Analytically coherent - Sebia ZOOM N7-sebia FLC_2.pdf · “Analytically coherent” OCTOBER 2017...
Transcript of Analytically coherent - Sebia ZOOM N7-sebia FLC_2.pdf · “Analytically coherent” OCTOBER 2017...
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“Analytically coherent”
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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.
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
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
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
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
Dilution Kappa free mg/L
1:1000 (standard) >98
1:10000 >980
1:100000 4818
Dilution Lambda free mg/L
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
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
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
Laboratory testSerum protein electrophoresis by CAPILLARYS PROTEIN(E) 6
M-peaks = 400 mg/L
Interpretation: Faint monoclonal peak in the end of gamma fraction. To be confirmed by immunotyping and/or immunofixation.
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
CLINICAL CASE #2
Laboratory testTyping of monoclonal component by CAPILLARYS IMMUNOTYPING
Interpretation:
Monoclonal free light chain kappa (or IgD/IgE kappa)
Monoclonal peak still present
Monoclonal peak still subtracted
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
CLINICAL CASE #2
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 10 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) 144.9 P
1:100 >1178
1:1000** 5437.4
Dilution Lambda free mg/L
1:10 (standard) 5.1
Ratio K/L = 1066
P: Tag indicating a potential prozone effect ** Dilution 1:1000 require a manual dilution step
Dilution Kappa free mg/L
1:1000 (standard) >98
1:10000 517.4
Dilution Lambda free mg/L
1:1000 (standard) 6.65
Ratio K/L = 77.7
Freelite® assay and SPAPLUS® analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
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
Laboratory testSerum protein electrophoresis by CAPILLARYS PROTEIN(E) 6
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
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
CLINICAL CASE #3
Laboratory testTyping of monoclonal component by CAPILLARYS IMMUNOTYPING
Interpretation: Monoclonal IgG kappa in gamma. Monoclonal free light chain kappa (or IgD/IgE kappa) in beta.
Monoclonal peak still present
Monoclonal peak still subtracted
BEYOND SEPARATION FLC LineBEYOND SEPARATION FLC Line
CLINICAL CASE #3
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 7 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) >165
1:100 >1778
1:1000** 11580.3
Dilution Lambda free mg/L
1:10 (standard) 10.2
Ratio K/L = 2185
P: Tag indicating a potential prozone effect ** Dilution 1:1000 require a manual dilution step
Dilution Kappa free mg/L
1:1000 (standard) >98
1:10000 >980
1:100000 1648.6
Dilution Lambda free mg/L
1:1000 (standard) 5.3
Ratio K/L = 311
Freelite® assay and SPAPLUS® analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product