{"id":8932,"date":"2023-07-13T04:10:29","date_gmt":"2023-07-13T04:10:29","guid":{"rendered":"https:\/\/vospan.com\/?p=8932"},"modified":"2024-03-20T08:22:00","modified_gmt":"2024-03-20T08:22:00","slug":"thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong","status":"publish","type":"post","link":"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/","title":{"rendered":"Ph\u01b0\u01a1ng ph\u00e1p SCANRDI\u00ae: Th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng thay th\u1ebf kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_68_1 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<label class=\"ez-toc-title ez-toc-toggle\" style=\"cursor: pointer\">T&oacute;m t\u1eaft n\u1ed9i dung<\/label>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" aria-label=\"Toggle Table of Content\"><span class=\"ez-toc-js-icon-con\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #0a0a0a;color:#0a0a0a\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #0a0a0a;color:#0a0a0a\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/span><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 eztoc-toggle-hide-by-default' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/#TOM_TAT\" title=\"T\u00d3M T\u1eaeT\">T\u00d3M T\u1eaeT<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/#TONG_QUAN\" title=\"T\u1ed4NG QUAN\">T\u1ed4NG QUAN<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/#Phuong_phap_SCANRDI%C2%AE\" title=\"Ph\u01b0\u01a1ng ph\u00e1p SCANRDI\u00ae\">Ph\u01b0\u01a1ng ph\u00e1p SCANRDI\u00ae<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/#THUC_HIEN_TOT_VIEC_SAN_XUAT\" title=\"TH\u1ef0C HI\u1ec6N T\u1ed0T VI\u1ec6C S\u1ea2N XU\u1ea4T\">TH\u1ef0C HI\u1ec6N T\u1ed0T VI\u1ec6C S\u1ea2N XU\u1ea4T<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/vospan.com\/thu-nghiem-vo-trung-thay-the-khong-dua-tren-tang-truong\/#VO_TRUNG_NGOAI_THONG_SO_KY_THUAT_BANG_PHUONG_PHAP_VI_SINH_NHANH_CHONG_KHONG_DUA_TREN_TANG_TRUONG\" title=\"V\u00d4 TR\u00d9NG NGO\u00c0I TH\u00d4NG S\u1ed0 K\u1ef8 THU\u1eacT B\u1eb0NG PH\u01af\u01a0NG PH\u00c1P VI SINH NHANH CH\u00d3NG KH\u00d4NG D\u1ef0A TR\u00caN T\u0102NG TR\u01af\u1edeNG\">V\u00d4 TR\u00d9NG NGO\u00c0I TH\u00d4NG S\u1ed0 K\u1ef8 THU\u1eacT B\u1eb0NG PH\u01af\u01a0NG PH\u00c1P VI SINH NHANH CH\u00d3NG KH\u00d4NG D\u1ef0A TR\u00caN T\u0102NG TR\u01af\u1edeNG<\/a><\/li><\/ul><\/nav><\/div>\n<h2><span class=\"ez-toc-section\" id=\"TOM_TAT\"><\/span><strong>T\u00d3M T\u1eaeT<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<ul>\n<li><a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> l\u00e0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p vi sinh v\u1eadt nhanh ch\u00f3ng kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng (RMM), ph\u00e1t hi\u1ec7n kh\u00f4ng ch\u1ec9 c\u00e1c t\u1ebf b\u00e0o vi sinh v\u1eadt kh\u1ea3 thi c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n l\u1eadp b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng \u0111\u0129a th\u1ea1ch m\u00e0 c\u00f2n c\u1ea3 c\u00e1c vi sinh v\u1eadt kh\u1ea3 thi nh\u01b0ng kh\u00f4ng th\u1ec3 nu\u00f4i c\u1ea5y (VBNC), bao g\u1ed3m c\u00e1c vi sinh v\u1eadt kh\u00f4ng \u0111\u01b0\u1ee3c ph\u1ee5c h\u1ed3i b\u1eb1ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y ti\u00eau chu\u1ea9n, l\u00e0m cho <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> nh\u1ea1y h\u01a1n c\u00e1c ph\u01b0\u01a1ng ph\u00e1p d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng.<\/li>\n<li>FDA \u0111\u00e3 ch\u1ec9 ra r\u1eb1ng c\u00f3 nh\u1eefng \u1ee9ng d\u1ee5ng thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t s\u1eed d\u1ee5ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> cho c\u00e1c th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng \u0111\u1ec3 ph\u00e1t h\u00e0nh s\u1ea3n ph\u1ea9m. Do \u0111\u00f3, c\u00f4ng ngh\u1ec7 \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn trong ng\u00e0nh d\u01b0\u1ee3c ph\u1ea9m.