{"id":6317,"date":"2021-07-29T12:19:54","date_gmt":"2021-07-29T03:19:54","guid":{"rendered":"https:\/\/www.hoe2021.com\/?p=6317"},"modified":"2021-08-15T23:58:38","modified_gmt":"2021-08-15T14:58:38","slug":"%e3%80%8ccdc%e3%81%8cpcr%e6%a4%9c%e6%9f%bb%e3%81%ae%e7%b7%8a%e6%80%a5%e4%bd%bf%e7%94%a8%e8%a8%b1%e5%8f%af%e3%82%92%e5%8f%96%e3%82%8a%e6%b6%88%e3%81%99%e3%81%a8%e6%b1%ba%e3%82%81%e3%81%9f%e3%80%8d","status":"publish","type":"post","link":"https:\/\/www.hoe2021.com\/?p=6317","title":{"rendered":"\u300cCDC\u304cPCR\u691c\u67fb\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d6\u308a\u6d88\u3059\u3068\u6c7a\u3081\u305f\u300d\u306f\u30df\u30b9\u30ea\u30fc\u30c9"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_83 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\">\u76ee\u6b21<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" 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>FDA\u304c\u8a8d\u53ef\u3057\u305f\u8a3a\u65ad\u65b9\u6cd5\u306e\u4e2d\u306bPCR\u691c\u67fb\u304c\u7121\u3044\uff1f\uff01<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-8\" href=\"https:\/\/www.hoe2021.com\/?p=6317\/#%E5%BE%93%E6%9D%A5%E3%81%AEPCR%E6%A4%9C%E6%9F%BB%E3%81%A7%E3%81%AF%E3%82%A4%E3%83%B3%E3%83%95%E3%83%AB%E3%82%A8%E3%83%B3%E3%82%B6%E3%81%A8%E6%96%B0%E5%9E%8B%E3%82%B3%E3%83%AD%E3%83%8A%E3%81%AE%E5%8C%BA%E5%88%A5%E3%81%8C%E3%81%A4%E3%81%84%E3%81%A6%E3%81%BE%E3%81%97%E3%81%9F%E3%81%8B%EF%BC%9F%EF%BC%81\" >\u5f93\u6765\u306ePCR\u691c\u67fb\u3067\u306f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u533a\u5225\u304c\u3064\u3044\u3066\u307e\u3057\u305f\u304b\uff1f\uff01<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-9\" href=\"https:\/\/www.hoe2021.com\/?p=6317\/#CDC%E3%81%8B%E3%82%89%E3%81%AE%E8%A3%9C%E8%B6%B3%E8%AA%AC%E6%98%8E\" >CDC\u304b\u3089\u306e\u88dc\u8db3\u8aac\u660e<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-10\" href=\"https:\/\/www.hoe2021.com\/?p=6317\/#%E3%81%9D%E3%81%AE%E4%BB%96%E3%81%AE%E5%8F%82%E8%80%83%E8%A8%98%E4%BA%8B\" >\u305d\u306e\u4ed6\u306e\u53c2\u8003\u8a18\u4e8b<\/a><ul class='ez-toc-list-level-3' ><li class='ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-11\" href=\"https:\/\/www.hoe2021.com\/?p=6317\/#%E3%80%8CCDC%E3%81%8CPCR%E6%A4%9C%E6%9F%BB%E5%8F%96%E3%82%8A%E3%82%84%E3%82%81%E3%82%92%E7%99%BA%E8%A1%A8%E3%80%8D%E3%81%AF%E3%83%87%E3%83%9E%EF%BC%88%E4%BC%8A%E8%B3%80%E6%B2%BB%E6%B0%8F%E3%83%8E%E3%83%BC%E3%83%88%EF%BC%89\" >\u300cCDC\u304cPCR\u691c\u67fb\u53d6\u308a\u3084\u3081\u3092\u767a\u8868\u300d\u306f\u30c7\u30de\uff08\u4f0a\u8cc0\u6cbb\u6c0f\u30ce\u30fc\u30c8\uff09<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-12\" href=\"https:\/\/www.hoe2021.com\/?p=6317\/#AP%E3%83%95%E3%82%A1%E3%82%AF%E3%83%88%E3%83%81%E3%82%A7%E3%83%83%E3%82%AF\" >AP\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af<\/a><\/li><\/ul><\/li><\/ul><\/nav><\/div>\n<h2 id=\"i-0\"><span class=\"ez-toc-section\" id=\"%E3%83%87%E3%83%9E%E3%81%AE%E5%86%85%E5%AE%B9\"><\/span>\u30c7\u30de\u306e\u5185\u5bb9<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u300c2021\u5e747\u670821\u65e5\u3001CDC\u306fPCR\u691c\u67fb\u304c\u4fe1\u983c\u3067\u304d\u306a\u3044\u3053\u3068\u3092\u8a8d\u3081\u3001PCR\u691c\u67fb\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d6\u308a\u6d88\u3059\u3053\u3068\u306b\u6c7a\u3081\u305f\u300d\u3068\u4e3b\u5f35\u3059\u308b\u4eba\u304c\u3044\u307e\u3059\u304c\u3001\u30c7\u30de\u3067\u3059\u3002<\/p>\n<p><a href=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_105119.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-6319 bigshadow\" src=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_105119.png\" alt=\"\" width=\"591\" height=\"644\" srcset=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_105119.png 591w, https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_105119-275x300.png 275w\" sizes=\"auto, (max-width: 591px) 100vw, 591px\"><\/a><br \/>\n<a href=\"https:\/\/twitter.com\/lkj_hgf_dsa_poi\/status\/1419592840271728641\" target=\"_blank\" rel=\"noopener\">https:\/\/twitter.com\/lkj_hgf_dsa_poi\/status\/1419592840271728641<\/a><\/p>\n<h2 id=\"i-1\"><span class=\"ez-toc-section\" id=\"%E7%B5%90%E8%AB%96\"><\/span>\u7d50\u8ad6<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>CDC\u306e\u767a\u8868\u306f\u3001\u300cCDC\u304c\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u5f97\u3066\u3044\u305f\u53e4\u3044PCR\u691c\u67fb\u306e\u4f7f\u7528\u3092\u3084\u3081\u3001\u6c11\u9593\u304c\u72ec\u81ea\u306bEUA\u3092\u5f97\u3066\u4f7f\u7528\u3057\u3066\u3044\u308b\u3088\u308a\u65b0\u3057\u304f\u52b9\u7387\u7684\u306aPCR\u691c\u67fb\u3078\u306e\u79fb\u884c\u3092\u3059\u3059\u3081\u3066\u3044\u304f\u300d\u3068\u3044\u3046\u3082\u306e\u3067\u3042\u308a\u3001PCR\u691c\u67fb\u306e\u4fe1\u983c\u6027\u306b\u7591\u5ff5\u3092\u5448\u3059\u308b\u3088\u3046\u306a\u3053\u3068\u306f\u4e00\u5207\u8ff0\u3079\u3066\u304a\u3089\u305a\u3001PCR\u691c\u67fb\u305d\u306e\u3082\u306e\u304c\u7121\u304f\u306a\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u3066\u3044\u307e\u305b\u3093\u3002<\/p>\n<h2 id=\"i-2\"><span class=\"ez-toc-section\" id=\"%E8%A7%A3%E8%AA%AC\"><\/span>\u89e3\u8aac<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 id=\"i-3\"><span class=\"ez-toc-section\" id=\"%E3%83%95%E3%82%A1%E3%82%AF%E3%83%88%E3%83%81%E3%82%A7%E3%83%83%E3%82%AF%E8%A8%98%E4%BA%8B%EF%BC%88FactCheckorg%EF%BC%89\"><\/span>\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u8a18\u4e8b\uff08FactCheck.org\uff09<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>FactCheck.org\u306b\u3088\u308b\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af\u8a18\u4e8b\u304b\u3089\u306e\u629c\u7c8b\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\">Viral Posts Misrepresent CDC Announcement on COVID-19 PCR Test<\/span><br \/>\n<a href=\"https:\/\/www.factcheck.org\/2021\/07\/scicheck-viral-posts-misrepresent-cdc-announcement-on-covid-19-pcr-test\/\" target=\"_blank\" rel=\"noopener\">CDC\u306e\u65b0\u578b\u30b3\u30ed\u30caPCR\u691c\u67fb\u306e\u767a\u8868\u306b\u95a2\u3059\u308b\u30c7\u30de<\/a><\/p>\n<p><span class=\"haiiro\">The agency in a July 21 notice recommended that labs use \u201cone of the many FDA-authorized alternatives\u201d and said it \u201cencourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.\u201d<\/span><br \/>\nCDC\u306f\u30012021\u5e747\u670821\u65e5\u306e\u901a\u77e5\u3067\u3001\u300cFDA\u304c\u627f\u8a8d\u3057\u305f\u591a\u304f\u306e\u4ee3\u66ff\u624b\u6bb5\u306e1\u3064\u300d\u3092\u4f7f\u7528\u3059\u308b\u3088\u3046\u306b\u7814\u7a76\u6a5f\u95a2\u306b\u5bfe\u3057\u3066\u63a8\u5968\u3057\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u306e\u691c\u51fa\u3068\u8b58\u5225\u304c\u5bb9\u6613\u306b\u3067\u304d\u308b\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\uff08\u591a\u91cd\u5316\uff09\u65b9\u5f0f\u306e\u63a1\u7528\u3092\u691c\u8a0e\u3059\u308b\u3088\u3046\u5968\u52b1\u3057\u307e\u3057\u305f\u3002<\/p>\n<p><span class=\"haiiro\">Such multiplex tests, including one from the CDC, can look for both the novel coronavirus and multiple types of influenza at the same time \u2014 which conserves testing materials and allows public health labs to do influenza surveillance while testing for SARS-CoV-2, or the virus that causes COVID-19.