{"id":9317,"date":"2025-12-17T13:12:26","date_gmt":"2025-12-17T06:12:26","guid":{"rendered":"https:\/\/biogroupvietnam.com\/?p=9317"},"modified":"2026-02-10T13:08:27","modified_gmt":"2026-02-10T06:08:27","slug":"cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao","status":"publish","type":"post","link":"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/","title":{"rendered":"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh &amp; t\u1ea7m quan tr\u1ecdng c\u1ee7a NAT trong x\u00e9t nghi\u1ec7m Mycoplasma cho s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o"},"content":{"rendered":"\n<p>Trong s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc ti\u00ean ti\u1ebfn, \u0111\u1eb7c bi\u1ec7t l\u00e0 <strong>li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 gen (ATMP \u2013 Advanced Therapy Medicinal Products)<\/strong>, vi\u1ec7c ki\u1ec3m so\u00e1t nhi\u1ec5m mycoplasma l\u00e0 m\u1ed9t y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c nh\u1eb1m \u0111\u1ea3m b\u1ea3o an to\u00e0n cho b\u1ec7nh nh\u00e2n. N\u1ebfu nh\u01b0 tr\u01b0\u1edbc \u0111\u00e2y ng\u00e0nh c\u00f4ng nghi\u1ec7p sinh h\u1ecdc ph\u1ee5 thu\u1ed9c ch\u1ee7 y\u1ebfu v\u00e0o <strong>ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y 28 ng\u00e0y<\/strong> theo ti\u00eau chu\u1ea9n USP v\u00e0 FDA, th\u00ec hi\u1ec7n nay, c\u00f9ng v\u1edbi s\u1ef1 ph\u00e1t tri\u1ec3n c\u1ee7a c\u00e1c quy \u0111\u1ecbnh m\u1edbi v\u00e0 \u0111\u1eb7c t\u00ednh \u201cth\u1eddi gian l\u01b0u h\u00e0nh ng\u1eafn\u201d c\u1ee7a s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o, <strong>ph\u01b0\u01a1ng ph\u00e1p NAT (PCR-based Mycoplasma Testing)<\/strong> \u0111\u00e3 tr\u1edf th\u00e0nh ti\u00eau chu\u1ea9n g\u1ea7n nh\u01b0 m\u1eb7c \u0111\u1ecbnh trong lot-release.<\/p>\n\n\n\n<p>B\u00e0i vi\u1ebft n\u00e0y t\u1ed5ng h\u1ee3p c\u00e1c th\u00f4ng tin c\u1eadp nh\u1eadt t\u1eeb t\u00e0i li\u1ec7u chuy\u00ean ng\u00e0nh m\u1edbi nh\u1ea5t, k\u1ebft h\u1ee3p c\u00f9ng khung quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh, nh\u1eb1m gi\u00fap c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t ATMP v\u00e0 c\u00e1c \u0111\u01a1n v\u1ecb nghi\u00ean c\u1ee9u t\u1ea1i Vi\u1ec7t Nam hi\u1ec3u r\u00f5:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>V\u00ec sao NAT \u0111ang \u0111\u01b0\u1ee3c \u01b0u ti\u00ean b\u1edfi FDA, EMA v\u00e0 nhi\u1ec1u c\u01a1 quan qu\u1ea3n l\u00fd.\u00a0<\/li>\n\n\n\n<li>C\u00e1c r\u00e0o c\u1ea3n c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y v\u00e0 ph\u01b0\u01a1ng ph\u00e1p enzyme.\u00a0<\/li>\n\n\n\n<li>Vai tr\u00f2 c\u1ee7a NAT trong b\u1ea3o \u0111\u1ea3m ch\u1ea5t l\u01b0\u1ee3ng, an to\u00e0n b\u1ec7nh nh\u00e2n v\u00e0 t\u1ed1i \u01b0u h\u00f3a v\u1eadn h\u00e0nh s\u1ea3n xu\u1ea5t.\u00a0<\/li>\n\n\n\n<li>Gi\u1ea3i ph\u00e1p MycoFinder<sup>TM<\/sup> cho x\u00e9t nghi\u1ec7m mycoplasma\u00a0<\/li>\n<\/ul>\n\n\n\n<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_80 counter-hierarchy ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">M\u1ee5c l\u1ee5c<\/p>\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: #999;color:#999\" 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: #999;color:#999\" 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 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#Mycoplasma_%E2%80%93_Moi_nguy_thuc_su_trong_san_xuat_lieu_phap_te_bao\" >Mycoplasma \u2013 M\u1ed1i nguy th\u1ef1c s\u1ef1 trong s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#Vi_sao_phuong_phap_nuoi_cay_28_ngay_khong_con_phu_hop_cho_ATMP\" >V\u00ec sao ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y 28 ng\u00e0y kh\u00f4ng c\u00f2n ph\u00f9 h\u1ee3p cho ATMP?