English 
Italian Le criticità della fase post-analitica della determinazione delle crioglobuline: risultati di uno studio pilota condotto in Emilia-Romagna
Critical issues of the post-analytical phase for cryoglobulin determination: results of a pilot study carried out in Emilia-Romagna, Italy
AUTORI
Annamaria Ottomano2, Giovanna Patelli1, Stefano Pizzicotti6, Rita Mancini3, Rossana Colla4, Romolo Dorizzi7,
Maria Teresa Mascia9, Tommaso Trenti1, Patrizia Natali1
1Medicina di Laboratorio, Ospedale Civile di Baggiovara AUSL di Modena - Dipartimento Interaziendale integrato di Medicina di Laboratorio e Anatomia Patologica Azienda Ospedaliero Universitaria e Azienda USL di Modena
2Laboratorio Centralizzato, Azienda Ospedaliero-Universitaria Policlinico di Modena - Dipartimento Interaziendale integrato di Medicina di Laboratorio e Anatomia Patologica Azienda Ospedaliero Universitaria e Azienda USL di Modena
3Laboratorio Unico Metropolitano Ospedale Maggiore - Azienda USL di Bologna
4Laboratorio Analisi Chimico Cliniche e Microbiologiche di Guastalla - Azienda USL di Reggio Emilia, Guastalla (RE)
5Laboratorio analisi chimico-cliniche e di endocrinologia - Arcispedale Santa Maria Nuova - Azienda USL-IRCCS di Reggio Emilia
6Laboratorio Unico Provinciale Arcispedale Sant’anna - Azienda Ospedaliero-Universitaria di Ferrara
7Laboratorio Unico Ausl Romagna Area Vasta Romagna, Pievesistina (FC)
8Laboratorio U.O. Diagnostica Ematochimica SSUO Diagnostica delle Malattie Autoimmuni- Azienda Ospedaliero Universitaria di Parma
9Cattedra di Reumatologia, Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto – Università di Modena e Reggio Emilia, Modena
ABSTRACT
Critical issues of the post-analytical phase for cryoglobulin determination: results of a pilot study carried out in Emilia-Romagna, Italy
Introduction: cryoglobulins (CRG) are immunoglobulins that precipitate at low temperature and dissolve at 37 °C. The difficulties associated to the analisys of cryoproteins, are related to the pre-analytical phase, including the collection of the sample and the maintenance of the heat chain; to the analytical phase, because of the many manual steps involved and, to the post-analytical phase as well, due to the operator-depending interpretation of immunofissation (IFE). The Department of Laboratory Medicine of Modena promoted a pilot study to verify the incidence of the post-analytical phase in the accuracy of the CRG analisys.
Methods: 30 images of CRG-IFE plates were selected and sent to 8 centers of the Emilia Romagna region that agreed to join the project; 13 different laboratory professionals have been involved in the IFE interpretation.
Results: out of 30 IFE, only 3 (10%) were interpreted with the excellent concordance of 100% by all the participants; 10 of them (33%) showed a good concordance, 75-99%; 14 (47%) sufficient concordance, 50-74%; 3 (10%) a poor concordance <50%. Out of 8 centers involved, 4 participated with more than one operator. Arbitrarily assuming that the analysis can be considered acceptable when at least 75% of the participants agree on the interpretation of the gels, the results show that only in 43% of cases the acceptability was reached.
Discussion: this pilot study highlights the need to harmonize the CRG determination, not only the pre-analytical and analytical procedures, but also the post-analytical phase. To this end, it could be highly recommended that the clinical laboratories participate to external quality assessment control programs, as the one promoted by UK-NEQAS. Moreover, scientific societies and their Study Groups, can play an important role by promoting the harmonization of CGR evaluation.