3D Printed Test Swabs for COVID-19 Testing

What are Test Swabs?

Problem

There is a nationwide shortage of the nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians are designing and testing their own swabs as quickly and safely as possible.

NP swabs are flexible sticks with a bristled end that are inserted into the nose to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles. The swab is then placed into a vial that contains a culture medium. Swab sticks have an intentionally weak point 7–8 cm from the bristled tip, which allows the stick to be broken to the correct length so that the vial can be capped before it is transported to a laboratory for testing.

This page describes efforts originating in the US. Find out more about the development of NP swabs in Spain.

How Are Test Swabs Made?

Solution

After identifying that nasal swabs for testing COVID-19 were in high demand and extremely limited in supply, a team from the USF Health’s 3D Clinical Applications Division created an initial design, working with Northwell Health and collaborating with Formlabs to develop prototypes and secure materials for a 3D printed alternative. Over the span of one week, the teams worked together to develop a nasal swab prototype and test it in the USF Health and Northwell Health labs. In two days, USF Health and Northwell Health developed prototypes using Formlabs’ 3D printers and biocompatible, autoclavable resins. 

Validation Status

The nasal swabs have cleared all testing hurdles and are now being produced. Key milestones in testing the swabs were conducted by USF Health faculty researchers in the Departments of Radiology and Infectious Diseases in collaboration with Northwell Health, including validation testing (24-hour, 3-day, and leaching), and rapid clinical testing at Northwell Health and Tampa General Hospital. All testing showed that the 3D printed nasal swabs perform as good as or better than traditional swabs used for nasopharyngeal specimen collection.

These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. 

 

How to Get 3D Printed Test Swabs

Material

Surgial Guide Resin is non-cytotoxic, not a sensitizer, non-irriating, and complies with ISO 109933-1:2018.

Dimensions

Length6.00" (150.00mm)
Head Diameter0.15" (3.85mm)
Head Length0.73" (18.60mm)
Neck Diameter0.06" (1.50mm)
Body Diameter0.10" (2.45mm)
Break Point Location From Tip(70mm)

Purchase 3D Printed Swabs

Formlabs is currently producing tens of thousands of swabs per day in its FDA-registered, ISO 13485 certified facility in Ohio, and is ramping up production to produce 100,000 swabs per day at peak capacity. The swabs are sold in packets of 25 3D printed test swabs. The swabs are unsterilized but come packaged in sterilization pouches. The quantity available to order depends on the need of the medical institution and on production capacity. The price of the swabs covers the costs of production, and Formlabs is not generating a profit from the sale of test swabs. 

Before use, please follow proper guidelines to ensure test samples are properly collected. 

Concordance

We have partnered with medical device distributor Concordance Healthcare Solution to ensure delivery of all COVID-19 swabs. Medical organizations may inquire about 3D printed swabs through Formlabs, but all orders will be processed by Concordance.

These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. 

3D Print Swabs Production Network

Nasopharyngeal swabs are medical devices that require manufacturers to comply with regulatory requirements. You can be eligible to produce swabs using Formlabs 3D printers if your organization is:

  • A dental lab or veterinary practice registered as a device manufacturer and have GMP or  ISO 13485 certification
  • A medical device manufacturer
  • A hospital or medical practice

If you fulfill the criteria above and are interested in 3D printing test swabs in-house, contact us.

"This is a prime example of the incredible impact we can have on human lives when teams of experts across academia, health care delivery, and the tech industry come together. During this current COVID-19 outbreak, there is little time for delay, and the swift, agile and adept action of everyone on this effort will greatly improve this nation’s ability to test patients."

Charles J. Lockwood, MD, MHCM, senior vice president for USF Health and dean of the USF Health Morsani College of Medicine

In Partnership With

Indications For Use

Formlabs 3D printed nasopharyngeal swabs are designed to collect upper respiratory specimens from patients with signs and symptoms of respiratory infection.

Disinfection and Sterilization

The swab may be cleaned, disinfected, and sterilized according to facility protocols. Tested methods of disinfection include: soaking the finished swab in fresh 70% IPA for five minutes. 

Swabs may be steam sterilized according to CDC recommended cycles (132 °C / 270 °F for four minutes in a pre-vacuum steam sterilizer or 30 minutes at 121 °C / 250 °F in a gravity displacement autoclave), or according to facility/autoclave manufacturer’s protocols, as long as the cycle does not exceed 20 minutes for 134 °C / 273 °F or 30 minutes at
121 °C / 250 °F.

Autoclave cycles should include a dry cycle to best maintain accuracy. For example, wrapped instruments sterilized in a prevacuum autoclave should be dried for 20-30 minutes according to CDC recommendations. Longer or hotter autoclave cycles than those listed above may result in degradation of physical properties and accuracy.

Please note, a color shift will be observed after autoclaving, this is normal.

After disinfection and sterilization inspect the swab for cracks to ensure the integrity of the swab.

Do not leave the part in the alcohol solution for an extended period.

Disclaimer

Formlabs has created this website and has become involved in varying degrees with the projects described here during a global medical crisis.  Formlabs is working on many projects to address global healthcare-related supply shortages around the world, but in trying to mitigate these shortages, patient safety is still Formlabs’ top concern. We must remind those who are helping to alleviate these shortages that masks, swabs, face shields, and other 3D printed products intended to prevent or treat COVID-19 are medical devices. These devices must be safe for their intended purpose and anyone considering the manufacturing of these products should consider the following items:

  • Formlabs is a manufacturer of 3D printing materials capable of fabricating finished devices according to their labeling and any other product manufactured from these materials should be verified and validated according to their intended purpose.

  • You may be fabricating a device that does not have the required regulatory approvals and clearances. If you are fabricating devices, follow the guidelines on the label for each material.  You may seek to obtain reliable regulatory advice. 

  • Please consider local regulations, material safety data sheets, software capabilities, sterilization requirements, and institutional requirements before 3D printing medical devices.

  • Regulatory agencies (such as the FDA) may consider expedited review of manufacturing information and/or premarket submissions.

Formlabs cannot warrant that any products not manufactured by Formlabs are suitable for their intended purpose.

Regulatory Statement

NP swabs, intended to collect specimens from a patient, are Class I devices exempt from premarket notifications according to 21 CFR § 880.6025 Absorbent tipped applicator.

FDA requires medical device manufacturers to register their facility and list their products according to 21 CFR § 807.20.

Formlabs facilities are registered:

Formlabs Inc. Registration Number: 3010279788 (Link)

Formlabs Ohio Inc. Registration Number: 3015491441 (Link)

Formlabs’ 3D Printed NP Swabs are listed. (Link)