{"id":2457780,"date":"2020-04-28T14:24:01","date_gmt":"2020-04-28T20:24:01","guid":{"rendered":"https:\/\/www.aspentimes.com\/news\/antibody-test-use-not-fda-approved\/"},"modified":"2020-04-28T14:24:01","modified_gmt":"2020-04-28T20:24:01","slug":"antibody-test-use-not-fda-approved","status":"publish","type":"post","link":"https:\/\/alwaysmountaintime.com\/kspn\/local-news\/antibody-test-use-not-fda-approved\/","title":{"rendered":"Antibody test use not FDA approved"},"content":{"rendered":"<figure class=\"wp-block-image p402_hide\">\n<div class=\"caption-container\"> <img loading=\"lazy\" decoding=\"async\" width=\"960\" height=\"720\" src=\"https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/04\/coronatestpitkin.jpg\" class=\"attachment-large size-large wp-post-image\" alt srcset=\"https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/04\/coronatestpitkin.jpg 960w, https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/04\/coronatestpitkin-300x225.jpg 300w, https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/04\/coronatestpitkin-768x576.jpg 768w\" sizes=\"auto, (max-width: 960px) 100vw, 960px\"><figcaption><strong>Pitkin County has 1,000 COVID-19 antibody tests from a Denver-based company.<\/strong><br \/><em>Courtesy Pitkin County<\/em><\/figcaption><\/div>\n<\/figure>\n<p class=\"STND-STND BodyText\">After dancing around the question for days, Pitkin County officials finally provided an answer Tuesday as to exactly why they won\u2019t use 1,000 COVID-19 antibody tests they received earlier this month.<\/p>\n<p class=\"STND-STND BodyText\">When Aytu Bioscience of Englewood first received emergency authorization from the Food and Drug Administration to distribute the tests last month, Pitkin County was one of the first in line to get them.<\/p>\n<p class=\"STND-STND BodyText\">But what they didn\u2019t know in those \u201cfast-moving, early days\u201d of the virus pandemic here was that while Aytu had received approval to distribute the tests, the company hadn\u2019t been granted authorization for their use, Pitkin County Manager Jon Peacock said Tuesday during a morning meeting of the county Board of Health.<\/p>\n<p class=\"STND-STND BodyText\">\u201cWe had the best information we could at the time,\u201d Peacock said. \u201cBut as more information came out \u2026 we thought it best to hold off until we got more clarity from the FDA \u2026\u201d<\/p>\n<div class=\"row\">\n<div class=\"col\" readability=\"6\">\n<div class=\"row at-donation at-donation-mobile p-0\" readability=\"7\">\n<div class=\"col-xl-4 p-2\">\n<div data-bg=\"url(https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/03\/AT-logo-white.png)\" class=\"p-0 mt-2 mb-2 h-75 text-center rocket-lazyload\"><img decoding=\"async\" src=\"https:\/\/cdn.aspentimes.com\/wp-content\/uploads\/sites\/5\/2020\/03\/AT-logo-white.png\" class=\"logo m-0 p-0 invisible\"><\/div>\n<\/div>\n<p><h3 class=\"d-inline mr-3\">Support Local Journalism<\/h3>\n<p><button class=\"btn d-inline\" type=\"button\" onclick=\"handleDonationButtonClickMidArticle()\">Donate<\/button><\/p>\n<\/div>\n<p><\/div>\n<\/div>\n<p class=\"STND-STND BodyText\">Pitkin County paid $25,000 for the 1,000 tests, or $25 per test, he said.<\/p>\n<p class=\"STND-STND BodyText\">The main issue is the accuracy of the test, which checks for the presence of antibodies produced by the body to fight COVID-19. That would indicate whether the person has had the disease, as opposed to another, widely used test that determines if a person is currently sick with the virus.<\/p>\n<p class=\"STND-STND BodyText\">Dr. Kimberly Levin, Pitkin County\u2019s medical officer and an emergency room doctor at Aspen Valley Hospital, said Tuesday that antibody tests tend to have a high rate of so-called \u201cfalse positives\u201d that can be between 30% and 40%.<\/p>\n<p class=\"STND-STND BodyText\">So that means someone who tests positive for the virus and returns to work thinking they no longer have to practice the social distancing techniques stressed over the past six weeks can be dangerous, she said.<\/p>\n<p class=\"STND-STND BodyText\">\u201cThat positive result is really a dangerous result,\u201d Levin said. \u201cIt could create a lot of danger in our community.\u201d<\/p>\n<p class=\"STND-STND BodyText\">The other issue is immunity, said Levin and Dr. Steve Ayers, the county\u2019s coroner and another AVH emergency room physician. Doctors and scientists don\u2019t know enough about what kind of immunity, if any, having COVID-19 provides, which further compromises the information gained from antibody testing, they said.<\/p>\n<p class=\"STND-STND BodyText\">\u201cIs it a week?\u201d Levin said of immunity. \u201cIs it for life? We have no idea.