<\/li>\n<li>Ng\u01b0\u1eddi ta nh\u1eadn ra r\u1eb1ng m\u1ed9t s\u1ed1 vi sinh v\u1eadt s\u1ebd kh\u00f4ng \u0111\u01b0\u1ee3c nu\u00f4i c\u1ea5y t\u1eeb m\u00e0ng sinh h\u1ecdc cho m\u1ee5c \u0111\u00edch nh\u1eadn d\u1ea1ng vi sinh v\u1eadt do nh\u1eefng h\u1ea1n ch\u1ebf li\u00ean quan \u0111\u1ebfn m\u00f4i tr\u01b0\u1eddng vi sinh th\u00f4ng th\u01b0\u1eddng v\u00e0 c\u00e1c th\u00f4ng s\u1ed1 \u1ee7 ho\u1eb7c ti\u1ebfp x\u00fac v\u1edbi \u1ee9ng su\u1ea5t li\u00ean quan \u0111\u1ebfn ph\u01b0\u01a1ng ph\u00e1p lu\u1eadn.<\/li>\n<li>C\u00e1c chi\u1ebfn l\u01b0\u1ee3c l\u01b0u gi\u1eef m\u1eabu n\u00ean \u0111\u01b0\u1ee3c ph\u00e1t tri\u1ec3n b\u1edfi ng\u01b0\u1eddi d\u00f9ng cu\u1ed1i cho ph\u00e9p h\u1ecd l\u1ea5y m\u1eabu l\u1ea1i c\u00f9ng m\u1ed9t v\u1eadt li\u1ec7u trong tr\u01b0\u1eddng h\u1ee3p h\u1ecd c\u1ea7n c\u1ed1 g\u1eafng ph\u1ee5c h\u1ed3i vi sinh v\u1eadt sau khi c\u00f3 k\u1ebft qu\u1ea3 <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> d\u01b0\u01a1ng t\u00ednh \u0111\u1ec3 h\u1ed7 tr\u1ee3 \u0111i\u1ec1u tra l\u1ed7i v\u00f4 tr\u00f9ng.<\/li>\n<li>C\u00e1c quy \u0111\u1ecbnh Th\u1ef1c h\u00e0nh s\u1ea3n xu\u1ea5t t\u1ed1t (cGMP) hi\u1ec7n t\u1ea1i y\u00eau c\u1ea7u c\u00e1c l\u1ed7i ki\u1ec3m tra v\u00f4 tr\u00f9ng ph\u1ea3i \u0111\u01b0\u1ee3c \u0111i\u1ec1u tra \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n c\u00f3 th\u1ec3 x\u1ea3y ra nh\u1ea5t c\u1ee7a s\u1ef1 c\u1ed1. Nh\u1eefng nghi\u00ean c\u1ee9u n\u00e0y c\u00f3 th\u1ec3 th\u1ef1c hi\u1ec7n \u0111\u01b0\u1ee3c m\u00e0 kh\u00f4ng c\u1ea7n x\u00e1c \u0111\u1ecbnh x\u00e1c \u0111\u1ecbnh vi sinh v\u1eadt.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"TONG_QUAN\"><\/span><strong>T\u1ed4NG QUAN<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>X\u00e9t nghi\u1ec7m v\u00f4 tr\u00f9ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng truy\u1ec1n th\u1ed1ng theo USP &lt;71&gt; c\u00f3 th\u1eddi gian \u1ee7 \u00edt nh\u1ea5t 14 ng\u00e0y. \u0110i\u1ec1u \u0111\u00f3 kh\u00f4ng ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng ng\u1eafn ho\u1eb7c c\u00e1c s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c chu\u1ea9n b\u1ecb \u0111\u1ec3 s\u1eed d\u1ee5ng ngay l\u1eadp t\u1ee9c bao g\u1ed3m c\u00e1c ch\u1ebf ph\u1ea9m v\u00f4 tr\u00f9ng h\u1ed7n h\u1ee3p (CSP). V\u00e0o th\u00e1ng 12 n\u0103m 2019, USP &lt;1071&gt; Th\u1eed nghi\u1ec7m vi khu\u1ea9n nhanh \u0111\u1ec3 tri\u1ec3n khai c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 tu\u1ed5i th\u1ecd ng\u1eafn v\u00f4 tr\u00f9ng: C\u00e1ch ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro \u0111\u00e3 tr\u1edf th\u00e0nh ch\u00ednh th\u1ee9c. Ch\u01b0\u01a1ng th\u00f4ng tin chung n\u00e0y cung c\u1ea5p h\u01b0\u1edbng d\u1eabn cho c\u00e1c b\u00ean li\u00ean quan v\u1ec1 vi\u1ec7c s\u1eed d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro \u0111\u1ec3 l\u1ef1a ch\u1ecdn ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra v\u00f4 tr\u00f9ng nhanh ph\u00f9 h\u1ee3p nh\u1ea5t cho m\u1ee5c \u0111\u00edch s\u1eed d\u1ee5ng d\u1ef1a tr\u00ean vi\u1ec7c xem x\u00e9t th\u1eddi gian cho k\u1ebft qu\u1ea3, \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u, gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n (LOD), c\u1ee1 m\u1eabu, thu\u1ed9c t\u00ednh s\u1ea3n ph\u1ea9m v\u00e0 s\u1ef1 an to\u00e0n c\u1ee7a b\u1ec7nh nh\u00e2n.