<\/span><br \/>\nCDC\u304c\u63a8\u5968\u3059\u308b\u3082\u306e\u3092\u542b\u3081\u3001\u3053\u306e\u3088\u3046\u306a\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u691c\u67fb\u3067\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3068\u8907\u6570\u7a2e\u985e\u306e\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u306e\u4e21\u65b9\u3092\u540c\u6642\u306b\u691c\u77e5\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u307e\u305f\u3001\u691c\u67fb\u6750\u6599\u306e\u7bc0\u7d04\u306b\u306a\u308a\u3001\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u304c\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u691c\u67fb\u3092\u3057\u306a\u304c\u3089\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u306e\u8abf\u67fb\u3082\u884c\u3046\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">But the CDC did not say it was no longer supporting the use of PCR tests in general, many of which have been&nbsp;<a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2\" target=\"_blank\" rel=\"noopener\">authorized<\/a>&nbsp;by the FDA \u2014 or that&nbsp;<a href=\"https:\/\/www.fda.gov\/media\/134919\/download\" target=\"_blank\" rel=\"noopener\">its original PCR test for SARS-CoV-2<\/a>&nbsp;can\u2019t tell the difference between coronavirus and influenza \u2014 as viral posts spreading online falsely claim.<\/span><br \/>\n\u30aa\u30f3\u30e9\u30a4\u30f3\u3067\u62e1\u6563\u3057\u3066\u3044\u308b\u8a71\u3068\u306f\u7570\u306a\u308a\u3001<strong>FDA\u306b\u3088\u3063\u3066<a href=\"https:\/\/www.fda.gov\/medical-devices\/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices\/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2\" target=\"_blank\" rel=\"noopener\">\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b<\/a>\u591a\u304f\u306e\u4e00\u822c\u7684\u306aPCR\u691c\u67fb\u306e\u4f7f\u7528\u306b\u3064\u3044\u3066CDC\u306f\u30b5\u30dd\u30fc\u30c8\u3057\u306a\u3044\u3068\u306f\u8ff0\u3079\u3066\u304a\u3089\u305a\u3001<a href=\"https:\/\/www.fda.gov\/media\/134919\/download\" target=\"_blank\" rel=\"noopener\">CDC\u72ec\u81ea\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9PCR\u691c\u67fb<\/a>\u304c\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u306e\u9055\u3044\u3092\u5224\u5225\u3067\u304d\u306a\u3044\u3068\u3082\u8ff0\u3079\u3066\u3044\u307e\u305b\u3093<\/strong>\u3002<\/p>\n<p><span class=\"haiiro\">the announcement in question came from the CDC and was about plans for the eventual discontinuation of its own test.<\/span><br \/>\n\u3053\u306e\u4ef6\u306fCDC\u304c\u767a\u8868\u3057\u305f\u3082\u306e\u3067\u3059\u304c\u3001\u305d\u306e\u5185\u5bb9\u306f\u3001CDC\u72ec\u81ea\u306e\u691c\u67fb\u306e\u4e2d\u6b62\u8a08\u753b\u306b\u3064\u3044\u3066\u8ff0\u3079\u305f\u3082\u306e\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\">The FDA did not revoke the CDC test\u2019s emergency use authorization or question the reliability of PCR tests, an FDA spokesman confirmed to us.<\/span><br \/>\nFDA\u306e\u30b9\u30dd\u30fc\u30af\u30b9\u30de\u30f3\u306b\u3088\u308c\u3070\u3001FDA\u306fCDC\u306e\u691c\u67fb\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d6\u308a\u6d88\u3057\u3066\u306f\u304a\u3089\u305a\u3001PCR\u691c\u67fb\u306e\u4fe1\u983c\u6027\u306b\u7591\u554f\u3092\u5448\u3059\u308b\u3088\u3046\u306a\u3053\u3068\u3082\u3057\u3066\u3044\u307e\u305b\u3093\u3002<\/p>\n<p><span class=\"haiiro\">Scientists consider PCR tests a reliable and highly specific diagnostic tool, as we\u2019ve&nbsp;<a href=\"https:\/\/www.factcheck.org\/2021\/01\/scicheck-viral-posts-distort-who-guidance-on-covid-19-tests\/\" target=\"_blank\" rel=\"noopener\">explained before<\/a>, but&nbsp;<a href=\"https:\/\/www.factcheck.org\/2021\/05\/scicheck-story-twists-facts-on-diagnosing-breakthrough-covid-19-cases\/\" target=\"_blank\" rel=\"noopener\">distortions<\/a>&nbsp;about them have persisted amid the COVID-19 pandemic.<\/span><br \/>\n<a href=\"https:\/\/www.factcheck.org\/2021\/01\/scicheck-viral-posts-distort-who-guidance-on-covid-19-tests\/\" target=\"_blank\" rel=\"noopener\">\u4ee5\u524d\u306b\u3082\u89e3\u8aac\u3057\u305f\u3088\u3046\u306b<\/a>\u3001PCR\u691c\u67fb\u306f\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u3001\u975e\u5e38\u306b\u6709\u52b9\u306a\u8a3a\u65ad\u30c4\u30fc\u30eb\u3067\u3042\u308b\u3068\u79d1\u5b66\u8005\u305f\u3061\u306f\u8003\u3048\u3066\u3044\u307e\u3059\u304c\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u30d1\u30f3\u30c7\u30df\u30c3\u30af\u306e\u4e2d\u3067\u3001<a href=\"https:\/\/www.factcheck.org\/2021\/05\/scicheck-story-twists-facts-on-diagnosing-breakthrough-covid-19-cases\/\" target=\"_blank\" rel=\"noopener\">PCR\u691c\u67fb\u306b\u95a2\u3059\u308b\u30c7\u30de<\/a>\u304c\u5f8c\u3092\u305f\u3061\u307e\u305b\u3093\u3002<\/p>\n<p><span class=\"haiiro\">In explaining the CDC\u2019s decision to end the use of its own PCR test at the end of 2021, Kristen Nordlund, an agency spokeswoman, in an email to us cited \u201cthe availability of commercial options for clinical diagnosis of SARS-CoV-2 infection, including multiplexed (discussed&nbsp;<a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/testing.html\" target=\"_blank\" rel=\"noopener noreferrer\" data-auth=\"NotApplicable\" data-linkindex=\"0\">here<\/a>) and high-throughput options\u201d \u2014 referring to&nbsp;<a href=\"https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing\" target=\"_blank\" rel=\"noopener\">technologies<\/a>&nbsp;that use an automated process to administer hundreds of tests per day.<\/span><br \/>\n2021\u5e74\u672b\u306b\u72ec\u81ea\u306ePCR\u691c\u67fb\u306e\u4f7f\u7528\u3092\u7d42\u4e86\u3059\u308b\u3068\u3044\u3046CDC\u306e\u6c7a\u5b9a\u3092\u8aac\u660e\u3059\u308b\u306b\u3042\u305f\u308a\u3001\u653f\u5e9c\u6a5f\u95a2\u306e\u30b9\u30dd\u30fc\u30af\u30b9\u30a6\u30fc\u30de\u30f3\u3067\u3042\u308b\u30af\u30ea\u30b9\u30c6\u30f3\u30fb\u30ce\u30fc\u30c9\u30e9\u30f3\u30c9\uff08Kristen Nordlund\uff09\u306f\u3001E\u30e1\u30fc\u30eb\u3067\u3001\uff11\u65e5\u306b\u6570\u767e\u306e\u691c\u67fb\u3092\u81ea\u52d5\u51e6\u7406\u3059\u308b<a href=\"https:\/\/www.cms.gov\/newsroom\/press-releases\/cms-changes-medicare-payment-support-faster-covid-19-diagnostic-testing\" target=\"_blank\" rel=\"noopener\">\u30c6\u30af\u30ce\u30ed\u30b8\u30fc<\/a>\u306b\u8a00\u53ca\u3057\u3001\u300c\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u81e8\u5e8a\u8a3a\u65ad\uff08<a href=\"https:\/\/www.cdc.gov\/coronavirus\/2019-ncov\/lab\/testing.html\" target=\"_blank\" rel=\"noopener\">\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9<\/a>\u304a\u3088\u3073\u5927\u91cf\u51e6\u7406\u3092\u542b\u3080\uff09\u306b\u95a2\u3057\u3066\u6c11\u9593\u3092\u5229\u7528\u3059\u308b\u9078\u629e\u80a2\u300d\u306b\u3064\u3044\u3066\u8ff0\u3079\u307e\u3057\u305f\u3002<\/p>\n<p><span class=\"haiiro\">Jim McKinney, an FDA spokesman, told us in an email that to date, &nbsp;\u201cthe FDA has authorized more than 380 tests and sample collection kits to diagnose COVID-19, many of which are PCR tests. PCR tests are generally considered to be the \u2018gold standard\u2019 for COVID-19 diagnosis.\u201d<\/span><br \/>\nFDA\u306e\u30b9\u30dd\u30fc\u30af\u30b9\u30de\u30f3\u3067\u3042\u308b\u30b8\u30e0\u30fb\u30de\u30c3\u30ad\u30cb\u30fc\uff08Jim McKinney\uff09\u306f\u3001\u3053\u308c\u307e\u3067\u306b\u96fb\u5b50\u30e1\u30fc\u30eb\u3067\u6b21\u306e\u3088\u3046\u306b\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u300cFDA\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u3092\u8a3a\u65ad\u3059\u308b\u305f\u3081\u306b380\u3092\u8d85\u3048\u308b\u691c\u67fb\u3068\u30b5\u30f3\u30d7\u30eb\u53ce\u96c6\u30ad\u30c3\u30c8\u3092\u627f\u8a8d\u3057\u3066\u304a\u308a\u3001\u305d\u306e\u591a\u304f\u306fPCR\u691c\u67fb\u3067\u3059\u3002PCR\u691c\u67fb\u306f\u3001\u4e00\u822c\u7684\u306b\u65b0\u578b\u30b3\u30ed\u30ca\u8a3a\u65ad\u306e\u300c\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u300d\u3068\u898b\u306a\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u300d<\/p>\n<p><span class=\"haiiro\">\u201cThe FDA has not issued any statement questioning the reliability of PCR test results in general and will continue to consider authorization for validated PCR tests,\u201d he added.