Raccomandazioni sulle tecniche di screening prenatale mediante la ricerca del Dna fetale su sangue materno

By | 13 ottobre 2013

  Si riportano di seguito alcune posizioni ufficiali: – La Società internazionale di Diagnosi Prenatale (ISPD), in sintesi, conclude che:

  1. Al momento lo screening più utilizzato e più attendibile per le maggiori trisomie consiste nel test combinato (misura della Translucenza nucale e dei marcatori sierici materni nel I trimestre di gravidanza).
  2. Lo screening del DNA fetale su sangue materno sembra essere una tecnologia emergente, ma non può sostituire gli attuali test diagnostici.
  3. La diagnosi di certezza delle aneuploidie fetali può essere ottenuta esclusivamente con l’amniocentesi o la villocentesi.
  • Position Statement from the Aneuploidy Screening Committee onBehalf of the Board of the International Society for Prenatal Diagnosis, April 2013P. Benn (Chair), A. Borell, R. Chiu, H. Cuckle, L. Dugoff, B. Faas, S. Gross, J. Johnson, R. Maymon, M. Norton, A. Odibo, P. Schielen, K. Spencer, T. Huang, D. Wright, Y. Yaron.

– L’ American College of Medical Genetics and Genomics (ACMG) in sintesi, conclude che:

  1. I test su sangue materno presentano oggi la possibilità di falsi positivi confinati a mosaicismi placentari o “vanishing twin”
  2. I test su sangue materno non sono diagnostici .
  3. Il valore predittivo negativo (NPV) può essere considerato alto mentre il predittivo positivo (PPV) non puo’ essere valutato.
  • ACMG statement on noninvasive prenatal screeningfor fetal aneuploidy A. R. Gregg, MD1, S.J. Gross2, R.G. Best3, K.G. Monaghan4, K. Bajaj2, B.G. Skotko5,B.H. Thompson6 and M.S. Watson; The Noninvasive Prenatal Screening Work Group of the American College of Medical Genetics and Genomics

– L’ American College of Obstetricians and Gynecologists Committee on Genetics (ACOGG) in sintesi, conclude che:

  1. I test sulla ricerca del fetal DNA free sul sangue materno non dovrebbero essere offerti come test routinari.
  2. Tali test non devono essere offerti alla popolazione generale o alle gemellari
  3. Le pazienti debbono essere informate che un test negativo non assicura che il feto sia sano.
  4. Le pazienti debbono essere informate che un test positivo non vuol significare che il feto sia affetto. La villocentesi deve essere offerta in tali casi

American College of Obstetricians and Gynecologists Committee on Genetics. Committee Opinion No. 545: Noninvasive
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prenatal testing for fetal aneuploidy. Obstet Gynecol. 2012 Dec;120(6):1532-4.

– Il California Technology Assessment Forum (CTAF) in sintesi, conclude che:

  1. Lo screening prenatale delle trisomie mediante ricerca del DNA fetale nel sangue materno è una tecnologia promettente, ma non è attualmente pronta per l’uso di routine nella pratica clinica, sia nelle donne ad alto che a basso rischio.
  2. Poichè lo screening prenatale delle trisomie mediante ricerca del DNA fetale nel sangue materno non incontra ancora i criteri di sicurezza, efficacia e miglioramento dell’ health outcomes, non può essere espressa nessuna raccomandazione a riguardo di tali test.

§ CTAF © 2012 California Technology Assessment Forum

– Le Linee Guida Nazionali Italiane concludono nel merito

  1. L’utilizzo delle cellule fetali su sangue materno per la diagnosi di anomalie
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    genetiche e cromosomiche non deve essere proposto quale alternativa alla diagnosi prenatale invasiva (RaccomandazioneIIA)Agenzia Nazionale Per i Servizi Sanitari Nazionali (AGENAS) Programma Nazionale Linee Guida: Linee guida “La Diagnosi prenatale ed ecografia in gravidanza. Maggio 2013”

In merito agli aspetti economici e legali che coinvolgono l’utilizzo di tali test, alcuni osservatori pongono l’accento sull’eccessivo costo ed ingiustificato rapporto costo/utilità, sull’interesse commerciale e infine, sul numeroso contenzioso legale oggi già in essere per tali metodiche. Queste considerazioni sono ulteriori elementi che debbono essere presi in esame ai fini del loro sviluppo e possibile introduzione clinica.

