Download - Biotest Overview March 2009
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Biotest Blood Bank Solutions
March 5th, 2009
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Presentation Overview
• Who is Biotest? • Traditional Blood Bank
Reagents– Product offerings
• Biotest Blood Bank Automation– Overview
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Biotest – 60+ years of Transfusion Diagnostics
2005 Tango Automated Blood Bank Analyzer launched in US/Canada
2 Manual reagents cleared in Canada and submitted to FDA
3 TANGO optimo launched
4 FDA approves Tango Optimo expanded menu and manual reagents
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 BiotestSerum-Institut GmbH
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Biotest Diagnostics CorporationUSA
• Founded in 1982, wholly owned subsidiary of Biotest AG
• Company Headquarters- Rockaway, NJ• Historical Product lines
Transplant HLA• Serological and Molecular Typing Reagents and Automation
Industrial Microbiology- Clean Room Monitoring• Particle counters• Air Samplers• Agar media
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Biotest Diagnostics Corporation • Late 2006
Transfusion Product Lines• Distribution of manual blood bank reagents in
Canada • TANGO Automated Blood Bank System
• March 2008 • Moved to a new facility in Rockaway, NJ• To support growth from new products
and additional customer support activities
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New Biotest Diagnostics Headquarters
• Three state-of-the-art labs
• Customer training facility
• Equipment service center
• Customer service & support
• Warehousing & distribution
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BDC Transfusion Management
• Personnel – 40% increase since 2006 to accommodate transfusion
• Upper Management– Bill Weiss – President, BDC
• BS Chemistry, MBA • Abbott - Sales & Marketing Abbott• Immucor – Director of Sales
– Candace Williams – VP, Diagnostics Division• MT(ASCP), SBB• 13 yrs hospital transfusion service• 17 yrs, Olympus blood bank product division
– John Beck – Director of Sales• Immucor - 8 yrs experience sales, sales management and
marketing experience
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Traditional Blood Bank Reagents
• Available in Europe, Canada
and USA.• Submitted to U.S.
FDA, approved on August 15th, 2008
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Traditional Blood Bank Reagents• ABO/Rh antisera
– A, B, A,B– D Blend – weak D– D 226 – RT, no weak D claim– Control
• Anti-Human Globulin (AHG)
– Anti-IgG– Polyspecific
• Reagent Red Cells – Screening cells – three options– Two panels– A1, B, A2 cells
• Rare Antisera – C, E, c, e, K, k, – Jka, Jkb, S, s, M, N, – Fya, Lea, P1
• Potentiators & Controls
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Rh Antisera
-IgM antibodies - anti-D detects D weak but not category D VI-monoclonal => short or no incubation (IS-5’ RT)-high specificity, high avidity- strong reaction-low protein content- suitable for all techniques except antiglobulin test
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)
-3 clones (1 IgM, 2 IgG) suitable for all techniques including Antiglobulin
-detects all D’s
BS242/ BS221/ H411B7 Seraclone® Anti-D (RH1) Blend
FeaturesClonesProduct
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Rare Antisera
5’ RT
-5’ RT
-5’ RT
-5’ RT
-5’ RT
-30’ RT
-30’ RT
-5’ RT
-IAT
-IAT
-5’ RT
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 MethodClonesProduct
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Reagent Red Cell Products• Antibody Screen
– Pooled cell– 2 cell
• R1R1 (CDe/CDe) and R2R2 (cDE/cDE)• Homozygous expression of Jka
– 3 cell screen• R1R1 (CDe/CDe), R2R2 (cDE/cDE), and rr (cde/cde)
• Homozygous expression of Jka and Fya
• Antibody Identification – 8 cell, 11 cell panels– 4 ml fill volume
• ABO– A1, A2 and B cells
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Additional Manual Reagents• AHG Reagents
– Anti-IgG (light chain)– Polyspecific Anti-IgG + C3d
• IgG Coated Control RBC
• LISS (MLB2)
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Traditional Reagents: The Biotest Advantage
• Biotest antisera all monoclonal• Biotest rare antisera do not require
antiglobulin phase except anti-s & anti-Fya
• Biotest panels have 4 ml vs. 3 ml fill volume
• 16 of 20 Biotest antisera specificities represent new clones for the US market
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Traditional Reagent Evaluation
• Mike Charapata, Manager, Transfusion Services, Puget Sound Blood Center
• Presented at 2008 AABB Annual Meeting, Montreal, 2008
• Evaluated Biotest rare antisera in comparison to Immucor and Ortho