<\/span><br \/>\n\u300c<strong>FDA\u306f\u3001\u4e00\u822c\u7684\u306aPCR\u691c\u67fb\u306e\u4fe1\u983c\u6027\u3092\u7591\u3046\u3088\u3046\u306a\u58f0\u660e\u3092\u767a\u8868\u3057\u3066\u304a\u3089\u305a\u3001\u691c\u8a3c\u6e08\u307f\u306ePCR\u691c\u67fb\u306e\u8a8d\u53ef\u3092\u5f15\u304d\u7d9a\u304d\u691c\u8a0e\u3057\u3066\u3044\u304d\u307e\u3059<\/strong>\u300d<\/p>\n<p><a href=\"https:\/\/www.hsph.harvard.edu\/hii\/people\/michael-mina-md-phd\/\" target=\"_blank\" rel=\"noopener\"><span class=\"haiiro\">Dr. Michael Mina<\/span><\/a><span class=\"haiiro\">, a Harvard University&nbsp;assistant professor of epidemiology, told us that the CDC\u2019s decision regarding its test made sense, given how the landscape has changed.<\/span><br \/>\n\u30cf\u30fc\u30d0\u30fc\u30c9\u5927\u5b66\u306e\u75ab\u5b66\u52a9\u6559\u6388\u3067\u3042\u308b<a href=\"https:\/\/www.hsph.harvard.edu\/hii\/people\/michael-mina-md-phd\/\" target=\"_blank\" rel=\"noopener\">\u30de\u30a4\u30b1\u30eb\u30fb\u30df\u30ca\u535a\u58eb<\/a>\u306f\u3001\u72b6\u6cc1\u306e\u5909\u5316\u3092\u8003\u616e\u3059\u308c\u3070\u3001\u691c\u67fb\u306b\u3064\u3044\u3066\u306eCDC\u306e\u6c7a\u5b9a\u306f\u7406\u306b\u304b\u306a\u3063\u3066\u3044\u308b\u3068\u8a9e\u3063\u305f\u3002<\/p>\n<p><span class=\"haiiro\">\u201cCDC is likely going to pull its own EUA for its test because hundreds of other labs now have their own EUAs and CDC no longer even needs to use its own test since many companies now have EUAs for manufactured tests,\u201d he said in an email.<\/span><br \/>\n\u300c<span class=\"keiko_red\"><strong>CDC\u306f\u691c\u67fb\u306e\u305f\u3081\u306e\u72ec\u81ea\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u53d6\u5f97\u3057\u306a\u304f\u306a\u308b\u304b\u3082\u3057\u308c\u307e\u305b\u3093\u3002\u306a\u305c\u306a\u3089\u3001\u73fe\u5728\u3001\u4ed6\u306e\u4f55\u767e\u3082\u306e\u7814\u7a76\u6a5f\u95a2\u304c\u72ec\u81ea\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u5f97\u3066\u304a\u308a\u3001\u591a\u304f\u306e\u4f01\u696d\u304c\u88fd\u9020\u30c6\u30b9\u30c8\u7528\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u53d6\u5f97\u3057\u3066\u3044\u308b\u305f\u3081\u3001CDC\u306f\u72ec\u81ea\u306e\u691c\u67fb\u3092\u4f7f\u7528\u3059\u308b\u5fc5\u8981\u304c\u306a\u304f\u306a\u3063\u305f<\/strong><\/span>\u305f\u3081\u3067\u3059\u300d\u3068\u5f7c\u306f\u96fb\u5b50\u30e1\u30fc\u30eb\u3067\u8ff0\u3079\u307e\u3057\u305f\u3002<\/p>\n<p><span class=\"haiiro\">\u201cThe major Companies like Roche, Hologic, Abbott all have their own test kits and instruments. Then the Thermo Fishers of the world have EUAs for their PCR kits that can be run in the exact same way as the CDC assay. So there really is no reason for CDC to retain their EUA.\u201d<\/span><br \/>\n\u300c\u30ed\u30b7\u30e5\u3001\u30db\u30ed\u30b8\u30c3\u30af\u3001\u30a2\u30dc\u30c3\u30c8\u306a\u3069\u306e\u4e3b\u8981\u4f01\u696d\u306f\u3059\u3079\u3066\u3001\u72ec\u81ea\u306e\u691c\u67fb\u30ad\u30c3\u30c8\u3068\u6a5f\u5668\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002\u305d\u3057\u3066\u3001\u30b5\u30fc\u30e2\u30d5\u30a3\u30c3\u30b7\u30e3\u30fc\u306f\u3001CDC<a href=\"https:\/\/ja.wikipedia.org\/wiki\/%E3%82%A2%E3%83%83%E3%82%BB%E3%82%A4\" target=\"_blank\" rel=\"noopener\">\u30a2\u30c3\u30bb\u30a4<\/a>\u3068\u307e\u3063\u305f\u304f\u540c\u3058\u65b9\u6cd5\u3067\u5b9f\u884c\u3067\u304d\u308bPCR\u30ad\u30c3\u30c8\u7528\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u4e16\u754c\u4e2d\u3067\u53d6\u5f97\u3057\u3066\u3044\u307e\u3059\u3002\u3057\u305f\u304c\u3063\u3066\u3001CDC\u304c\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u4fdd\u6301\u3059\u308b\u7406\u7531\u306f\u3001\u5b9f\u969b\u306e\u3068\u3053\u308d\u3001\u3042\u308a\u307e\u305b\u3093\u3002\u300d<\/p>\n<p><span class=\"haiiro\">Mina said the move had to be done carefully, since some public health labs may currently be relying on the CDC\u2019s test.<\/span><br \/>\n\u30df\u30ca\u6c0f\u306f\u3001\u4e00\u90e8\u306e\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u306f\u73fe\u5728CDC\u306e\u691c\u67fb\u306b\u4f9d\u5b58\u3057\u3066\u3044\u308b\u53ef\u80fd\u6027\u304c\u3042\u308b\u305f\u3081\u3001\u79fb\u884c\u306f\u614e\u91cd\u306b\u884c\u3046\u5fc5\u8981\u304c\u3042\u308b\u3068\u8ff0\u3079\u305f\u3002<\/p>\n<h3 id=\"i-4\"><span class=\"ez-toc-section\" id=\"CDC%E3%81%8C%E5%85%AC%E9%96%8B%E3%81%97%E3%81%9F%E8%A8%98%E4%BA%8B\"><\/span>CDC\u304c\u516c\u958b\u3057\u305f\u8a18\u4e8b<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>CDC\u304c\u516c\u958b\u3057\u305f\u8a18\u4e8b\u300c<a href=\"https:\/\/www.cdc.gov\/csels\/dls\/locs\/2021\/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html\" target=\"_blank\" rel=\"noopener\">07\/21\/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing<\/a>\u300d\u304c\u3053\u3061\u3089\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\">07\/21\/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing<\/span><br \/>\n2021\u5e747\u670821\u65e5\uff1a\u7814\u7a76\u6a5f\u95a2\u5411\u3051\u306e\u8b66\u544a\uff1a\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u691c\u67fb CDC RT-PCR \u306b\u95a2\u3059\u308b\u5909\u66f4<\/p>\n<p><span class=\"haiiro\">After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only.<\/span><br \/>\nCDC\u306f\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u3092\u30012021\u5e7412\u670831\u65e5\u4ee5\u964d\u304b\u3089\u3001FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u306b\u8981\u8acb\u3057\u306a\u3044\u3053\u3068\u3068\u3057\u307e\u3059\u3002\u3053\u306e\u691c\u67fb\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u307f\u3092\u691c\u77e5\u3059\u308b\u305f\u3081\u306b\u30012020\u5e742\u6708\u306b\u6700\u521d\u306b\u5c0e\u5165\u3055\u308c\u305f<a href=\"https:\/\/ja.wikipedia.org\/wiki\/%E3%82%A2%E3%83%83%E3%82%BB%E3%82%A4\" target=\"_blank\" rel=\"noopener\">\u30a2\u30c3\u30bb\u30a4<\/a>\uff08\u65b9\u6cd5\uff09\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\">CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives.<\/span><br \/>\nCDC\u306b\u3088\u308b\u3053\u306e\u4e8b\u524d\u901a\u77e5\u306e\u76ee\u7684\u306f\u3001\u81e8\u5e8a\u691c\u67fb\u5ba4\u306b\u5341\u5206\u306a\u6e96\u5099\u671f\u9593\uff08FDA\u304c\u627f\u8a8d\u3057\u305f\u591a\u304f\u306e\u4ee3\u66ff\u6848\u306e\u3044\u305a\u308c\u304b\u3092\u9078\u629e\u3057\u3001\u5b9f\u88c5\u3059\u308b\u6642\u9593\uff09\u3092\u63d0\u4f9b\u3059\u308b\u3053\u3068\u3067\u3059\u3002<\/p>\n<p><a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4c129f9a,147a6e6f,147a9998&amp;ACSTrackingID=USCDC_2146-DM61940&amp;ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing\" target=\"_blank\" rel=\"noopener\"><span class=\"haiiro\">Visit the FDA website<\/span><\/a><span class=\"haiiro\"> for a list of authorized COVID-19 diagnostic methods.<\/span><br \/>\n\u8a8d\u53ef\u3055\u308c\u305f\u65b0\u578b\u30b3\u30ed\u30ca\u8a3a\u65ad\u65b9\u6cd5\u306e\u30ea\u30b9\u30c8\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4c129f9a,147a6e6f,147a9998&amp;ACSTrackingID=USCDC_2146-DM61940&amp;ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing\" target=\"_blank\" rel=\"noopener\">FDA\u306eWeb\u30b5\u30a4\u30c8\u306b\u30a2\u30af\u30bb\u30b9<\/a>\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><span class=\"haiiro\">For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel,&nbsp;<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4c129f9a,147a6e6f,147a9999&amp;ACSTrackingID=USCDC_2146-DM61940&amp;ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing\" target=\"_blank\" rel=\"noopener\">visit this page<\/a>.<br \/>\n<\/span>FDA\u30ea\u30d5\u30a1\u30ec\u30f3\u30b9\u30d1\u30cd\u30eb\u3092\u4f7f\u7528\u3057\u305fFDA\u8a8d\u53ef\u306e\u5206\u5b50\u6cd5\u306e\u6027\u80fd\u306e\u6982\u8981\u306b\u3064\u3044\u3066\u306f\u3001<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4c129f9a,147a6e6f,147a9999&amp;ACSTrackingID=USCDC_2146-DM61940&amp;ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing\" target=\"_blank\" rel=\"noopener\">\u3053\u306e\u30da\u30fc\u30b8\u306b\u30a2\u30af\u30bb\u30b9<\/a>\u3057\u3066\u304f\u3060\u3055\u3044\u3002<\/p>\n<p><span class=\"haiiro\">In preparation for this change, CDC recommends clinical laboratories and testing sites that have been using the CDC 2019-nCoV RT-PCR assay select and begin their transition to another FDA-authorized COVID-19 test.