product specialist training
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Product Specialist TrainingProduct Specialist Training
1
Product Specialist Training ® – V3 – QWALYS
AGENDA
I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests overview
III. Grouping and Phenotyping on QWALYS®
IV. Antibody screening on QWALYS®
V. QWALYS® Presentation
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I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests overview
III. Grouping and Phenotyping on QWALYS®
V. QWALYS® Presentation
IV. Antibody screening on QWALYS®
AGENDA
3 Product Specialist Training ® – V3 – QWALYS
I. Definition and principleE.M.® Technology : Erythrocyte Magnetized Technology
New technology based on the magnetization of red blood cells (RBCs)
The magnetic force by attracting the red blood cells replaces centrifugation
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RBC
Magnetic particles
Iron particleAnti-GPAGPA
• Specific magnetization: the magnetization occurs thanks to anti-GPA antibodycoupled to an iron particle.
(ex: Coombs, Extended phenotyping…)
• Adsorption: red cells are magnetized thanks to magnetic particles(ex: panels during production process)
Magnetization of RBC
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I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests overview
III. Grouping and Phenotyping on QWALYS®
V. QWALYS® Presentation
IV. Antibody screening on QWALYS®
Agenda
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II. E.M.® Technology tests
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Grouping / Phenotyping13 configurations to meet countries requirementsDIAGAST monoclonal antibodiesPatients RBCs magnetization on board
Antibody Screening (AbS)3 set of RBCs for receiver AbSPool of 2 RBCs for donor AbSPre-magnetized panels
Antibody IdentificationPanel of 11 magnetized RBCsPre-magnetized panel
HEMALYS A1, B
HEMALYS A1, A2, B, O
HEMASCREEN
HEMASCREEN POOL
HEMA-IDENT
II. E.M.® Technology tests
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Antibody Screening (AbS)3 set of RBCs for receiver AbSPool of 2 RBCs for donor AbSPre-magnetized panels
Antibody IdentificationPanel of 11 magnetized RBCsPre-magnetized panel
I-Mag Screen
I-Mag Pool
I-Mag Ident
On board magnetization with IRONMAG
II. E.M.® Technology tests
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Weak-D / Partial-D TestDetermination of Weak-D and Partial-D Ag (hospitalization, pregnancy)
Direct Antiglobulin Test (DAT)Check if patients RBCs are sensitized with unexpected antibody (IgG type) or complement protein (C3d)
Extended PhenotypingDetermine precisely the phenotype of a patient or a donorJK1 – JK2 – FY1 – FY2 – MNS3 – MNS4 – KEL2
CrossmatchCheck the compatibility between a recipient and packed red cells
I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests overview
III. Grouping and Phenotyping on QWALYS®
V. QWALYS® Presentation
IV. Antibody screening on QWALYS®
AGENDA
Product Specialist Training ® – V3 – QWALYS13
III. Grouping and Phenotyping on Qwalys - Products
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Kits for Grouping & Phenotyping include :Microplates with pre-dispensed reagentsMagnetizing solution «MagneLys »
2 packaging available for Bromeline enzyme1 x 100 mL5 x 100 mL
Reverse typing cells – HEMALYS : already magnetized and ready-to-use
All the products are barcoded (for a complete traceability)
Reference Designation Composition Nbr of test / kit
79960 DuoLysMagnelys 40 mL
96 tests12 plates of 8 tests
79851 D-Plates 10 microplates 960 tests
69024Bromeline
1 x 100 mL 192 tests
5 x 100 mL 960 tests69860
59659 HemaLysA1, B 2 x 5 mL 192 tests
59661 HemaLys A1, A2, B, O 4 x 5 mL 192 tests
20700 CleanLys 1L -
III. Grouping and Phenotyping on Qwalys - Products
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Designation5 days storage configuration On board configurationShelf life after
opening Storage Shelf life after opening Storage
DuoLys
5 days
4°C covered48h
Room T°HemaLys A1, B
4°CBromeline5 days
MagneLys
CleanLys 24h (on board)10 days (after dilution) Room T° 24h (on board)
10 days (after dilution)Room T°
D – Plate - -
CONFIGURATION
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A B AB D C c E e K Ctl
A B D Ctl A B D Ctl
A B AB D1 D2 Ctl
A B AB D1 D3 Ctl
DuoLys
ABD-Lys
Groupa 2 Lys
Groupa DVI Lys
MICROPLATES