<\/p>\n<p>L\u00e0 m\u1ed9t ph\u1ea7n c\u1ee7a \u0111\u00e1nh gi\u00e1 r\u1ee7i ro, li\u1ec7u m\u1ed9t ch\u1ea5t ma t\u00fay kh\u00f4ng v\u00f4 tr\u00f9ng c\u00f3 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng trong h\u1ed7n h\u1ee3p hay kh\u00f4ng, s\u1ed1 l\u01b0\u1ee3ng thao t\u00e1c v\u00f4 tr\u00f9ng, m\u1ee9c \u0111\u1ed9 ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng trong c\u01a1 s\u1edf h\u1ed7n h\u1ee3p v\u00e0 kh\u1ed1i l\u01b0\u1ee3ng s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c ti\u00eam ho\u1eb7c truy\u1ec1n n\u00ean \u0111\u01b0\u1ee3c xem x\u00e9t trong vi\u1ec7c ch\u1ec9 \u0111\u1ecbnh CSP nh\u01b0 m\u1ed9t ch\u1ebf ph\u1ea9m c\u00f3 nguy c\u01a1 th\u1ea5p, trung b\u00ecnh ho\u1eb7c cao. V\u00ec CSP s\u1ebd c\u00f3 th\u1eddi gian ng\u1eafn ngo\u00e0i s\u1eed d\u1ee5ng, kh\u1ea3 n\u0103ng ho\u00e0n th\u00e0nh th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng trong v\u00f2ng 3-4 gi\u1edd b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng Ph\u01b0\u01a1ng ph\u00e1p Vi sinh nhanh (RMM) thay th\u1ebf, lo\u1ea1i b\u1ecf c\u00e1c l\u00f4 b\u1ecb \u00f4 nhi\u1ec5m vi sinh v\u1eadt v\u00e0 gi\u1ea3i ph\u00f3ng c\u00e1c CSP qua kho\u1ea3ng tr\u1ed1ng m\u00e0 kh\u00f4ng c\u1ea7n ti\u1ebfn h\u00e0nh th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng t\u1ed5ng h\u1ee3p 14 ng\u00e0y cho ph\u00e9p c\u00e1c c\u01a1 s\u1edf duy tr\u00ec \u0111\u1ee7 h\u00e0ng t\u1ed3n kho \u0111\u1ec3 \u0111\u00e1p \u1ee9ng nhu c\u1ea7u y t\u1ebf v\u00e0 s\u1ef1 an to\u00e0n c\u1ee7a b\u1ec7nh nh\u00e2n.<\/p>\n<p>RMM \u0111\u1ec3 ki\u1ec3m tra v\u00f4 tr\u00f9ng bao g\u1ed3m c\u1ea3 ph\u01b0\u01a1ng ph\u00e1p d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng v\u00e0 kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng. B\u1ea5t k\u1ec3 lo\u1ea1i RMM n\u00e0o, t\u1ea5t c\u1ea3 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c ph\u1ea3i \u0111\u01b0\u1ee3c \u0111\u00e1nh gi\u00e1 v\u1ec1 kh\u1ea3 n\u0103ng t\u01b0\u01a1ng th\u00edch v\u1edbi c\u00f4ng ngh\u1ec7 thay th\u1ebf v\u00e0 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn \u0111\u1ec3 th\u1ec3 hi\u1ec7n kh\u1ea3 n\u0103ng so s\u00e1nh v\u1edbi ph\u01b0\u01a1ng ph\u00e1p t\u1ed5ng h\u1ee3p b\u1eb1ng c\u00e1ch tu\u00e2n theo USP &lt;1223&gt; X\u00e1c nh\u1eadn c\u00e1c ph\u01b0\u01a1ng ph\u00e1p vi sinh thay th\u1ebf. Th\u00f4ng tin chung Ch\u01b0\u01a1ng &lt;1223&gt; cung c\u1ea5p h\u01b0\u1edbng d\u1eabn v\u1ec1 c\u00e1c th\u00f4ng s\u1ed1 x\u00e1c nh\u1eadn \u0111\u01b0\u1ee3c khuy\u1ebfn ngh\u1ecb th\u1ef1c hi\u1ec7n cho x\u00e9t nghi\u1ec7m v\u00f4 tr\u00f9ng \u0111\u1ecbnh t\u00ednh s\u1ef1 hi\u1ec7n di\u1ec7n\/v\u1eafng m\u1eb7t.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"alignnone wp-image-8940 size-full\" src=\"https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21.png\" alt=\"\" width=\"2076\" height=\"530\" srcset=\"https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21.png 2076w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-300x77.png 300w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-1024x261.png 1024w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-768x196.png 768w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-1536x392.png 1536w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-2048x523.png 2048w, https:\/\/vospan.com\/wp-content\/uploads\/2023\/07\/Anh-man-hinh-2023-07-13-luc-11.15.21-510x130.png 510w\" sizes=\"(max-width: 2076px) 100vw, 2076px\" \/><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Phuong_phap_SCANRDI%C2%AE\"><\/span><strong>Ph\u01b0\u01a1ng ph\u00e1p<a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\"> SCANRDI\u00ae<\/a><\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> l\u00e0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p vi sinh nhanh ch\u00f3ng c\u00e1c t\u1ebf b\u00e0o pha r\u1eafn \u0111\u00e3 \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u \u0111\u1ecbnh t\u00ednh c\u1ee7a USP &lt;1223&gt; v\u00e0 c\u00f3 th\u1ec3 ph\u00e1t hi\u1ec7n c\u00e1c t\u1ebf b\u00e0o \u0111\u01a1n l\u1ebb kh\u1ea3 thi c\u1ee7a nhi\u1ec1u lo\u1ea1i vi khu\u1ea9n, n\u1ea5m