<\/span><br \/>\n\u3053\u306e\u5909\u66f4\u306b\u5099\u3048\u3066\u3001CDC\u306f\u3001CDC 2019-nCoV RT-PCR \u30a2\u30c3\u30bb\u30a4\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u81e8\u5e8a\u691c\u67fb\u5ba4\u3068\u691c\u67fb\u30b5\u30a4\u30c8\u306b\u5bfe\u3057\u3066\u3001FDA\u304c\u627f\u8a8d\u3057\u305f\u5225\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u691c\u67fb\u3092\u9078\u629e\u3057\u3066\u79fb\u884c\u3092\u958b\u59cb\u3059\u308b\u3088\u3046\u306b\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">CDC encourages laboratories to consider adoption of a multiplexed method that can facilitate detection and differentiation of SARS-CoV-2 and influenza viruses.<\/span><br \/>\nCDC\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u306e\u691c\u51fa\u3068\u8b58\u5225\u3092\u5bb9\u6613\u306b\u884c\u3046\u3053\u3068\u304c\u53ef\u80fd\u306a\u3001\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u6cd5\u306e\u63a1\u7528\u3092\u691c\u8a0e\u3059\u308b\u3088\u3046\u7814\u7a76\u6240\u306b\u5968\u52b1\u3057\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">Such assays can facilitate continued testing for both influenza and SARS-CoV-2 and can save both time and resources as we head into influenza season.<\/span><br \/>\n\u3053\u306e\u3088\u3046\u306a\u30a2\u30c3\u30bb\u30a4\u306f\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u4e21\u65b9\u3092\u7d99\u7d9a\u7684\u306b\u691c\u67fb\u3059\u308b\u3053\u3068\u3092\u5bb9\u6613\u306b\u3057\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30fb\u30b7\u30fc\u30ba\u30f3\u3092\u8fce\u3048\u308b\u3068\u304d\u306b\u6642\u9593\u3068\u30ea\u30bd\u30fc\u30b9\u306e\u4e21\u65b9\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">Laboratories and testing sites should validate and verify their selected assay within their facility before beginning clinical testing.<\/span><br \/>\n\u7814\u7a76\u6240\u304a\u3088\u3073\u691c\u67fb\u30b5\u30a4\u30c8\u306f\u3001\u81e8\u5e8a\u8a66\u9a13\u3092\u958b\u59cb\u3059\u308b\u524d\u306b\u3001\u9078\u629e\u3057\u305f\u30a2\u30c3\u30bb\u30a4\u3092\u65bd\u8a2d\u5185\u3067\u78ba\u8a8d\u304a\u3088\u3073\u691c\u8a3c\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<h3 id=\"i-5\"><span class=\"ez-toc-section\" id=\"NewsGuard%E3%81%AB%E3%82%88%E3%82%8B%E3%83%81%E3%82%A7%E3%83%83%E3%82%AF\"><\/span>NewsGuard\u306b\u3088\u308b\u30c1\u30a7\u30c3\u30af<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>\u3061\u306a\u307f\u306b\u3001<a href=\"https:\/\/greatgameindia.com\/cdc-revokes-rt-pcr-test\/\" target=\"_blank\" rel=\"noopener\">\u30c7\u30de\u30c3\u30bf\u30fc\u304c\u5f15\u7528\u3057\u3066\u3044\u308b\u30c7\u30de\u5143\u3089\u3057\u304d\u30b5\u30a4\u30c8<\/a>\u3092NewsGuard\u3067\u898b\u3066\u307f\u308b\u3068\u300c<span class=\"keiko_red\"><strong>\u6ce8\u610f\u304c\u5fc5\u8981\u3067\u3059\uff1a\u3053\u306e Web \u30b5\u30a4\u30c8\u306f\u5831\u9053\u502b\u7406\u898f\u5b9a\u306b\u8457\u3057\u304f\u9055\u53cd\u3057\u3066\u3044\u307e\u3059<\/strong><\/span>\u300d\u3068\u3044\u3046\u8b66\u544a\u304c\u51fa\u307e\u3059\u3002<\/p>\n<p><a href=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_112454.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-6320 bigshadow\" src=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_112454.png\" alt=\"\" width=\"684\" height=\"790\" srcset=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_112454.png 684w, https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/shot_210728_112454-260x300.png 260w\" sizes=\"auto, (max-width: 684px) 100vw, 684px\"><\/a><\/p>\n<h2 id=\"i-6\"><span class=\"ez-toc-section\" id=\"FDA%E3%81%8C%E8%AA%8D%E5%8F%AF%E3%81%97%E3%81%9F%E8%A8%BA%E6%96%AD%E6%96%B9%E6%B3%95%E3%81%AE%E4%B8%AD%E3%81%ABPCR%E6%A4%9C%E6%9F%BB%E3%81%8C%E7%84%A1%E3%81%84%EF%BC%9F%EF%BC%81\"><\/span>FDA\u304c\u8a8d\u53ef\u3057\u305f\u8a3a\u65ad\u65b9\u6cd5\u306e\u4e2d\u306bPCR\u691c\u67fb\u304c\u7121\u3044\uff1f\uff01<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u300c<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4c129f9a,147a6e6f,147a9998&amp;ACSTrackingID=USCDC_2146-DM61940&amp;ACSTrackingLabel=Lab%20Alert%3A%20Changes%20to%20CDC%20RT-PCR%20for%20SARS-CoV-2%20Testing\" target=\"_blank\" rel=\"noopener\">FDA\u304c\u8a8d\u53ef\u3057\u305f\u8a3a\u65ad\u65b9\u6cd5<\/a>\u306e\u4e2d\u306bPCR\u691c\u67fb\u304c\u7121\u3044\u3058\u3083\u306a\u3044\u304b\uff01\u300d\u3068\u4e3b\u5f35\u3059\u308b\u4eba\u304c\u3044\u307e\u3057\u305f\u304c\u3001\u3061\u3083\u3093\u3068\u3042\u308a\u307e\u3059\u3002<\/p>\n<p>\u4e0b\u56f3\u306e\u8d64\u7dda\u3092\u5f15\u3044\u305f molecular tests\uff08\u5206\u5b50\u691c\u67fb\uff09\u3068\u3044\u3046\u30ab\u30c6\u30b4\u30ea\u30fc\u306b RT-PCR \u691c\u67fb\u3082\u542b\u307e\u308c\u3066\u3044\u307e\u3059\uff08\u305d\u306e\u4ed6\u306e\u5206\u5b50\u691c\u67fb\u3068\u3057\u3066\u306f LAMP \u6cd5\u304c\u3088\u304f\u77e5\u3089\u308c\u3066\u3044\u307e\u3059\uff09\u3002<\/p>\n<p><a href=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/2021-07-30.png\"><img loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-6360 bigshadow\" src=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/2021-07-30.png\" alt=\"\" width=\"785\" height=\"359\" srcset=\"https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/2021-07-30.png 785w, https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/2021-07-30-300x137.png 300w, https:\/\/www.hoe2021.com\/wp-content\/uploads\/2021\/07\/2021-07-30-768x351.png 768w\" sizes=\"auto, (max-width: 785px) 100vw, 785px\"><\/a><\/p>\n<h2 id=\"i-7\"><span class=\"ez-toc-section\" id=\"%E5%BE%93%E6%9D%A5%E3%81%AEPCR%E6%A4%9C%E6%9F%BB%E3%81%A7%E3%81%AF%E3%82%A4%E3%83%B3%E3%83%95%E3%83%AB%E3%82%A8%E3%83%B3%E3%82%B6%E3%81%A8%E6%96%B0%E5%9E%8B%E3%82%B3%E3%83%AD%E3%83%8A%E3%81%AE%E5%8C%BA%E5%88%A5%E3%81%8C%E3%81%A4%E3%81%84%E3%81%A6%E3%81%BE%E3%81%97%E3%81%9F%E3%81%8B%EF%BC%9F%EF%BC%81\"><\/span>\u5f93\u6765\u306ePCR\u691c\u67fb\u3067\u306f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u533a\u5225\u304c\u3064\u3044\u3066\u307e\u3057\u305f\u304b\uff1f\uff01<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\u300c\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u3092\u540c\u6642\u306b\u5224\u5b9a\u3067\u304d\u308bPCR\u691c\u67fb\u304c\u3053\u308c\u304b\u3089\u63a8\u5968\u306b\u306a\u308b\u3068\u3044\u3046\u3053\u3068\u306f\u3001\u3044\u307e\u307e\u3067\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u533a\u5225\u304c\u3064\u3044\u3066\u306a\u304b\u3063\u305f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u304b\uff1f\u300d\u3068\u3044\u3046\u8cea\u554f\u3092\u3057\u3066\u304f\u308b\u65b9\u304c\u3044\u307e\u3059\u3002<\/p>\n<p>\u3044\u3044\u3048\u3002\u3053\u308c\u307e\u3067\u3082\u660e\u78ba\u306b\u533a\u5225\u306f\u3064\u3044\u3066\u307e\u3057\u305f\uff08\u5f53\u7136\uff09\u3002<\/p>\n<p>\u3053\u308c\u307e\u3067\u306f\u3001<\/p>\n<ul>\n<li>\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u307f\u3092\u5bfe\u8c61\u306b\u967d\u6027\u30fb\u9670\u6027\u3092\u5224\u5b9a\u3059\u308bPCR\u691c\u67fb<\/li>\n<li>\u65b0\u578b\u30b3\u30ed\u30ca\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3092\u540c\u6642\u306b\u533a\u5225\u3057\u3066\u5224\u5b9a\u3067\u304d\u308b\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9PCR\u691c\u67fb<\/li>\n<\/ul>\n<p>\u304c\u6df7\u5728\u3057\u3066\u4f7f\u7528\u3055\u308c\u3066\u3044\u307e\u3057\u305f\u3002\u3053\u306e\u3046\u3061\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u307f\u3092\u5bfe\u8c61\u3068\u3057\u3066\u3044\u305fPCR\u691c\u67fb\u3092\u3084\u3081\u3066\u3001\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9PCR\u691c\u67fb\u306a\u3069\u3092\u542b\u3081\u305f\u6700\u65b0\u306e\u691c\u67fb\u306b\u79fb\u884c\u3057\u3066\u3044\u304f\u3068\u3044\u3046\u3053\u3068\u3067\u3059\u3002\u305d\u3046\u3059\u308c\u3070\u691c\u67fb\u306e\u6750\u6599\u3082\u624b\u9593\u3082\u7701\u3051\u307e\u3059\u304b\u3089\u3002<\/p>\n<p>\u5f93\u6765\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u307f\u3092\u5bfe\u8c61\u3068\u3057\u305fPCR\u691c\u67fb\u3082\u3001\u30a6\u30a4\u30eb\u30b9\u306e\u907a\u4f1d\u5b50\uff08\u4eba\u9593\u306e\u6307\u7d0b\u306e\u3088\u3046\u306a\u3082\u306e\uff09\u3092\u8abf\u3079\u308b\u691c\u67fb\u306a\u306e\u3067\u3001\u5f53\u7136\u306a\u304c\u3089\u975e\u5e38\u306b\u6b63\u78ba\u3067\u3059\u3002\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u9593\u9055\u3048\u3066\u5224\u5b9a\u3059\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<h2 