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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

Product Specialist Training ® – V3 – QWALYS2






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


Principle

1

2

3


Visualization of RBCs attraction


Principle

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



Magnetization of RBC






Agenda


II. E.M.® Technology tests


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



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



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






AGENDA


III. Grouping and Phenotyping on Qwalys - Products


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


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


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


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


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


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


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


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


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


PROTOCOL


PREANALYTICAL STEP

PROTOCOL


+ -

Shaking 11 min 30 s

Shaking 22 min 45 s

Reading

Incubation 8 min 30 sRoom temperature

Magnetization 4 minutes

PROTOCOL


Anti-A Anti-B Anti-AB Anti-D Anti-C Anti-c Anti-E Anti-e Anti-K Ctl neg A1 B

EXAMPLE







AGENDA


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


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


ScreenLys – 32 testsIgG

H1 H2 H3 H1 H2 H3 H1 H2 H3 H1 H2 H3

MICROPLATE


Designation Phenotype

SERA CQI D Strong reaction

SERA CQI Fya Weak reaction

SERA CQI Neg Negative reaction



Serum or plasma

Screen DiluentNanoLys

Magnetic plate

HemaScreen

Anti-Human Globulin (AHG)

Indirect Antiglobulin Test principle (Indirect Coombs)


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


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


Magnetized RBC

Negative reaction-

RESULTS


PROTOCOL


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


Negative reaction

Negative reaction-Positive reaction

Positive reaction

+

RESULTS


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


AbS and IdentificationI-Mag Range

I-Mag Range – MAY2019 – Confidential

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


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


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


Negative reaction

Positive reaction

Magnetized RBC


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


Magnetized RBC

Negative reaction-

RESULTS with I-Mag Cells


EXAMPLE


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


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






AGENDA


Our values at the service of transfusion

Creativity Performance Commitment


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