Multicenter evaluation of the hemolysis index in automated clinical chemistry systems : Clinical Chemistry and Laboratory Medicine

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Clinical Chemistry and Laboratory Medicine (CCLM)

Published in Association with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM)

Editor-in-Chief: Plebani, Mario

Ed. by Gillery, Philippe / Lackner, Karl J. / Lippi, Giuseppe / Melichar, Bohuslav / Schlattmann, Peter / Tate, Jillian R. / Tsongalis, Gregory J.


IMPACT FACTOR 2014: 2.707
Rank 6 out of 30 in category Medical Laboratory Technology in the 2014 Thomson Reuters Journal Citation Report/Science Edition

SCImago Journal Rank (SJR) 2014: 0.741
Source Normalized Impact per Paper (SNIP) 2014: 1.011
Impact per Publication (IPP) 2014: 2.310

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Multicenter evaluation of the hemolysis index in automated clinical chemistry systems

Giuseppe Lippi1, 9, 10 / Gian Luca Salvagno1 / Norbert Blanckaert2, 9 / Davide Giavarina3 / Sol Green4, 9 / Steve Kitchen5, 9 / Vladimir Palicka6, 9 / Anne J. Vassault7, 9 / Mario Plebani8–10, ,

1Clinical Chemistry Laboratory, University of Verona, Verona, Italy

2Laboratory Medicine, University Hospital Leuven, Leuven, Belgium

3Clinical Chemistry Laboratory, San Bortolo Hospital, Vicenza, Italy

4BD Diagnostics – Preanalytical Systems, New Jersey, USA

5Sheffield Hemophilia and Thrombosis Center, Royal Hallamshire Hospital, Sheffield, England

6Institute of Clinical Biochemistry and Diagnostics, Charles University, University Hospital, Hradec Kralove, Czech Republic

7Laboratoire de Biochimie B Hôpital Necker Enfants Malades, AP-HP, Paris, France

8Department of Laboratory Medicine, University of Padova, Padova, Italy

9EPSC – European Preanalytical Scientific Committee (www.specimencare.com)

10International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Patient's Safety

Corresponding author: Prof. Giuseppe Lippi, MD, Sezione di Chimica e Microscopia Clinica, Dipartimento di Scienze Morfologico-Biomediche, Università degli Studi di Verona, Ospedale Policlinico G.B. Rossi, Piazzale Scuro, 10, 37134 Verona, Italy Phone: +39-045-8124308, Fax: +39-045-8201889, ;

Citation Information: Clinical Chemistry and Laboratory Medicine. Volume 47, Issue 8, Pages 934–939, ISSN (Online) 1437-4331, ISSN (Print) 1434-6621, DOI: 10.1515/CCLM.2009.218, June 2009

Publication History

Received:
2009-03-24
Accepted:
2009-05-06
Published Online:
2009-06-24

Abstract

Background: In vitro hemolysis, the prevailing cause of preanalytical error in routine laboratory diagnostics, might influence the reliability of several tests, affect the quality of the total testing process and jeopardize patient safety. Although laboratory instrumentation is now routinely equipped with systems capable of automatically testing and eventually correcting for hemolysis interference, to our knowledge there are no reports that have compared the efficiency of different analytical platforms for identifying and classifying specimens with hemolysis.

Methods: Serum from a healthy volunteer was spiked with varying amounts of hemolyzed blood from the same volunteer, providing a serum free hemoglobin concentration ranging from 0.0 g/L to 2.0 g/L as measured by the reference cyanmethemoglobin assay. The spiked serum samples were shipped to seven separate laboratories and the hemolysis index (HI) was tested in triplicate on the following analytical platforms: Roche Modular System P (n=4) and Integra 400 Plus (n=1), Siemens Dimension RxL (n=3), ADVIA 2400 (n=1) and ADVIA 1800 (n=1), Olympus AU 680 (n=1) and Coulter DXC 800 (n=1).

Results: Satisfactory agreement of HI results was observed among the various analytical platforms, despite a trend toward overestimation by the ADVIA 2400 and 1800. After normalizing results according to the instrument-specific alert value, discrepancies were considerably reduced. All instruments except for the Dimension RxL gave values normalized to the instrument-specific alert value, <1.0 for the sample with 0.048 g/L free hemoglobin, and >1.0 for the sample with 0.075 g/L free hemoglobin. The results of the four Modular System P tests were also highly reproducible among the different facilities. When evaluating instruments that provided quantitative HI results, the mean intra-assay coefficient of variation (CV) calculated for the triplicate determinations was always between 0.1% and 2.7%.