id=\"i-8\"><span class=\"ez-toc-section\" id=\"CDC%E3%81%8B%E3%82%89%E3%81%AE%E8%A3%9C%E8%B6%B3%E8%AA%AC%E6%98%8E\"><\/span>CDC\u304b\u3089\u306e\u88dc\u8db3\u8aac\u660e<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p>\uff12\uff10\uff12\uff11\u5e74\uff18\u6708\uff12\u65e5\u3001\u3053\u306e\u4ef6\u306b\u95a2\u3057\u3066<a href=\"https:\/\/www.cdc.gov\/csels\/dls\/locs\/2021\/08-02-2021-lab-alert-Clarifications_about_Retirement_CDC_2019_Novel_Coronavirus_1.html\" target=\"_blank\" rel=\"noopener\">CDC\u304b\u3089\u88dc\u8db3\u8aac\u660e<\/a>\u304c\u51fa\u305f\u306e\u3067\u3001\u305d\u306e\u307b\u307c\u5168\u6587\u306e\u539f\u6587\u30fb\u8a33\u6587\u3092\u63b2\u8f09\u3057\u307e\u3059\u3002<\/p>\n<p><span class=\"big\"><strong><span class=\"haiiro\">08\/02\/2021: Lab Alert: Clarifications about the Retirement of the CDC 2019 Novel Coronavirus (2019-nCov) Real-Time RT-PCR Diagnostic Panel<\/span><\/strong><\/span><br \/>\n<span class=\"big\"><strong>2021\u5e748\u67082\u65e5\uff1a\u30e9\u30dc\u30a2\u30e9\u30fc\u30c8\uff1a\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCov\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u5ec3\u6b62\u306b\u95a2\u3059\u308b\u8aac\u660e<\/strong><\/span><\/p>\n<p><span class=\"haiiro\"><strong>Why is CDC retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?<\/strong><\/span><br \/>\n<strong>CDC \u304c\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u3092\u5ec3\u6b62\u3059\u308b\u306e\u306f\u306a\u305c\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\">CDC is retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel because&nbsp;the U.S. Food and Drug Administration (FDA) has authorized hundreds of other SARS-CoV-2 diagnostic tests, many of which are now higher throughput or can test for more than one illness at a time.&nbsp;At the time CDC deployed the 2019-nCoV Real-Time RT-PCR Diagnostic Panel, there were no other FDA-authorized methods available within the United States.<\/span><br \/>\nCDC \u306f\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d\u3092\u5ec3\u6b62\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002\u306a\u305c\u306a\u3089\u3001\u73fe\u5728\u3067\u306f FDA\uff08\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff09\u304c\u4ed6\u306e\u4f55\u767e\u3082\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u8a3a\u65ad\u691c\u67fb\u3092\u627f\u8a8d\u3057\u3066\u3044\u308b\u304b\u3089\u3067\u3059\u3002\u305d\u306e\u691c\u67fb\u306e\u591a\u304f\u306f\u77ed\u6642\u9593\u306b\u5927\u91cf\u306e\u51e6\u7406\u304c\u53ef\u80fd\u3067\u3042\u308a\u3001\u307e\u305f\u306f\u3001\u4e00\u5ea6\u306b\u8907\u6570\u306e\u75c5\u6c17\u306e\u691c\u67fb\u3092\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002CDC \u304c\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d\u3092\u5c55\u958b\u3057\u305f\u5f53\u6642\u3001\u7c73\u56fd\u5185\u3067 FDA \u304b\u3089\u627f\u8a8d\u3055\u308c\u3066\u3044\u308b\u4ed6\u306e\u5229\u7528\u53ef\u80fd\u306a\u691c\u67fb\u306f\u3042\u308a\u307e\u305b\u3093\u3067\u3057\u305f\u3002<\/p>\n<p><span class=\"haiiro\">CDC began distributing the CDC 2019 Novel Coronavirus (2019-nCOV) Real-Time RT-PCR Diagnostic Panel to fill a gap. The wide availability of other SARS-CoV-2 diagnostic tests means that the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is no longer filling an unmet need. Retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel will allow CDC to focus its resources on public health surveillance testing and other response activities.<\/span><br \/>\nCDC\u306f\u3001\u9700\u8981\u3092\u6e80\u305f\u3059\u305f\u3081\u306b\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d\u306e\u914d\u5e03\u3092\u958b\u59cb\u3057\u307e\u3057\u305f\u3002\u3057\u304b\u3057\u3001\u4ed6\u306e\u591a\u304f\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u8a3a\u65ad\u691c\u67fb\u304c\u5229\u7528\u3067\u304d\u308b\u306a\u3089\u3070\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d\u306f\u3082\u306f\u3084\u9700\u8981\u3092\u6e80\u305f\u3057\u3066\u3044\u306a\u3044\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u3002\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d\u3092\u5ec3\u6b62\u3059\u308b\u3053\u3068\u3067\u3001CDC\u306f\u305d\u306e\u30ea\u30bd\u30fc\u30b9\u3092\u516c\u8846\u885b\u751f\u306e\u76e3\u8996\u691c\u67fb\u304a\u3088\u3073\u305d\u306e\u4ed6\u306e\u5bfe\u5fdc\u6d3b\u52d5\u306b\u632f\u308a\u5411\u3051\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">CDC is recommending that laboratories that routinely conduct influenza testing as well as COVID-19 testing, such as public health laboratories, consider transitioning to a test that can generate a result for both influenza and SARS-CoV-2, rather than running separate tests for each virus. The&nbsp;<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ec&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay<\/a>, one such assay available to public health laboratories, can simultaneously detect and differentiate SARS-CoV-2, Influenza A, and Influenza B with one test. It is a more resource-efficient way for public health laboratories to meet influenza and SARS-CoV-2 surveillance goals.<\/span><br \/>\n\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u691c\u67fb\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u691c\u67fb\u3092\u5b9a\u671f\u7684\u306b\u5b9f\u65bd\u3057\u3066\u3044\u308b\u7814\u7a76\u6240\uff08\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u306a\u3069\uff09\u306f\u3001\u305d\u308c\u3089\u306e\u691c\u67fb\u3092\u5225\u3005\u306b\u884c\u3046\u306e\u3067\u306f\u306a\u304f\u3001\u4e21\u65b9\u306e\u691c\u67fb\u7d50\u679c\u3092\u51fa\u529b\u3067\u304d\u308b\u691c\u67fb\u3078\u79fb\u884c\u3059\u308b\u3088\u3046 CDC \u306f\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002\u305f\u3068\u3048\u3070\u3001\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u3067\u5229\u7528\u3067\u304d\u308b\u300c<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ec&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">CDC Influenza SARS-CoV-2\uff08Flu SC2\uff09\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4<\/a>\u300d\u306f\u3001\uff11\u56de\u306e\u691c\u67fb\u3067\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff0f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6A\uff0f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6B\u3092\u540c\u6642\u306b\u691c\u51fa\u3057\u8b58\u5225\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u3067\u3053\u308c\u3092\u4f7f\u7528\u3059\u308c\u3070\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u306e\u76e3\u8996\u306b\u8cbb\u3084\u3059\u30ea\u30bd\u30fc\u30b9\u3092\u7bc0\u7d04\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><strong><span class=\"haiiro\">Does the retirement of this test apply to all RT-PCR-based tests or all SARS-CoV-2 tests that have received Emergency Use Authorization from FDA?