Shortage of COVID-19 sample collection tools will be short-lived, suppliers say
Skip to main content
MDHC_Logotype_white
Subscribe
  • My Account
  • Login
  • Subscribe
  • News
    • This Week's News
    • COVID-19
    • Providers
    • Insurance
    • Government
    • Finance
    • Technology
    • Safety & Quality
    • People
    • Regional News
    • Digital Edition
    • Billing, antitrust exemption changes upend negotiations between insurers and providers
      Few nursing home residents have received second COVID-19 vaccine dose
      Fresenius building renal genomic registry to inform precision care for kidney disease
      clinic_2.jpg
      Cleveland Clinic project expected to create 1,000 R&D jobs, lands state tax credits
    • Few nursing home residents have received second COVID-19 vaccine dose
      The missing piece in our fight against COVID-19: primary care
      Google to convert office space for COVID-19 vax clinics
      The Check Up: Dr. Joseph Kerschner
      The Check Up: Dr. Joseph Kerschner of the Medical College of Wisconsin
    • Ascension’s St. Mary’s Hospital Surgery Center at Towne Centre and Allegheny Health Network’s Bethel Park surgery center
      Hospitals see opportunity, risk in ambulatory surgery centers
      Health suffers as rural hospitals close
      Medicare ACO participants fell in 2021
      Louisiana gets reports vaccine providers are discriminating
    • Billing, antitrust exemption changes upend negotiations between insurers and providers
      MAIN-Health Bill_iStock_i.jpg
      Insurance-tech firm MultiPlan makes $155M buy after blank-check deal
      Last-minute COVID costs cut into UnitedHealthcare's $396 million operating income
      CMS approves rule forcing insurers to ease prior authorization
    • It's a secret: California keeps key virus data from public
      lacewell_linda_supertinendent_dept_of_financial_services_8.47.jpg
      New York state investigates drug price spikes during pandemic
      Health experts blame rapid expansion for vaccine shortages
      HHS freezes rule targeting community health centers' drug discounts
    • KPMG says deal activity will stay high in '21: 10 takeaways
      By the Numbers: 20 largest healthcare investment banks in 2020
      Providers await new HHS coronavirus grant reporting deadline
      Operation Warp Speed Dr. Moncef Slaoui, Pfizer Group President Angela Hwang, Moderna CEO Stephane Bancel, CVS Health Executive Vice President Karen Lynch and McKesson CEO Brian Tyler participate in a panel discussion on the COVID-19 vaccine.
      Hospitals, drug companies strive to stand out virtually at JPM
    • Google to convert office space for COVID-19 vax clinics
      Dr. Karen DeSalvo
      Next Up Podcast: What to expect with telehealth and healthcare technology in the next four years
      Next Up Podcast: What to expect with telehealth and healthcare technology in the next 4 years - Transcript
      A man in a room with servers.
      Momentum grows to outsource hospital tech functions in 2021
    • China pushes conspiracy theories on COVID origin, vaccines
      An older man wearing a mask receiving a vaccine.
      Want more diversity in clinical trials? Start with the researchers
      Avocado
      Avocado a day keeps the doctor away
      50% of Americans make resolutions. Fewer than 27% keep them over time.
      Data Points: Sticking with your resolutions
    • WEb_i.jpg
      Q&A: Dr. Cliff Megerian, University Hospitals' soon-to-be CEO
      ZentyWeb_i.jpg
      Tom Zenty is leaving a legacy of transformational growth at University Hospitals
      Cerner names Erceg as new CFO
      Elizabeth Richter will serve as acting CMS administrator
    • Midwest
    • Northeast
    • South
    • West
  • Insights
    • ACA 10 Years After
    • Best Practices
    • InDepth Special Reports
    • Innovations
    • The Affordable Care Act after 10 years
    • New care model helps primary-care practices treat obesity
      doctor with patient
      COVID-19 treatment protocol developed in the field helps patients recover
