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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 C. Artusi

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
 
Caso atipico di orticaria
A case of atypical urticaria
<p>Adult onset Still&rsquo;s disease (AOSD) is a rare clinical entity with unknown etiology and&nbsp;pathogenesis, characterized by high spiking fevers, arthritis, typical evanescent, nonpruritic, macular and salmon<br />coloured rash, and multiorgan involvement. AOSD remains a diagnostic challenge due to the overlapping features&nbsp;with numerous infective, neoplastic and rheumatological conditions. A case of AOSD with atypical cutaneous&nbsp;manifestations in a 50-year-old female is reported. The patient&rsquo;s symptoms included: remittent fever, widespread&nbsp;urticarial, maculopapular erythema and a sore throat. Hematological investigations showed leukocytosis with&nbsp;neutrophilia. There were markedly elevated levels of serum ferritin (20.920 &mu;g/L) and mild liver dysfunction. A&nbsp;glycosylated ferritin assay was performed because of a severe hyperferritinemia, showing a reduction of the&nbsp;glycosylated fraction (&lt;20%), a newly proposed diagnostic criteria for AOSD. We emphasize the diagnostic value of&nbsp;low glycosylated ferritin concentration for the differential diagnosis of this rare disease, particularly in case of atypical&nbsp;presentation.</p>
Biochimica Clinica ; 39(5) e10-e12
Casi clinici - Case report
 
Screening tossicologico su matrice pilifera: verifica delle prestazioni analitiche secondo lo standard internazionale ISO 15189
Hair drug screening test for illegal drugs: method verification according to ISO 15189 standard
<p>Introduction: hair testing is an alternative matrix for diagnosis and monitoring of drug misuse. The aim of the present study was to evaluate the analytical performances of 7 semi-quantitative immunoassays using hair specimens according to the ISO 15189 standard, in order to introduce hair drug screening in our practice.<br />Methods: QuantILab DRI Cocaine Metabolite, Opiate, Cannabinoid, Methadone, Amphetamines, Ecstasy and Immunalysis Buprenorphine, were applied on Ilab Taurus (Instrumentation Laboratory SpA, a Werfen Company, Milano). The imprecision verification study consisted in calculating the within-laboratory imprecision (SWL) using positive quality control hair materials, followed by assessment of uniformity with manufacturer&rsquo;s inter-assay claims and acceptability of test results. A total of 25 EQAS and 29 hair specimens were tested to verify the diagnostic sensitivity (SELAB) and specificity (SPLAB). To confirm the results, an UPLC-MS/MS method accredited according to ISO 15189 standard was used.<br />Results: SWL obtained for 3 assays were lower than those specified by the manufacturer, opposed to Cannabinoid, Amphetamines, Buprenorphine and Ecstasy assays; thus Upper Verification Limit (UVL) were calculated. SWL for Cannabinoid, Amphetamines and Buprenorphine assays were lower than UVL; Ecstasy assay SWL (8.40%) was greater than UVL (8.39%), but still lower than state-of-the-art imprecision (&lt;15%). SELAB and SPLAB were 100% for all assays except SPLAB for Cannabinoid (95.2%) and Amphetamines (92.9%); 95% confidence intervals of manufacturer diagnostic specificity (SPPROD) were calculated. SPLAB for both assays were included in the 95% CI of SPPROD.<br />Discussion: for all immunoassays, the verifications were successful and exhibit good diagnostic efficiency for hair drug screening.</p>
Biochimica Clinica ; 17(1)
Contributi Scientifici - Scientific Papers