&nbsp;<\/span><\/strong><br \/>\n<strong>\u691c\u67fb\u306e\u5ec3\u6b62\u306f\u3001\u3059\u3079\u3066\u306e RT-PCR \u30d9\u30fc\u30b9\u306e\u691c\u67fb\uff08FDA \u304b\u3089\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d7\u3051\u305f\u3059\u3079\u3066\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u691c\u67fb\uff09\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u304b\uff1f&nbsp;<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.<\/strong>&nbsp;The discontinuation of Emergency Use Authorization (EUA)&nbsp;<strong>only&nbsp;<\/strong>applies to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel test. It does&nbsp;<strong>not&nbsp;<\/strong>affect any other SARS-CoV-2 test that has received EUA from FDA.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA\uff09\u306e\u5ec3\u6b62\u306f\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u691c\u67fb\u300d<strong>\u306e\u307f<\/strong>\u306b\u9069\u7528\u3055\u308c\u307e\u3059\u3002FDA \u304b\u3089\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d7\u3051\u3066\u3044\u308b\u4ed6\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u691c\u67fb\u306b\u306f\u5f71\u97ff<strong>\u3057\u307e\u305b\u3093<\/strong>\u3002<\/p>\n<p><span class=\"haiiro\"><strong>Does the retirement of this test affect any other CDC tests for SARS-CoV-2?<\/strong><\/span><br \/>\n<strong>\u3053\u306e\u691c\u67fb\u306e\u5ec3\u6b62\u306f\u3001CDC \u306e\u4ed6\u306e\u65b0\u578b\u30b3\u30ed\u30ca\u691c\u67fb\u306b\u5f71\u97ff\u3057\u307e\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.&nbsp;<\/strong>The CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay received EUA from FDA in July 2020, and its status is not impacted by the decision to retire the CDC 2019 Novel Coronavirus Real-Time RT-PCR Diagnostic Panel. CDC and public health laboratories continue to use the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>2020\u5e747\u6708\u306bFDA\u304b\u3089\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u5f97\u305f\u300cCDC Influenza SARS-CoV-2\uff08Flu SC2\uff09\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4\u300d\u304a\u3088\u3073\u305d\u306e\u30b9\u30c6\u30fc\u30bf\u30b9\u306f\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u5ec3\u6b62\u306e\u6c7a\u5b9a\u306b\u3088\u308b\u5f71\u97ff\u3092\u53d7\u3051\u307e\u305b\u3093\u3002CDC\u304a\u3088\u3073\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u306f\u3001\u5f15\u304d\u7d9a\u304d\u300cCDC Influenza SARS-CoV-2\uff08Flu SC2\uff09\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4\u300d\u3092\u4f7f\u7528\u3057\u307e\u3059\u3002<\/p>\n<p><strong><span class=\"haiiro\">Was the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel revoked because it failed its review by FDA?<\/span><\/strong><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u3001FDA \u306e\u5be9\u67fb\u306b\u4e0d\u5408\u683c\u306b\u306a\u3063\u305f\u304b\u3089\u53d6\u308a\u6d88\u3055\u308c\u305f\u306e\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.<\/strong>&nbsp;The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel did&nbsp;<strong>not&nbsp;<\/strong>fail a full review and was&nbsp;<strong>not&nbsp;<\/strong>revoked by the FDA.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u300cCDC2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u3001\u5b8c\u5168\u306a\u5be9\u67fb\u306b\u4e0d\u5408\u683c\u306b\u306f<strong>\u306a\u3063\u3066\u304a\u3089\u305a<\/strong>\u3001FDA \u306b\u53d6\u308a\u6d88\u3055\u308c\u3066\u306f<strong>\u3044\u307e\u305b\u3093<\/strong>\u3002<\/p>\n<p><strong><span class=\"haiiro\">Is CDC retiring the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel because it has produced inaccurate results?&nbsp;<\/span><\/strong><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u304c\u4e0d\u6b63\u78ba\u306a\u7d50\u679c\u3092\u51fa\u3057\u305f\u304b\u3089\u5ec3\u6b62\u3059\u308b\u306e\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.&nbsp;<\/strong>There are no performance concerns with this test. The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel is a highly accurate test. It has been used to successfully detect SARS-CoV-2 since February 2020.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u3053\u306e\u691c\u67fb\u306b\u6027\u80fd\u4e0a\u306e\u61f8\u5ff5\u306f\u3042\u308a\u307e\u305b\u3093\u3002\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u975e\u5e38\u306b\u6b63\u78ba\u306a\u691c\u67fb\u3067\u3059\u3002\u3053\u306e\u691c\u67fb\u306b\u3088\u308a\u30012020\u5e742\u6708\u304b\u3089\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u6b63\u3057\u304f\u691c\u51fa\u3067\u304d\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">Since the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel continues to perform well, CDC will continue to make the design of the primers and probes used in the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel publicly available on the CDC website. Laboratories and test developers are free to use the design in their own research or diagnostic test.<\/span><br \/>\n\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u5f15\u304d\u7d9a\u304d\u826f\u597d\u306b\u6a5f\u80fd\u3059\u308b\u305f\u3081\u3001CDC \u306f\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u3067\u4f7f\u7528\u3055\u308c\u3066\u3044\u308b\u30d7\u30e9\u30a4\u30de\u30fc\u3068\u30d7\u30ed\u30fc\u30d6\u306e\u8a2d\u8a08\u3092 CDC \u306e Web\u30b5\u30a4\u30c8\u3067\u516c\u958b\u3057\u7d9a\u3051\u307e\u3059\u3002\u7814\u7a76\u6240\u3068\u691c\u67fb\u958b\u767a\u8005\u306f\u3001\u305d\u306e\u8a2d\u8a08\u3092\u72ec\u81ea\u306e\u7814\u7a76\u307e\u305f\u306f\u8a3a\u65ad\u691c\u67fb\u3067\u81ea\u7531\u306b\u4f7f\u7528\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">CDC will also continue to extend Right of Reference to anyone who wishes to reference the data in CDC\u2019s Emergency Use Authorization (EUA 200001) to support their own regulatory submission to FDA. The retirement of the test and the discontinuation of the associated EUA will have no impact on the availability of the design or Right of Reference. The CDC submission will remain on file at FDA<\/span>.<br \/>\nCDC \u306f\u307e\u305f\u3001\u5e0c\u671b\u3059\u308b\u3059\u3079\u3066\u306e\u4eba\u304c CDC \u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\uff08EUA 200001\uff09\u306e\u30c7\u30fc\u30bf\u3092\u53c2\u7167\u3067\u304d\u308b\u3088\u3046\u306b\u53c2\u7167\u6a29\u306e\u62e1\u5f35\u3092\u7d9a\u3051\u3001FDA \u3078\u306e\u66f8\u985e\u63d0\u51fa\u3092\u30b5\u30dd\u30fc\u30c8\u3057\u3066\u3044\u304d\u307e\u3059\u3002\u8a72\u5f53\u691c\u67fb\u306e\u5ec3\u6b62\u304a\u3088\u3073\u95a2\u9023\u3059\u308b\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u306e\u4e2d\u6b62\u306f\u3001\u8a2d\u8a08\u306e\u5229\u7528\u307e\u305f\u306f\u53c2\u7167\u6a29\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u307e\u305b\u3093\u3002CDC \u304c FDA \u306b\u63d0\u51fa\u3057\u305f\u66f8\u985e\u306f FDA \u3067\u30d5\u30a1\u30a4\u30eb\u3055\u308c\u7d9a\u3051\u307e\u3059\u3002<\/p>\n<p><strong><span class=\"haiiro\">Does the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel detect both SARS-CoV-2 (the virus that causes COVID-19)&nbsp;and&nbsp;influenza (flu)?&nbsp;<\/span><\/strong><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff08\u65b0\u578b\u30b3\u30ed\u30ca\u3092\u5f15\u304d\u8d77\u3053\u3059\u30a6\u30a4\u30eb\u30b9\uff09\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u306e\u4e21\u65b9\u3092\u691c\u51fa\u3057\u307e\u3059\u304b\uff1f&nbsp;<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.<\/strong>&nbsp;The CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel was specifically designed to&nbsp;<strong>only&nbsp;<\/strong>detect SARS-CoV-2 viral genetic material. It does not detect influenza or differentiate between influenza and SARS-CoV-2. The presence of influenza viral genetic material within a specimen will not cause a false positive result.