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HbA1c Testing - Mrs Lutteri

1) The clinical biochemistry laboratory at CHU Liège hospital successfully converted from using HPLC to capillary electrophoresis using the Sebia CAPILLARYS 3 OCTA system for measuring HbA1c levels. 2) Over 20,000 HbA1c tests per year are performed with high accuracy and reproducibility compared to the previous HPLC method. 3) The CAPILLARYS 3 OCTA system allows detection of hemoglobin variants that were previously missed by HPLC, aiding in the diagnosis of hemoglobinopathies.

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43 views38 pages

HbA1c Testing - Mrs Lutteri

1) The clinical biochemistry laboratory at CHU Liège hospital successfully converted from using HPLC to capillary electrophoresis using the Sebia CAPILLARYS 3 OCTA system for measuring HbA1c levels. 2) Over 20,000 HbA1c tests per year are performed with high accuracy and reproducibility compared to the previous HPLC method. 3) The CAPILLARYS 3 OCTA system allows detection of hemoglobin variants that were previously missed by HPLC, aiding in the diagnosis of hemoglobinopathies.

Uploaded by

Nawfal Faik
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© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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SEBIA

20 avril 2023

HbA1c testing: successful conversion


to capillary electrophoresis.

L.Lutteri
Clinical Biologist
Clinical Chemistry Department
Professor Cavalier
CHU Liège 1
CHU LIEGE, site Sart Tilman
Biochemistry lab, CHU LIEGE
Biochemistry lab, CHU LIEGE

2007 :

CAPILLARYS -> 2 (2012) HYDRASYS HYDRASYS


Serum Protein FOCUSING
Electrophoresis
.Serum Immunofixation
.Urine electrophoresis
.Urine Immunofixation
.Iso LDH
.Iso CK
.Iso PAL
.OCB
HbA1c by HPLC.
Biochemistry lab, CHU LIEGE

2023 :

HYDRASYS
CAPILLARYS 3 OCTA FOCUSING
.Serum Immunofixation
Serum Protein Electrophoresis
.Urine electrophoresis
HbA1c
.Urine Immunofixation
CDT
.Iso PAL
Hemoglobinopathy
.OCB
CAPILLARYS 3 OCTA

Every day, from Monday to Friday :

+/- 100 serum proteins electrophoresis +/- 100 HbA1c

Once a week, CDT run. Once a week, hemoglobinopathy run.


HbA1c

Annual number of HbA1c


22000

21000

20000

19000

18000

17000

16000

15000
2015 2016 2017 2018 2019 2020 2021 2022
CHU LIEGE,
site Notre Dame des Bruyères

Every day, from Monday to Sunday :

+/- 25 HbA1c
CAPILLARYS 3 OCTA :
from installation to use.

End of June 2022 End of August 2022

1 day of training
1-2 weeks of validation 1-2 weeks week of validation

2 weeks of reporting 2 weeks of reporting

BELAC Began : 9,01,2023


Began : 25,08,2022
CAPILLARYS 3 OCTA :
benefits.

• Automatic wake-up :
CAPILLARYS 3 OCTA :
benefits.

Switch : on Wednesday, we begin by hemoglobinopathies


and when the run is finished, we switch very easily to HbA1c.
CAPILLARYS 3 OCTA :
benefits.

Bidirectional system : name of the patients -> follow-up


CAPILLARYS 3 OCTA :
benefits.

Single-platform for
. HbA1c,
. hemoglobinopathies,
. serum protein electrophoresis
. CDT.

 One type of maintenance


 Back-up
CAPILLARYS 3 OCTA :
benefits.

Visual alarm in case of atypical profile.


CAPILLARYS 3 OCTA :
benefits.

Variants : as a minimum : S, C, D, E, F + A2
CAPILLARYS 3 OCTA :
benefits.
HbA2 :

HPLC : No result of HbA2


(coelution with HbA0)
CAPILLARYS 3 OCTA :
benefits.

Variants :

HPLC :
No result
CAPILLARYS 3 OCTA :
benefits.

• Traceability of the reagents : RfID tag.


CAPILLARYS 3 OCTA :
status quo

Speed : HPLC : 1.5 min / 8 capillaries : +/- 15 minutes…but higher resolution !

Dia de Sebia
CAPILLARYS 3 OCTA :

VALIDATION

. Accuracy : precision and « trueness »


.Correlation of methods
CAPILLARYS 3 OCTA :

Precision :
Reproductibility :

Dia de Sebia
CAPILLARYS 3 OCTA :

Reproductibility : 5 x 5

1 2
CAPILLARYS 3 OCTA :

« Trueness »:
no analyser bias in the QCE
CAPILLARYS 3 OCTA :

« Trueness »: no analyser bias in the QCE


CAPILLARYS 3 OCTA :

Correlation N = 213

Schéma de Sebia
Capillarys 3 OCTA :

DAILY USE
Internal control

• Each day :
– morning : Sebia level 1 (normal) on each
capillary

– evening : Sebia level 2 (high) on each


capillary
NORMAL PROFILE
VARIANTS

• Each day : 1-3 variants observed with


HbA1c program.

• Since the begining of HbA1c on Capillarys


3 : 111 unknown variants were observed
and transmitted to genetic lab for
hemoglobinopathies perfomed on
Capillarys 3.
UNKNOWN VARIANTS

Detected by HbA1c program :

Variants HbA1c program Hemoglobinopathy


HbA2 41 HbA2 : Bêta-thalassemia
HbC 2 Hétéro A/C
HbD 3 Hétéro A/D
HbE 3 Hétéro 2 A/E +
1 homo E/E
HbS 25 Hétéro A/S
HbF 22 + 2> 23% HbF
Delta 9 Normal profile /
Hétéro HbA2
? 2 Normal profile
? 2 Hb Lepore to be
confirmed
VARIANTS HbS on HbA1c program

Capillarys 3 <- HPLC


VARIANTS HbC on HbA1c program

Capillarys 3 <- HPLC


VARIANTS HbD on HbA1c program

Capillarys 3 <- HPLC


VARIANTS HbE on HbA1c program

Capillarys 3 <- HPLC


VARIANTS delta on HbA1c program

Capillarys 3
VARIANTS HbF on HbA1c program
Conclusions

Main benefits :

Automatic wake-up

Switch

Traceability

Variants detection

Accuracy
38

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