SD Dojavi
OSMRTNICE
PRETPLATA
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stdClass Object ( [id] => 1070025 [title] => Nove varijante koronavirusa mogle bi utjecati na lažno negativne rezultate PCR testova: FDA upozorila na važnost ponovnog testiranja [alias] => nove-varijante-koronavirusa-mogle-bi-utjecati-na-lazno-negativne-rezultate-pcr-testova-fda-upozorila-na-vaznost-ponovnog-testiranja [catid] => 241 [published] => 1 [introtext] => [fulltext] =>

Američka uprava za hranu i lijekove (FDA) upozorila je medicinsko i laboratorijsko osoblje da bi genetske mutacije koronavirusa, uključujući i varijantu B.1.1.7 otkrivenu u Velikoj Britaniji, mogle dovesti do lažno negativnih rezultata molekularnih testova (PCR) prilikom testiranja na covid-19.

PCR test je molekularni postupak koji se temelji na dokazivanju prisutnosti virusne RNK molekule. 

Agencija je upozorila osoblje kliničkih laboratorija i pružatelje zdravstvenih usluga na moguće lažno negativne rezultate bilo kojeg PCR testa te ih je pozvala da pozorno razmotre takve rezultate u kombinaciji s kliničkim opažanjima te da ponove ispitivanje, ali nekim drugim testom ako i dalje sumnjaju na covid-19 .

Lažno negativan rezultat može se dogoditi kod bilo kojeg PCR testa ako se mutacija dogodila u dijelu njegova genoma koji test ispituje, upozorava FDA, dodajući ipak kako je opasnost od toga da ovakve mutacije utječu na sveukupnu točnost testiranja niska.

Agencija je zamijetila da je analizom utvrđeno da bi na rezultate triju testova na koronavirus koja su dobila odobrenje za nužnu upotrebu u u Sjedinjenim Državama mogle utjecati genetske mutacije koronavirusa, no čini se da taj utjecaj nije od velikog značaja.

Zaraznija varijanta covida-19 koja je zahvatila Ujedinjeno Kraljevstvo uočena je u najmanje pet američkih saveznih država, izvijestio je prošli tjedan ravnatelj Nacionalnog zavoda za zdravlje Francis Collins, a znanstvenici su u petak izvijestili da bi novorazvijena cjepiva trebala biti jednako učinkovita i protiv nove varijante koronavirusa.

Stephen Hahn iz FDA je istaknuo da će Agencija i dalje nastaviti s nadzorom genetskih mutacija koronavirusa kako bi se zajamčilo da svi dosad odobreni testovi daju točne rezultate. 

"Nastavit ćemo raditi s autoriziranim tvrtkama koje rade na razvoju testova te ćemo pomno proučavati podatke kako bismo zajamčili da se dijagnosticiraju svi pacijenti zaraženi SARS-CoVom-2, uključujući i one zaražene mutiranim sojevima", rekao je Hahn.

FDA u ovom trenutku smatra da su cjepiva koja trenutačno imaju dozvolu za upotrebu i dalje učinkovita u zaštiti od mutiranih sojeva. Liječnici i javnost bit će obaviješteni o potencijalnim novim saznanjima.

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Američka uprava za hranu i lijekove (FDA) upozorila je medicinsko i laboratorijsko osoblje da bi genetske mutacije koronavirusa, uključujući i varijantu B.1.1.7 otkrivenu u Velikoj Britaniji, mogle dovesti do lažno negativnih rezultata molekularnih testova (PCR) prilikom testiranja na covid-19.

PCR test je molekularni postupak koji se temelji na dokazivanju prisutnosti virusne RNK molekule. 

Agencija je upozorila osoblje kliničkih laboratorija i pružatelje zdravstvenih usluga na moguće lažno negativne rezultate bilo kojeg PCR testa te ih je pozvala da pozorno razmotre takve rezultate u kombinaciji s kliničkim opažanjima te da ponove ispitivanje, ali nekim drugim testom ako i dalje sumnjaju na covid-19 .

Lažno negativan rezultat može se dogoditi kod bilo kojeg PCR testa ako se mutacija dogodila u dijelu njegova genoma koji test ispituje, upozorava FDA, dodajući ipak kako je opasnost od toga da ovakve mutacije utječu na sveukupnu točnost testiranja niska.

Agencija je zamijetila da je analizom utvrđeno da bi na rezultate triju testova na koronavirus koja su dobila odobrenje za nužnu upotrebu u u Sjedinjenim Državama mogle utjecati genetske mutacije koronavirusa, no čini se da taj utjecaj nije od velikog značaja.

Zaraznija varijanta covida-19 koja je zahvatila Ujedinjeno Kraljevstvo uočena je u najmanje pet američkih saveznih država, izvijestio je prošli tjedan ravnatelj Nacionalnog zavoda za zdravlje Francis Collins, a znanstvenici su u petak izvijestili da bi novorazvijena cjepiva trebala biti jednako učinkovita i protiv nove varijante koronavirusa.

Stephen Hahn iz FDA je istaknuo da će Agencija i dalje nastaviti s nadzorom genetskih mutacija koronavirusa kako bi se zajamčilo da svi dosad odobreni testovi daju točne rezultate. 

"Nastavit ćemo raditi s autoriziranim tvrtkama koje rade na razvoju testova te ćemo pomno proučavati podatke kako bismo zajamčili da se dijagnosticiraju svi pacijenti zaraženi SARS-CoVom-2, uključujući i one zaražene mutiranim sojevima", rekao je Hahn.

FDA u ovom trenutku smatra da su cjepiva koja trenutačno imaju dozvolu za upotrebu i dalje učinkovita u zaštiti od mutiranih sojeva. Liječnici i javnost bit će obaviješteni o potencijalnim novim saznanjima.

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AFP
AFP
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StoryEditorOCM
SvijetGenetske mutacije

Nove varijante koronavirusa mogle bi utjecati na lažno negativne rezultate PCR testova: FDA upozorila na važnost ponovnog testiranja

Piše Hina
11. siječnja 2021. - 09:38
15722286
PREMIUM
AFP

Američka uprava za hranu i lijekove (FDA) upozorila je medicinsko i laboratorijsko osoblje da bi genetske mutacije koronavirusa, uključujući i varijantu B.1.1.7 otkrivenu u Velikoj Britaniji, mogle dovesti do lažno negativnih rezultata molekularnih testova (PCR) prilikom testiranja na covid-19.

PCR test je molekularni postupak koji se temelji na dokazivanju prisutnosti virusne RNK molekule. 

Agencija je upozorila osoblje kliničkih laboratorija i pružatelje zdravstvenih usluga na moguće lažno negativne rezultate bilo kojeg PCR testa te ih je pozvala da pozorno razmotre takve rezultate u kombinaciji s kliničkim opažanjima te da ponove ispitivanje, ali nekim drugim testom ako i dalje sumnjaju na covid-19 .

Lažno negativan rezultat može se dogoditi kod bilo kojeg PCR testa ako s...

#KORONAVIRUS#COVID - 19#FDA#PCR TEST
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