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Results of Rh Antisera Evaluation
Biotest Significantly Outperforms
61496Anti-e
108
110
110
97
Number of samples tested
Roughly Equivalent
1014Anti-c
Roughly Equivalent
53Anti-E
Roughly Equivalent
2914Anti-C
Roughly Equivalent
1814Anti-D Blend
Conclusion# Stronger with Biotest Rgts
# Stronger
with Reference
Rgts
Antisera
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Rare Antisera Evaluation
Biotest Outperforms
17231Anti-s
Biotest Outperforms
10031Anti-S
Roughly Equivalent
6230Anti-N
Roughly Equivalent
0111Anti-k
Equivalent0041Anti-K
Conclusion# Stronger with Biotest Rgts
# Stronger with Reference Rgts
# Samples testedAntisera
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Rare Antisera Evaluation
Roughly Equivalent
4030Anti-Lea
Biotest Outperforms
10018Anti-P1
Roughly Equivalent
2231Anti-Jkb
Roughly Equivalent
3831Anti-Jka
Biotest Outperforms
11031Anti-Fya
Conclusion# Stronger with Biotest Rgts
# Stronger with Reference Rgts
# Samples testedAntisera
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Rare Antisera Evaluation Conclusions
• Performance qualification– Anti-e significantly outperforms reference reagents– Anti-S, -s, -Fya, and –P1 shows stronger reactivity
than reference reagent– All reagents show at least equivalent reactivity
– Test Methodology = ease-of-use
– Labor and time savings due to number of antisera not requiring antiglobulin phase
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Traditional Reagents: The Biotest Advantage
• Biotest antisera all monoclonal• 16 of 26 Biotest antisera specificities represent
new clones for the US market• Biotest rare antisera do not require antiglobulin
phase except anti-s & anti-Fya
– 5’ RT - Anti-S, anti-K, anti-k, anti-P1– 15’ RT - Anti-Jka, anti-Jkb, anti-Lea
• Biotest panels have 4 ml vs. 3 ml fill volume• Many of the Rh and Rare antisera exhibit greater
avidity (reaction strength) and ease-of-use vs. other supplier’s products
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Fully-automated instrument for the hospital transfusion service, prenatal testing and donor centers.
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Features• Flexibility
– Batch or random access analyzer– Two, Three or Pooled antibody screening options– 2 STAT modes (Emergency and Express)
• User-Friendly - As easy as 1-2-3. (Load sample, confirm order, press start).
• Seven day on-board reagent and microplate storageIn addition:• Batch or single sample result validation • Enhanced automated maintenance• Automated QC testing – only once per day
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Microplate Storage•10 plates•7 days on-board
Plate Loading•Plate barcodes•Strip barcodes
Transport Channel•Individual strips •Test setup and mixing•RT and 37C incubation
Transport Channel•Centrifugation•Washing•Add AHG, if required
Results Interpretation•Measurement chamber•Transport belt to waste
Liquid Reagent Storage•7 day on-board storage•RT and refrigerated storage•Continuous access•Reads barcodes
Sample Loading•Continuous loading•Holds 144 samples
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Erytype and Solidscreen Platform
• Eight wells/strip• Strips move through
instrument – not plates
• 12 strips/plate
• Barcoded strips and plates– Product – Strip number– Lot number– Strip type– Expiration date
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Superior Reagent Stability
Microplates• Erytype Strips• Solidscreen StripsLiquid Reagents• AHG/IgG• MLB (LISS)• Reverse Cells• Screen Cells• Bromelin
On-board– 7 Days– 7 Days
– 7 Days– 7 Days– 7 Days– 7 Days– 24 Hours
Shelf-life– 18 months– 2 years
– 2 years– 18 months– 5 weeks– 5 weeks– 6 months
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ABO/Rh Methodology Erytype S• Standard
hemagglutination testing
• Monoclonal antisera dried in microwells– Reduces waste from
dead volume– Reduces reagent loading– Reduces solid waste
• 7 day onboard shelf-life• 18 month product
shelf-life
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ABO/Rh Method• Wells coated with dried monoclonal
antisera
• Red cells suspended in bromelin are pipetted into wells
• Antisera dissolves, test mixture incubated
• Centrifugation and resuspension of test mixture
• TANGO interprets well images
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TANGO ABO/Rh Results• Grades reactions• Makes interpretation• Compares with historical results • Stores results and interpretations (~15,000 patients)
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Field Trial ABO/Rh NTD Rates
• 51% ABO NTD due to patients condition, multiple transfusions, oncology, bone marrow transplant, etc.
