US Food and Drug Administration (FDA) e tseba hore United States e na le litšitiso tse kholo phepelong ea li-tubes tse 'maloa tsa pokello ea mali (ho hula mali) ka lebaka la keketseho ea tlhokeho nakong ea koluoa ea COVID-19 ea bophelo bo botle ba sechaba le liphephetso tsa phepelo ea barekisi ba morao-rao. .FDA e ntse e eketsa lenane la khaello ea lisebelisoa tsa bongaka ho kenyelletsa li-tubes tsohle tsa pokello ea mali.FDA e kile ea fana ka lengolo le eang ho basebeletsi ba tsa bophelo bo botle le laboratori ka Phuptjane10, 2021, mabapi le khaello ea pokello ea mali a sodium citrate (kaholimo bo boputsoa bo bobebe).
Likhothaletso
FDA e khothaletsa bafani ba tlhokomelo ea bophelo bo botle, batsamaisi ba laboratori, li-phlebotomists, le basebetsi ba bang ho nahana ka maano a latelang a paballo ho fokotsa tšebeliso ea methapo ea mali le ho boloka boleng le polokeho ea tlhokomelo ea bakuli:
• Etsa feela ho hula mali ho nkoang ho hlokahala ho ea ka meriana. Fokotsa litlhahlobo maetong a tloaelo a bophelo bo botle le litekong tsa ho kula feela ho tse shebaneng le maemo a itseng a mafu kapa moo ho tla fetola kalafo ea mokuli.
• Tlosa litaelo tsa tlhahlobo tse kopitsoang ho qoba ho hula mali ho sa hlokahaleng.
• Qoba ho etsa liteko khafetsa kapa ho eketsa nako lipakeng tsa liteko ha ho khoneha.
• Nahana ka tlhahlobo ea tlatsetso kapa lisampole tsa ho arolelana lipakeng tsa mafapha a laboratori haeba mehlala e bokeletsoeng pele e le teng.
• Haeba o hloka tšupu ea ho lahla, sebelisa mofuta oa tšupu o nang le bongata bo bongata sebakeng sa heno.
• Nahana ka ntlha ea tlhahlobo ea tlhokomelo e sa hlokeng ho sebelisa li-tubes tsa pokello ea mali (liteko tsa lateral flow).
Liketso tsa FDA
Ka la 19 Pherekhong 2022, FDA e ile ea nchafatsa lethathamo la khaello ea lisebelisoa tsa bongaka ho kenyelletsa li-tubes tsohle tsa pokello ea mali (likhoutu tsa lihlahisoa tsa GIM le JKA).Karolo ea 506J ea Federal Food, Drug, and Cosmetic Act (FD&C Act) e hloka hore FDA e boloke lethathamo le fumanehang phatlalatsa, la morao-rao la lisebelisoa tseo FDA e lemohileng hore lia haella.
Nakong e fetileng, ka:
• La 10 Phuptjane 2021, FDA e ekelitse li-tubes tsa sodium citrate (top blue blue) tlas'a likhoutu tse tšoanang tsa sehlahisoa (GIM le JKA) lenaneng la khaello ea lisebelisoa tsa bongaka nakong ea tšohanyetso ea COVID-19 ea bophelo bo botle ba sechaba.
• Phupu 22, 2021, FDA e ile ea fana ka Tumello ea Tšebeliso ea Tšohanyetso ho Becton Dickinson bakeng sa mohlala o itseng oa sodium citrate mali (boputsoa bo boputsoa bo boputsoa) o sebelisoang ho bokella, ho tsamaisa le ho boloka lisampole tsa mali bakeng sa tlhahlobo ea coagulation ho tseba hantle le ho alafa coagulopathy ho bakuli. ka COVID-19 e tsebahalang kapa e belaelloang.
FDA e ntse e tsoela pele ho beha leihlo boemo ba hajoale ho thusa ho netefatsa hore tlhahlobo ea mali e lula e fumaneha bakeng sa bakuli moo tlhahlobo e hlokahalang ho tsa bongaka.FDA e tla tsebisa sechaba haeba tlhahisoleseling e ncha ea bohlokoa e fumaneha.
Nako ea poso: Aug-12-2022