3D Printed Test Swabs for COVID-19 Testing

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

Length 6.00" (150.00mm)
Head Diameter 0.15" (3.85mm)
Head Length 0.73" (18.60mm)
Neck Diameter 0.06" (1.50mm)
Body Diameter 0.10" (2.45mm)
Break Point Location From Tip (70mm)

Formlabs' Production Network for 3D Printing Swabs

Formlabs has partnered with healthcare systems, medical device manufacturers and governments all over the world to help them print their own swabs locally and become self-sufficient during the COVID-19 pandemic. 

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

Swab Production in Singapore

Meet Dr. Ho Chaw Sing

 'We are extremely proud to be helping in the global fight against COVID-19. NP swabs enable testing, which is a critical element in controlling the pandemic, and Project Python will provide Singapore with significant domestic production capabilities of these swabs. We have now helped establish swab manufacturing facilities in several countries around the world, which is a testament to the agility and distributed manufacturing capabilities 3D printing can offer.”

Formlabs CEO Max Lobovsky

As COVID-19 went global, test swab shortages impacted healthcare systems around the world. In Singapore, a healthcare consortium led by Dr. Ho Chaw Sing went to work to develop their own test swab design. Dr. Ho Chaw Sing, the managing director of the National Additive Manufacturing Innovation Cluster (NAMIC), called upon the support of Formlabs and our distribution partner Eye 2 Eye as they needed to quickly develop a clinically validated, cost-effective 3D printed NP swab to combat imminent supply chain shortages. 

Multiple divisions at National University of Singapore (NUS) worked to rapidly develop and test thirty prototypes. After rigorous testing, the Python swab demonstrates comparable accuracy, performance, and comfort, with no significant performance difference compared to a non-3D printed swab. After successful clinical trials, the Python was chosen for mass production. Due to the versatility and accuracy of the Form 3B, the NUS team operated with minimal design restraints, producing an accurate, delicate geometry at scale.

The swabs are being printed using Surgical Guide Resin. This resin has been developed by our team of materials engineers specifically for Formlabs printers. It’s a biocompatible material that meets Class I requirements and is CE certified, and is typically used in medical applications involving short-term skin or mucosal membrane contact that require high dimensional accuracy, stiffness, and strength.

Surgical Guide Resin has been rigorously tested with autoclaves, solvents, and implant systems. As each swab is being individually sterilized and packaged before being delivered it was the perfect candidate for this project. 

In less than two months, Dr. Ho Chaw Sing and team had designed, tested, validated, and mass produced a swab. Eye to Eye, ramped production to 30,000 Python swabs a day with a fleet of Form 3B printers, and as of today they have printed over two million swabs and counting. Their goal is to produce more than four million swabs before the end of 2020. 

“We are proud to play a part in Singapore’s efforts to help combat COVID-19,” said Miles Podmore, Chief Executive Officer of Eye-2-Eye Communications. “It has not only been an excellent opportunity to showcase the advantages of 3D printing for rapid design and development but it has also shown Formlabs effectiveness in being able to mass produce products in very short timeframes. Also, as we see spikes in cases across the globe it is reassuring to know we can scale our production relatively easily to meet demand if required.”

Chief Executive Officer of Eye-2-Eye Communications Miles Podmore

 

In Partnership With

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)


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