\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#Han_che_cua_phuong_phap_enzyme_trong_Lot-Release_ATMP\" >H\u1ea1n ch\u1ebf c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p enzyme trong Lot-Release ATMP\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#NAT_PCR-based_Testing_%E2%80%93_Lua_chon_duoc_FDA_va_EMA_khuyen_nghi\" >NAT (PCR-based Testing) \u2013 L\u1ef1a ch\u1ecdn \u0111\u01b0\u1ee3c FDA v\u00e0 EMA khuy\u1ebfn ngh\u1ecb\u00a0<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#MycoFinder%E2%84%A2_%E2%80%93_Giai_phap_NAT_toi_uu_cho_phat_hien_Mycoplasma\" >MycoFinder\u2122 \u2013 Gi\u1ea3i ph\u00e1p NAT t\u1ed1i \u01b0u cho ph\u00e1t hi\u1ec7n Mycoplasma\u00a0<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#Uu_diem_cua_bo_kit_MycoFinder%E2%84%A2\" >\u01afu \u0111i\u1ec3m c\u1ee7a b\u1ed9 kit MycoFinder\u2122\u00a0<\/a><\/li><\/ul><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-7\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/#Tai_lieu_tham_khao\" >T\u00e0i li\u1ec7u tham kh\u1ea3o<\/a><\/li><\/ul><\/nav><\/div>\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Mycoplasma_%E2%80%93_Moi_nguy_thuc_su_trong_san_xuat_lieu_phap_te_bao\"><\/span><strong>Mycoplasma \u2013 M\u1ed1i nguy th\u1ef1c s\u1ef1 trong s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o<\/strong>\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Mycoplasma l\u00e0 nh\u00f3m vi khu\u1ea9n c\u00f3 kh\u1ea3 n\u0103ng ph\u00e1t tri\u1ec3n tr\u00ean m\u00f4i tr\u01b0\u1eddng nh\u00e2n t\u1ea1o v\u00e0 \u0111\u01b0\u1ee3c xem l\u00e0 nh\u1eefng vi khu\u1ea9n nh\u1ecf nh\u1ea5t c\u00f3 th\u1ec3 t\u1ef1 nh\u00e2n l\u00ean. V\u1ec1 m\u1eb7t ph\u00e2n lo\u1ea1i h\u1ecdc, thu\u1eadt ng\u1eef \u201cmycoplasma\u201d d\u00f9ng \u0111\u1ec3 ch\u1ec9 chung c\u00e1c lo\u00e0i thu\u1ed9c l\u1edbp Mollicutes, bao g\u1ed3m c\u00e1c chi nh\u01b0 <em>Mycoplasma, Ureaplasma, Spiroplasma v\u00e0 Acholeplasma<\/em>. Hi\u1ec7n \u0111\u00e3 bi\u1ebft h\u00e0ng tr\u0103m lo\u00e0i kh\u00e1c nhau, v\u1edbi h\u00ecnh th\u00e1i r\u1ea5t \u0111a d\u1ea1ng tu\u1ef3 theo ch\u1ee7ng \u2013 t\u1eeb d\u1ea1ng c\u1ea7u, d\u1ea1ng s\u1ee3i cho \u0111\u1ebfn d\u1ea1ng xo\u1eafn. Khi nu\u00f4i c\u1ea5y tr\u00ean th\u1ea1ch, ch\u00fang th\u01b0\u1eddng t\u1ea1o nh\u1eefng khu\u1ea9n l\u1ea1c c\u00f3 h\u00ecnh d\u1ea1ng \u0111\u1eb7c tr\u01b0ng gi\u1ed1ng \u201cm\u1eaft tr\u1ee9ng \u1ed1p la\u201d.