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A B AB D1 CDE Ctl
C c E e K Ctl C c E e K Ctl
C1 c1 E1 e1 K1 Ctl C2 c2 E2 e2 K2 Ctl
A A1 B AB D1 D2 Ctl
Groupa CDE Lys
PhenoLys
Pheno 1,2 Lys
Groupa A1 Lys
MICROPLATES
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A B AB D C c E e K Ctl
A B DVI+ Ctl A B DVI+ Ctl A B DVI+ Ctl
A B DVI- Ctl A B DVI- Ctl A B DVI- Ctl
C c E e K Ctl C c E e K Ctl
C1 c1 E1 e1 K1 Ctl C2 c2 E2 e2 K2 Ctl
DuoLys v2
ABDVI-Lys v2
ABD-Lys v2
PhenoLys v2
MICROPLATES
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Pheno 1,2 Lys v2
Designation Group Phenotype
HEMA CQI 1 AB D-C-E-c+e+ RH -1, -2, -3, 4, 5
K-KEL-1
HEMA CQI 2 B D+C+E-c-e+RH 1, 2, -3, -4, 5
K-KEL-1
HEMA CQI 3 O D+C+E+c+e+ RH 1, 2, 3, 4, 5
K+ KEL 1
HEMA CQI 4 A D+C-E+c+e-RH 1, -2, 3, 4, -5
K-KEL-1
Internal Quality Control – IQC
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Known samples used to check the validity of the entire analysis system (reagents,
instrument and method).
The results obtained by the system must match with the expected ones.
It is strongly advised to perform daily tests (Mandatory in some countries).
Glycoproteins coverantigens
Glycoproteins
Bromeline
Bromeline lyses glycoproteinsAntibodies can bound antigens
+ =
Antigen
Monoclonal IgM (reagent)
Red blood cellantigens Agglutination
Main principle of agglutination
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Magnetic particulesMagneLys
Bromeline
Pre-dispensed monoclonal antibodies
Magnetic plate
The magnetic field attracts the red cells to the bottom of the wells
Main principle of agglutination
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No antibody/antigen affinityHomogeneous solution of red cells in the well
Antibody/antigen affinitySpecific agglutination in the middle of the well
Negative reaction
Negative reaction-Positive reaction
Positive reaction
+
RESULTS
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+ -
Shaking 11 min 30 s
Shaking 22 min 45 s
Reading
Incubation 8 min 30 sRoom temperature
Magnetization 4 minutes
PROTOCOL
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Anti-A Anti-B Anti-AB Anti-D Anti-C Anti-c Anti-E Anti-e Anti-K Ctl neg A1 B
EXAMPLE
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I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests
III. Grouping and Phenotyping on QWALYS®
V. QWALYS® Presentation
IV. Antibody screening on QWALYS®
AGENDA
Product Specialist Training ® – V3 – QWALYS29
Reference Designation Composition Nbr of test / kit
79853 ScreenLys
6 plates of 32 tests
192 testsScreenDiluent (40mL)
NanoLys (7 x 8 mL)
59852 HemaScreen
HemaScreen 1 (4,5 mL)
192 testsHemaScreen 2 (4,5 mL)
HemaScreen 3 (4,5 mL)
20700 CleanLys 1L -
IV. Antibody screening on QWALYS® – Products
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Designation5 days storage configuration
Shelf life after opening Storage
ScreenLys 8 days Room T°
HemaScreen 5 days
4°CNanoLys 8 days
Screen Diluent 20 days
CleanLys 24h (on board)10 days (after dilution) Room T°
CONFIGURATION
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ScreenLys – 32 testsIgG
H1 H2 H3 H1 H2 H3 H1 H2 H3 H1 H2 H3
MICROPLATE
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Designation Phenotype
SERA CQI D Strong reaction
SERA CQI Fya Weak reaction
SERA CQI Neg Negative reaction
Internal Quality Control – IQC
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Serum or plasma
Screen DiluentNanoLys
Magnetic plate
HemaScreen
Anti-Human Globulin (AHG)
Indirect Antiglobulin Test principle (Indirect Coombs)
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Using microplates pre-coated with anti-IgG Anti-Human Globulin (AHG)
Nanolys plays an essential density barrier role:More specificityAvoid washing step
The magnetic force attracts cells at the bottom of the well
Negative reaction
Positive reaction
Magnetized RBC
Anti-Human Globulin (AHG)
Unexpected antibody
Anti-Human Globulin captures the RBC-bounded antibody, The RBC/antibody complex forms a layer on the well
Positive reaction
+
There is no unexpected antibody in the serum. RBCs do not react with the AGH and create a dot in the center of the well
Anti-Human Globulin (AHG)
Magnetized RBC
Negative reaction-
RESULTS
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Incubation20 min – 37°C
Magnetic shaking4 min5 6
HemaScreen bound unexpected antibodies.