      Rachel Wyatt
      Project to curb pressure injuries in hospitals shows promise
      Yale New Haven's COVID-19 nurse-staffing model has long-term benefits
    • Modern Healthcare InDepth: Breaking the bias that impedes better healthcare
      Videos: Healthcare industry executives describe their encounters with racism
      Michellene Davis
      Healthcare leadership lacks the racial diversity needed to reduce health disparities
      Dr. James Hildreth
      How medical education can help fight racism
      Quotes from rebadged employees
      Outsourcing IT, revenue cycle takes toll on internal culture
    • A phone screen showing the question, "Mary we hope this information was helpful and we'd like to keep guiding you. Are you interested in knowing when it's your turn to receive the vaccine?"
      Chatbots, texting campaigns help manage influx of COVID vax questions
      A woman with a wearable sensor talking to her provider.
      Wearable sensors help diagnose heart rhythm problems in West Virginia
      self service station
      COVID-19 pushes patient expectations toward self-service
      Targeting high-risk cancer patients with genetics
  • Transformation
    • Patients
    • Operations
    • Care Delivery
    • Payment
    • Highmark Health inks six-year cloud, tech deal with Google
      Study: 1 in 5 patients report discrimination when getting healthcare
      HHS proposes changing HIPAA privacy rules
      Android health records app launches at 230 health systems
    • California hospitals prepare ethical protocol to prioritize lifesaving care
      Amazon, JPMorgan Chase, Berkshire Hathaway disband Haven
      Digital pathways poised to reshape healthcare continuum in 2021
      Healthcare was the hardest hit by supply shortages across all U.S. industries
    • A phone screen showing the question, "Mary we hope this information was helpful and we'd like to keep guiding you. Are you interested in knowing when it's your turn to receive the vaccine?"
      Chatbots, texting campaigns help manage influx of COVID vax questions
      A woman with a wearable sensor talking to her provider.
      Wearable sensors help diagnose heart rhythm problems in West Virginia
      New care model helps primary-care practices treat obesity
      How hospitals are building on COVID-19 telehealth momentum
    • Regional insurers bet big on virtual-first plans
      MedPAC votes to boost hospital payments, freeze or cut other providers
      Most Next Gen ACOs achieved bonuses in 2019
      Congress recalibrates Medicare Physician Fee Schedule after lobbying
  • Data/Lists
    • Rankings/Lists
    • Interactive Databases
    • Data Points
    • Health Systems Financials
      Executive Compensation
      Physician Compensation
  • Op-Ed
    • Bold Moves
    • Breaking Bias
    • Commentaries
    • Letters
    • Vital Signs Blog
    • From the Editor
    • Wellstar CEO calls adapting for the pandemic her bold move
      Howard P. Kern
      Recognizing the value of telehealth in its infancy
      Dr. Stephen Markovich
      A bold move helped take him from family doctor to OhioHealth CEO
      Dr. Bruce Siegel
      Why taking a hospital not-for-profit was Dr. Bruce Siegel’s boldest move
    • Barry Ostrowsky
      Ending racism is a journey taken together; the starting point must be now
      Laura Lee Hall and Gary Puckrein
      Increased flu vaccination has never been more important for communities of color
      John Daniels Jr.
      Health equity: Making the journey from buzzword to reality
      Mark C. Clement and David Cook
      We all need to 'do something' to fight inequities and get healthcare right, for every patient, every time
    • The missing piece in our fight against COVID-19: primary care
      Ambulatory surgery centers offer extraordinary value in a high-cost healthcare system
       Alan B. Miller
      Looking ahead with optimism as we continue to transform healthcare
      Dr. Bruce Siegel
      By protecting the healthcare safety net, Biden can put us on the path to a stronger country