&nbsp;&nbsp;<\/p>\n\n\n\n<p>\u0110i\u1ec3m \u0111\u1eb7c bi\u1ec7t c\u1ee7a mycoplasma l\u00e0 <strong>kh\u00f4ng c\u00f3 th\u00e0nh t\u1ebf b\u00e0o<\/strong>, khi\u1ebfn ch\u00fang c\u00f3 t\u00ednh m\u1ec1m d\u1ebbo cao v\u00e0 c\u00f3 th\u1ec3 l\u1ecdt qua m\u00e0ng l\u1ecdc ti\u1ec7t tr\u00f9ng 0,22 \u00b5m \u2013 lo\u1ea1i m\u00e0 th\u00f4ng th\u01b0\u1eddng c\u00f3 th\u1ec3 gi\u1eef l\u1ea1i ph\u1ea7n l\u1edbn vi khu\u1ea9n kh\u00e1c. \u0110\u1ed3ng th\u1eddi, do kh\u00f4ng c\u00f3 th\u00e0nh t\u1ebf b\u00e0o, mycoplasma <strong>kh\u00f4ng nh\u1ea1y v\u1edbi kh\u00e1ng sinh nh\u00f3m beta-lactam<\/strong>, khi\u1ebfn vi\u1ec7c ki\u1ec3m so\u00e1t nhi\u1ec5m c\u00e0ng tr\u1edf n\u00ean kh\u00f3 kh\u0103n. Trong t\u1ef1 nhi\u00ean, mycoplasma t\u1ed3n t\u1ea1i r\u1ed9ng r\u00e3i \u1edf c\u1ea3 \u0111\u1ed9ng v\u1eadt v\u00e0 th\u1ef1c v\u1eadt, v\u00e0 th\u01b0\u1eddng bi\u1ec3u hi\u1ec7n t\u00ednh \u0111\u1eb7c hi\u1ec7u theo lo\u00e0i v\u1eadt ch\u1ee7.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o, ngu\u1ed3n nguy c\u01a1 nhi\u1ec5m c\u00f3 th\u1ec3 \u0111\u1ebfn t\u1eeb:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Nguy\u00ean li\u1ec7u \u0111\u1ea7u v\u00e0o (huy\u1ebft thanh, m\u00f4i tr\u01b0\u1eddng, supplement).\u00a0<\/li>\n\n\n\n<li>Quy tr\u00ecnh thao t\u00e1c m\u1edf trong ph\u00f2ng s\u1ea1ch.\u00a0<\/li>\n\n\n\n<li>Ch\u00ednh <strong>m\u1eabu sinh h\u1ecdc c\u1ee7a b\u1ec7nh nh\u00e2n<\/strong> (\u0111\u1eb7c bi\u1ec7t l\u00e0 li\u1ec7u ph\u00e1p t\u1ef1 th\u00e2n \u2013 autologous).\u00a0<\/li>\n<\/ul>\n\n\n\n<p>M\u1ed9t khi x\u1ea3y ra nhi\u1ec5m, h\u1eadu qu\u1ea3 kh\u00f4ng ch\u1ec9 d\u1eebng \u1edf vi\u1ec7c <strong>h\u1ee7y l\u00f4 s\u1ea3n ph\u1ea9m<\/strong>, m\u00e0 c\u00f2n c\u00f3 th\u1ec3 g\u00e2y:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>L\u00e2y nhi\u1ec5m ch\u00e9o sang c\u00e1c m\u1ebb s\u1ea3n xu\u1ea5t kh\u00e1c.\u00a0<\/li>\n\n\n\n<li>T\u1ea1m d\u1eebng to\u00e0n b\u1ed9 d\u00e2y chuy\u1ec1n s\u1ea3n xu\u1ea5t \u0111\u1ec3 \u0111i\u1ec1u tra nguy\u00ean nh\u00e2n.\u00a0<\/li>\n\n\n\n<li>Thi\u1ec7t h\u1ea1i t\u00e0i ch\u00ednh l\u1edbn v\u00e0 \u1ea3nh h\u01b0\u1edfng uy t\u00edn \u0111\u01a1n v\u1ecb.\u00a0<\/li>\n<\/ul>\n\n\n\n<p>V\u1edbi s\u1ea3n ph\u1ea9m t\u1ebf b\u00e0o d\u00e0nh cho \u0111i\u1ec1u tr\u1ecb, \u0111\u1eb7c bi\u1ec7t l\u00e0 b\u1ec7nh nh\u00e2n ung th\u01b0, nhi\u1ec5m mycoplasma kh\u00f4ng ch\u1ec9 g\u00e2y <strong>m\u1ea5t t\u00ednh to\u00e0n v\u1eb9n sinh h\u1ecdc<\/strong>, m\u00e0 c\u00f2n c\u00f3 th\u1ec3 <strong>\u0111e d\u1ecda t\u00ednh m\u1ea1ng ng\u01b0\u1eddi b\u1ec7nh<\/strong> n\u1ebfu s\u1ea3n ph\u1ea9m \u0111\u01b0\u1ee3c truy\u1ec1n v\u00e0o c\u01a1 th\u1ec3.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Vi_sao_phuong_phap_nuoi_cay_28_ngay_khong_con_phu_hop_cho_ATMP\"><\/span><strong>V\u00ec sao ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y 28 ng\u00e0y kh\u00f4ng c\u00f2n ph\u00f9 h\u1ee3p cho ATMP?<\/strong>\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Theo FDA 21 CFR 610.30 v\u00e0 USP &lt;63&gt;, ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y truy\u1ec1n th\u1ed1ng y\u00eau c\u1ea7u:&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>28 ng\u00e0y \u1ee7 tr\u00ean m\u00f4i tr\u01b0\u1eddng l\u1ecfng v\u00e0 r\u1eafn.\u00a0<\/li>\n\n\n\n<li>Ki\u1ec3m tra d\u01b0\u1edbi \u0111i\u1ec1u ki\u1ec7n hi\u1ebfu kh\u00ed v\u00e0 k\u1ef5 kh\u00ed.\u00a0<\/li>\n\n\n\n<li>Thao t\u00e1c b\u1edfi k\u1ef9 thu\u1eadt vi\u00ean c\u00f3 kinh nghi\u1ec7m cao.