men v\u00e0 n\u1ea5m m\u1ed1c. M\u1ed9t m\u00f4 t\u1ea3 v\u1ec1 c\u00f4ng ngh\u1ec7 v\u00e0 c\u00e1c chi ti\u1ebft x\u00e1c nh\u1eadn \u0111\u00e3 \u0111\u01b0\u1ee3c tr\u00ecnh l\u00ean FDA d\u01b0\u1edbi d\u1ea1ng File t\u1ed5ng th\u1ec3 thu\u1ed1c (Lo\u1ea1i V CDER DMF 014621). Ngo\u00e0i ra, m\u1ed9t s\u1ed1 t\u00e0i li\u1ec7u x\u00e1c nh\u1eadn bioM\u00e9rieux c\u00f3 s\u1eb5n cho c\u00e1c c\u00f4ng ty s\u1eed d\u1ee5ng H\u1ec7 th\u1ed1ng SCANRDI \u0111\u1ec3 th\u1eed nghi\u1ec7m CSP. B\u00e1o c\u00e1o x\u00e1c th\u1ef1c ch\u00ednh (BMX.1.076552 phi\u00ean b\u1ea3n 1.0) cung c\u1ea5p b\u1ea3n t\u00f3m t\u1eaft d\u1eef li\u1ec7u \u0111\u1ec3 h\u1ed7 tr\u1ee3 LOD, T\u00ednh \u0111\u1eb7c hi\u1ec7u, \u0110\u1ed9 b\u1ec1n, \u0110\u1ed9 ch\u1eafc ch\u1eafn v\u00e0 T\u01b0\u01a1ng \u0111\u01b0\u01a1ng. H\u01b0\u1edbng d\u1eabn x\u00e1c th\u1ef1c (BMX.1.076403 phi\u00ean b\u1ea3n 1.0) cung c\u1ea5p h\u01b0\u1edbng d\u1eabn v\u1ec1 s\u1ef1 ph\u00f9 h\u1ee3p c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p cho CSP.&#8221;<\/p>\n<p>Trong qu\u00e1 tr\u00ecnh ph\u00e2n t\u00edch m\u1eabu, <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> c\u00f3 th\u1ec3 ph\u00e1t hi\u1ec7n t\u1ea5t c\u1ea3 c\u00e1c hi\u1ec7n t\u01b0\u1ee3ng hu\u1ef3nh quang \u1edf b\u1ec1 m\u1eb7t m\u00e0ng v\u00e0 nh\u1eadn ra c\u00e1c vi sinh v\u1eadt \u0111\u01b0\u1ee3c d\u00e1n nh\u00e3n nh\u1edd thu\u1eadt to\u00e1n ph\u00e2n bi\u1ec7t. Thu\u1eadt to\u00e1n n\u00e0y c\u00f3 th\u1ec3 lo\u1ea1i b\u1ecf c\u00e1c h\u1ea1t hu\u1ef3nh quang kh\u00f4ng \u0111\u1eb7c hi\u1ec7u, tuy nhi\u00ean v\u1eabn c\u00f3 th\u1ec3 c\u00f3 m\u1ed9t s\u1ed1 tr\u01b0\u1eddng h\u1ee3p \u0111\u00f2i h\u1ecfi ph\u1ea3i x\u00e1c minh c\u1ee7a nh\u00e0 ph\u00e2n t\u00edch. Chuy\u00ean vi\u00ean ph\u00f2ng th\u00ed nghi\u1ec7m \u0111\u01b0\u1ee3c \u0111\u00e0o t\u1ea1o s\u1eed d\u1ee5ng k\u00ednh hi\u1ec3n vi hu\u1ef3nh quang t\u1edbi \u0111\u1ec3 th\u1ef1c hi\u1ec7n x\u00e1c minh. C\u00e1c t\u1ebf b\u00e0o vi sinh v\u1eadt kh\u1ea3 thi d\u1ec5 d\u00e0ng \u0111\u01b0\u1ee3c ph\u00e2n bi\u1ec7t b\u1edfi h\u00ecnh d\u1ea1ng, k\u00edch th\u01b0\u1edbc, c\u01b0\u1eddng \u0111\u1ed9 hu\u1ef3nh quang v\u00e0 m\u1edd d\u1ea7n khi ti\u1ebfp x\u00fac l\u00e2u h\u01a1n trong k\u00ednh hi\u1ec3n vi hu\u1ef3nh quang v\u1edbi b\u01b0\u1edbc s\u00f3ng k\u00edch th\u00edch t\u1eeb c\u00e1c h\u1ea1t v\u00e0 s\u1ee3i hu\u1ef3nh quang t\u1ef1 \u0111\u1ed9ng c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb s\u1ea3n ph\u1ea9m.<\/p>\n<p>H\u1ec7 th\u1ed1ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> \u0111\u01b0\u1ee3c ghi nh\u1eadn trong vi\u1ec7c ph\u00e1t hi\u1ec7n vi sinh v\u1eadt trong c\u00e1c dung d\u1ecbch c\u00f3 th\u1ec3 l\u1ecdc v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m h\u00f2a tan. C\u00e1c nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 g\u1ea7n \u0111\u00e2y \u0111\u00e3 cho th\u1ea5y H\u1ec7 th\u1ed1ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> li\u1ec7t k\u00ea c\u00e1c vi sinh v\u1eadt kh\u1ea3 thi trong n\u01b0\u1edbc c\u1ea5p d\u01b0\u1ee3c ph\u1ea9m, natri clorua 0,9% ti\u00eam v\u00e0 c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c nh\u00e3n khoa (1-4). C\u00f4ng ngh\u1ec7 <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> \u0111\u00e3 \u0111\u01b0\u1ee3c ch\u1ee9ng minh l\u00e0 cung c\u1ea5p k\u1ebft qu\u1ea3 nh\u1ea5t qu\u00e1n v\u00e0 \u0111\u00e1ng tin c\u1eady, v\u01b0\u1ee3t tr\u1ed9i v\u1ec1 m\u1eb7t s\u1ed1 l\u01b0\u1ee3ng v\u00e0 kh\u00f4ng thua k\u00e9m v\u1ec1 m\u1eb7t th\u1ed1ng k\u00ea so v\u1edbi th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng t\u1ed5ng h\u1ee3p li\u00ean quan \u0111\u1ebfn gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n (4). C\u00e1c chi ti\u1ebft c\u1ee7a c\u00e1c quy \u0111\u1ecbnh kh\u00f4ng \u0111\u01b0\u1ee3c ti\u1ebft l\u1ed9, tuy nhi\u00ean, FDA \u0111\u00e3 ch\u1ec9 ra r\u1eb1ng c\u00f3 nh\u1eefng \u1ee9ng d\u1ee5ng thu\u1ed1c \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t s\u1eed d\u1ee5ng SCANRDI\u00ae cho c\u00e1c th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng \u0111\u1ec3 ph\u00e1t h\u00e0nh s\u1ea3n ph\u1ea9m (5).