positive Negative LISS Tube Results (post-thaw)   Solidscreen II Results   Known Antibody Positive Samples (n=59)
Comparison of Solid-Phase Antibody  Screening Tests with  Pooled Red Cells in Blood Donors  Reference: Vox Sang 1996;71:37-42 Solid-phase antibody screening in 10,008 blood donors Technique number of Detection of donors with donors detected IgG Antibodies  (n=41)    IgG a   nonspecific b   sensitivity  specificity  test  %  %  efficiency c Capture R Ready Screen 40  61 97.6  99.39  1.40  Solidscreen II (polyspecific AHG) 39  11  95.1  99.88  1.89 Solidscreen II – (Anti-IgG) 38  2  92.7  99.98  1.95 Total  d   41  67  a  Correct positive test result: IgG antibody with blood group specificity detected. b  False-positive test result: nonspecific positive reactions with all panel cells including the autocontrol. c  The test efficiency (result validity) is the sum of the predictive values for positive and negative test results. A value of 2.0 indicates an optimal test efficiency.
Comparative Studies in Antibody Screening of Blood Donations with Three Different Pooled Red Blood Cell Reagents O. Mannherz, B. Siebert, E. A. Scharberg Biotest Medical Diagnostics, Dreieich, Germany; DRK-BSD-Nord, Institut Lütjensee, Germany; DRK-BSD Baden-Württemberg-Hessen, Institut Baden-Baden, Germany ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Load  and walk away ,[object Object],[object Object],[object Object]
Ordering Tests ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sample Requirements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Reagent Loading and Storage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Sample   Throughput ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The  Advantage ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
It's time to

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Biotest Overview March 2009

  • 1. Biotest Blood Bank Solutions March 5 th , 2009
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  • 16. Results of Rh Antisera Evaluation Biotest Significantly Outperforms 61 4 96 Anti-e 108 110 110 97 Number of samples tested Roughly Equivalent 10 14 Anti-c Roughly Equivalent 5 3 Anti-E Roughly Equivalent 29 14 Anti-C Roughly Equivalent 18 14 Anti-D Blend Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts Antisera
  • 17. Rare Antisera Evaluation Biotest Outperforms 17 2 31 Anti-s Biotest Outperforms 10 0 31 Anti-S Roughly Equivalent 6 2 30 Anti-N Roughly Equivalent 0 1 11 Anti-k Equivalent 0 0 41 Anti-K Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera
  • 18. Rare Antisera Evaluation Roughly Equivalent 4 0 30 Anti-Lea Biotest Outperforms 10 0 18 Anti-P1 Roughly Equivalent 2 2 31 Anti-Jkb Roughly Equivalent 3 8 31 Anti-Jka Biotest Outperforms 11 0 31 Anti-Fya Conclusion # Stronger with Biotest Rgts # Stronger with Reference Rgts # Samples tested Antisera
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  • 34. Solidscreen II Reaction Patterns Positive Antibody Screen Negative Antibody Screen
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  • 38. Comparison of Solid-Phase Antibody Screening Tests with Pooled Red Cells in Blood Donors Reference: Vox Sang 1996;71:37-42 Solid-phase antibody screening in 10,008 blood donors Technique number of Detection of donors with donors detected IgG Antibodies (n=41) IgG a nonspecific b sensitivity specificity test % % efficiency c Capture R Ready Screen 40 61 97.6 99.39 1.40 Solidscreen II (polyspecific AHG) 39 11 95.1 99.88 1.89 Solidscreen II – (Anti-IgG) 38 2 92.7 99.98 1.95 Total d 41 67 a Correct positive test result: IgG antibody with blood group specificity detected. b False-positive test result: nonspecific positive reactions with all panel cells including the autocontrol. c The test efficiency (result validity) is the sum of the predictive values for positive and negative test results. A value of 2.0 indicates an optimal test efficiency.
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