\u00a0<\/li>\n<\/ul>\n\n\n\n<p>Ph\u01b0\u01a1ng ph\u00e1p n\u00e0y \u0111\u01b0\u1ee3c xem nh\u01b0 \u201cti\u00eau chu\u1ea9n v\u00e0ng\u201d trong nhi\u1ec1u th\u1eadp ni\u00ean v\u00ec \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u t\u1ed1t v\u00e0 kh\u1ea3 n\u0103ng nu\u00f4i \u0111\u01b0\u1ee3c c\u00e1c ch\u1ee7ng mycoplasma quan tr\u1ecdng.&nbsp;<\/p>\n\n\n\n<p>Tuy nhi\u00ean, khi ng\u00e0nh c\u00f4ng nghi\u1ec7p ph\u00e1t tri\u1ec3n c\u00e1c s\u1ea3n ph\u1ea9m autologous cell therapy v\u1edbi th\u1eddi gian s\u1ea3n xu\u1ea5t ch\u1ec9 t\u1eeb 5\u20137 ng\u00e0y (nh\u01b0 CAR-T), vi\u1ec7c \u0111\u1ee3i 28 ng\u00e0y \u0111\u1ec3 c\u00f3 k\u1ebft qu\u1ea3 lot-release l\u00e0 ho\u00e0n to\u00e0n b\u1ea5t kh\u1ea3 thi.&nbsp;&nbsp;<\/p>\n\n\n\n<p>Ngo\u00e0i ra, ATMP kh\u00f4ng tr\u1ea3i qua b\u01b0\u1edbc b\u1ea5t ho\u1ea1t virus ho\u1eb7c thanh l\u1ecdc cu\u1ed1i nh\u01b0 protein t\u00e1i t\u1ed5 h\u1ee3p, khi\u1ebfn y\u00eau c\u1ea7u ph\u00e1t hi\u1ec7n mycoplasma c\u00e0ng kh\u1eaft khe h\u01a1n.&nbsp;<\/p>\n\n\n\n<p>K\u1ebft lu\u1eadn: ph\u01b0\u01a1ng ph\u00e1p 28 ng\u00e0y kh\u00f4ng th\u1ec3 \u0111\u00e1p \u1ee9ng nhu c\u1ea7u t\u1ed1c \u0111\u1ed9 v\u00e0 an to\u00e0n c\u1ee7a ng\u00e0nh ATMP.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Han_che_cua_phuong_phap_enzyme_trong_Lot-Release_ATMP\"><\/span><strong>H\u1ea1n ch\u1ebf c\u1ee7a ph\u01b0\u01a1ng ph\u00e1p enzyme trong Lot-Release ATMP<\/strong>\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>M\u1eb7c d\u00f9 USP &lt;63&gt; phi\u00ean b\u1ea3n m\u1edbi cho ph\u00e9p s\u1eed d\u1ee5ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p d\u1ef1a tr\u00ean ho\u1ea1t t\u00ednh enzyme (enzymatic activity\u2013based methods) nh\u01b0 m\u1ed9t l\u1ef1a ch\u1ecdn thay th\u1ebf cho x\u00e9t nghi\u1ec7m mycoplasma truy\u1ec1n th\u1ed1ng, nh\u01b0ng \u0111i\u1ec1u ki\u1ec7n m\u00e0 ti\u00eau chu\u1ea9n n\u00e0y \u0111\u1eb7t ra l\u1ea1i v\u00f4 c\u00f9ng kh\u1eaft khe: <strong>ph\u01b0\u01a1ng ph\u00e1p ph\u1ea3i ch\u1ee9ng minh \u0111\u01b0\u1ee3c \u201ct\u00ednh t\u01b0\u01a1ng \u0111\u01b0\u01a1ng\u201d v\u1edbi quy tr\u00ecnh nu\u00f4i c\u1ea5y 28 ng\u00e0y v\u1ec1 \u0111\u1ed9 nh\u1ea1y v\u00e0 \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u<\/strong>. Tr\u00ean l\u00fd thuy\u1ebft, \u0111i\u1ec1u n\u00e0y c\u00f3 v\u1ebb kh\u1ea3 thi, nh\u01b0ng trong th\u1ef1c t\u1ebf s\u1ea3n xu\u1ea5t li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, \u0111a s\u1ed1 c\u00e1c ph\u01b0\u01a1ng ph\u00e1p enzyme hi\u1ec7n nay \u0111\u1ec1u kh\u00f4ng \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u n\u00e0y.&nbsp;<\/p>\n\n\n\n<p>M\u1ed9t trong nh\u1eefng h\u1ea1n ch\u1ebf quan tr\u1ecdng nh\u1ea5t c\u1ee7a enzymatic-based tests l\u00e0 <strong>\u0111\u1ed9 nh\u1ea1y kh\u00f4ng \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u c\u1ee7a c\u01a1 quan qu\u1ea3n l\u00fd<\/strong>. Theo d\u01b0\u1ee3c \u0111i\u1ec3n ch\u00e2u \u00c2u (EP 2.6.7), ph\u01b0\u01a1ng ph\u00e1p thay th\u1ebf cho nu\u00f4i c\u1ea5y 28 ng\u00e0y ph\u1ea3i \u0111\u1ea1t gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n <strong>10 CFU\/mL<\/strong>. \u0110i\u1ec1u n\u00e0y khi\u1ebfn ch\u00fang kh\u00f4ng th\u1ec3 v\u01b0\u1ee3t qua ti\u00eau ch\u00ed k\u1ef9 thu\u1eadt \u0111\u1ec3 s\u1eed d\u1ee5ng trong lot-release s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.