<\/p>\n<p><strong>\u01afu \u0111i\u1ec3m c\u1ee7a c\u00e1c ph\u01b0\u01a1ng ph\u00e1p kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng s\u1eed d\u1ee5ng T\u1ebf b\u00e0o pha r\u1eafn bao g\u1ed3m:<\/strong><\/p>\n<ul>\n<li>Kh\u1ea3 n\u0103ng ph\u00e1t hi\u1ec7n c\u00e1c t\u1ebf b\u00e0o kh\u00f4ng ho\u1ea1t \u0111\u1ed9ng, khi nu\u00f4i c\u1ea5y theo c\u00e1ch truy\u1ec1n th\u1ed1ng, \u0111\u00f2i h\u1ecfi th\u1eddi gian \u1ee7 b\u1ec7nh l\u00e2u h\u01a1n, c\u0169ng nh\u01b0 c\u00e1c t\u1ebf b\u00e0o c\u00f3 y\u00eau c\u1ea7u t\u0103ng tr\u01b0\u1edfng ph\u1ee9c t\u1ea1p h\u01a1n th\u01b0\u1eddng \u0111\u01b0\u1ee3c m\u00f4 t\u1ea3 l\u00e0 vi sinh v\u1eadt kh\u1ea3 thi nh\u01b0ng kh\u00f4ng th\u1ec3 nu\u00f4i c\u1ea5y (VBNC).<\/li>\n<li>Kh\u00f4ng ph\u1ee5 thu\u1ed9c v\u00e0o c\u00e1c h\u1ea1n ch\u1ebf li\u00ean quan \u0111\u1ebfn vi\u1ec7c l\u1ef1a ch\u1ecdn v\u00e0 t\u1ed1i \u01b0u h\u00f3a m\u00f4i tr\u01b0\u1eddng t\u0103ng tr\u01b0\u1edfng vi sinh v\u00e0 \u0111i\u1ec1u ki\u1ec7n \u1ee7 \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng cho th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng t\u1ed5ng h\u1ee3p.<\/li>\n<li>Tr\u00e1nh s\u1ef1 ph\u1ee5c h\u1ed3i ch\u1eadm tr\u1ec5 c\u1ee7a c\u00e1c vi sinh v\u1eadt ph\u00e1t tri\u1ec3n ch\u1eadm c\u00f3 th\u1ec3 d\u1eabn \u0111\u1ebfn \u00f4 nhi\u1ec5m vi khu\u1ea9n b\u1ecb lo\u1ea1i b\u1ecf b\u1eb1ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng.<\/li>\n<li>Kh\u1ea3 n\u0103ng c\u1ee7a x\u00e9t nghi\u1ec7m v\u00f4 tr\u00f9ng kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng kh\u00f4ng b\u1ecb \u1ea3nh h\u01b0\u1edfng b\u1edfi kh\u00e1ng sinh ho\u1eb7c c\u00e1c th\u00e0nh ph\u1ea7n kh\u00e1c c\u00f3 ho\u1ea1t t\u00ednh kh\u00e1ng khu\u1ea9n trong m\u1eabu th\u1eed.<\/li>\n<li>Kh\u1ea3 n\u0103ng x\u00e1c \u0111\u1ecbnh s\u1ef1 hi\u1ec7n di\u1ec7n \/ v\u1eafng m\u1eb7t c\u1ee7a vi sinh v\u1eadt trong CSP trong \u00edt nh\u1ea5t l\u00e0 3 gi\u1edd; cho ph\u00e9p ph\u00e1t hi\u1ec7n v\u00e0 ph\u1ea3n h\u1ed3i theo th\u1eddi gian th\u1ef1c trong tr\u01b0\u1eddng h\u1ee3p c\u00f3 k\u1ebft qu\u1ea3 ngo\u00e0i th\u00f4ng s\u1ed1 k\u1ef9 thu\u1eadt.<\/li>\n<\/ul>\n<p><strong>Nh\u1eefng th\u00e1ch th\u1ee9c c\u1ee7a c\u00e1c ph\u01b0\u01a1ng ph\u00e1p kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng s\u1eed d\u1ee5ng T\u1ebf b\u00e0o pha r\u1eafn bao g\u1ed3m:<\/strong><\/p>\n<ul>\n<li>C\u00e1c k\u1ef9 thu\u1eadt vi\u00ean \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u \u0111\u00e0o t\u1ea1o \u0111\u1ec3 x\u00e1c th\u1ef1c b\u1eb1ng k\u00ednh hi\u1ec3n vi cu\u1ed1i c\u00f9ng. Th\u00e1ch th\u1ee9c n\u00e0y \u0111\u01b0\u1ee3c kh\u1eafc ph\u1ee5c b\u1eb1ng c\u00e1ch c\u00f3 m\u1ed9t ch\u01b0\u01a1ng tr\u00ecnh \u0111\u00e0o t\u1ea1o n\u1ed9i b\u1ed9 c\u00f3 th\u1ec3 bao g\u1ed3m \u0111\u00e0o t\u1ea1o b\u1ed3i d\u01b0\u1ee1ng t\u1ea1i ch\u1ed7 t\u1eeb bioM\u00e9rieux v\u00e0 ki\u1ec3m tra tr\u00ecnh \u0111\u1ed9.<\/li>\n<li>Kh\u00f4ng c\u00f3 kh\u1ea3 n\u0103ng nu\u00f4i c\u1ea5y nh\u1ea5t qu\u00e1n v\u00e0 x\u00e1c \u0111\u1ecbnh t\u1ea5t c\u1ea3 c\u00e1c vi sinh v\u1eadt \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n sau khi qu\u00e9t m\u00e0ng.