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Seralite® Resources

    1. Drayson MT, Tans LX, Drew R, Mead GP, Carr-Smith H, Bradwell AR. Serum free light-chain measurements for identifying and monitoring patients with nonsecretory multiple myeloma. Blood 2001; 97(9):2900-2
    2. Bradwell AR, Carr-Smith HD, Mead GP, Harvey TC, Drayson MT. Serum test for assessment of patients with Bence Jones myeloma. Lancet 2003 8;361:489-91
    3. Hutchison CA, Blade J, Cockwell P, Cook M, Drayson M, Fermand JP, Kastritis E, Kyle R, Leung N, Pasquali S, Winearls C. International Kidney and Monoclonal Gammopathy Research Group. Novel approaches for reducing free light chains in patients with myeloma kidney. Nat Rev Nephrol. 2012 21;8(4):234-243
    4. Drayson MT. Using single protein biomarkers to predict health and disease in diverse patient populations: a new role for assessment of immunoglobulin free light chains. Mayo Clin Proc 2012 87(6):505-7
    5. Dispenzieri A, Kyle R, Merlini G, Miguel JS, Ludwig H, Hajek R, Palumbo A, Jagannath S, Blade J, Lonial S, Dimopoulos M, Comenzo R, Einsele H, Barlogie B, Anderson K, Gertz M, Harousseau JL, Attal M, Tosi P, Sonneveld P, Boccadoro M, Morgan G, Richardson P, Sezer O, Mateos MV, Cavo M, Joshua D, Turesson I, Chen W, Shimizu K, Powles R, Rajkumar SV, Durie BG. International Myeloma Working Group guidelines for serum-free light chain analysis in multiple myeloma and related disorders. 2009 Feb;23(2):215-24.
    6. Dimopoulos M, Kyle R, Fermand JP Rajkumar SV, San Miguel J, Chanan-Khan A, Ludwig H, Joshua D, Mehta J, Gertz M, Avet-Loiseau H, Beksaç M, Anderson KC, Moreau P Singhal S, Goldschmidt H, Boccadoro M, Kumar S, Giralt S, Munshi NC, Jagannath S; International Myeloma Workshop Consensus Panel 3. Consensus recommendations for standard investigative workup: report of the International Myeloma Workshop Consensus Panel 3. Blood. 2011 May 5;117(18):4701-5.
    7. Bird JM, Owen, RG, D’sa, S et al. Guidelines for the diagnosis and management of multiple myeloma 2014.
    8. Harousseau JL, Dreyling M. Multiple myeloma: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol 2009;20:97-9
    9. Rajkumar SV, Kyle RA, Therneau TM, Melton LJ, 3rd, Bradwell AR, Clark RJ, et al. Serum free light chain ratio is an independent risk factor for progression in monoclonal gammopathy of undetermined significance. Blood 2005;106:812–7
    10. Kyle RA, Durie BG, Rajkumar SV, Landgren O, Blade J, Merlini G, et al. Monoclonal gammopathy of undetermined significance (MGUS) and smoldering (asymptomatic) multiple myeloma: IMWG consensus perspectives risk factors for progression and guidelines for monitoring and management. Leukemia 2010;24:1121-7
    11. John P Campbell, Mark Cobbold, Yanyun Wang, Margaret Goodall, Sarah L. Bonney, Anita Chamba, Jane Birtwistle, Timothy Plant, Zaheer Afzal, Roy Jefferis, Mark T. Drayson. Development of a highly-sensitive multi-plex assay using monoclonal antibodies for the simultaneous measurement of kappa and lambda immunoglobulin free light chains in serum and urine. Journal of Immunological Methods. 2013; 391: 1-13.
    12. John P. Campbell, Jennifer L.J. Heaney, Meena Shemar, Dene Baldwin, Ann E. Griffin, Emma Oldridge, Margaret Goodall, Zaheer Afzal, Tim Plant, Mark Cobbold, Roy Jefferis, Joannes F.M. Jacobs, Christopher Hand, Mark T. Drayson. Development of a rapid and quantitative lateral flow assay for the simultaneous measurement of serum κ and λ immunoglobulin free light chains (FLC): inception of a new near-patient FLC screening tool. Clinical Chemistry and Laboratory Medicine (CCLM). Published Online: 2016-08-09
    13. Jennifer L. J. Heaney, John P. Campbell, Anne E. Griffin, Jane Birtwistle, Meena Shemar, J Anthony Child, Walter M. Gregory, David A. Cairns, Gareth Morgan, Graham Jackson, Mark T. Drayson. Diagnosis and monitoring for light chain only and oligosecretory myeloma using serum free light chain tests. British Journal of Haematology. First published: June 2017
    14. Jennifer L. J. Heaney, John P. Campbell, Punit Yadav, Ann E. Griffin, Meena Shemar, Jennifer H. Pinney,Mark T. Drayson. Multiple myeloma can be accurately diagnosed in acute kidney injury patients using a rapid serum free light chain test. BMC Nephrology (2017) 18:247
    15. Chérina K.A. Fleming, Tim Swarttouw, Corrie M. de Kat Angelino, Joannes F.M. Jacobs, Henk Russcher. Method comparison of four clinically available assays for serum free light chain analysis. Clinical Chemistry and Laboratory Medicine (CCLM), 20190533, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: https://doi.org/10.1515/cclm-2019-0533.

  • The  Seralite® – FLC Serum* rapid test complies with Directive 98/79/EC of the European Parliament and the Medical Devices Directive.

    Seralite® – FLC Serum is registered with the UK Notified Body the Medicines and Healthcare Products Regulatory Agency (MHRA) and is designated in the “General” IVDD classification and as such does not require assessment by the Notified Body.

    According to the Directive, Seralite® – FLC Serum is in compliance with EC Declaration of Conformity (Annex III) and Essential Requirements (Annex I) and as such the CE Mark can be applied to the in vitro diagnostic device.

    A CE mark is a logo that is placed on medical devices to show they conform to the requirements in the directives. It shows that the device is fit for its intended purpose stated and meets legislation relating to safety within the European Union.

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    *Not available for sale in the USA.