    • Letters: Eliminating bias in healthcare needs to be ‘deliberate and organic’
      Letters: Maybe dropping out of ACOs is a good thing for patients
      Letters: White House and Congress share blame for lack of national COVID strategy
      Letters: VA making strides to improve state veterans home inspections
    • Sponsored Content Provided By Optum
      How blockchain could ease frustration with the payment process
      Sponsored Content Provided By Optum
      Three steps to better data-sharing for payer and provider CIOs
      Sponsored Content Provided By Optum
      Reduce total cost of care: 6 reasons why providers and payers should tackle the challenge together
      Sponsored Content Provided By Optum
      Why CIOs went from back-office operators to mission-critical innovators
  • Awards
    • Award Programs
    • Nominate
    • Previous Award Programs
    • Other Award Programs
    • Best Places to Work in Healthcare Logo for Navigation
      Nominations Open - Best Places to Work in Healthcare
      Nominations Open - Health Care Hall of Fame
      Nominations Open - 50 Most Influential Clinical Executives
    • 100 Most Influential People
    • 50 Most Influential Clinical Executives
    • Best Places to Work in Healthcare
    • Health Care Hall of Fame
    • Healthcare Marketing Impact Awards
    • Top 25 Emerging Leaders
    • Top 25 Innovators
    • Top 25 Minority Leaders
    • Top 25 Women Leaders
    • Excellence in Nursing Awards
    • Design Awards
    • Top 25 COOs in Healthcare
    • 100 Top Hospitals
    • ACHE Awards
  • Events
    • Conferences
    • Galas
    • Webinars
    • COVID-19 Event Tracker
    • bright.md logo lockup webinar
      Sponsored Content Provided By Bright.md
      Webinar: Enabling a hybrid care model — Streamlining the patient path to both telehealth and in-person care
    • Leadership Symposium
    • Healthcare Transformation Summit
    • Women Leaders in Healthcare Conference
    • Workplace of the Future Conference
    • Strategic Marketing Conference
    • Social Determinants of Health Symposium
    • Best Places to Work Awards Gala
    • Health Care Hall of Fame Gala
    • Top 25 Minority Leaders Gala (2022)
    • Top 25 Women Leaders Gala
  • Listen
    • Podcast - Next Up
    • Podcast - Beyond the Byline
    • Sponsored Podcast - Healthcare Insider
    • Video Series - The Check Up
    • Sponsored Video Series - One on One
    • Dr. Karen DeSalvo
      Next Up Podcast: What to expect with telehealth and healthcare technology in the next four years
      Carter Dredge
      Next Up Podcast: Ready, set, innovate! Innovation and disruption in healthcare
      Next Up Podcast: COVID-19, social determinants highlight health inequities — what next?
      Ceci Connolly
      Next Up Podcast: How to navigate the murky post-election waters
    • Beyond the Byline: Regulators aim to boost value push with fraud and abuse law updates
      An older man wearing a mask receiving a vaccine.
      Beyond the Byline: Verifying information on the chaotic COVID-19 vaccine rollout
      doctor burnout
      Beyond the Byline: How healthcare supply chain struggles contribute to employee burnout
      Beyond the Byline: Covering race and diversity in the healthcare industry
    • Leading intention promote diversity and inclusion
      Introducing Healthcare Insider Podcast
    • The Check Up: Dr. Joseph Kerschner
      The Check Up: Dr. Joseph Kerschner of the Medical College of Wisconsin
      The Check Up: Chip Kahn
      The Check Up: Chip Kahn of the Federation of American Hospitals
      The Check Up: Trenda Ray
      The Check Up: Trenda Ray of the University of Arkansas for Medical Sciences
      The Check Up: Dr. Kenneth Davis
      The Check Up: Dr. Kenneth Davis of Mount Sinai Health System
    • Video: Ivana Naeymi Rad of Intelligent Medical Objects
  • MORE +
    • Advertise
    • Media Kit
    • Newsletters
    • Jobs
    • People on the Move
    • Reprints & Licensing
MENU
Breadcrumb
  1. Home
  2. Supply Chain
March 22, 2020 01:01 PM