<\/li>\n<\/ul>\n<h2><span class=\"ez-toc-section\" id=\"THUC_HIEN_TOT_VIEC_SAN_XUAT\"><\/span><strong>TH\u1ef0C HI\u1ec6N T\u1ed0T VI\u1ec6C S\u1ea2N XU\u1ea4T<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>C\u00e1c quy \u0111\u1ecbnh c\u1ee7a FDA li\u00ean quan \u0111\u1ebfn c\u00e1c y\u00eau c\u1ea7u cGMP \u0111\u1ed1i v\u1edbi vi\u1ec7c \u0111i\u1ec1u ch\u1ebf c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c \u0111\u00e3 \u0111\u01b0\u1ee3c thi\u1ebft l\u1eadp trong 21 CFR ph\u1ea7n 210 v\u00e0 211 c\u1ee7a Lu\u1eadt Th\u1ef1c ph\u1ea9m, D\u01b0\u1ee3c ph\u1ea9m v\u00e0 M\u1ef9 ph\u1ea9m. FDA \u0111\u00e3 ban h\u00e0nh b\u1ea3n s\u1eeda \u0111\u1ed5i 2 c\u1ee7a d\u1ef1 th\u1ea3o h\u01b0\u1edbng d\u1eabn cho ng\u00e0nh c\u00f4ng nghi\u1ec7p v\u00e0o th\u00e1ng 1 n\u0103m 2020 v\u1ec1 Th\u1ef1c hi\u1ec7n t\u1ed1t vi\u1ec7c s\u1ea3n xu\u1ea5t -H\u01b0\u1edbng d\u1eabn cho c\u00e1c c\u01a1 s\u1edf gia c\u00f4ng h\u1ed7n h\u1ee3p thu\u1ed1c \u1edf ng\u01b0\u1eddi theo M\u1ee5c 503B c\u1ee7a Lu\u1eadt FD&amp;C (6). D\u1ef1 th\u1ea3o h\u01b0\u1edbng d\u1eabn m\u1edbi cung c\u1ea5p c\u00e1c \u0111i\u1ec1u ki\u1ec7n r\u1eb1ng FDA s\u1ebd kh\u00f4ng th\u1ef1c hi\u1ec7n h\u00e0nh \u0111\u1ed9ng ph\u00e1p l\u00fd li\u00ean quan \u0111\u1ebfn c\u00e1c y\u00eau c\u1ea7u cGMP nh\u1ea5t \u0111\u1ecbnh trong 21 CFR ph\u1ea7n 210 v\u00e0 211 cho \u0111\u1ebfn khi c\u00e1c quy \u0111\u1ecbnh m\u1edbi c\u1ee7a FDA v\u1ec1 c\u00e1c y\u00eau c\u1ea7u cGMP c\u1ee5 th\u1ec3 \u0111\u01b0\u1ee3c c\u00f4ng b\u1ed1 cho c\u00e1c c\u01a1 s\u1edf gia c\u00f4ng. Tr\u1ecdng t\u00e2m ch\u00ednh c\u1ee7a d\u1ef1 th\u1ea3o h\u01b0\u1edbng d\u1eabn l\u00e0 ph\u1ea7n 211 li\u00ean quan \u0111\u1ebfn vi\u1ec7c \u0111\u1ea3m b\u1ea3o v\u00f4 tr\u00f9ng c\u00e1c s\u1ea3n ph\u1ea9m thu\u1ed1c v\u00f4 tr\u00f9ng. C\u00e1c khuy\u1ebfn ngh\u1ecb ph\u00f9 h\u1ee3p v\u1edbi c\u00e1c nguy\u00ean t\u1eafc c\u1ee7a GMP nh\u01b0ng n\u00f3 c\u0169ng cung c\u1ea5p c\u00e1ch ti\u1ebfp c\u1eadn d\u1ef1a tr\u00ean r\u1ee7i ro \u0111\u1ed1i v\u1edbi c\u00e1c y\u00eau c\u1ea7u cGMP.<\/p>\n<p>H\u01b0\u1edbng d\u1eabn c\u1ee7a FDA n\u0103m 2020 cho ng\u00e0nh c\u00f4ng nghi\u1ec7p n\u00eau r\u00f5 r\u1eb1ng th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng n\u00ean \u0111\u01b0\u1ee3c ti\u1ebfn h\u00e0nh b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng USP &lt;71&gt; Th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng. B\u1ea5t k\u1ef3 ph\u01b0\u01a1ng ph\u00e1p n\u00e0o kh\u00e1c \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng ph\u1ea3i \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn v\u00e0 khuy\u1ebfn ngh\u1ecb USP &lt;1223&gt; X\u00e1c nh\u1eadn c\u00e1c ph\u01b0\u01a1ng ph\u00e1p vi sinh thay th\u1ebf \u0111\u1ec3 \u0111\u01b0\u1ee3c h\u01b0\u1edbng d\u1eabn chung.<\/p>\n<h2><span class=\"ez-toc-section\" id=\"VO_TRUNG_NGOAI_THONG_SO_KY_THUAT_BANG_PHUONG_PHAP_VI_SINH_NHANH_CHONG_KHONG_DUA_TREN_TANG_TRUONG\"><\/span><strong>V\u00d4 TR\u00d9NG NGO\u00c0I TH\u00d4NG S\u1ed0 K\u1ef8 THU\u1eacT B\u1eb0NG PH\u01af\u01a0NG PH\u00c1P VI SINH NHANH CH\u00d3NG KH\u00d4NG D\u1ef0A TR\u00caN T\u0102NG TR\u01af\u1edeNG<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>Kh\u00e1ch h\u00e0ng c\u1ee7a <a href=\"https:\/\/vospan.com\/product-brands\/biomerieux\/\">bioM\u00e9rieux<\/a> \u0111\u00e3 ch\u1ec9 ra r\u1eb1ng M\u1ee5c 503B C\u01a1 s\u1edf gia c\u00f4ng h\u1ed7n h\u1ee3p v\u00f4 tr\u00f9ng v\u00e0 c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m h\u1ee3p \u0111\u1ed3ng h\u1ed7 tr\u1ee3 c\u00e1c c\u01a1 s\u1edf n\u00e0y s\u1eed d\u1ee5ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> \u0111\u1ec3 ki\u1ec3m tra v\u00f4 tr\u00f9ng b\u00e1o c\u00e1o t\u1ef7 l\u1ec7 th\u1ea5t b\u1ea1i v\u00f4 tr\u00f9ng l\u00e0 &lt;0,2%. \u0110i\u1ec1u n\u00e0y c\u00f3 ngh\u0129a l\u00e0 &gt;99% th\u1eddi gian c\u00e1c l\u00f4 s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c x\u00e1c nh\u1eadn \u0111\u01b0\u1ee3c ph\u00e1t hi\u1ec7n l\u00e0 kh\u00f4ng c\u00f3 vi sinh v\u1eadt v\u00e0 c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e1t h\u00e0nh \u0111\u1ec3 qu\u1ea3n l\u00fd trong v\u00f2ng 4 gi\u1edd.