Skip to main content
Subscribe
  • Sign Up Free
  • Login
  • Subscribe
  • News
    • Current News
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • Digital Health
    • Transformation
    • ESG
    • People
    • Regional News
    • Digital Edition (Web Version)
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Midwest
    • Northeast
    • South
    • West
  • Blogs
    • AI
    • Deals
    • Layoff Tracker
    • HIMSS 2023
  • Opinion
    • Breaking Bias
    • Commentaries
    • Letters
    • From the Editor
  • Events & Awards
    • Awards
    • Conferences
    • Galas
    • Virtual Briefings
    • Webinars
    • Nominate/Eligibility
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • 40 Under 40
    • Best Places to Work in Healthcare
    • Excellence in Governance
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top Innovators
    • Diversity in Healthcare
      • - Luminaries
      • - Top 25 Diversity Leaders
      • - Leaders to Watch
    • Women in Healthcare
      • - Luminaries
      • - Top 25 Women Leaders
      • - Women to Watch
    • Digital Health Transformation Summit
    • ESG: The Implementation Imperative Summit
    • Leadership Symposium
    • Social Determinants of Health Symposium
    • Women Leaders in Healthcare Conference
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Diversity Leaders Gala
    • Top 25 Women Leaders Gala
    • - Hospital of the Future
    • - Value Based Care
    • - Hospital at Home
    • - Workplace of the Future
    • - AI and Digital Health
    • - Future of Staffing
    • - Hospital of the Future (Fall)
  • Multimedia
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Sponsored Video Series - One on One
    • Sponsored Video Series - Checking In with Dan Peres
  • Data & Insights
    • Data & Insights Home
    • Hospital Financials
    • Staffing & Compensation
    • Quality & Safety
    • Mergers & Acquisitions
    • Data Archive
    • Resource Guide: By the Numbers
    • Surveys
    • Data Points
  • Newsletters
  • MORE+
    • Contact Us
    • Advertise
    • Media Kit
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Politics & Policy
March 05, 2020 06:49 PM

Nation's labs await virus-testing kits promised by administration

Modern Healthcare
  • Tweet
  • Share
  • Share
  • Email
  • More
    Reprints Print

    Trump administration officials doubled down on their promise to deliver 1 million tests for the coronavirus this week as states reported limited testing supplies and federal lawmakers expressed doubts about the government's timeline.

    Health and Human Services Secretary Alex Azar told reporters Thursday that a private manufacturer authorized to make the tests expects to ship the kits to U.S. laboratories by week's end. That amounts to the capacity to test roughly 400,000 people, given that it takes multiple test samples to a confirm a result.

    The number of U.S. cases has grown rapidly in the last several days after more labs started testing and guidelines for eligibility were expanded. The U.S. tally stood at about 200 cases on Thursday, including 12 deaths — 11 in Washington state and one in California.

    The test kits from Iowa-based Integrated DNA Technologies are one part of the government's effort to ramp up testing. But the U.S. has trailed other countries in rolling out tests, because of problems with its test kits and because the Centers for Disease Control and Prevention initially limited the number of eligible people.

    U.S. senators who were briefed on the plan said it could take days or weeks before thousands of medical personnel are trained to run the tests.

    Washington state already has "a huge demand" for testing, Dr. Kathy Lofy, state health officer, said Wednesday at news conference in Seattle. She said lots of people who are sick want to know whether they have the virus.

    The state lab planned to ramp up its testing capacity over the next several days. Commercial labs have been urged to start testing too.

    The Washington lab is one of about 70 state, city and county testing facilities that are already using the CDC kit, with an expected capacity to test 75,000 people by the end of the week. Azar acknowledged issues with the test's availability.

    "Right now, it is a challenge," Azar said. "If you are a doctor and wanting to get someone tested, you need to reach out to your public health lab."

    The third part of the government strategy involves spurring private testing companies, such as Quest Diagnostics and LabCorp, to run and develop their own tests. The U.S. Food and Drug Administration granted those companies permission to begin developing and using those tests on patients last weekend. Companies can then seek FDA authorization after the fact, submitting details of their test within 15 days. An agency spokeswoman said four testing companies have contacted the agency under the policy.

    Quest, one of the nation's largest lab networks, said it will begin processing tests for coronavirus on Monday at a laboratory in California.

    As concerns about the lack of testing capacity have grown, Trump administration officials have repeatedly suggested that policies put in place during the Obama presidency slowed the authorization for private labs run by companies, universities and hospitals. But a former senior FDA official rejected that claim.

    "The law gives the agency the ability to tailor its response in an emergency, which is what we did and is what FDA should be doing now," said Dr. Joshua Sharfstein, an FDA official during the Obama administration who is now a vice dean at the Johns Hopkins-Bloomberg School of Public Health.

    Traditionally, the FDA has not regulated tests developed by private labs. During the Obama administration, some public health experts expressed concerns about the lack of oversight of genetic tests for high-risk diseases and conditions. The agency drafted a proposal to oversee some of those tests, but it was never implemented. And it did not apply to the agency's powers during public health emergencies.

