3D Printed Test Swabs. Invented by Doctors. Printed by Formlabs.

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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 beginning to design and test 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.

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How are Test Swabs Made?

Solution

Currently we are optimizing swab designs co-created by doctors at USF Health and Northwell Health in order to maximize throughput in order to ship as many swabs as possible to health systems in need. The entire swab is printed as one piece. We continue to evaluate designs from other leading hospitals.

Validation Status

Formlabs has printed hundreds of samples of the test swab using the same biocompatible, autoclavable material as Surgical Guide Resin. These samples have passed a variety of tests at USF Health, which has received an Emergency IRB approval as well as authorization from regulatory, infectious disease, and virology, among others.

These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. Formlabs will produce swabs in its FDA-registered, ISO 13485 certified facility in the United States.

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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.