{"id":35176,"date":"2022-01-11T14:54:00","date_gmt":"2022-01-11T22:54:00","guid":{"rendered":"https:\/\/sweet-pascal.52-27-215-206.plesk.page\/?p=35176"},"modified":"2022-01-12T05:18:40","modified_gmt":"2022-01-12T13:18:40","slug":"fda-canh-bao-khong-nen-su-dung-mot-so-xet-nghiem-khang-nguyen-va-khang-the-do-nguy-co-sai-lech-ket-qua-cao","status":"publish","type":"post","link":"https:\/\/vietvalley.com\/fda-canh-bao-khong-nen-su-dung-mot-so-xet-nghiem-khang-nguyen-va-khang-the-do-nguy-co-sai-lech-ket-qua-cao\/","title":{"rendered":"FDA c\u1ea3nh b\u00e1o kh\u00f4ng n\u00ean s\u1eed d\u1ee5ng m\u1ed9t s\u1ed1 x\u00e9t nghi\u1ec7m kh\u00e1ng nguy\u00ean v\u00e0 kh\u00e1ng th\u1ec3 do nguy c\u01a1 sai l\u1ec7ch k\u1ebft qu\u1ea3 cao"},"content":{"rendered":"\n
C\u01a1 quan Qu\u1ea3n L\u00fd Th\u1ef1c Ph\u1ea9m v\u00e0 D\u01b0\u1ee3c Ph\u1ea9m Hoa K\u1ef3 \u0111ang k\u00eau g\u1ecdi ng\u01b0\u1eddi ti\u00eau d\u00f9ng ng\u1eebng s\u1eed d\u1ee5ng c\u00e1c x\u00e9t nghi\u1ec7m kh\u00e1ng nguy\u00ean (antigen) v\u00e0 kh\u00e1ng th\u1ec3 (anitbody) c\u1ee7a m\u1ed9t c\u00f4ng ty do ho\u1ea1t \u0111\u1ed9ng kh\u00f4ng hi\u1ec7u qu\u1ea3 v\u00e0 c\u00f3 nguy c\u01a1 cao d\u1eabn \u0111\u1ebfn k\u1ebft qu\u1ea3 sai.<\/p>\n\n\n\n
X\u00e9t nghi\u1ec7m kh\u00e1ng nguy\u00ean COVID-19 c\u1ee7a ph\u00f2ng th\u00ed nghi\u1ec7m LuSys (N\u01b0\u1edbc m\u0169i \/ N\u01b0\u1edbc b\u1ecdt) v\u00e0 x\u00e9t nghi\u1ec7m kh\u00e1ng nguy\u00ean COVID-19 IgG \/ IgM c\u1ee7a Ph\u00f2ng th\u00ed nghi\u1ec7m LuSys ch\u01b0a \u0111\u01b0\u1ee3c \u1ee7y quy\u1ec1n ho\u1eb7c ph\u00ea duy\u1ec7t \u0111\u1ec3 ph\u00e2n ph\u1ed1i ho\u1eb7c s\u1eed d\u1ee5ng \u1edf Hoa K\u1ef3. X\u00e9t nghi\u1ec7m kh\u00e1ng nguy\u00ean s\u1eed d\u1ee5ng t\u0103m b\u00f4ng ho\u1eb7c n\u01b0\u1edbc b\u1ecdt trong khi x\u00e9t nghi\u1ec7m kh\u00e1ng th\u1ec3 s\u1eed d\u1ee5ng huy\u1ebft thanh, huy\u1ebft t\u01b0\u01a1ng ho\u1eb7c m\u1eabu m\u00e1u.<\/p>\n\n\n\n
C\u00e1c th\u1eed nghi\u1ec7m, \u0111\u01b0\u1ee3c cho l\u00e0 \u0111\u00e3 \u0111\u01b0\u1ee3c ph\u00e2n ph\u1ed1i \u0111\u1ec3 s\u1eed d\u1ee5ng trong c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m ho\u1eb7c th\u1eed nghi\u1ec7m t\u1ea1i nh\u00e0, hi\u1ec7n \u0111ang \u0111\u01b0\u1ee3c b\u00e1n d\u01b0\u1edbi t\u00ean c\u00f4ng ty Luscient Diagnostics ho\u1eb7c Vivera Pharmaceuticals, ho\u1eb7c v\u1edbi t\u00ean th\u01b0\u01a1ng m\u1ea1i l\u00e0 EagleDx.<\/p>\n\n\n\n
FDA b\u00e1o c\u00e1o c\u1ea3 hai x\u00e9t nghi\u1ec7m \u0111\u1ec1u c\u00f3 kh\u1ea3 n\u0103ng cho k\u1ebft qu\u1ea3 \u00e2m t\u00ednh gi\u1ea3 v\u00e0 d\u01b0\u01a1ng t\u00ednh gi\u1ea3 nh\u01b0ng kh\u00f4ng ch\u1ec9 ra k\u1ebft qu\u1ea3 n\u00e0o ph\u1ed5 bi\u1ebfn h\u01a1n.<\/p>\n\n\n\n
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