I-AIOS ye-Macro & Micro-Test Ithola Ukuvunyelwa kwe-NMPA, Ithuthukisa Ukulungiselela Umtapo Wolwazi Ozenzakalelayo Ngokugcwele Wokulandelana

I-Macro & Micro-Test iyajabula ukumemezela ukuthi ithuthukiswe ngokuzimelaUhlelo Lokulungiselela Umtapo Wolwazi Olusebenzisa I-All-in-One Cartridge (HWTS-AIOS) Oluzenzakalelayo Ngokugcweleithole ngokusemthethweniimvume yokubhaliswa kwedivayisi yezokwelapha evela ku-National Medical Products Administration (NMPA) yaseShayina.

Lesi sinyathelo siqinisekisa ukuthi i-AIOS ihlangabezana nezimfuneko eziqinile zikazwelonke zeukuphepha, ukusebenza, ukuthobela imithetho, kanye nokuthembeka kwezokwelapha, okubonisa isinyathelo esibalulekile ekuletheniukulungiswa komtapo wolwazi wesizukulwane esilandelayo ojwayelekile, ozenzakalelayo (NGS)kuzinhlelo zokusebenza zezokwelapha nezomphakathi ezivamile.

Ukuzenzakalela Kwangempela “Kwesampula-kuya-Kulayibhulali” Ohlelweni Oluvaliwe

I-AIOS ineziciumklamo wekhatriji ohlanganisiwe, osetshenziswa kanye kuphelalokho kuhlanganisaukukhipha i-nucleic acid, ukulungiswa komtapo wolwazi, kanye nokuhlanzwakuhlelo lokusebenza olulodwa oluhlanganisiwe ngokuphelele. Kusukela ekufakweni kwesampula ye-RNA/DNA kuya emitatsheni yolwazi elungele ukulandelana, yonke inqubo iqedwa ngokuzenzakalelayo—ukunciphisa isikhathi sokusebenza, ukunciphisa ingozi yokungcola, nokuqinisekisa imiphumela ephindaphindwayo.

Lokhu “isampula ingenile, umtapo wolwazi uphumile"Ikhono lenza i-AIOS ifaneleke kakhulu ezindaweni laphoukungaguquguquki, ukuphepha kwezinto eziphilayo, kanye nobulula bokusebenzazibalulekile.

I-Reagent Elungele Ukusetshenziswa

Ukulungela Ukulawula Kuhlangabezana Nokusungula Okuqinisekisiwe

Ngaphambi kwalokhu kuvunyelwa, ama-Macro kanye nama-Micro-TestIsixazululo Sokulandelana Kwe-Microbial Whole-Genome Esizenzakalelayo Ngokugcwelewayesevele eqashelwa njenge-Ubuchwepheshe Obusha baseBeijing kanye Nomkhiqizo OmushaNjengoba i-AIOS manje ithola isaphulelo esisemthethweni

Ukubhaliswa kwe-NMPA, ikhambi lifinyelela umgomo oqinileukusekelwa okubili kokusungula izinto ezintsha kanye nokuhambisana nemithetho—ukuqinisa ubuholi benkampani ekulungiseleleni umtapo wolwazi we-NGS ozenzakalelayo.

Ukunika amandla ukulandelana kwezempilo zomphakathi kanye nokwezempilo okukalayo

Ukuvunyelwa kwe-AIOS kusekela ukuguquka okubanzi kokuhlolwa kwe-genomic kusuka kuma-laboratory akhethekile kuyaukuthunyelwa kwezempilo kanye nokwezempilo yomphakathi okukwazi ukukhuliswa, okungokoqobo:

-Kwamalabhorethri emitholampilo:
Izindlela zokusebenza ezijwayelekile ezinokuthembela okuncishisiwe ngesandla, ukuphindaphindwa okuthuthukisiwe, kanye nezikhathi zokushintsha ngokushesha.

-Ngezinhlelo zezempilo zomphakathi kanye nokulawula izifo:
Ukuhlonza ngokushesha izifo ezibangelwa amagciwane kanye namakhono okuhlola amakhulu ukuze kuthuthukiswe ukulungela ukuqubuka kwezifo ezithelelanayo.

-Kwezikhungo zocwaningo kanye nama-laboratory ezinkampani zangaphandle:
Ubunzima bokusebenza obuphansi kanye nezidingo zokuqeqeshwa, okuvumela ukukhiqizwa kwedatha okuzinzile, okunomthamo ophezulu.

Ukubheka Phambili

I-Macro & Micro-Test isalokhu izibophezele ekuletheniuhlakaniphile, usebenza kahle, uphephile, futhi uyathobela imithethoubuchwepheshe be-genomic obunika amandlaukuxilongwa okunembile kanye nokubhekwa kwempilo yomphakathiemhlabeni wonke. Ngokwakhela kulesi sinyathelo esibalulekile sokulawula, inkampani izoqhubeka nokuthuthukaizixazululo zokulandelana ezizenzakalelayo ngokuphelele, ezihlanganisiwe, ukusebenzisana eduze nabalingani bomhlaba wonke ukwenza ukuhlolwa kwezakhi zofuzoesebenza kahle kakhulu, ethembekile, futhi efinyeleleka kalula.