Conclusions: The results of this multicenter evaluation confirm that efficiency of different analytical platforms to correctly identify and classify unsuitable samples is satisfactory. However, more effort should be placed on the standardization of reporting HI. All the instruments that we tested provide either quantitative or qualitative results that are essentially comparable, but which should always be compared with the instrument-specific alert values to harmonize their efficiency.

Clin Chem Lab Med 2009;47:934–9.

Keywords: errors; hemolysis; hemolysis index (HI); patient safety; preanalytical variability

Citing Articles

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[1]
Mario Plebani
Clinical Chemistry and Laboratory Medicine, 2013, Volume 51, Number 1
[3]
Shweta Agarwal, German Vargas, Cristina Nordstrom, Estella Tam, Gregory J. Buffone, and Sridevi Devaraj
Clinica Chimica Acta, 2015, Volume 438, Page 241
[5]
Giuseppe Lippi, Davide Giavarina, Matteo Gelati, and Gian Luca Salvagno
Clinica Chimica Acta, 2014, Volume 429, Page 143
[6]
Alberto Dolci and Mauro Panteghini
Clinica Chimica Acta, 2014, Volume 432, Page 38
[7]
Giuseppe Lippi, Paola Avanzini, and Gianfranco Cervellin
Clinical Biochemistry, 2013, Volume 46, Number 7-8, Page 561
[8]
Giuseppe Lippi and Massimo Franchini
Transfusion and Apheresis Science, 2013, Volume 49, Number 2, Page 181
[9]
G. Lippi, F. Pavesi, C. Cattabiani, P. Avanzini, and S. Pipitone
International Journal of Laboratory Hematology, 2013, Volume 35, Number 2, Page 225
[10]
Marlies Oostendorp, Wouter W. van Solinge, and Hans Kemperman
Archives of Pathology & Laboratory Medicine, 2012, Volume 136, Number 10, Page 1262
[11]
Giuseppe Lippi, Paola Avanzini, Valentina Zobbi, and Luigi Ippolito
Blood Coagulation & Fibrinolysis, 2012, Volume 23, Number 5, Page 461
[12]
Nada Majkić-Singh and Zorica Šumarac
Journal of Medical Biochemistry, 2012, Volume 31, Number 3
[13]
G. LIPPI, R. MUSA, P. AVANZINI, R. ALOE, S. PIPITONE, and F. SANDEI
International Journal of Laboratory Hematology, 2012, Volume 34, Number 2, Page 179
[14]
Giuseppe Lippi, Mariella Mercadanti, Rosalia Aloe, and Giovanni Targher
European Journal of Internal Medicine, 2012, Volume 23, Number 2, Page 150
[15]
Giuseppe Lippi, Rossana Fontana, Paola Avanzini, Rosalia Aloe, Luigi Ippolito, Franca Sandei, and Emmanuel J. Favaloro
Blood Coagulation & Fibrinolysis, 2012, Volume 23, Number 1, Page 82
[16]
Giuseppe Lippi, Marco Caputo, Giuseppe Banfi, Massimo Daves, Alberto Dolci, Martina Montagnana, Valentino Miconi, Bruno Milanesi, Margherita Morandini, Elisa Piva, Gian Luca Salvagno, Teresa Troiano, and Davide Giavarina
La Rivista Italiana della Medicina di Laboratorio - Italian Journal of Laboratory Medicine, 2011, Volume 7, Number 3, Page 144
[17]
Giuseppe Lippi, Paola Avanzini, Mariella Dipalo, Rosalia Aloe, and Gianfranco Cervellin
Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 12
[18]
Giuseppe Lippi, Jeffrey J. Chance, Stephen Church, Paola Dazzi, Rossana Fontana, Davide Giavarina, Kjell Grankvist, Wim Huisman, Timo Kouri, Vladimir Palicka, Mario Plebani, Vincenzo Puro, Gian Luca Salvagno, Sverre Sandberg, Ken Sikaris, Ian Watson, Ana K. Stankovic, and Ana-Maria Simundic
Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 7
[19]
Giuseppe Lippi, Luigi Ippolito, and Rossana Fontana
Clinical Chemistry and Laboratory Medicine, 2011, Volume 49, Number 5
[20]
Giuseppe Lippi and Mario Plebani
Scandinavian Journal of Clinical & Laboratory Investigation, 2009, Volume 69, Number 8, Page 811
[21]
Robert C. Hawkins
Clinical Chemistry and Laboratory Medicine, 2010, Volume 48, Number 7
[22]
Mario Plebani and Elisa Piva
Journal of Medical Biochemistry, 2010, Volume 29, Number 4
[23]

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