Diagnostic Swabs

Need Exploration and Identification

For nasopharyngeal swabs, it is important the swab is compatible with the diagnostic test being used. This compatibility is based on the material used to manufacture the swab. For example, synthetic tips made of rayon, dacron, polyester, nylon with aluminum or plastic shafts are compatible with RT-PCR but calcium alginate, cotton, and wood shafts are not.

Existing Solutions

• Current supply chains
  • Copan
  • BD
  • Fisher scientific 
  • Puritan
  • McKesson
  • Thermo Scientific/ Remel
  • There are many distributors selling products produced by companies previously listed
• Alternative supply chains
  • ○      Formlabs (NYC based) and 3D systems are making 3D printed swabs
    • These are undergoing validation tests 
  • Resolution Medical- 3D printed swabs 
  • US Cotton, a subsidiary of Parkdale-Mills is making polyester Q-tip type swabs that are approved by the FDA as of April 16, 2020. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-gates-foundation-unitedhealth-group-quantigen-and-us-cotton

Market Analysis

• Evidence to support that currently the market is overloaded 
  • Testing has increased as the FDA approves more COVID-19 test kits leading to a shortage of materials needed to conduct testing, including nasopharyngeal swabs.
  • Johns Hopkins Coronavirus Resource Center lists the number of tests conducted in the United States
    • https://coronavirus.jhu.edu/map.html
  • The CDC is also conducting surveillance on testing however there are limitations. 
    • https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/testing-in-us.html
  • Puritan is ramping up to make a million swabs per week
    • https://www.bloomberg.com/features/2020-coronavirus-puritan-medical-test-swab/
  • Copan’s supply chain is unbroken despite Lombardy being affected by COVID-19, Copan and BD are producing swabs 24 hours/day
    • https://www.modernhealthcare.com/supply-chain/shortage-covid-19-sample-collection-tools-will-be-short-lived-suppliers-say
• Market/supply chain reasons to support why we are going down the route we are going down
  • Increase in testing is causing shortage of products needed to conduct tests

Alternative Solutions

• Operational
  • Leadership decision on who should be tested
• Re-engineering
  • 3D printing of swabs

Concept Screening

• Clinical
  • Requirements for compatibility with RT-PCR testing
    • All swabs must be sterile
    • Synthetic tip made of Rayon, dacron, polyester, nylon
    • Aluminum or plastic shaft
    • NOT compatible: calcium alginate, wood shaft, or cotton tip
• Engineering
  • Validation of products is required
• Regulatory
  • Individual tests may require specific swabs and guidelines

Strategic Development

• Explore current supply chains with established suppliers and exhaust those supplies
• Look for other sources of product from distributors
• Explore alternative swab options such as 3D printed swabs
• Explore alternative diagnostic tests that do not require nasopharyngeal swabs
• Determine the effectiveness of the swabs
• Regulatory – the Quality System Regulation (21 CFR 820) (https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) also known as “Good Manufacturing Practices”  both for the manufacturing as well as the sterilization processes need to be observed.