Shortage of COVID-19 sample collection tools will be short-lived, suppliers say

Madeleine Johnson, Genomeweb
  • Tweet
  • Share
  • Share
  • Email
  • More
    Print

    The latest bottleneck to rolling out diagnostic testing for COVID-19 has been a shortage of tools and equipment needed to collect and transport samples. Manufacturers of swabs and transport media say that this is likely to be a short-lived shortage, however, as they have already ramped up manufacturing.

    Although lowly nasopharyngeal swabs are rarely in the spotlight, they became a hot topic this week when some hospitals began reporting back orders from their primary suppliers. Likewise, specially designed commercial transport media was reportedly becoming hard to procure.

    The market for NP swabs and transport media is dominated by Becton Dickinson, Copan Diagnostics, Puritan Medical Products, and Thermo Fisher Scientific. Other companies, like Lucence and Longhorn Vaccines and Diagnostics, also make special sample collection media that could potentially be used in the COVID-19 crisis.

    NP swabs are not the ordinary Q-tip. They have extra-long, flexible, thin shafts, to reach far into the nose, and they are manufactured in a such a way to reduce the likelihood of contaminating nucleic acids that might interfere with testing.

    There are now seven molecular diagnostic tests for COVID-19 and they have varying requirements for swabs and transport media.

    For example, DiaSorin's product information for its EUA Simplexa COVID-19 Direct Test specifies that the acceptable specimen type is nasopharyngeal swabs in approximately 3 mL of Copan Universal Transport Media (UTM) or BD Viral Transport Media (VTM), "or equivalent." In terms of swabs, the information does not specify a manufacturer, only that swabs have a synthetic tip, for example, made with Dacron, nylon, or rayon, as well as an aluminum or plastic shaft. The instructions note that calcium alginate swabs—which are typically used to obtain samples for bacterial culture—may contain substances that inhibit PCR testing and should not be used.

    Hologic's instructions for the Panther Fusion test recommend a polyester-, rayon-, or nylon-tipped swab, and state that the test has been verified with Copan UTM, BD VTM, and also certain formulations of a transport media from Remel MicroTest.

    Roche's Cobas test meanwhile specifies nasopharyngeal and oropharyngeal swab samples collected in a Copan UTM-RT System (UTM-RT) or BD Universal Viral Transport System (UVT), which are essentially kits that contain the transport media in a tube as well as the swab.

    The Quidel Lyra assay does not constrain the swab manufacturer, but requires viral transport media to be certain formulations of Remel MicroTest or Copan's UTM.

    The test information for the Abbott RealTime test directs users to Centers for Disease Control and Prevention guidelines for specimen collection, which were updated to adjust for the shortages. The CDC guidelines now say that an oropharyngeal swab is an acceptable specimen type if NP swabs are not available. They also note that standard operating procedure for public health labs is to create their own viral transport media in accordance with CDC's protocols.

    Quest Diagnostics, meanwhile, guides users of its lab-based testing to use its "V-C-M transport medium or other comparable transport medium," as well as CDC-guided sample collection methods.

    Working overtime

    Copan is a main supplier of the special swabs used for NP sample collection as well as viral transport kits. But Copan is located in the Italian city of Brescia, in the Lombardy region that is the epicenter of an intense COVID-19 outbreak in Northern Italy.

    Irene Acerbi, a business development manager at Copan, said in an email that the firm's supply chain is as yet unbroken.

    "The lockdown ordered by the Italian authorities is an extreme measure intended to contain the propagation of the virus and is primarily aimed at individuals," Acerbi said. "It does not affect the businesses or the import and export of goods." As such, Copan is currently manufacturing its products 24 hours a day, seven days a week, and "has deployed a number of precautions to protect its workers and keep production running," she said.

    "Together with our suppliers, we are working with the Italian regional and national authorities to preserve the current manufacturing conditions in order to serve the world with our products, even in case heavier restrictions are applied in Italy."

    Becton Dickinson also makes swabs and sample collection kits. "We have certainly seen extremely high demand for swab products, given the prolonged flu season and coronavirus," said Troy Kirkpatrick, BD's senior director of public relations.

    The manufacturing facility for BD's swabs and collection devices used for coronavirus sample collection is also running operations 24 hours a day, seven days a week, and has ramped up production, Kirkpatrick said.

    "We will be providing hundreds of thousands of swabs to the U.S. market each week," he said.

    The BD Universal Viral Transport (UVT) System, which includes swabs, vials, and prepackaged kits, is used to collect and transport clinical specimens for viral testing, including for the diagnosis of the flu or the coronavirus.

