analytically coherent - sebia zoom n7-sebia flc_2.pdf · “analytically coherent” october 2017...

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“Analytically coherent”

OCTOBER 2017N°7

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References- PN 5100 sebia FLC

Kappa kit- PN 5101 sebia FLC

Lambda kit

Compatible Instruments- PN 5000 das AP22 ELITE

Other references- PN 4785 Normal Control

Serum- PN 4787 Hypergamma

Control Serum- PN 5300 Dilution blocks- PN 5303 Non coated

ELISA Plates

Related publications- Jacobs FM et al.

Clin Chem Lab Med 2017- de Kat Angelino CM et al.Clin Chem 2010;56:1188-90

Posters*IFCC 2017- R. van der Molen- V. Frenkel- Sebia R&D

Performances• Broad dynamic range: 3 to 4 times less

retesting than with the historical methods• Excellent precision• Antigen excess free• Enhanced linearity • Better coherence with the “gold standard” for

M-spike quantification: Serum Protein Electrophoresis

• Lower lot-to-lot variability

sebia FLC: ELISA simplified• All reagents, calibrators and controls are ready

to use • Kappa and Lambda plates are

pre-coated with polyclonal anti-free light chain antibodies

• Test are done in single• Fully automated• Final results can be exported to the LIS

PrincipleThe sebia FLC Kappa & sebia FLC Lambda kits are based on a solid phase sandwich enzyme-linked immunosorbent assay (ELISA) for the measurement of kappa and lambda Free Light Chains (FLC) in human serum. The kits can be used either as a manual technique or fully automated with the das AP22 ELITE Elisa processor. This test has been designed to offer a better coherence with the referenced technics, less retesting and to overcome most of the proven analytical issues related to sFLC quantitative assays based on nephelometry/turbidimetry techniques.

Free light chain testing coherent with electrophoretic methods

sebia FLC

SPE: 3.1 g/LFLC Nephelometry: 32.2 g/LFLC ELISA: 3.1 g/L

Learn more about sebia FLC through the following clinical cases...

BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line

sFLC CLINICAL CASES

BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line

CLINICAL CASE #1*

DATE OF BIRTH April 11th, 1952

SERUM PEAK/Pathology Kappa Light Chain (K) Multiple Myeloma

URINE PEAK Free Light Chain K

Maria T.*Real case. Courtesy of an European University Hospital

Laboratory testSerum protein electrophoresis by CAPILLARYS PROTEIN(E) 6

M-peaks = 3000 mg/L

Interpretation: Two faints monoclonal peaks in the middle of gamma fraction. To be confirmed by immunotyping and/or immunofixation.


CLINICAL CASE #1

Laboratory testTyping of monoclonal component by CAPILLARYS IMMUNOTYPING

Interpretation:

Polymerized monoclonal free light chain kappa (or IgD/IgE kappa)

Monoclonal peak still present

Monoclonal peak still subtracted


CLINICAL CASE #1

Laboratory testSerum Free Light Chain

Interpretation: Both methods detected elevated kappa free light chains and K/L ratio. The Sebia FLC assay provided a kappa value 9 times lower than the turbidimetry test, showing more coherence with the peak measurement done by the electrophoretic methods.

Freelite® on SPAPLUS®

sebia FLC on AP22 ELITE

Dilution Kappa free mg/L

1:10 (standard) 85.7 P

1:100 1300 P

1:1000** >16570

1:10000** 36400

Dilution Lambda free mg/L

1:10 (standard) 24.43

Ratio K/L = 1490

P: Tag indicating a potential prozone effect ** Dilution 1:1000 and 1:10000 require a manual dilution step


1:1000 (standard) >98

1:10000 >980

1:100000 4818


1:1000 (standard) 18.6

Ratio K/L = 259

Freelite® assay and SPAPLUS® analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product


CLINICAL CASE #2*

DATE OF BIRTH June 10th, 1951

SERUM PEAK/Pathology Kappa Light Chain (K) Multiple Myeloma

Helmut Z.*Real case. Courtesy of an European University Hospital


M-peaks = 400 mg/L

Interpretation: Faint monoclonal peak in the end of gamma fraction. To be confirmed by immunotyping and/or immunofixation.


CLINICAL CASE #2


Interpretation:

Monoclonal free light chain kappa (or IgD/IgE kappa)




CLINICAL CASE #2


Interpretation: Both methods detected elevated kappa free light chains and K/L ratio.The Sebia FLC assay provided a kappa value 10 times lower than the turbidimetry test, showing more coherence with the peak measurement done by the electrophoretic methods.




1:10 (standard) 144.9 P

1:100 >1178

1:1000** 5437.4


1:10 (standard) 5.1

Ratio K/L = 1066

P: Tag indicating a potential prozone effect ** Dilution 1:1000 require a manual dilution step


1:1000 (standard) >98

1:10000 517.4


1:1000 (standard) 6.65

Ratio K/L = 77.7



CLINICAL CASE #3*

DATE OF BIRTH September 4th, 1938

SERUM PEAK/Pathology IgG Kappa Multiple Myeloma

URINE PEAK Free Light Chain K

PROTEINURIA Mixed

Jose R.*Real case. Courtesy of an European University Hospital


Interpretation: Two monoclonal peaks one in beta and one in the middle of gamma. To be confirmed by immunotyping and/or immunofixation.

M-peak 1 = 1300 mg/L

M-peak 2 = 1900 mg/L


CLINICAL CASE #3


Interpretation: Monoclonal IgG kappa in gamma. Monoclonal free light chain kappa (or IgD/IgE kappa) in beta.




CLINICAL CASE #3


Interpretation: Both methods detected elevated kappa free light chains and K/L ratio.The Sebia FLC assay provided a kappa value 7 times lower than the turbidimetry test, showing more coherence with the peak measurement done by the electrophoretic methods.




1:10 (standard) >165

1:100 >1778

1:1000** 11580.3


1:10 (standard) 10.2

Ratio K/L = 2185

P: Tag indicating a potential prozone effect ** Dilution 1:1000 require a manual dilution step


1:1000 (standard) >98

1:10000 >980

1:100000 1648.6


1:1000 (standard) 5.3

Ratio K/L = 311


analytically coherent - sebia zoom n7-sebia flc_2.pdf · “analytically coherent” october 2017...

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