• 24% due to clots/fibrin
• 21% due to weak isohemagglutinins
• 4 % Miscellaneous causes
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
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Antiglobulin Test MethodologySolidscreen II
– Microplate configuration– Strip and plate barcode process controls– On-board shelf-life is 7 days
– Product shelf-life is 2 years– Unique solidscreen methodology
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• Microplate well contains a layer of Protein A, which has a high affinity for the Fc portion of the Anti-Human Globulin (Anti-IgG)
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• Screening RBC’s are coated with patient antibodies, if antibodies are present in serum/plasma
•Plasma or serum added to well, followed by MLB (modified LISS) and screening cells
•Incubates for 20 min
at 37 degrees
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• Sensitized RBC’s and Anti-IgG bind with Protein A on well surface
• Unsensitized RBC’s form button at bottom of well
•Wells are washed with PBS
•Anti-IgG is added to the wells
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Solidscreen II Reaction Patterns
Positive Antibody Screen
Negative Antibody Screen
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Field Trial Sensitivity by Method
# Positive with
SolidScreen on TANGO
TANGO Sensitivity
(%)Reference
Method
# Positive with reference method
Reference Method
Sensitivity (%)
36 35 97.2% Immucor Capture 33 91.6%
64 60 93.7% LISS Manual Tube 53 82.8%
19 17 89.5% Ortho Gel 17 89.5%
119 112 94.1% All Methods 103 86.5%
TANGO Reference Methods
# Samples containing antibodies
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Antibodies Not Detected
By TANGO• Passive anti-D• Anti-E (3)
– IgM (1)
– +/- LISS (1)
• Anti-C – (Gel -, LISS w+)
• Anti-M (2)
By Reference Method
• Anti-D• Anti-E (3)• Anti- E, K
• Anti-K
• Anti-E, Jka• Anti-M• Anti-Lua
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Linauts S, Lammers C, Transfusion, Vol. 44, No. 9S, 2004, p. 123A.
• anti-C
• anti-Jka
• anti-C+Jka
• anti-E
• anti-K
• anti-D
• anti-c+Jka
• anti-c x2
• anti-I
• anti-M x 2
• anti-C (wk +)
• anti-D (micro +) 59509Total
161602 to 3+
30255w to 1+
1394Neg
TotalPositiveNegative
LISS Tube Results (post-thaw)
Solidscreen II Results
Known Antibody Positive Samples (n=59)
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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 donorsTechnique number of Detection of donors with
donors detected IgG Antibodies (n=41)
IgGa nonspecificb 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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Comparative Studies in Antibody Screening of Blood Donations with Three Different Pooled Red Blood Cell
ReagentsO. 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
• Tested 19,130 using pooled reagent red cells for Solidscreen II and Capture R
• Used semi-automated methods (workstations)
Specificity Sensitivity – Solidscreen II 100% 89.2%– Capture R 99.8% 90%
• Positive Predictive value (probability that when the test is positive that it contains an antibody
– Solidscreen II 97.9%– Capture R 45% (80 positive results/ only 32 were true antibodies)
• Conclusion– “Extremely low rate of false positives with Solidscreen II is highly beneficial by
reducing the amount of extra work required to resolve false positives.”
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Load and walk away
144 sample loading capacity
• 12 Racks with 12 samples each
• Continuous availability for sample loading and unloading
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Ordering Tests• Random Access Analyzer
– LIS ordering via bidirectional interface– Operator ordering via touchscreen/keyboard/mouse
• Individually by sample• All samples on screen
• Batch Analyzer– Barcoded sample rack – orders same tests for all samples in
rack• Stat Testing
– Add Stat samples at any time– Change sample status to Stat at any time prior to sampling– TANGO skips routine samples and pipettes stats as first
sample in next “mini-batch” (4 samples)
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Sample Requirements• Use of primary tubes
– Serum or plasma samples for antibody screening– All common tubes can be used simultanously
(10-16,5mm diameter, 20-115 mm height)
• Positive sample identification– All common barcodes can be read including ISBT code 128
• Sample requirements– 500 ul minimum
• Barcodes on sample rack– The rack barcodes can be used to define single tests or test
profiles.
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Reagent Loading and Storage• 12 cooled/ 6 RT positions
• Cells are kept in suspension
• Automatically reads reagent barcodes upon loading
• True level sensing
• 7-day on-board shelf-life for all reagents except bromelin
• Tracks on-board shelf-life
• Can load multiple vials or lot numbers of same reagent
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Sample Throughput
• 25 ABO/Rh tests per hour• 60 Antibody screens per hour (2 wells)• 50 ABO/Rh Confirmations per hour• Time to complete
– One ABO/Rh 17 minutes– Four ABO/Rh 22 minutes– One Type and Screen 32 minutes– Four Type and Screens 37 minutes
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The Advantage
• Easy to operate:– Flexible operations; continuous access capability– Load samples, request tests, press start– Stores reagents for multiple assay types– Happier techs! - Easy to use by generalists & dedicated staff
• Low Operating Costs:– QC only once a day – Controls not required with each sample or batch– Two, three or pooled screen cell options– Excellent specificity/sensitivity = fewer repeats– On-board reagent storage (7 days) = minimal reagent waste
• Increased Productivity– True Stat capability - Linear rack system means no lock out period– Daily maintenance in less than 10 minutes– Excellent process control– Less reagent manipulation
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