    "We also make other viral transport products, but not ones that are currently validated for coronavirus testing," Kirkpatrick said. "The industry is working with FDA to determine if other collection and transport devices are appropriate for use in testing for coronavirus and if so, taking the necessary steps to validate these for use with coronavirus."

    Thermo Fisher also makes a transport media, as does Puritan, and they both also sell swabs. A spokesperson from Puritan acknowledged that there has been a "tremendous surge in demand" for swabs and transport systems which has resulted in inventory and order delays for many of Puritan's products.

    "As a trusted source for testing supplies, we're in close contact with government agencies and the Coronavirus White House Task Force, gathering the latest information on COVID-19. It is our goal to continuously supply and support all distribution channels during this challenging time," the spokesperson said.

    In terms of other options for transport media, Jeff Fischer, president of Longhorn Vaccines and Diagnostics said that his firm makes a product called PrimeStore Molecular Transport Medium (MTM) that was FDA cleared for respiratory samples in 2018.

    It is slightly different than VTM and UTM because the latter two are meant to keep viral material intact, he said in an interview. Those media were "really designed for doing culture and other testing," he said, so they are "not ideal for molecular testing." And, they have components, such as gelatin, that make them not as easy to manufacture quickly at a large scale and may inhibit PCR to some degree, he said.

    "Our product is a chemical mixture which is very easy to scale and is made from reagents that are generally not used for other items in the COVID-19 testing chain," Fischer said.

    The firm's media also inactivates the virus, essentially by performing a chemical lysis step.

    "Therefore, there is no potential hazard, either in the transport process or once the sample gets to the laboratory," Fischer said. He added that CDC guidelines currently recommend samples suspected of containing COVID-19 be inactivated in a biological safety cabinet, or hood, and Fischer suggested that the inactivation of samples arriving in the lab in UTM or VTM might be one of the slowdown points in the lab workflow.

    "Our sample is inactivated at the point of collection, and therefore doesn't need to go through that process," Fischer said. Sample in the Longhorn media is also stable at room temperature for up to 28 days, he said, although the product is currently only cleared by FDA to keep nucleic acids stable for eight days at ambient temperature. And, the inactivation component also inactivates other enzymes and proteins that degrade nucleic acids, resulting in improved sensitivity in molecular tests, he said, noting that the inactivation component is what made the media a class II device requiring a de novo FDA submission.

    "The FDA has been pushing us to get as much into the market as possible, and we are working very closely with them," Fischer said.

    Another company, Lucence, also announced Friday that it has developed a transport method, called SAFER-Sample, which is a collection kit that comes with a bottle of stabilization fluid to be mixed with the sample at the point of collection, keeping viral RNA stable at room temperature for up to one week.

    For Fischer, there is now a huge market opening up for transport media. "We are seeing unlimited demand—right now we are holding orders for several million [tubes], and we are working with states, large distributors, and large hospital systems," Fischer said. "We don't see a cap on demand right now, so it is just a matter of how fast we can make it and how fast we can get it out."

    Why no stockpile?

    Sample collection may have gotten lost in the shuffle as the U.S. watched the wave of COVID-19 infection approaching.

    The U.S. has a designated system to warehouse potentially critical medical supplies, called the Strategic National Stockpile. The SNS had been managed by the CDC until October 1, 2018, at which point it fell under the aegis of the Office of the Assistant Secretary for Preparedness and Response (ASPR) of HHS. ASPR also oversees the Biomedical Advanced Research and Development Authority, or BARDA.

    Longhorn's Fisher said that in late January he reached out to the appropriate divisions of HHS, namely the Office of the Secretary, as well as ASPR and BARDA, to propose they stockpile between 5 million and 10 million of his firm's transport tubes.

    "They responded that they talked to their diagnostics team and they confirmed that while BARDA does support the development of sample collection devices, they have no authority or funding to purchase them," Fischer said.

    He said he was also informed that the SNS did not plan to purchase sample collection devices at that time, and that in general BARDA does not perform diagnostic testing as part of its mission space.

    The Longhorn team is now working with HHS to see which is the right agency arm for authorizing and purchasing testing equipment.

    An HHS spokesperson said in an email that to date the SNS has not had any established requirements to stockpile diagnostics or related items.