<\/p>\n<p>Y\u00eau c\u1ea7u c\u1ee7a cGMP l\u00e0 ti\u1ebfn h\u00e0nh \u0111i\u1ec1u tra c\u00e1c th\u1eed nghi\u1ec7m v\u00f4 tr\u00f9ng kh\u00f4ng \u0111\u1ea1t \u0111\u1ec3 x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n g\u1ed1c r\u1ec5 c\u00f3 th\u1ec3 x\u1ea3y ra nh\u1ea5t c\u1ee7a l\u1ed7i. C\u00e1c cu\u1ed9c \u0111i\u1ec1u tra n\u00ean bao g\u1ed3m xem x\u00e9t h\u1ed3 s\u01a1 l\u00f4, \u0111\u00e1nh gi\u00e1 m\u1ecdi sai l\u1ec7ch trong s\u1ea3n xu\u1ea5t, ph\u00e2n t\u00edch k\u1ebft qu\u1ea3 gi\u00e1m s\u00e1t m\u00f4i tr\u01b0\u1eddng bao g\u1ed3m gi\u00e1m s\u00e1t nh\u00e2n s\u1ef1 v\u00e0 ph\u00e2n t\u00edch xu h\u01b0\u1edbng, x\u00e1c nh\u1eadn hi\u1ec7u qu\u1ea3 c\u1ee7a c\u00e1c bi\u1ec7n ph\u00e1p ki\u1ec3m so\u00e1t m\u00f4i tr\u01b0\u1eddng, v\u00e0 xem x\u00e9t c\u00e1c l\u1ed7i ki\u1ec3m tra \u0111\u1ed9 v\u00f4 tr\u00f9ng \u0111\u1ed1i v\u1edbi c\u00e1c m\u1eabu. Vi\u1ec7c \u0111i\u1ec1u tra c\u0169ng c\u00f3 th\u1ec3 bao g\u1ed3m vi\u1ec7c ph\u00e2n l\u1eadp v\u00e0 x\u00e1c \u0111\u1ecbnh (c\u00e1c) vi sinh v\u1eadt ch\u1ecbu tr\u00e1ch nhi\u1ec7m v\u1ec1 l\u1ed7i v\u00f4 tr\u00f9ng \u0111\u1ec3 gi\u00fap x\u00e1c \u0111\u1ecbnh ngu\u1ed3n g\u1ed1c c\u1ee7a (c\u00e1c) vi sinh v\u1eadt khi c\u00f3 th\u1ec3.&#8221;<\/p>\n<p>V\u1ec1 \u0111i\u1ec1u tra do cGMP b\u1eaft bu\u1ed9c, ng\u01b0\u1eddi d\u00f9ng cu\u1ed1i c\u00f3 th\u1ec3 l\u1ea5y m\u1eabu l\u1ea1i c\u00f9ng m\u1ed9t v\u1eadt li\u1ec7u v\u00e0 th\u1ef1c hi\u1ec7n ph\u01b0\u01a1ng ph\u00e1p ki\u1ec3m tra \u0111\u1ed9 v\u00f4 tr\u00f9ng truy\u1ec1n th\u1ed1ng ho\u1eb7c c\u00f3 th\u1ec3 th\u1eed v\u00e0 ph\u00e1t tri\u1ec3n c\u00e1c t\u1ebf b\u00e0o thu th\u1eadp sau khi qu\u00e9t. Tuy nhi\u00ean, <a href=\"https:\/\/vospan.com\/product-brands\/biomerieux\/\">bioM\u00e9rieux<\/a> \u0111\u00e3 th\u1ef1c hi\u1ec7n m\u1ed9t s\u1ed1 nghi\u00ean c\u1ee9u v\u00e0 \u0111\u00e3 tr\u00ecnh b\u00e0y m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p t\u0103ng tr\u01b0\u1edfng sau qu\u00e9t d\u1ec5 d\u00e0ng s\u1eed d\u1ee5ng m\u1ed9t \u0111\u0129a th\u1ea1ch s\u00f4 c\u00f4 la \u0111\u01b0\u1ee3c \u1ee7 \u1edf 30-35oC trong 20 -72 gi\u1edd.<\/p>\n<p>C\u00e1c nghi\u00ean c\u1ee9u \u0111\u01b0\u1ee3c gi\u1edbi h\u1ea1n \u1edf c\u00e1c vi sinh v\u1eadt hi\u1ebfu kh\u00ed v\u00e0 d\u1eef li\u1ec7u cho th\u1ea5y kh\u1ea3 n\u0103ng ph\u1ee5c h\u1ed3i t\u0103ng tr\u01b0\u1edfng t\u1ed1t sau khi qu\u00e9t \u0111\u1ed1i v\u1edbi n\u1ea5m men, n\u1ea5m m\u1ed1c v\u00e0 vi khu\u1ea9n gram d\u01b0\u01a1ng \u0111\u01b0\u1ee3c th\u1eed nghi\u1ec7m. Vi khu\u1ea9n gram \u00e2m d\u1ec5 b\u1ecb h\u00fat \u1ea9m nh\u1ea5t v\u00e0 \u00edt c\u00f3 kh\u1ea3 n\u0103ng \u0111\u01b0\u1ee3c ph\u1ee5c h\u1ed3i sau khi qu\u00e9t.<\/p>\n<p>C\u00e1c t\u1ebf b\u00e0o vi sinh thu th\u1eadp \u0111\u01b0\u1ee3c thi\u1ebfu s\u1ef1 ph\u00e1t tri\u1ec3n kh\u00f4ng c\u00f3 ngh\u0129a l\u00e0 th\u00f4ng tin v\u1ec1 vi sinh v\u1eadt \u0111\u00f3 ho\u00e0n to\u00e0n kh\u00f4ng \u0111\u01b0\u1ee3c bi\u1ebft \u0111\u1ebfn. H\u00ecnh th\u00e1i t\u1ebf b\u00e0o c\u1ee7a ch\u1ea5t g\u00e2y \u00f4 nhi\u1ec5m \u0111\u01b0\u1ee3c quan s\u00e1t d\u01b0\u1edbi k\u00ednh hi\u1ec3n vi s\u1ebd cung c\u1ea5p m\u1ed9t s\u1ed1 th\u00f4ng tin \u0111\u1ec3 h\u1ed7 tr\u1ee3 \u0111i\u1ec1u tra. V\u00ed d\u1ee5, c\u00e1c que kh\u00f4ng h\u00ecnh th\u00e0nh b\u00e0o t\u1eed h\u1ea7u h\u1ebft c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb n\u01b0\u1edbc trong khi c\u1ea7u khu\u1ea9n c\u00f3 ngu\u1ed3n g\u1ed1c t\u1eeb da ng\u01b0\u1eddi. C\u00e1c t\u1ebf b\u00e0o n\u1ea5m men v\u00e0 c\u00e1c m\u1ea3nh s\u1ee3i n\u1ea5m s\u1ebd cho th\u1ea5y s\u1ef1 nhi\u1ec5m n\u1ea5m. Ngay c\u1ea3 khi kh\u00f4ng c\u00f3 \u0111\u1eb7c \u0111i\u1ec3m k\u1ef9 thu\u1eadt, v\u1eabn c\u00f3 th\u1ec3 ho\u00e0n th\u00e0nh m\u1ed9t cu\u1ed9c \u0111i\u1ec1u tra m\u1ea1nh m\u1ebd v\u00e0 x\u00e1c \u0111\u1ecbnh nguy\u00ean nh\u00e2n c\u1ee7a k\u1ebft qu\u1ea3 ngo\u00e0i \u0111\u1eb7c \u0111i\u1ec3m k\u1ef9 thu\u1eadt.