&nbsp;<\/p>\n\n\n\n<p>B\u00ean c\u1ea1nh \u0111\u00f3, ph\u01b0\u01a1ng ph\u00e1p enzyme <strong>kh\u00f4ng ph\u00e1t hi\u1ec7n \u0111\u01b0\u1ee3c mycoplasma \u0111\u00e3 ch\u1ebft<\/strong>, trong khi DNA t\u1eeb c\u00e1c t\u1ebf b\u00e0o n\u00e0y v\u1eabn c\u00f3 th\u1ec3 hi\u1ec7n di\u1ec7n trong nhi\u1ec1u m\u1eabu nu\u00f4i c\u1ea5y. PCR c\u00f3 th\u1ec3 nh\u1eadn bi\u1ebft c\u1ea3 d\u1ea1ng s\u1ed1ng v\u00e0 d\u1ea1ng ch\u1ebft, nh\u01b0ng enzyme th\u00ec kh\u00f4ng, t\u1ea1o ra nguy c\u01a1 b\u1ecf s\u00f3t v\u00e0 d\u1eabn \u0111\u1ebfn c\u1ea3m gi\u00e1c an to\u00e0n gi\u1ea3 trong quy tr\u00ecnh s\u1ea3n xu\u1ea5t.&nbsp;<\/p>\n\n\n\n<p>M\u1ed9t v\u1ea5n \u0111\u1ec1 kh\u00e1c l\u00e0 <strong>t\u00ednh \u0111\u1eb7c hi\u1ec7u k\u00e9m<\/strong>. Enzymatic assay ph\u1ea3n \u1ee9ng v\u1edbi t\u00edn hi\u1ec7u sinh h\u1ecdc t\u1ed5ng th\u1ec3 thay v\u00ec nh\u1eadn di\u1ec7n t\u1eebng lo\u00e0i mycoplasma c\u1ee5 th\u1ec3, khi\u1ebfn ch\u00fang kh\u00f3 \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u nghi\u00eam ng\u1eb7t c\u1ee7a ATMP \u2013 n\u01a1i m\u1ee9c \u0111\u1ed9 an to\u00e0n cho b\u1ec7nh nh\u00e2n l\u00e0 tuy\u1ec7t \u0111\u1ed1i.&nbsp;<\/p>\n\n\n\n<p>M\u1eb7c d\u00f9 c\u00f3 \u01b0u \u0111i\u1ec3m v\u1ec1 t\u1ed1c \u0111\u1ed9, ph\u01b0\u01a1ng ph\u00e1p enzyme v\u1eabn kh\u00f4ng \u0111\u01b0\u1ee3c ch\u1ea5p nh\u1eadn trong h\u1ed3 s\u01a1 regulatory. Cho \u0111\u1ebfn nay, <strong>ch\u01b0a c\u00f3 s\u1ea3n ph\u1ea9m ATMP n\u00e0o \u0111\u01b0\u1ee3c FDA ho\u1eb7c EMA ph\u00ea duy\u1ec7t<\/strong> s\u1eed d\u1ee5ng enzymatic assay l\u00e0m x\u00e9t nghi\u1ec7m mycoplasma cho lot-release. Trong khi \u0111\u00f3, NAT\/PCR \u0111\u00e3 ch\u1ee9ng minh \u0111\u01b0\u1ee3c \u0111\u1ed9 nh\u1ea1y, \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u v\u00e0 t\u00ednh ph\u00f9 h\u1ee3p th\u00f4ng qua nhi\u1ec1u tr\u01b0\u1eddng h\u1ee3p \u0111\u01b0\u1ee3c ph\u00ea duy\u1ec7t th\u1ef1c t\u1ebf.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"NAT_PCR-based_Testing_%E2%80%93_Lua_chon_duoc_FDA_va_EMA_khuyen_nghi\"><\/span><strong>NAT (PCR-based Testing) \u2013 L\u1ef1a ch\u1ecdn \u0111\u01b0\u1ee3c FDA v\u00e0 EMA khuy\u1ebfn ngh\u1ecb<\/strong>\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>NAT, \u0111\u1eb7c bi\u1ec7t l\u00e0 PCR, \u0111ang tr\u1edf th\u00e0nh ph\u01b0\u01a1ng ph\u00e1p trung t\u00e2m trong ki\u1ec3m nghi\u1ec7m mycoplasma cho c\u00e1c s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o. Nhi\u1ec1u h\u01b0\u1edbng d\u1eabn c\u1ee7a FDA v\u00e0 EMA cho th\u1ea5y c\u00e1c c\u01a1 quan qu\u1ea3n l\u00fd \u0111\u00e3 s\u1eb5n s\u00e0ng ch\u1ea5p nh\u1eadn PCR nh\u01b0 m\u1ed9t gi\u1ea3i ph\u00e1p thay th\u1ebf h\u1ee3p l\u1ec7 cho ph\u01b0\u01a1ng ph\u00e1p nu\u00f4i c\u1ea5y 28 ng\u00e0y, mi\u1ec5n l\u00e0 ph\u01b0\u01a1ng ph\u00e1p \u0111\u01b0\u1ee3c th\u1ea9m \u0111\u1ecbnh \u0111\u1ea7y \u0111\u1ee7 v\u1ec1 \u0111\u1ed9 nh\u1ea1y v\u00e0 \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u.