Analytically coherent

Transcription

1 ZO M OCTOBER 2017 N 7 sebia FLC Free light chain testing coherent with electrophoretic methods Analytically coherent SPE: 3.1 g/l FLC Nephelometry: 32.2 g/l FLC ELISA: 3.1 g/l Principle The sebia FLC Kappa & sebia FLC Lambda kits are based on a solid phase sandwich enzymelinked 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. 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 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 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 blocks - PN 5303 Non coated ELISA Plates Related publications - Jacobs FM et al. Clin Chem Lab Med de Kat Angelino CM et al. Clin Chem 2010;56: Posters* IFCC R. van der Molen - V. Frenkel - Sebia R&D SEBIA reserves the right to change this information at any time without prior notice. sflc z7-en 10/ Trademarks : Learn more about sebia FLC through the following clinical cases... * Available on our website

2 sflc CLINICAL CASES

3 CLINICAL CASE #1* DATE OF BIRTH April 11 th, 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 Serum protein electrophoresis by CAPILLARYS PROTEIN(E) 6 M-peaks = 3000 mg/l Two faints monoclonal peaks in the middle of gamma fraction. To be confirmed by immunotyping and/or immunofixation.

4 CLINICAL CASE #1 Typing of monoclonal component by CAPILLARYS IMMUNOTYPING Monoclonal peak still present Monoclonal peak still subtracted Polymerized monoclonal free light chain kappa (or IgD/IgE kappa)

5 CLINICAL CASE #1 Serum Free Light Chain Freelite on SPAPLUS 1:10 (standard) 85.7 P 1: P 1:1000** > :10 (standard) Ratio K/L = :10000** P: Tag indicating a potential prozone effect ** 1:1000 and 1:10000 require a manual dilution step sebia FLC on AP22 ELITE 1:1000 (standard) >98 1:10000 >980 1: :1000 (standard) 18.6 Ratio K/L = 259 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 assay and SPAPLUS analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product

6 CLINICAL CASE #2* DATE OF BIRTH June 10 th, 1951 SERUM PEAK/Pathology Kappa Light Chain (K) Multiple Myeloma Helmut Z. *Real case. Courtesy of an European University Hospital Serum protein electrophoresis by CAPILLARYS PROTEIN(E) 6 M-peaks = 400 mg/l Faint monoclonal peak in the end of gamma fraction. To be confirmed by immunotyping and/or immunofixation.

7 CLINICAL CASE #2 Typing of monoclonal component by CAPILLARYS IMMUNOTYPING Monoclonal peak still present Monoclonal peak still subtracted Monoclonal free light chain kappa (or IgD/IgE kappa)

8 CLINICAL CASE #2 Serum Free Light Chain Freelite on SPAPLUS 1:10 (standard) P 1:100 >1178 1:1000** :10 (standard) 5.1 Ratio K/L = 1066 P: Tag indicating a potential prozone effect ** 1:1000 require a manual dilution step sebia FLC on AP22 ELITE 1:1000 (standard) >98 1: :1000 (standard) 6.65 Ratio K/L = 77.7 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 assay and SPAPLUS analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product

9 CLINICAL CASE #3* Jose R. *Real case. Courtesy of an European University Hospital DATE OF BIRTH September 4 th, 1938 SERUM PEAK/Pathology URINE PEAK PROTEINURIA IgG Kappa Multiple Myeloma Free Light Chain K Mixed Serum protein electrophoresis by CAPILLARYS PROTEIN(E) 6 M-peak 1 = 1300 mg/l M-peak 2 = 1900 mg/l Two monoclonal peaks one in beta and one in the middle of gamma. To be confirmed by immunotyping and/or immunofixation.

10 CLINICAL CASE #3 Typing of monoclonal component by CAPILLARYS IMMUNOTYPING Monoclonal peak still present Monoclonal peak still subtracted Monoclonal IgG kappa in gamma. Monoclonal free light chain kappa (or IgD/IgE kappa) in beta.

11 CLINICAL CASE #3 Serum Free Light Chain Freelite on SPAPLUS 1:10 (standard) >165 1:100 >1778 1:1000** :10 (standard) 10.2 Ratio K/L = 2185 P: Tag indicating a potential prozone effect ** 1:1000 require a manual dilution step sebia FLC on AP22 ELITE 1:1000 (standard) >98 1:10000 >980 1: :1000 (standard) 5.3 Ratio K/L = 311 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 assay and SPAPLUS analyser are THE BINDING SITE (Birmingham, UK) products; AP22 ELITE analyser is a DAS (Palombara Sabina, Italy) product