RBCs are attracted at the bottom of the well.
RBCs sensitized by unexpected antibodies will bound the AHG all around the well during the shaking step Not sensitized RBCs will directly fall to the bottom of the well.
Nanolys filters unspecific antibodies which are not bound to RBCs.
Shaking step promotes contact between AHG coated all around the well and unexpected antibodies.
PROTOCOL
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Negative reaction
Negative reaction-Positive reaction
Positive reaction
+
RESULTS
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Sera CQI D1/4
Sera CQI D1/8
Sera CQI D1/16
Sera CQI D1/32
D CNRGS1,25 ng
D CNRGS0,6 ng
PureSera CQI Fya
Sera CQI Fya 1/2
Sera CQI Fya 1/4
PureSera CQI D
Sera CQI D1/2
D CNRGS5 ng
D CNRGS2,5 ng
EXAMPLE
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RBC
Magnetic particles
Iron particleAnti-GPAGPA
• Specific magnetization: the magnetization occurs thanks to anti-GPA antibodycoupled to an iron particle in a new buffer: I-Mag Diluent.
Panels magnetized during production process I-Mag Screen / I-Mag Ident
• Adsorption: red cells are magnetized thanks to magnetic particlesPanels magnetized during production process HEMASCREEEN / HEMA-IDENT
NEW WAY OF MAGNETISATION
I-Mag Range – MAY2019 – Confidential
I-Mag RANGE
I-Mag Range – MAY2019 – Confidential
Reference Designation Composition
79861 ScreenLys Plate 6 microplate coated with AHG anti-IgG
69305 NanoLys 8 vials of Nanolys
69312 I-Mag Diluent 1 vial of 50 mL
59857 I-Mag Screen Panel of 3 magnetized RBC for Antibody Screening test
59859 I-Mag Ident Panel of 11 magnetized RBC for Antibody Identification test
20000 IRONMAG Anti-GPA coupled with magnetized bead used for the autologous control
Protocol
I-Mag Range – MAY2019 – Confidential
50 μl NanoLys
50 μl I-Mag Diluent
15 μl I-Mag Screen 1/2/3
15 μl Plasma/Sérum
Incubationat 37°C for 20 min
Magnetic Shaking7 minutes
Magnetized RBC will only be the one
crossing the NanoLys barrier
= Magnetic field has no effect on non-
specific antibodies
= No washing step
+
-Sedimentation point
Layer of RBC
Protocol
I-Mag Range – MAY2019 – Confidential
Negative reaction
Positive reaction
Magnetized RBC
Anti-Human Globulin (AHG)
Unexpected antibody
Anti-Human Globulin captures the RBC-bounded antibody, The RBC/antibody complex forms a layer on the well
Positive reaction
+
There is no unexpected antibody in the serum. RBCs do not react with the AHG and create a dot in the center of the well
Anti-Human Globulin (AHG)
Magnetized RBC
Negative reaction-
RESULTS with I-Mag Cells
I-Mag Range – MAY2019 – Confidential
EXAMPLE
I-Mag Range – MAY2019 – Confidential
D 2,5 ng
D 1,25 ng
D 0,625 ng
SCQI D
SCQI Fya
SCQI Fya 1/2
SCQI Neg
NB: Blue control is used as a control of plasma dispensing at the EFS in FranceIt becomes blue when it comes in contact with plasma proteins
ADVANTAGE
I-Mag Range – MAY2019 – Confidential
Same price• Same as Hemascreen cells
Expiry date• 3 weeks 6 weeks• Shipment every 3 weeks • Overlapping of 2 week between 2 batches
Autologous control in Identification• Patient plasma VS his/her own RBC• Autoantibody VS Alloantibody
I. Definition and principle of E.M.® Technology
II. E.M.® Technology tests overview
III. Grouping and Phenotyping on QWALYS®
V. QWALYS® Presentation
IV. Antibody screening on QWALYS®
AGENDA
Product Specialist Training ® – V3 – QWALYS48