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u907a\u4f1d\u7269\u8cea<strong>\u306e\u307f<\/strong>\u3092\u691c\u51fa\u3059\u308b\u3088\u3046\u306b\u7279\u5225\u306b\u8a2d\u8a08\u3055\u308c\u307e\u3057\u305f\u3002\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u3092\u691c\u51fa\u3059\u308b\u3053\u3068\u306f\u306a\u304f\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u533a\u5225\u3059\u308b\u3082\u306e\u3067\u3082\u3042\u308a\u307e\u305b\u3093\u3002\u691c\u4f53\u5185\u306b\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u306e\u907a\u4f1d\u7269\u8cea\u304c\u5b58\u5728\u3057\u3066\u3044\u305f\u3068\u3057\u3066\u3082\u3001\u691c\u67fb\u7d50\u679c\u304c\u507d\u967d\u6027\u306b\u306a\u308b\u3053\u3068\u306f\u3042\u308a\u307e\u305b\u3093\u3002<\/p>\n<p><span class=\"haiiro\">There are other multianalyte tests available, including the CDC Influenza SARS-CoV-2 Multiplex Assay,&nbsp; that can simultaneously detect and differentiate Influenza A, Influenza B, and SARS-CoV-2.<\/span><br \/>\n\u305d\u306e\u4ed6\u306e\u591a\u691c\u4f53\u691c\u67fb\uff08\u300cCDC \u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6 SARS-CoV-2 \u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4\u300d\u3092\u542b\u3080\uff09\u3092\u4f7f\u7528\u3059\u308c\u3070\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6A\uff0f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6B\uff0f\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u540c\u6642\u306b\u691c\u51fa\u304a\u3088\u3073\u533a\u5225\u3059\u308b\u3053\u3068\u304c\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><strong>Does the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel confuse influenza with SARS-CoV-2?<\/strong><\/span><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u6df7\u540c\u3057\u307e\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.<\/strong>&nbsp;The CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel does not confuse influenza with SARS-CoV-2. It is a highly accurate test that detects the presence or absence of SARS-CoV-2 viral genetic material within a patient specimen.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306f\u3001\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u3068\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3092\u6df7\u540c\u3057\u307e\u305b\u3093\u3002\u3053\u308c\u306f\u3001\u60a3\u8005\u306e\u691c\u4f53\u5185\u306b\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u907a\u4f1d\u7269\u8cea\u304c\u5b58\u5728\u3059\u308b\u304b\u3069\u3046\u304b\u3092\u975e\u5e38\u306b\u6b63\u78ba\u306b\u5224\u5b9a\u3067\u304d\u308b\u691c\u67fb\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><strong>Does the retirement of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time PCR Diagnostic Panel mean that the previous results from this test are invalid?<\/strong><\/span><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u5ec3\u6b62\u306f\u3001\u3053\u306e\u691c\u67fb\u306e\u4ee5\u524d\u306e\u7d50\u679c\u304c\u7121\u52b9\u3067\u3042\u308b\u3053\u3068\u3092\u610f\u5473\u3057\u307e\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>No.<\/strong>&nbsp;Results from this test are reliable, valid, and specific to SARS-CoV-2.<\/span><br \/>\n<strong>\u3044\u3044\u3048\u3002<\/strong>\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u56fa\u6709\u306e\u3053\u306e\u691c\u67fb\u306e\u7d50\u679c\u306f\u3001\u4fe1\u983c\u6027\u304c\u9ad8\u304f\u6709\u52b9\u3067\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><strong>Are RT-PCR-based tests valid for the detection of SARS-CoV-2?<\/strong><\/span><br \/>\n<strong>RT-PCR \u30d9\u30fc\u30b9\u306e\u691c\u67fb\u306f\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u306e\u691c\u51fa\u306b\u6709\u52b9\u3067\u3059\u304b\uff1f<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>Yes.<\/strong>&nbsp;RT-PCR-based tests are one type of laboratory-based&nbsp;<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ed&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">nucleic acid amplification test<\/a>&nbsp;(NAAT), which continue to be the \u201cgold standard\u201d of diagnostic testing for COVID-19. Many diagnostic tests for SARS-CoV-2 that have received EUA from FDA use RT-PCR-based tests, including both the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay.<\/span><br \/>\n<strong>\u306f\u3044\u3002<\/strong>RT-PCR \u30d9\u30fc\u30b9\u306e\u691c\u67fb\u306f\u3001\u7814\u7a76\u5ba4\u30d9\u30fc\u30b9\u306e<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ed&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">\u6838\u9178\u5897\u5e45\u691c\u67fb<\/a>\uff08NAAT\uff09\u306e\u4e00\u7a2e\u3067\u3042\u308a\u3001\u65b0\u578b\u30b3\u30ed\u30ca\u8a3a\u65ad\u691c\u67fb\u306e\u300c\u30b4\u30fc\u30eb\u30c9\u30b9\u30bf\u30f3\u30c0\u30fc\u30c9\u300d\u3067\u3042\u308a\u7d9a\u3051\u3066\u3044\u307e\u3059\u3002FDA \u304b\u3089\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d7\u3051\u305f\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u8a3a\u65ad\u691c\u67fb\u306e\u591a\u304f\u306f\u3001RT-PCR \u30d9\u30fc\u30b9\u306e\u691c\u67fb\u3092\u4f7f\u7528\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u306b\u306f\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u304a\u3088\u3073\u300cCDC Influenza SARS-CoV-2\uff08Flu SC2\uff09\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4\u300d\u3082\u542b\u307e\u308c\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><strong>What tests can laboratories and testing sites use instead of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?&nbsp;<\/strong><\/span><br \/>\n<strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u4ee3\u308f\u308a\u306b\u3001\u7814\u7a76\u6240\u3084\u691c\u67fb\u30b5\u30a4\u30c8\u3067\u4f7f\u7528\u3067\u304d\u308b\u691c\u67fb\u306f\u4f55\u3067\u3059\u304b\uff1f&nbsp;<\/strong><\/p>\n<p><span class=\"haiiro\">CDC encourages public health laboratories to adopt the CDC Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay for the simultaneous surveillance testing of both SARS-CoV-2 and influenza. The test specifies whether a patient specimen is positive for SARS-CoV-2, influenza, or both.<\/span><br \/>\n\u516c\u8846\u885b\u751f\u7814\u7a76\u6240\u304c\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u3068\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\u306e\u4e21\u65b9\u3092\u540c\u6642\u306b\u76e3\u8996\u3057\u691c\u67fb\u3059\u308b\u624b\u6bb5\u3068\u3057\u3066\u3001\u300cCDC Influenza SARS-CoV-2\uff08Flu SC2\uff09\u30de\u30eb\u30c1\u30d7\u30ec\u30c3\u30af\u30b9\u30fb\u30a2\u30c3\u30bb\u30a4\u300d\u3092\u63a1\u7528\u3059\u308b\u3088\u3046\u306b CDC \u306f\u63a8\u5968\u3057\u3066\u3044\u307e\u3059\u3002\u3053\u306e\u691c\u67fb\u3067\u306f\u3001\u60a3\u8005\u306e\u691c\u4f53\u304c\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff0f\u30a4\u30f3\u30d5\u30eb\u30a8\u30f3\u30b6\u30a6\u30a4\u30eb\u30b9\uff0f\u305d\u306e\u4e21\u65b9\u306b\u967d\u6027\u3067\u3042\u308b\u304b\u3069\u3046\u304b\u3092\u5224\u5b9a\u3067\u304d\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\">Clinical laboratories that use a SARS-CoV-2 diagnostic test based on the CDC EUA of February 2020 should&nbsp;<a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ee&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">visit the FDA website<\/a>&nbsp;for a list of authorized COVID-19 diagnostic molecular methods.<\/span><br \/>\n2020\u5e742\u6708\u306e CDC \u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u306b\u57fa\u3065\u304f\u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\u8a3a\u65ad\u691c\u67fb\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u81e8\u5e8a\u691c\u67fb\u5ba4\u306f\u3001\u8a8d\u53ef\u3055\u308c\u3066\u3044\u308b\u65b0\u578b\u30b3\u30ed\u30ca\u8a3a\u65ad\u5206\u5b50\u6cd5\u306e\u30ea\u30b9\u30c8\u306b\u3064\u3044\u3066 <a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ee&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">FDA \u306e Web \u30b5\u30a4\u30c8\u3092\u53c2\u7167<\/a>\u3059\u308b\u5fc5\u8981\u304c\u3042\u308a\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><strong>What if a laboratory or testing site is using a test with Right of Reference to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?