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Editor-in-chief
Maria Stella Graziani

Deputy Director
Martina Zaninotto

Associate Editors
Ferruccio Ceriotti
Davide Giavarina
Bruna Lo Sasso
Giampaolo Merlini
Martina Montagnana
Andrea Mosca
Paola Pezzati
Rossella Tomaiuolo
Matteo Vidali

EIC Assistant
Francesco Busardò

International Advisory Board Khosrow Adeli Canada
Sergio Bernardini Italy
Marcello Ciaccio Italy
Eleftherios Diamandis Canada
Philippe Gillery France
Kjell Grankvist Sweden
Hans Jacobs The Netherlands
Eric Kilpatrick UK
Magdalena Krintus Poland
Giuseppe Lippi Italy
Mario Plebani Italy
Sverre Sandberg Norway
Ana-Maria Simundic Croatia
Tommaso Trenti Italy
Cas Weykamp The Netherlands
Maria Willrich USA
Paul Yip Canada


Publisher
Biomedia srl
Via L. Temolo 4, 20126 Milano

Responsible Editor
Giuseppe Agosta

Editorial Secretary
Chiara Riva
Biomedia srl
Via L. Temolo 4, 20126 Milano
Tel. 0245498282
email: biochimica.clinica@sibioc.it

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ISSN print: 0393 – 0564
ISSN digital: 0392- 7091



BC: Articoli scritti da S. Borille

Valutazione del sistema Optilite™ per la misura delle catene leggere libere delle immunoglobuline nel siero
Evaluation of the Optilite™ system for the determination of immunoglobulin free light chains in serum (sFLC)
<p>The measurement of sFLC<span style="font-size:14px"><span style="color:rgb(35, 31, 32); font-family:symbol">k</span></span> and l and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:#231F20; font-family:symbol; font-size:12.0pt">l</span> ratio calculation is recommended for evaluation and management of plasma cell disorders. However, some analytical issues persist in their measurements, among which a too large long-term imprecision seems to be the main challenge. We evaluated the new Optilite system (The Binding Site) for sFLC determination by comparing its performance with specifications for bias, imprecision (as CV) and total error derived from biological variation of sFLC. We collected data during one year of routine use by employing three reagent lots. The system alignment was checked using the two-level (L and H) Optilite control material by comparing the obtained long-term experimental mean (n=233, both levels) with the manufacturer&rsquo;s assigned values. The protocol for CV evaluation employed the liquid-frozen BioRad Liquichek Control and a frozen serum pool tested for 125 and 79 runs, respectively. Inaccuracy was evaluated by results of four UK-NEQAS exercises [system-specific (Optilite) consensus value as reference]. Average cumulative bias [1.1% (L) and -2.0% (H) for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>; 5.4% (L) and 0.1% (H) for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span>, respectively] fulfilled the desirable goals. CVs for sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span> (7.1% for Liquichek and 6.6% for the pool, respectively), sFLC<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span> (7.8% for both Liquichek and the pool) and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:12pt">l&nbsp;</span>ratio (8.9% for Liquichek and 10.2% for the pool, respectively) failed however to reach minimum quality goals. In EQAS evaluation, all sFLC <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span> and <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:16px">l</span> and 3 out of 4 <span style="color:rgb(35, 31, 32); font-family:symbol; font-size:14px">k</span>/<span style="color:rgb(35, 31, 32); font-family:symbol; font-size:12pt">l</span> ratio results were within the allowable total error. In our experience, the Optilite system shows a good method alignment suitable for sFLC interpretation using fixed cut-offs. However, the assay reproducibility is probably not suitable for optimal long-term monitoring of individual patients.</p>
Biochimica Clinica ; 42(1) 32-38
Contributi scientifici - Scientific papers