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Harmony test

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annaloi
Novizio
Novizio
Harmony test
Status: OFFLINE


ma il prenatal safe che è quello italiano è fatto tutto in Italia???????



nutellina
Novizio
Novizio
Harmony test
Status: OFFLINE


Assolutamente no! Il prenatal safe non presenta marcatura CE!!!!!!!!!!!!!!
onelove
Novizio
Novizio
Harmony test
Status: OFFLINE


Pensa al fatto che il prenatal safe non ha marcatura CEE e non può essere svolto in Italia perchè le macchine non funzionano ancora!!!
Patry83
Novizio
Novizio
Harmony test
Status: OFFLINE


Non presenta un'autorizzazione, dicono essere svolto in italia ma molto spesso lo inviano in America!!! Comunque io non lo farei mai un test del genere non è per nulla affidabile , sto leggendo di moltissimi falsi!!!!
dras80
Novizio
Novizio
Harmony test
Status: OFFLINE


Loro dicono di si.. Ma a quanto leggo non è vero ...
serinnis
Novizio
Novizio
Harmony Test - Altro
Status: OFFLINE


Allora guarda facciamo un po' di chiarezza a riguardo ... si comunica che il Prenatal safe viene eseguito completamente in Italia senza alcuna esternalizzazione verso paesi stranieri, ma questo non sarebbe possibile perché in Italia il test non è stato ancora validato e quindi non può essere immesso in commercio. Inoltre, l'assenza della marcatura CE non è presente nel caso del Prenatal safe, e questa invece sarebbe essenziale. Inoltre vorrei però precisare che, nonostante siano lo stesso tipo di test, vi sono delle differenze che possono sembrare piccole, ma non lo sono, fra Harmony test e Prenatal Safe. L'Harmony test, infatti, risulta essere molto più "onesto e trasparente", nella modalità di fornire i risultati alla gestante. Infatti quando non viene trovato il DNA fetale e non sono in grado di fornire il risultato lo dicono; mentre nel caso in cui possano fornirli, i risultati non sono del tipo "presenza malattia" o "assenza malattia" ma scrivono e precisano "alto rischio" o "basso rischio" .... il che è molto più onesto! Già questa differenza non è assolutamente poco, perché vuol dire che ancora una volta ribadiscono che i risultati ottenuti sono delle probabilità sul verificarsi della malattia, e non delle certezze diagnostiche!!!!
elenagi5
Novizio
Novizio
Harmony test
Status: OFFLINE


No assolutamente lo mandano in America perchè in Italia non può essere svolto! La comunità scientifica non ha dato l'approvazione a questo test lo considera solo uno screening!
Clarycla
Novizio
Novizio
Harmony test
Status: OFFLINE


Ho sentito dire anche io che in realtà non viene svolto in italia, ma in America !!!
Amelietu
User
User
Harmony test
Status: OFFLINE


Il prenatal è praticamente L'harmony in italia. Molti dicono che lo svolgo in italia altri no.
Amelietu
User
User
Harmony test
Status: OFFLINE


Il prenatal è praticamente L'harmony in italia. Molti dicono che lo svolgo in italia altri no.
melaniab
User
User
Harmony test
Status: OFFLINE


Tecnicamente è impossibile, perché in Italia non è stato ancora validato, e i macchinari non presentano marchiatura CE, che è una condizione necessaria!
fiorella
Novizio
Novizio
Harmony test
Status: OFFLINE


Anche se ho sentito che ultimamente si stiano muovendo per validità, ma possono dargliela con tutti questi falsi?? Ma io non capisco ragazze!! Sarebbe assurdo...
melaniab
User
User
Harmony test
Status: OFFLINE


Guardate, ho ritrovato l'articolo che avevo letto e che super dettagliatissimo proprio riguardo l'argomento! Vi posto il link e vi copio le parti più importanti! Link : LINK VISIBILE SOLO AGLI UTENTI REGISTRATI

Come abbiamo già detto l’Harmony, negli Stati Uniti, non è approvato dalla Food and Drug Administration, l’Agenzia pubblica che vigila sulla sicurezza dei farmaci. E in Europa? Siccome l’analisi di fatto ha luogo in territorio statunitense (cioè nei laboratori di Ariosa dove le provette vengono inviate per essere esaminate) il test non è sottoposto alle procedure di controllo e autorizzazione previste in Unione Europea. Per il momento, quindi, l’Harmony (e altri test analoghi) viene messo in commercio senza nessun tipo di controllo indipendente. Quello che è utilizzato in Europa e quindi, per essere venduto, deve essere certificata CE la provetta.
serinnis
Novizio
Novizio
Harmony Test - Altro
Status: OFFLINE


Ma vogliamo parlare del fatto che : "Come ha potuto verificare ilfattoquotidiano.it, le provette utilizzate per Harmony non sono semplici contenitori sterili. Sono invece prodotti molto specifici, realizzati negli Stati Uniti dalla Streck, azienda leader nella produzione di dispositivi medici per laboratori clinici. Queste speciali provette devono, infatti, garantire la perfetta stabilizzazione e il trasporto sicuro dei frammenti di DNA fetale presenti nel sangue materno – una caratteristica produttiva coperta da brevetto depositato. E’ con una verifica sul sito della Streck che scopriamo un ulteriore tassello, che non appare sulla brochure dell’Harmony: questo tipo di provette sono “For research use only. Not to use in diagnostic procedures”. Significa che devono essere utilizzate esclusivamente a fini di ricerca. Mai per procedure diagnostiche che possano condurre a decisioni mediche, per le quali è necessaria un’autorizzazione specifica, molto difficile da ottenere."

Cioè, quindi fanno fare a pagamento una cosa che è brevettata e approvata invece per la ricerca??? Pazzesco!!
king001
Membro ufficiale
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Harmony test
Status: OFFLINE


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king001
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Harmony test
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