    For weeks, Sharfstein noted, the only coronavirus test authorized by the FDA was the one developed by the CDC, which had limited availability and accuracy problems. In retrospect, he said, FDA officials could have used their powers to authorize private tests earlier.

    "I think one of the challenges they underappreciated was how quickly this virus would spread," Sharfstein said. "So they went small, instead of big."

    In early February, the FDA authorized the CDC to send the test kits out. But before they were put into use, officials in most states said the kits proved to be faulty, providing inconclusive results to samples that should have tested positive.

    The problem was blamed on one of three reagents used in the testing, but CDC officials have not provided details.

    Whatever the reason for the problem, only about a half dozen state and local public health labs had fully functional kits as of early last week. By late last week, the CDC said labs could proceed with testing using just two of the reagents. As of Thursday, state and local labs were able to do tests in 44 states, according to the Association of Public Health Laboratories.

    That will be a small part of the total testing that should be coming online, officials said.

    Since January, the CDC has been testing specimens at agency labs in Atlanta. As of Wednesday, 1,526 patients had been tested at the CDC, the agency reported.

    For a time, testing was limited, in part because CDC guidelines said it should be focused on travelers who had been to mainland China or to patients who had been in close contact with infected people. Last week, the CDC changed its criteria, saying it's also appropriate to test a patient if flu and other respiratory illnesses have been ruled out and no source of exposure has been identified.

    Letter
    to the
    Editor

    Send us a letter

    Have an opinion about this story? Click here to submit a Letter to the Editor, and we may publish it in print.

    Recommended for You
    mccarthy healthcare 1.png
    Hospital, health program cuts delayed under stopgap spending deal
    1920_masks-2_i.jpg
    New bill seeks safe staffing standards for Ohio nurses
    Most Popular
    1
    Centene to lay off 2,000 workers
    2
    How health systems are battling price-gouging allegations
    3
    Senate advances bill to temporarily aid hospitals, health centers
    4
    Elevance, Blue Cross Louisiana halt $2.5B proposed deal
    5
    Tower Health to sell urgent care centers, close others
    Sponsored Content
    Modern Healthcare Alert: Sign up for this breaking news email to be kept in the loop as urgent healthcare business news unfolds.
    Get Newsletters

    Sign up for enewsletters and alerts to receive breaking news and in-depth coverage of healthcare events and trends, as they happen, right to your inbox.

    Subscribe Today
    MH Magazine Cover

    MH magazine offers content that sheds light on healthcare leaders’ complex choices and touch points—from strategy, governance, leadership development and finance to operations, clinical care, and marketing.

    Subscribe
    Connect with Us
    • LinkedIn
    • Twitter
    • Facebook
    • RSS

    Our Mission

    Modern Healthcare empowers industry leaders to succeed by providing unbiased reporting of the news, insights, analysis and data.

    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Help Center
    • Advertise with Us
    • Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2023. Crain Communications, Inc. All Rights Reserved.
    • News
      • Current News
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • Digital Health
      • Transformation
        • Patients
        • Operations
        • Care Delivery
        • Payment
      • ESG
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition (Web Version)
    • Blogs
      • AI
      • Deals
      • Layoff Tracker
      • HIMSS 2023
    • Opinion
      • Breaking Bias
      • Commentaries
      • Letters
      • From the Editor
    • Events & Awards
      • Awards
        • Nominate/Eligibility
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • 40 Under 40
        • Best Places to Work in Healthcare
        • Excellence in Governance
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top Innovators
        • Diversity in Healthcare
          • - Luminaries
          • - Top 25 Diversity Leaders
          • - Leaders to Watch
        • Women in Healthcare
          • - Luminaries
          • - Top 25 Women Leaders
          • - Women to Watch
      • Conferences
        • Digital Health Transformation Summit
        • ESG: The Implementation Imperative Summit
        • Leadership Symposium
        • Social Determinants of Health Symposium
        • Women Leaders in Healthcare Conference
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Diversity Leaders Gala
        • Top 25 Women Leaders Gala
      • Virtual Briefings
        • - Hospital of the Future
        • - Value Based Care
        • - Hospital at Home
        • - Workplace of the Future
        • - AI and Digital Health
        • - Future of Staffing
        • - Hospital of the Future (Fall)
      • Webinars
    • Multimedia
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Sponsored Video Series - One on One
      • Sponsored Video Series - Checking In with Dan Peres
    • Data & Insights
      • Data & Insights Home
      • Hospital Financials
      • Staffing & Compensation
      • Quality & Safety
      • Mergers & Acquisitions
      • Data Archive
      • Resource Guide: By the Numbers
      • Surveys
      • Data Points
    • Newsletters
    • MORE+
      • Contact Us
      • Advertise
      • Media Kit
      • Jobs
      • People on the Move
      • Reprints & Licensing