&nbsp;<\/p>\n\n\n\n<p>FDA \u0111\u00e3 n\u00eau r\u00f5 trong h\u01b0\u1edbng d\u1eabn CMC r\u1eb1ng v\u1edbi c\u00e1c s\u1ea3n ph\u1ea9m c\u00f3 th\u1eddi h\u1ea1n s\u1eed d\u1ee5ng ng\u1eafn, ch\u1eb3ng h\u1ea1n nh\u01b0 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o t\u1ef1 th\u00e2n, kh\u00f4ng th\u1ec3 \u00e1p d\u1ee5ng x\u00e9t nghi\u1ec7m nu\u00f4i c\u1ea5y k\u00e9o d\u00e0i. Trong nh\u1eefng tr\u01b0\u1eddng h\u1ee3p n\u00e0y, c\u01a1 quan qu\u1ea3n l\u00fd <strong>khuy\u1ebfn ngh\u1ecb s\u1eed d\u1ee5ng PCR-based mycoplasma assays<\/strong> nh\u1eb1m \u0111\u1ea3m b\u1ea3o k\u1ebft qu\u1ea3 nhanh m\u00e0 v\u1eabn \u0111\u00e1p \u1ee9ng y\u00eau c\u1ea7u an to\u00e0n.&nbsp;<\/p>\n\n\n\n<p>T\u1ea1i ch\u00e2u \u00c2u, D\u01b0\u1ee3c \u0111i\u1ec3n ch\u00e2u \u00c2u (EP 2.6.7) y\u00eau c\u1ea7u gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n ph\u1ea3i \u0111\u1ea1t 10 CFU\/mL khi \u00e1p d\u1ee5ng ph\u01b0\u01a1ng ph\u00e1p thay th\u1ebf. PCR ho\u00e0n to\u00e0n \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c y\u00eau c\u1ea7u n\u00e0y, trong khi enzymatic-based assays th\u01b0\u1eddng kh\u00f4ng \u0111\u1ea1t \u0111\u1ebfn m\u1ee9c \u0111\u1ed9 nh\u1ea1y c\u1ea7n thi\u1ebft. \u0110\u00e2y l\u00e0 l\u00fd do khi\u1ebfn NAT tr\u1edf th\u00e0nh l\u1ef1a ch\u1ecdn \u01b0u ti\u00ean khi c\u00e1c c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t mu\u1ed1n thay th\u1ebf ph\u01b0\u01a1ng ph\u00e1p truy\u1ec1n th\u1ed1ng.&nbsp;<\/p>\n\n\n\n<p>FDA c\u0169ng nh\u1ea5n m\u1ea1nh trong Final Rule 2020 r\u1eb1ng c\u00e1c ph\u01b0\u01a1ng ph\u00e1p nh\u1ea1y v\u00e0 \u0111\u1eb7c hi\u1ec7u h\u01a1n \u0111ang \u0111\u01b0\u1ee3c s\u1eed d\u1ee5ng r\u1ed9ng r\u00e3i v\u00e0 ph\u00f9 h\u1ee3p v\u1edbi s\u1ef1 ph\u00e1t tri\u1ec3n c\u00f4ng ngh\u1ec7 hi\u1ec7n nay. Th\u00f4ng \u0111i\u1ec7p n\u00e0y ng\u1ea7m th\u1ec3 hi\u1ec7n s\u1ef1 \u1ee7ng h\u1ed9 \u0111\u1ed1i v\u1edbi NAT, v\u1ed1n l\u00e0 ph\u01b0\u01a1ng ph\u00e1p hi\u1ec7n \u0111\u1ea1i duy nh\u1ea5t \u0111\u00e1p \u1ee9ng \u0111\u01b0\u1ee3c c\u1ea3 t\u1ed1c \u0111\u1ed9 l\u1eabn ti\u00eau chu\u1ea9n k\u1ef9 thu\u1eadt nghi\u00eam ng\u1eb7t.&nbsp;<\/p>\n\n\n\n<p>Nh\u1edd \u0111\u00e1p \u1ee9ng t\u1ed1t c\u00e1c y\u00eau c\u1ea7u v\u1ec1 th\u1eddi gian, \u0111\u1ed9 nh\u1ea1y v\u00e0 kh\u1ea3 n\u0103ng t\u00edch h\u1ee3p v\u00e0o quy tr\u00ecnh s\u1ea3n xu\u1ea5t, NAT\/PCR \u0111\u01b0\u1ee3c xem l\u00e0 l\u1ef1a ch\u1ecdn t\u1ed1i \u01b0u trong lot-release c\u1ee7a ATMP v\u00e0 hi\u1ec7n \u0111\u00e3 tr\u1edf th\u00e0nh ti\u00eau chu\u1ea9n \u0111\u01b0\u1ee3c FDA v\u00e0 EMA khuy\u1ebfn ngh\u1ecb cho ng\u00e0nh li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o.&nbsp;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"MycoFinder%E2%84%A2_%E2%80%93_Giai_phap_NAT_toi_uu_cho_phat_hien_Mycoplasma\"><\/span><strong>MycoFinder\u2122 \u2013 Gi\u1ea3i ph\u00e1p NAT t\u1ed1i \u01b0u cho ph\u00e1t hi\u1ec7n Mycoplasma<\/strong>\u00a0<span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>Trong b\u1ed1i c\u1ea3nh PCR tr\u1edf th\u00e0nh ti\u00eau chu\u1ea9n \u01b0u ti\u00ean cho ki\u1ec3m nghi\u1ec7m mycoplasma trong c\u00e1c s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o, b\u1ed9 kit <strong>MycoFinder\u2122<\/strong> c\u1ee7a Shimadzu n\u1ed5i l\u00ean nh\u01b0 m\u1ed9t l\u1ef1a ch\u1ecdn \u0111\u00e1ng tin c\u1eady, \u0111\u01a1n gi\u1ea3n v\u00e0 hi\u1ec7u qu\u1ea3 cho c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m c\u1ea7n tri\u1ec3n khai NAT m\u1ed9t c\u00e1ch