\u201d<\/p>\n<p class=\"STND-STND BodyText\">Ayers said two questions make antibody testing \u201cworthless\u201d at this point.<\/p>\n<p class=\"STND-STND BodyText\">\u201cIt\u2019s why I think it\u2019s not a valuable test,\u201d he said. \u201cAre you immune? Don\u2019t know. Did you actively have (COVID-19)? Unsure.\u201d<\/p>\n<p class=\"STND-STND BodyText\">Levin put the question of receiving a positive result from an antibody test another way.<\/p>\n<p class=\"STND-STND BodyText\">\u201cWhat do you do with that information?\u201d she asked. \u201cThere\u2019s no value in guiding the person in their behavior.\u201d<\/p>\n<p class=\"STND-STND BodyText\">The only possible current use Levin said she could envision was running a batch of the tests on residents for whatever beneficial epidemiological information could be gleaned from the results, but not providing the specific results to residents.<\/p>\n<p class=\"STND-STND BodyText\">\u201c\u2026 (That) is the only benefit I can think of,\u201d she said. \u201cIt does not have any value in terms of what they result is.\u201d<\/p>\n<p class=\"STND-STND BodyText\">Current antibody tests get hung up on other coronaviruses, of which there are many including the common flu, Ayers said.<\/p>\n<p class=\"STND-STND BodyText\">That\u2019s why everyone from county leaders including Peacock and Sheriff Joe DiSalvo to doctors like Levin and Ayers to leaders of the local team responding to the virus outbreak like Public Health Director Karen Koenemann have strongly advocated another kind of widespread community testing.<\/p>\n<p class=\"STND-STND BodyText\">That procedure \u2014 called a PCR test \u2014 uses a nasal swab and subsequent lab test to determine if a person is actively sick with COVID-19. It is the basis of a new Pitkin County strategy that began Friday in which everyone in the county with even mild symptoms of the virus will be tested, quarantined then isolated and monitored if they test positive.<\/p>\n<p class=\"STND-STND BodyText\">In addition, the county has added staff to trace the contacts of everyone who tests positive for COVID-19, then quarantine them as well.<\/p>\n<p class=\"STND-STND BodyText\">Since Friday, officials have tested 18 people, though the results are still pending, Koenemann said Tuesday morning.<\/p>\n<p class=\"STND-STND BodyText\">Public health officials announced Friday that they were pivoting away from the previously announced antibody testing strategy to the PCR testing. At the time, despite numerous questions from The Times about why the antibody tests were not being used, those officials did not expressly provide the reason given Tuesday.<\/p>\n<p class=\"STND-STND BodyText\">The Aytu antibody tests could be used in the future if the FDA approves it, Peacock said.<\/p>\n<p class=\"STND-STND BodyText\"><a href=\"mailto:jauslander@aspentimes.com\">jauslander@aspentimes.com<\/a><\/p>\n<p><a href=\"https:\/\/www.aspentimes.com\/news\/antibody-test-use-not-fda-approved\/\" target=\"_blank\" rel=\"noopener noreferrer\">via:: The Aspen Times<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pitkin County has 1,000 COVID-19 antibody tests from a Denver-based company.Courtesy Pitkin County After dancing around the question for days, Pitkin County officials finally provided an answer Tuesday as to exactly why they won\u2019t use 1,000 COVID-19 antibody tests they received earlier this month. When Aytu Bioscience of Englewood first received emergency authorization from the [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[49],"tags":[],"class_list":["post-2457780","post","type-post","status-publish","format-standard","category-local-news"],"acf":[],"publishpress_future_action":{"enabled":false,"date":"2026-08-17 22:11:21","action":"change-status","newStatus":"draft","terms":[],"taxonomy":"category","extraData":[]},"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"distributor_meta":false,"distributor_terms":false,"distributor_media":false,"distributor_original_site_name":"KSPN The Valley&#039;s Quality Rock","distributor_original_site_url":"https:\/\/alwaysmountaintime.com\/kspn","push-errors":false,"_links":{"self":[{"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/posts\/2457780","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/comments?post=2457780"}],"version-history":[{"count":0,"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/posts\/2457780\/revisions"}],"wp:attachment":[{"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/media?parent=2457780"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/categories?post=2457780"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/alwaysmountaintime.com\/kspn\/wp-json\/wp\/v2\/tags?post=2457780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}