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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

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


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

BC: Articoli scritti da A. Nonnato

Validazione dei metodi quantitativi bioanalitici in spettrometria di massa: regole e protocolli sperimentali
Bioanalytical method validation of quantitative mass spectrometry based assay: experimental protocols and regulations
<p>Liquid chromatography-mass spectrometry (LC-MS) technique has rapidly extended the spectrum of clinical chemistry methods during the past decade and it has became a standard tool for endogenous and exogenous substances in research laboratories as well as in many clinical laboratories. To date, many guidelines for bioanalytical method validation have been published, but there is still the need to have specific guidelines and experimental protocols. In particular, we need to further focus and investigate the overall clinical aspects of spectrometry method validation, for both exogenous and endogenous molecules. The aim of the present document is to suggest specific experimental regulations and protocols for bioanalytical LC-MS method validation for exogenous and endogenous molecules, inspired by actual international guidelines and integrated with practical tips to obtain better performance on methods used in routine clinical practice. Here we have introduced new concepts such as &ldquo;normalized matrix effect&rdquo;, and protocols for method validation using &ldquo;pathological samples&rdquo; and &ldquo;altered samples&rdquo;, as these are the most commonly samples encountered in laboratory routine. In conclusion, the new rules and protocols reported in this work do not intend to replace international guidelines; we believe that these rules have to be considered besides the available guidelines with the aim to help the LC-MS users by recommending a number of experimental steps to be performed during each method/kit validation.</p>
Biochimica Clinica ; 42(1) 51-61
Documenti - Documents
Validazione del dosaggio delle metanefrine plasmatiche mediante cromatografia liquida associata alla spettrometria di massa tandem
Validation of the measurement of plasma metanephrines by liquid chromatography-tandem mass spectrometry (LC-MS/MS)
<p>The prevalence of arterial hypertension is very high all over the world. ~0.1% of subjects with secondary hypertension has a pheochromocytoma, a tumor producing catecholamines. The quantification of free plasma o-methylated metabolites, metanephrine (p-MN) and normetanephrine (p-NMN), is considered the most accurate test for both the diagnosis and monitoring of pheochromocytoma. The aim of this work was to validate of an assay for measuring plasma metanephrines by LC-MS/MS. Calibration curves showed good linearity (R<sup>2</sup> &gt;0.99). Intra-assay repeatibility, assessed on two pools, normal and pathological, resulted in a CV of 5.1% and 3.9% for p-MN and 8.2% and 10.5% for p-NMN, respectively. Inter-assay CVs were 15.9% and 11.9% for p-MN and 16.6% and 16.1% for p-NMN, respectively. The limit of detection was 8 pM for p-MN and 66 pM for p-MNM, while the limit of quantification was 26 pM for p-MN and 83 pM for p-NMN. 638 plasma samples were analyzed, providing a representative sample to assess potential clinical impact of the validated method.</p>
Biochimica Clinica ; 41(1) 050-059
Contributi scientifici - Scientific papers