nhanh ch\u00f3ng. MycoFinder\u2122 \u0111\u01b0\u1ee3c thi\u1ebft k\u1ebf d\u01b0\u1edbi d\u1ea1ng <strong>qPCR m\u1ed9t b\u01b0\u1edbc<\/strong>, t\u00edch h\u1ee3p \u0111\u1ea7y \u0111\u1ee7 enzyme, m\u1ed3i v\u00e0 thu\u1ed1c th\u1eed c\u1ea7n thi\u1ebft trong c\u00f9ng m\u1ed9t b\u1ed9 kit, gi\u00fap r\u00fat ng\u1eafn th\u1eddi gian chu\u1ea9n b\u1ecb m\u1eabu v\u00e0 gi\u1ea3m sai s\u1ed1 thao t\u00e1c. B\u1ed9 kit cho ph\u00e9p ph\u00e1t hi\u1ec7n \u0111\u1ed3ng th\u1eddi <strong>nhi\u1ec1u ch\u1ee7ng mycoplasma<\/strong> ph\u1ed5 bi\u1ebfn v\u1edbi <strong>\u0111\u1ed9 nh\u1ea1y cao<\/strong>, th\u1eddi gian tr\u1ea3 k\u1ebft qu\u1ea3 nhanh, \u0111\u00e1p \u1ee9ng c\u00e1c y\u00eau c\u1ea7u k\u1ef9 thu\u1eadt m\u00e0 FDA v\u00e0 EMA \u0111ang h\u01b0\u1edbng \u0111\u1ebfn cho quy tr\u00ecnh lot-release.&nbsp;&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Uu_diem_cua_bo_kit_MycoFinder%E2%84%A2\"><\/span><strong>\u01afu \u0111i\u1ec3m c\u1ee7a b\u1ed9 kit MycoFinder\u2122\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Ph\u00e1t hi\u1ec7n nhanh trong ~1 gi\u1edd: <\/strong>Master Mix \u0111\u00e3 \u0111\u01b0\u1ee3c \u0111\u1ecbnh l\u01b0\u1ee3ng tr\u01b0\u1edbc trong m\u1ed7i tube, gi\u00fap gi\u1ea3m thi\u1ec3u th\u1eddi gian chu\u1ea9n b\u1ecb m\u1eabu v\u00e0 chu tr\u00ecnh PCR (35 \u2013 60 ph\u00fat).\u00a0<\/li>\n\n\n\n<li><strong>Tu\u00e2n th\u1ee7 y\u00eau c\u1ea7u D\u01b0\u1ee3c \u0111i\u1ec3n Ch\u00e2u \u00c2u, Nh\u1eadt B\u1ea3n, Hoa K\u1ef3 <\/strong>(E<strong>.<\/strong>P.2.6.7; JP17, USP 63) v\u1ec1 LOD, \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u: gi\u1edbi h\u1ea1n ph\u00e1t hi\u1ec7n LOD d\u01b0\u1edbi 10 CFU\/mL; \u0111\u1ed9 \u0111\u1eb7c hi\u1ec7u cao \u2013 ph\u00e1t hi\u1ec7n \u0111\u1ebfn 142 ch\u1ee7ng Mycoplasma kh\u00e1c nhau (<em>in silico)<\/em>\u00a0<\/li>\n\n\n\n<li><strong>Hi\u1ec7u qu\u1ea3 chi ph\u00ed &amp; gi\u1ea3m nguy c\u01a1 nhi\u1ec5m ch\u00e9o: <\/strong>c\u00e1c strip \u0111\u00f3ng g\u00f3i s\u1eb5n, b\u1ea3o qu\u1ea3n 2-8<sup>o<\/sup>C t\u1ed1i \u0111a 12 th\u00e1ng \u2013 ch\u1ec9 s\u1eed d\u1ee5ng s\u1ed1 l\u01b0\u1ee3ng c\u1ea7n thi\u1ebft cho m\u1ed7i l\u1ea7n ch\u1ea1y.\u00a0\u00a0<\/li>\n\n\n\n<li><strong>Ph\u00f9 h\u1ee3p cho c\u1ea3 nghi\u00ean c\u1ee9u v\u00e0 QC s\u1ea3n xu\u1ea5t: <\/strong>\u00c1p d\u1ee5ng t\u1ed1t trong nu\u00f4i c\u1ea5y t\u1ebf b\u00e0o, s\u1ea3n xu\u1ea5t sinh ph\u1ea9m, li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m ki\u1ec3m nghi\u1ec7m.\u00a0<\/li>\n\n\n\n<li><strong>Quy tr\u00ecnh th\u1ef1c hi\u1ec7n \u0111\u01a1n gi\u1ea3n:<\/strong><\/li>\n<\/ul>\n\n\n\n<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"626\" height=\"443\" src=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/12\/quy-trinh.png\" alt=\"\" class=\"wp-image-9318\" srcset=\"https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/12\/quy-trinh.png 626w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/12\/quy-trinh-300x212.png 300w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/12\/quy-trinh-600x425.png 600w, https:\/\/biogroupvietnam.com\/wp-content\/uploads\/2025\/12\/quy-trinh-76x54.png 76w\" sizes=\"(max-width: 626px) 100vw, 626px\" \/><\/figure>\n\n\n\n<p>Xem th\u00eam th\u00f4ng tin s\u1ea3n