  • Paul Brady • Simon Ardui • Joris Robert Vermeesch. Curr GenetMed Rep (2013) ;
  • Nicholas J. Wald, Jonathan P. Bestwick PLOS ONE – 6 March 2013 – Volume 8- Issue 3
  • Ashwin Agarwal, Lauren C. Sayres, Mildred K. Cho, Robert Cook-Deegan, Subhashini Chandrasekharan Commercial landscape of noninvasive prenatal testing in the United States MAY 2013

In sintesi: – Al giorno di oggi gli unici test di screening accreditati (ancorché con i limiti noti) sono quelli “combinati” basati sulla Translucenza nucale e sulle proteine placentari. Di tali test la nostra Società scientifica, in ossequio alle linee guida, propone quelli sperimentati nella popolazione nazionale (SCA-TEST). – Gli unici test diagnostici rimangono la villocentesi e l’amniocentesi che, attualmente risultano comportare un rischio di aborto pari a quello della popolazione generale(*). Tali metodiche, tra l’altro, con la introduzione delle moderne e validate tecniche genomiche mediante CGH, hanno enormemente amplificato il loro campo diagnostico. – L’impiego routinario e diagnostico dei test basati sulla ricerca del DNA fetale nel Sangue Materno, al giorno d’oggi, non può essere ancora proposto come test di prima scelta. Allorché venga richiesto dalla stessa gestante corre il dovere di fornire una informazione dettagliata ed esplicita sui suoi limiti. (*)

  • Eddleman KA, Malone FD, Sullivan L, Dukes K, Berkowitz RL, Kharbutli Y, Porter TF, Luthy DA, Comstock CH, Saade GR, Klugman S, Dugoff L, Craigo SD, Timor-Tritsch IE, Carr SR, Wolfe HM, D’Alton ME. Pregnancy loss rates after midtrimester amniocentesis. Obstet Gynecol. 2006 Nov;108(5):1067-72
  • Odibo AO, Gray DL, Dicke JM, Stamilio DM, Macones GA, Crane JP. Revisiting the fetal loss rate after second-trimester genetic amniocentesis: a single center’s 16-year experience. Obstet Gynecol. 2008 Mar;111(3):589-95
  • Giorlandino C, Cignini P, Cini M, Brizzi C, Carcioppolo O, Milite V, Coco C, Gentili P, Mangiafico L, Mesoraca A, Bizzoco D, Gabrielli I, Mobili L. Antibiotic prophylaxis before second-trimester genetic amniocentesis (APGA): a single-centre open randomised controlled trial. Prenat Diagn. 2009 Jun;29(6):606-12
  • Gabbe Obstetrics: Normal and Problem Pregnancies, 5th ed. 2007. CHAPTER 7 – Prenatal Genetic Diagnosis

RACCOMANDAZIONI: – Lo screening della sindrome di Down mediante ricerca del DNA fetale sul sangue materno non deve essere consigliato come screening di prima scelta, esistendo i testcombinati, sperimentati, riconosciuti, diffusi e, ad oggi, ritenuti più attendibili. – Le gestanti che decidono di avvalersi dello screening prenatale delle aneuploidie cromosomiche mediante ricerca del DNA fetale su sangue materno devono essere informate che tale test non fornisce risultati clinicamente validatida studi prospettici di adeguata potenza.La recente diffusione di tali test nella pratica clinica non risulta essere giustificata dalla comunità scientifica internazionale e la loro diffusione commerciale, da parte di aziende e laboratori che li propongono, rischia di far esporre, chi li utilizza ai fini diagnostici, a Responsabilità professionale medico legale. Pertanto il clinico, sia al fine di operare correttamente, che di avere una giusta tutela nella denegata ipotesi di incorrere in vertenza di Responsabilità professionale, deve informare che:

  • L’utilizzo clinico di tali test di screening non è validato e non può, ancora, sostituire i test combinati.
  • Esiste totale differenza tra un test di screening ed un test diagnostico. Se una coppia desidera ottenere certezze, è dovere informare che i soli test diagnostici sono quelli eseguiti su materiale fetale prelevato mediante Villocentesi, Amniocentesi, Cordocentesi.

Estratto e tradotto da: “Position Statement from the Aneuploidy Screening Committee on Behalf of the Board of the Italian College of Fetal Maternal MedicineThe Journal of Prenatal Medicine, Giugno 2013in Press

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