I-AIOS yeMacro kunye neMicro-Test ifumene imvume ye-NMPA, iqhubela phambili ukulungiswa kweThala leeNcwadi elizenzekelayo ngokupheleleyo ukuze lilandelelaniswe

I-Macro kunye ne-Micro-Test ziyavuya ukuvakalisa ukuba iphuhliswe ngokuzimeleyoInkqubo Yokulungiselela Ithala Leencwadi Esebenzisa Ikhatriji Eyodwa Ezenzekelayo Ngokupheleleyo (HWTS-AIOS)ifumene ngokusesikweniimvume yokubhaliswa kwezixhobo zonyango evela kwi-National Medical Products Administration (NMPA) yaseTshayina.

Olu phawu luqinisekisa ukuba i-AIOS iyahlangabezana neemfuno ezingqongqo zesizweukhuseleko, ukusebenza, ukuthobela imithetho, kunye nokuthembeka kweklinikhi, nto leyo ebonisa inyathelo elibalulekileyo ekuziseniukulungiswa kwethala leencwadi elimiselweyo, elizenzekelayo nelilandelelanayo lesizukulwana esilandelayo (NGS)kwizicelo zesiqhelo zezonyango kunye nezempilo yoluntu.

Ukuzenzekelayo kwe-"Sampuli ukuya kwiThala leeNcwadi" kokwenyani kwinkqubo evaliweyo

I-AIOS ineempawuuyilo lwekhatriji oludibeneyo, olusetyenziswa kanyeoko kudibanisaukukhutshwa kwe-nucleic acid, ukulungiswa kwethala leencwadi, kunye nokucocaukuya kumsebenzi omnye ovalekileyo ngokupheleleyo. Ukusuka ekufakweni kwesampulu ye-RNA/DNA ukuya kwiilayibrari ezilungele ukulandelelana, yonke inkqubo igqitywa ngokuzenzekelayo—ukunciphisa ixesha lokusebenza, ukunciphisa umngcipheko wongcoliseko, kunye nokuqinisekisa iziphumo eziphindaphindwayo.

Oku “isampuli ingenile, ilayibrari iphumile"Ubuchule benza i-AIOS ifaneleke ngakumbi kwiindawo aphoukungqinelana, ukhuseleko lwezinto eziphilayo, kunye nokulula kokusebenzazibalulekile.

I-Reagent Ekulungele Ukusetyenziswa

Ukulungela Ukulawula Kuhlangabezana Nobuchule Obuqinisekisiweyo

Ngaphambi kolu vunywa, iiMacro kunye neeMicro-TestIsisombululo Sokulandelelanisa Iintsholongwane Ezipheleleyo Esizenzekelayo Ngokupheleleyowayesele eqatshelwe njengeItekhnoloji eNtsha yaseBeijing kunye neMveliso eNtshaNjengoko i-AIOS ngoku ifumana ulwazi olusemthethweni

Ubhaliso lwe-NMPA, isisombululo sifezekisa inkqubela phambiliukuqinisekiswa kabini kobuchule bokuvelisa izinto ezintsha kunye nokuthotyelwa kwemithetho—ukuqinisa ubunkokeli benkampani ekulungiseleleni ithala leencwadi le-NGS ngokuzenzekelayo.

Ukuvumela Ulandelelwano Lwempilo Yoluntu Olunokulinganiswa

Ukuvunywa kwe-AIOS kuxhasa utshintsho olubanzi lovavanyo lwe-genomic ukusuka kwiilabhoratri ezikhethekileyo ukuyaukusasazwa kwezonyango kunye nempilo yoluntu okunokwandiswa, kwihlabathi lokwenyani:

-Kwiilabhoratri zeklinikhi:
Iindlela zokusebenza ezisemgangathweni ezinokuxhomekeka okuncitshisiweyo ngesandla, ukuphinda kuphuculwe, kunye namaxesha okusebenza ngokukhawuleza.

-Kwiinkqubo zempilo yoluntu kunye nolawulo lwezifo:
Ukuchonga ngokukhawuleza izifo ezibangela iintsholongwane kunye nokukwazi ukuhlola ngokubanzi ukuphucula ukulungela ukuqhambuka kwezifo ezisulelayo.

-Kwiziko zophando kunye neelabhoratri zomntu wesithathu:
Ubunzima bokusebenza obuphantsi kunye neemfuno zoqeqesho, okuvumela ukuveliswa kwedatha ezinzileyo nephuma kakhulu.

Ukujonga Phambili

Uvavanyo lweMacro kunye nolweMicro luzimisele ukufezekisa okuukrelekrele, usebenza kakuhle, ukhuselekile, kwaye uyathobelaubuchwepheshe be-genomic obunika amandlaukuxilongwa ngokuchanekileyo kunye nokuhlolwa kwempilo yoluntuNgokwakha phezu kwesi siganeko sibalulekileyo solawulo, inkampani iya kuqhubeka nokuqhubela phambiliizisombululo zokulandelelana ezizenzekelayo ngokupheleleyo nezidibeneyo, besebenzisana ngokusondeleyo namaqabane ehlabathi ukwenza uvavanyo lwemfuzaisebenza ngakumbi, inokuthenjwa ngakumbi, kwaye ifikeleleka lula.