ph\u1ea9m: <a href=\"https:\/\/biogroupvietnam.com\/vi\/san-pham\/mycofinder-real-time-pcr-kit-mycoplasma\/\">Myco Finder\u2122<\/a>\u00a0\u00a0<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span class=\"ez-toc-section\" id=\"Tai_lieu_tham_khao\"><\/span><strong>T\u00e0i li\u1ec7u tham kh\u1ea3o<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p><em>1. Shimadzu Diagnostics Corporation. (n.d.). \u30de\u30a4\u30b3\u30d7\u30e9\u30ba\u30de\u5426\u5b9a\u8a66\u9a13 | \u518d\u751f\u533b\u7642\u5206\u91ce \u7d30\u80de\u57f9\u990a\u95a2\u9023\u30b5\u30a4\u30c8 [Mycoplasma negative test \/ cell culture-related site]. Shimadzu Diagnostics. <a href=\"https:\/\/cell-culture.biz.sdc.shimadzu.co.jp\/reagent\/mycoplasma\/\">https:\/\/cell-culture.biz.sdc.shimadzu.co.jp\/reagent\/mycoplasma\/<\/a>\u00a0<\/em><\/p>\n\n\n\n<p><em>2. US Pharmacopeia, \u201c63 Mycoplasma tests\u201d (2012). Available at: <a href=\"https:\/\/bit.ly\/36nDdae\">https:\/\/bit.ly\/36nDdae<\/a>\u00a0[3] Nims, Raymond W., and Elizabeth Meyers. &#8220;USP&lt; 63> mycoplasma tests: a new regulation for mycoplasma testing.&#8221;\u202fBioPharm International\u202f23.8 (2010): 54-59.<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Trong s\u1ea3n xu\u1ea5t c\u00e1c s\u1ea3n ph\u1ea9m sinh h\u1ecdc ti\u00ean ti\u1ebfn, \u0111\u1eb7c bi\u1ec7t l\u00e0 li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o v\u00e0 gen (ATMP \u2013 Advanced Therapy Medicinal Products), vi\u1ec7c ki\u1ec3m so\u00e1t nhi\u1ec5m mycoplasma l\u00e0 m\u1ed9t y\u00eau c\u1ea7u b\u1eaft bu\u1ed9c nh\u1eb1m \u0111\u1ea3m b\u1ea3o an to\u00e0n cho b\u1ec7nh nh\u00e2n. N\u1ebfu nh\u01b0 tr\u01b0\u1edbc \u0111\u00e2y ng\u00e0nh c\u00f4ng nghi\u1ec7p sinh h\u1ecdc ph\u1ee5 thu\u1ed9c<\/p>\n<div class=\"klb-readmore post-buttons\"><a class=\"button rounded primary\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/\">Read More <i class=\"klbth-icon-right-arrow\"><\/i><\/a><\/div>\n","protected":false},"author":1,"featured_media":9319,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[19],"tags":[],"class_list":["post-9317","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-tin-tuc"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>C\u1eadp nh\u1eadt quy \u0111\u1ecbnh &amp; t\u1ea7m quan tr\u1ecdng c\u1ee7a NAT trong x\u00e9t nghi\u1ec7m Mycoplasma cho s\u1ea3n ph\u1ea9m li\u1ec7u ph\u00e1p t\u1ebf b\u00e0o<\/title>\n<meta name=\"description\" content=\"T\u1ed5ng h\u1ee3p c\u00e1c th\u00f4ng tin c\u1eadp nh\u1eadt t\u1eeb t\u00e0i li\u1ec7u chuy\u00ean ng\u00e0nh m\u1edbi nh\u1ea5t, k\u1ebft h\u1ee3p c\u00f9ng khung quy \u0111\u1ecbnh hi\u1ec7n h\u00e0nh, nh\u1eb1m gi\u00fap c\u00e1c ph\u00f2ng th\u00ed nghi\u1ec7m, c\u01a1 s\u1edf s\u1ea3n xu\u1ea5t ATMP v\u00e0 c\u00e1c \u0111\u01a1n v\u1ecb nghi\u00ean c\u1ee9u t\u1ea1i Vi\u1ec7t Nam c\u1eadp nh\u1eadt quy \u0111\u1ecbnh Mycoplasma.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biogroupvietnam.com\/vi\/tin-tuc\/cap-nhat-quy-dinh-tam-quan-trong-nat-trong-xet-nghiem-mycoplasma-san-pham-lieu-phap-te-bao\/\" \/>\n<meta property=\"og:locale\" content=\"vi_VN\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"C\u1eadp nh\u1eadt quy \u0111\u1ecbnh &amp; 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