<\/p>\n<p><strong>C\u00e1c t\u00e0i li\u1ec7u x\u00e1c nh\u1eadn <a href=\"https:\/\/vospan.com\/product-brands\/biomerieux\/\">bioM\u00e9rieux<\/a> c\u00f3 s\u1eb5n cho c\u00e1c c\u01a1 s\u1edf gia c\u00f4ng h\u1ed7n h\u1ee3p v\u00f4 tr\u00f9ng:<\/strong><\/p>\n<ul>\n<li>B\u00e1o c\u00e1o x\u00e1c nh\u1eadn ch\u00ednh c\u1ee7a h\u1ec7 th\u1ed1ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> &#8211; Chu\u1ea9n b\u1ecb v\u00f4 tr\u00f9ng h\u1ed7n h\u1ee3p: doc no. BMX 1.076552 phi\u00ean b\u1ea3n 1.0 (D\u1eef li\u1ec7u h\u1ed7 tr\u1ee3 Gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n, T\u00ednh \u0111\u1eb7c hi\u1ec7u, \u0110\u1ed9 b\u1ec1n &amp; \u0110\u1ed9 ch\u1eafc ch\u1eafn)<\/li>\n<li>H\u01b0\u1edbng d\u1eabn x\u00e1c th\u1ef1c h\u1ec7 th\u1ed1ng <a href=\"https:\/\/vospan.com\/san-pham\/scanrdi-thiet-bi-phat-hien-nhanh-va-dem-vi-khuan\/\">SCANRDI\u00ae<\/a> &#8211; Ki\u1ec3m tra t\u00ednh ph\u00f9 h\u1ee3p c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p \u0111\u1ed1i v\u1edbi ch\u1ebf ph\u1ea9m v\u00f4 tr\u00f9ng h\u1ed7n h\u1ee3p: doc no. BMX 1.076403 phi\u00ean b\u1ea3n 1.0.<\/li>\n<\/ul>\n<p><em>Ngu\u1ed3n: <a href=\"https:\/\/www.biomerieux.com\/corp\/en\/resource-hub\/knowledge\/white-papers\/pharmaceutical-qc-white-papers\/non-growth-based-alternative-sterility-testing-white-paper.html\" target=\"_blank\" rel=\"noopener\">https:\/\/www.biomerieux.com\/corp\/en\/resource-hub\/knowledge\/white-papers\/pharmaceutical-qc-white-papers\/non-growth-based-alternative-sterility-testing-white-paper.html<\/a><\/em><\/p>\n<p><strong>Minh Khang l\u00e0 nh\u00e0 ph\u00e2n ph\u1ed1i v\u00e0 nh\u1eadp kh\u1ea9u tr\u1ef1c ti\u1ebfp c\u00e1c thi\u1ebft b\u1ecb <a href=\"https:\/\/vospan.com\/product-category\/cong-nghe-sinh-hoc\/thiet-bi-phan-tich-sinh-hoc\/kiem-tra-vi-sinh-vat\/\" rel=\"tag\">Ki\u1ec3m tra vi sinh v\u1eadt<\/a>\u00a0h\u00e3ng <a href=\"https:\/\/vospan.com\/product-brands\/biomerieux\/\">bioM\u00e9rieux<\/a>.<\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>T\u00d3M T\u1eaeT SCANRDI\u00ae l\u00e0 m\u1ed9t ph\u01b0\u01a1ng ph\u00e1p vi sinh v\u1eadt nhanh ch\u00f3ng kh\u00f4ng d\u1ef1a tr\u00ean t\u0103ng tr\u01b0\u1edfng (RMM), ph\u00e1t hi\u1ec7n kh\u00f4ng ch\u1ec9 c\u00e1c t\u1ebf b\u00e0o vi sinh v\u1eadt kh\u1ea3 thi c\u00f3 th\u1ec3 \u0111\u01b0\u1ee3c ph\u00e2n l\u1eadp b\u1eb1ng c\u00e1ch s\u1eed d\u1ee5ng \u0111\u0129a th\u1ea1ch m\u00e0 c\u00f2n c\u1ea3 c\u00e1c vi sinh v\u1eadt kh\u1ea3 thi nh\u01b0ng kh\u00f4ng th\u1ec3 nu\u00f4i c\u1ea5y&#8230;<\/p>\n","protected":false},"author":3,"featured_media":8936,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[40],"tags":[],"class_list":["post-8932","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"_links":{"self":[{"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/posts\/8932"}],"collection":[{"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/comments?post=8932"}],"version-history":[{"count":9,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/posts\/8932\/revisions"}],"predecessor-version":[{"id":11917,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/posts\/8932\/revisions\/11917"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/media\/8936"}],"wp:attachment":[{"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/media?parent=8932"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/categories?post=8932"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/vospan.com\/wp-json\/wp\/v2\/tags?post=8932"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}