&nbsp;<\/strong><\/span><br \/>\n<strong>\u7814\u7a76\u6240\u307e\u305f\u306f\u691c\u67fb\u30b5\u30a4\u30c8\u304c\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u3078\u306e\u53c2\u7167\u6a29\u3092\u6301\u3064\u691c\u67fb\u3092\u4f7f\u7528\u3057\u3066\u3044\u308b\u5834\u5408\u306f\u3069\u3046\u306a\u308a\u307e\u3059\u304b\uff1f&nbsp;<\/strong><\/p>\n<p><span class=\"haiiro\">Tests that use the Right of Reference to the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel and that have received their own EUA from FDA are not affected by the retirement of the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel. CDC will continue to extend Right of Reference to anyone who wishes to reference CDC\u2019s EUA for the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel in their own regulatory submission. Even after the CDC requests that the authorization for the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel be discontinued, the submission will remain on file at FDA.<\/span><br \/>\n\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u53c2\u7167\u6a29\u3092\u4f7f\u7528\u3057\u3001FDA \u304b\u3089\u72ec\u81ea\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u5f97\u3066\u3044\u308b\u691c\u67fb\u306f\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u5ec3\u6b62\u306e\u5f71\u97ff\u3092\u53d7\u3051\u307e\u305b\u3093\u3002\u66f8\u985e\u63d0\u51fa\u306e\u305f\u3081\u306b\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u306e\u53c2\u7167\u3092\u5e0c\u671b\u3059\u308b\u3059\u3079\u3066\u306e\u4eba\u306b\u5bfe\u3057\u3066\u3001CDC \u306f\u5f15\u304d\u7d9a\u304d\u53c2\u7167\u6a29\u3092\u62e1\u5927\u3057\u3066\u3044\u304d\u307e\u3059\u3002\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306e\u627f\u8a8d\u306e\u505c\u6b62\u8981\u6c42\u306e\u5f8c\u3082\u3001\u63d0\u51fa\u66f8\u985e\u306f FDA \u306b\u30d5\u30a1\u30a4\u30eb\u3055\u308c\u7d9a\u3051\u307e\u3059\u3002<\/p>\n<p><strong><span class=\"haiiro\">Can laboratories and testing sites continue to use the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel?<\/span><\/strong><br \/>\n<strong>\u7814\u7a76\u6240\u3084\u691c\u67fb\u30b5\u30a4\u30c8\u306f\u3001\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u3092\u5f15\u304d\u7d9a\u304d\u4f7f\u7528\u3067\u304d\u307e\u3059\u304b\uff1f&nbsp;<\/strong><\/p>\n<p><span class=\"haiiro\"><strong>Yes.&nbsp;<\/strong>Because there are no performance concerns with the CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, laboratories and testing sites may continue to use this test until it is retired at the end of December 2021. CDC is making this announcement now to give laboratories and testing sites time to select and shift to one of the many other FDA-authorized tests.<\/span><br \/>\n<strong>\u306f\u3044\u3002<\/strong>\u300cCDC 2019 \u65b0\u578b\u30b3\u30ed\u30ca\u30a6\u30a4\u30eb\u30b9\uff082019-nCoV\uff09\u30ea\u30a2\u30eb\u30bf\u30a4\u30e0 RT-PCR \u8a3a\u65ad\u30d1\u30cd\u30eb\u300d\u306b\u306f\u6027\u80fd\u4e0a\u306e\u61f8\u5ff5\u304c\u306a\u3044\u305f\u3081\u3001\u7814\u7a76\u6240\u304a\u3088\u3073\u691c\u67fb\u30b5\u30a4\u30c8\u306f\u30012021\u5e7412\u6708\u672b\u306b\u5ec3\u6b62\u3055\u308c\u308b\u307e\u3067\u3001\u3053\u306e\u691c\u67fb\u3092\u5f15\u304d\u7d9a\u304d\u4f7f\u7528\u3067\u304d\u307e\u3059\u3002\u7814\u7a76\u6240\u3068\u691c\u67fb\u30b5\u30a4\u30c8\u306b\u5bfe\u3057\u3066\u3001FDA \u304b\u3089\u8a8d\u53ef\u3055\u308c\u305f\u4ed6\u306e\u591a\u304f\u306e\u691c\u67fb\u306e\u3044\u305a\u308c\u304b\u3092\u9078\u629e\u3057\u3066\u79fb\u884c\u3059\u308b\u7336\u4e88\u3092\u4e0e\u3048\u308b\u305f\u3081\u306b\u3001CDC \u306f\u3053\u306e\u767a\u8868\u3092\u884c\u3063\u3066\u3044\u307e\u3059\u3002<\/p>\n<p><span class=\"haiiro\"><a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ef&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">Opt in to receive updates from the CDC Laboratory Outreach Communication System (LOCS)<\/a>.<br \/>\n<\/span><a href=\"https:\/\/t.emailupdates.cdc.gov\/r\/?id=h4d2caa86,148df7fd,148e54ef&amp;ACSTrackingID=USCDC_2146-DM62994&amp;ACSTrackingLabel=Lab%20Alert%3A%20Clarifications%20about%20the%20Retirement%20of%20the%20CDC%202019%20Novel%20Coronavirus%20(2019-nCov)%20Real-Time%20RT-PCR%20Diagnostic%20Panel\" target=\"_blank\" rel=\"noopener\">LOCS\uff08CDC \u3068\u7814\u7a76\u6240\u306e\u305f\u3081\u306e\u30b3\u30df\u30e5\u30cb\u30b1\u30fc\u30b7\u30e7\u30f3\u30b7\u30b9\u30c6\u30e0\uff09\u304b\u3089\u30a2\u30c3\u30d7\u30c7\u30fc\u30c8\u3092\u53d7\u3051\u308b\u305f\u3081\u306e\u30aa\u30d7\u30c8\u30a4\u30f3<\/a><\/p>\n<h2 id=\"i-9\"><span class=\"ez-toc-section\" id=\"%E3%81%9D%E3%81%AE%E4%BB%96%E3%81%AE%E5%8F%82%E8%80%83%E8%A8%98%E4%BA%8B\"><\/span>\u305d\u306e\u4ed6\u306e\u53c2\u8003\u8a18\u4e8b<span class=\"ez-toc-section-end\"><\/span><\/h2>\n<h3 id=\"i-10\"><span class=\"ez-toc-section\" id=\"%E3%80%8CCDC%E3%81%8CPCR%E6%A4%9C%E6%9F%BB%E5%8F%96%E3%82%8A%E3%82%84%E3%82%81%E3%82%92%E7%99%BA%E8%A1%A8%E3%80%8D%E3%81%AF%E3%83%87%E3%83%9E%EF%BC%88%E4%BC%8A%E8%B3%80%E6%B2%BB%E6%B0%8F%E3%83%8E%E3%83%BC%E3%83%88%EF%BC%89\"><\/span>\u300cCDC\u304cPCR\u691c\u67fb\u53d6\u308a\u3084\u3081\u3092\u767a\u8868\u300d\u306f\u30c7\u30de\uff08\u4f0a\u8cc0\u6cbb\u6c0f\u30ce\u30fc\u30c8\uff09<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a href=\"https:\/\/note.com\/osamu_iga\/n\/naee903ea32bc\" target=\"_blank\" rel=\"noopener\">https:\/\/note.com\/osamu_iga\/n\/naee903ea32bc<\/a><\/p>\n<h3 id=\"i-11\"><span class=\"ez-toc-section\" id=\"AP%E3%83%95%E3%82%A1%E3%82%AF%E3%83%88%E3%83%81%E3%82%A7%E3%83%83%E3%82%AF\"><\/span>AP\u30d5\u30a1\u30af\u30c8\u30c1\u30a7\u30c3\u30af<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p><a href=\"https:\/\/apnews.com\/article\/fact-checking-436833075130?utm_medium=APFactCheck&amp;utm_campaign=SocialFlow&amp;utm_source=Twitter\" target=\"_blank\" rel=\"noopener\">CDC encourages use of new tests that detect both COVID-19 and the flu<\/a><\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u30c7\u30de\u306e\u5185\u5bb9 \u300c2021\u5e747\u670821\u65e5\u3001CDC\u306fPCR\u691c\u67fb\u304c\u4fe1\u983c\u3067\u304d\u306a\u3044\u3053\u3068\u3092\u8a8d\u3081\u3001PCR\u691c\u67fb\u306e\u7dca\u6025\u4f7f\u7528\u8a31\u53ef\u3092\u53d6\u308a\u6d88\u3059\u3053\u3068\u306b\u6c7a\u3081\u305f\u300d\u3068\u4e3b\u5f35\u3059\u308b\u4eba\u304c\u3044\u307e\u3059\u304c\u3001\u30c7\u30de\u3067\u3059\u3002 https:\/\/twitter.com\/lkj_hgf_ &#8230; <\/p>\n","protected":false},"author":2,"featured_media":6328,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[4,11,5],"tags":[],"class_list":{"0":"post-6317","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-covid-19","8":"category-pcr","9":"category-5","10":"entry"},"_links":{"self":[{"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/posts\/6317","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=6317"}],"version-history":[{"count":3,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/posts\/6317\/revisions"}],"predecessor-version":[{"id":6876,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/posts\/6317\/revisions\/6876"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=\/wp\/v2\/media\/6328"}],"wp:attachment":[{"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=6317"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=6317"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.hoe2021.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=6317"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}