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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



Articoli con TAG: verifica analitica

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