La IV indagine del GdS MM SIPMeL: i marcatori miocardici di “necrosi” in Italia View Full Text


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Article Info

DATE

2018-06-20

AUTHORS

Gianni Antonio Galli, Lucia Malloggi, Marco Moretti, Margherita Morandini, Francesca Veneziani, Maria Aurora Burgio, Massimiliano Manno, Elisabetta Stenner, Daniela Rubin, Giulio Marino, Deborah Mazzei, Dina Di Maria, Matteo Cassin, Alessio Gamboni, Valentino Miconi, Piero Cappelletti

ABSTRACT

Background.The IV survey on the use of cardiac markers in Italy was made by Working Group on Cardiac Markers of Italian Society for Clinical Pathology and Laboratory Medicine (GdS MM SIPMeL) in 2017 for evaluating the evolution of the laboratory cardiac diagnostics in the last five years.Methods.122 colleagues from 20 Italian Regions, in 75% of cases serving a Cardiac Coronary Unit (CCU), answered a 62-items Questionnaire on the SIPMeL website in summer and fall 2017.Results.Conflicting results were obtained from this study in a real-world environment. Encouraging results were: 100% of the Laboratories used troponin (cTn) as the preferred marker for acute coronary syndromes (ACS) and 66% used only cTn; 77% used hs-cTn (61% introduced it in the last five years); 75% Laboratories used international guidelines (GL) and/or shared protocols (P) and 65% recent ESC 2015; no proliferation of other cardiac markers; 100% of the Laboratories run IQC and 90% EQA; 65% measured intra-laboratory TAT (Turnaround Time) and 92.5% had <60 min one; 85% used the decision limit (DL) 99°percentile (±CV10%) and 88% no longer double DL for myocardial infarction and injury; 82% used correct reporting unit. Main concerns were: 25% of the Laboratories did not accept international guidelines and 44% lacked of agreed protocols; 40% used combined measurement with another marker (33% CK-MB m, 26% myoglobin, 10% obsolete markers); 33% used serum, in spite of its negative effect on TAT; 34% measured total TAT and 33% had a total TAT >60 min; only 35% were aware of false positive/false negative (FP/FN) issues in cTn measuring; 64% derived DL from manufacturers’ data and only 11% produced a local validation; only 21% used differentiated DLs for gender and/or age, although 77% used hs-cTn.Conclusions.Technological innovation (hs-cTn) was an opportunity for cultural growth (improved knowledge and practice of “high-sensitivity” concept, DLs and TATs) but small Laboratories and the group using contemporary cTn are still in difficulty. Several issues remain: the percentages of obsolete tests is still too high, only 75% use GL/P, and the use of differentiated DLs is too low. Moreover, total TAT should be measured and improved, FP/FN issue should be better known and EQA should be used by 100% of Laboratories. The survey showed that analytic knowledge is the base for a quality Laboratory diagnostics in Cardiology and the clinic-laboratory interface work at pre–pre and post–post phases is crucial for improving some negative points, such as lack of GLs and Ps and use of obsolete or useless markers, because they depend mainly on clinicians’ convictions. More... »

PAGES

87-96

References to SciGraph publications

  • 2014-10-10. Stato dell’arte dei marcatori cardiaci in Italia: la III indagine del GdS MM SIMeL in LA RIVISTA ITALIANA DELLA MEDICINA DI LABORATORIO - ITALIAN JOURNAL OF LABORATORY MEDICINE
  • 2017-11-13. Brain-to-brain loop 2020: è ancora utile il ciclo di Lundberg? in LA RIVISTA ITALIANA DELLA MEDICINA DI LABORATORIO - ITALIAN JOURNAL OF LABORATORY MEDICINE
  • 2018-06-13. La troponina ad alta sensibilità in Italia in LA RIVISTA ITALIANA DELLA MEDICINA DI LABORATORIO - ITALIAN JOURNAL OF LABORATORY MEDICINE
  • 2017-04-06. High-sensitivity assays for troponin in patients with cardiac disease in NATURE REVIEWS CARDIOLOGY
  • 2018-03-22. Troponina cTnT-hs: una questione di genere e di età? Valutazione di limiti decisionali differenziati per genere ed età in una popolazione afferente al Dipartimento di Emergenza in LA RIVISTA ITALIANA DELLA MEDICINA DI LABORATORIO - ITALIAN JOURNAL OF LABORATORY MEDICINE
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    11 schema:description Background.The IV survey on the use of cardiac markers in Italy was made by Working Group on Cardiac Markers of Italian Society for Clinical Pathology and Laboratory Medicine (GdS MM SIPMeL) in 2017 for evaluating the evolution of the laboratory cardiac diagnostics in the last five years.Methods.122 colleagues from 20 Italian Regions, in 75% of cases serving a Cardiac Coronary Unit (CCU), answered a 62-items Questionnaire on the SIPMeL website in summer and fall 2017.Results.Conflicting results were obtained from this study in a real-world environment. Encouraging results were: 100% of the Laboratories used troponin (cTn) as the preferred marker for acute coronary syndromes (ACS) and 66% used only cTn; 77% used hs-cTn (61% introduced it in the last five years); 75% Laboratories used international guidelines (GL) and/or shared protocols (P) and 65% recent ESC 2015; no proliferation of other cardiac markers; 100% of the Laboratories run IQC and 90% EQA; 65% measured intra-laboratory TAT (Turnaround Time) and 92.5% had <60 min one; 85% used the decision limit (DL) 99°percentile (±CV10%) and 88% no longer double DL for myocardial infarction and injury; 82% used correct reporting unit. Main concerns were: 25% of the Laboratories did not accept international guidelines and 44% lacked of agreed protocols; 40% used combined measurement with another marker (33% CK-MB m, 26% myoglobin, 10% obsolete markers); 33% used serum, in spite of its negative effect on TAT; 34% measured total TAT and 33% had a total TAT >60 min; only 35% were aware of false positive/false negative (FP/FN) issues in cTn measuring; 64% derived DL from manufacturers’ data and only 11% produced a local validation; only 21% used differentiated DLs for gender and/or age, although 77% used hs-cTn.Conclusions.Technological innovation (hs-cTn) was an opportunity for cultural growth (improved knowledge and practice of “high-sensitivity” concept, DLs and TATs) but small Laboratories and the group using contemporary cTn are still in difficulty. Several issues remain: the percentages of obsolete tests is still too high, only 75% use GL/P, and the use of differentiated DLs is too low. Moreover, total TAT should be measured and improved, FP/FN issue should be better known and EQA should be used by 100% of Laboratories. The survey showed that analytic knowledge is the base for a quality Laboratory diagnostics in Cardiology and the clinic-laboratory interface work at pre–pre and post–post phases is crucial for improving some negative points, such as lack of GLs and Ps and use of obsolete or useless markers, because they depend mainly on clinicians’ convictions.
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