    "Federal agencies including ASPR, CDC, National Institutes of Health, FDA, the Veteran's Administraton, and the Department of Defense coordinate efforts to develop medical products needed to protect the American people from chemical, biological, radiological and nuclear threats and emerging infectious diseases, and together set the overall goals for what products to stockpile and the quantities needed," the spokesperson said.

    Specifically regarding stockpiling NP swabs, the spokesperson also said, "Priorities for SNS inventory must be balanced against available funding, and market availability for swabs previously was adequate."

    Copan's Acerbi noted that swabs and transport kits do have "a relatively short shelf life" of 15 to 36 months, which is why stockpiling is not normally considered for these essential products.

    "It is indeed a challenging period for the world, and we're making tremendous effort to cope with the demand," Acerbi added.

    This story first appeared in our sister publication, Genomeweb.

    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
    Merck ends development of two potential COVID-19 vaccines
    Merck ends development of two potential COVID-19 vaccines
    Civica Rx to build manufacturing facility in Virginia, creating 180 jobs
    Civica Rx to build manufacturing facility in Virginia, creating 180 jobs
    Sponsored Content
    Get Free Newsletters

    Sign up for free 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

    The weekly magazine, websites, research and databases provide a powerful and all-encompassing industry presence. We help you make informed business decisions and lead your organizations to success.

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

    Stay Connected

    Join the conversation with Modern Healthcare through our social media pages

    MDHC_Logotype_white
    Contact Us

    (877) 812-1581

    Email us

     

    Resources
    • Contact Us
    • Advertise with Us
    • Ad Choices Ad Choices
    • Sitemap
    Editorial Dept
    • Submission Guidelines
    • Code of Ethics
    • Awards
    • About Us
    Legal
    • Terms and Conditions
    • Privacy Policy
    • Privacy Request
    Modern Healthcare
    Copyright © 1996-2021. Crain Communications, Inc. All Rights Reserved.
    • News
      • This Week's News
      • COVID-19
      • Providers
      • Insurance
      • Government
      • Finance
      • Technology
      • Safety & Quality
      • People
      • Regional News
        • Midwest
        • Northeast
        • South
        • West
      • Digital Edition
    • Insights
      • ACA 10 Years After
      • Best Practices
      • InDepth Special Reports
      • Innovations
    • Transformation
      • Patients
      • Operations
      • Care Delivery
      • Payment
    • Data/Lists
      • Rankings/Lists
      • Interactive Databases
      • Data Points
    • Op-Ed
      • Bold Moves
      • Breaking Bias
      • Commentaries
      • Letters
      • Vital Signs Blog
      • From the Editor
    • Awards
      • Award Programs
        • 100 Most Influential People
        • 50 Most Influential Clinical Executives
        • Best Places to Work in Healthcare
        • Health Care Hall of Fame
        • Healthcare Marketing Impact Awards
        • Top 25 Emerging Leaders
        • Top 25 Innovators
        • Top 25 Minority Leaders
        • Top 25 Women Leaders
      • Nominate
      • Previous Award Programs
        • Excellence in Nursing Awards
        • Design Awards
        • Top 25 COOs in Healthcare
      • Other Award Programs
        • 100 Top Hospitals
        • ACHE Awards
    • Events
      • Conferences
        • Leadership Symposium
        • Healthcare Transformation Summit
        • Women Leaders in Healthcare Conference
        • Workplace of the Future Conference
        • Strategic Marketing Conference
        • Social Determinants of Health Symposium
      • Galas
        • Best Places to Work Awards Gala
        • Health Care Hall of Fame Gala
        • Top 25 Minority Leaders Gala (2022)
        • Top 25 Women Leaders Gala
      • Webinars
      • COVID-19 Event Tracker
    • Listen
      • Podcast - Next Up
      • Podcast - Beyond the Byline
      • Sponsored Podcast - Healthcare Insider
      • Video Series - The Check Up
      • Sponsored Video Series - One on One
    • MORE +
      • Advertise
      • Media Kit
      • Newsletters
      • Jobs
      • People on the Move
      • Reprints & Licensing