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La Rivista Italiana della Medicina di Laboratorio 2019 Giugno;15(2):150-8

DOI: 10.23736/S1825-859X.19.00019-7


language: Italian

The issue of false positive and false negative results of troponin. Part IV: recommendations by SIPMeL Working Group on Myocardial Markers (GdS MM)

Francesca VENEZIANI 1 , Marco MORETTI 2, Elisabetta STENNER 3, Massimiliano MANNO 4, Margherita MORANDINI 5, Gianni A. GALLI 6, Maria A. BURGIO 7, Lucia MALLOGGI 8, Giulio MARINO 9, Dina DI MARIA 10, Deborah MAZZEI 8, Daniela RUBIN 11, Matteo CASSIN 12, Alessio GAMBONI 13, Piero CAPPELLETTI 14, a nome del Gruppo di Studio sui Marcatori Miocardici (GdS MM) della Società Italiana di Patologia Clinica e Medicina di Laboratorio (SIPMeL)

1 SOS Laboratorio Analisi, Ospedale S. Maria Nuova, USL Centro Toscana, Firenze, Italia; 2 Dipartimento di Patologia Clinica, Azienda Ospedaliero Universitaria Ospedali Riuniti, Ancona, Italia; 3 Struttura Complessa di Patologia Clinica, ASUITS, Trieste, Italia; 4 Laboratorio Analisi, Città di Lecce Hospital-GVM Care&Research, Lecce, Italia; 5 Struttura Complessa Laboratorio Analisi, AAS5, Pordenone, Italia; 6 Estote Misericordes, Firenze, Italia; 7 Dipartimento di Patologia Clinica, Ospedale Barone Lombardo, Canicattì, Agrigento, Italia; 8 Laboratorio Analisi, Azienda Ospedaliero Universitaria di Pisa, Pisa, Italia; 9 Laboratorio Analisi, AUSL Bologna, Vergato, Bologna, Italia; 10 Laboratorio Analisi Polimedica, Ravanusa, Agrigento, Italia; 11 Laboratorio Analisi AULSS2, Conegliano Veneto, Treviso, Italia; 12 Dipartimento di Cardiologia, Casa di Cura San Giorgio, Pordenone, Italia; 13 Unità di Medicina d’Urgenza, ASL2 Foligno, Perugia, Italia; 14 SIPMeL, Castelfranco Veneto, Treviso, Italia

The analytical interferences in troponin (cTn) and high sensitivity troponin (hs-cTn) methods are extensively described in the scientific literature, usually as clinical cases and rarely as systematic reviews with the aim to give guidance for clinical practice. The incidence of false positives (FP) and false negatives (FN) of cTn and hs-cTn is ≤1%, nevertheless they should be detected for their potentially clinical risk. Then, comprehensive good practice recommendations for the everyday clinical laboratory are needed. The GdS MM SIPMeL defined ten “Recommendations for the prevention and correction of FP/FN of cTn”, using the criteria of Strength of Recommendations and Level of Evidence according to NACB LMPG/AACC and by a modified Delphi method, and a “Pattern of action” for the resolution the FP/FN of cTn. The Position Paper was posted on the SIPMeL website from 12 September to 18 December 2018 and submitted to an external evaluation of GdS EBLM and Quality Committee of SIPMeL. The first three Recommendations summarize the preventive measures against FP/FN to be implemented by the Laboratory. The second three Recommendations are designed to provide a logical sequence to the clinician in the case of suspected FP/FN of cTn and to highlight the need of clinical-laboratory collaboration. The Recommendations 7-to-9 suggest logical paths to solve the suspicion of analytical FP/FN that the Laboratory should follow. Finally, the Recommendation 10 insists on collecting data for a quality assurance of the laboratory as well as for the construction of scientific evidence and on the need of a positive collaboration with the manufacturers. The Recommendations can be a useful tool in the laboratory daily practice for the prevention and solution of FP/FN of cTn and a reference to the clinical management of suspected analytical and preanalytical “false” cTn results.

KEY WORDS: Troponin; False positive reactions; False negative reactions

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