3D-Printed Nasal Swabs for COVID-19 Testing | OPT Industries

The Rise of 3D-Printed Nasal Swabs

The years 2020 and 2021 saw widespread familiarity with nasal swabs. However, these seemingly simple tools proved surprisingly difficult to obtain, exceeding initial supply predictions. A survey conducted in May 2020, encompassing 118 laboratories across the United States, revealed that 60% were experiencing limitations in swab supplies – identifying a shortage of swabs as the most prevalent supply-chain challenge.

OPT Industries Steps In

Amidst this scarcity, OPT Industries, a Massachusetts-based company established just two years prior and employing 15 individuals, emerged as a key player in swab production. The company specializes in additive manufacturing – commonly known as 3D printing – of intricate, dense microfiber structures. While their printers and software are capable of producing more than just swabs, their primary focus since 2020 has been the InstaSwab, a 3D-printed swab designed for COVID-19 testing.

Within a four-month period in 2020, OPT Industries successfully manufactured 800,000 nasal swabs for commercial entities such as Kaiser Permanente and medical product distributor Henry Schein. Following this initial production run, the company anticipates a significant increase in manufacturing capacity. Founder Jifei Ou highlights that their newer, modular machines can now generate approximately 30,000 swabs daily.

A Technology Demonstrating its Potential

“I believe the pandemic has provided us with an opportunity to showcase a specific medical application where our technology excels,” Ou stated to TechCrunch.

Although the pandemic remains a global concern, the availability of vaccines has altered the landscape of testing protocols. OPT Industries is strategically positioning itself to navigate a potential decline in COVID-19 testing within the U.S. by developing a superior swab and concentrating on the growing home-testing market.

Funding and Research

The pandemic served as an initial proving ground for OPT, which has secured approximately $5 million in seed funding to date. Ou notes that the company is currently not pursuing additional investment, but is instead engaged in a further testing phase for their swab products, with the results having been recently released.

According to data released by OPT Industries, their 3D-printed nasal swabs demonstrated an average viral gene transfer rate of 63% into detection assays. In comparison, flocked fiber swabs achieved a 36% transfer rate, while polyester swabs yielded approximately 14%.

Study Details and Limitations

These tests were conducted at Boston University Medical Center; however, the findings have not yet been published in a peer-reviewed journal, although further studies are underway with the aim of achieving publication. Importantly, the tests were performed in vitro, rather than on human COVID-19 patients.

The InstaSwabs are theorized to be more effective at collecting viral traces from the back of the nose and throat. Ou argues that a specifically designed swab, incorporating his company’s dense microfiber structures, could capture a greater amount of virus, potentially reducing false negatives – particularly during the early stages of infection when viral loads are lower.

False Negative Rates in COVID-19 Testing

Numerous studies have investigated the estimation of false negative rates associated with the various COVID-19 tests utilized. For example, a systematic review of 34 studies revealed estimated false negative rates ranging from 2% to 29%.

Evidence also suggests a correlation between low viral load and false negative results. A study conducted at the Public Health Laboratory in Alberta, Canada, analyzed over 100,000 COVID-19 tests from approximately 95,000 patients (with some individuals undergoing multiple tests). The authors identified five confirmed false negative test results.

The Role of Sample Collection Timing

These false negatives were attributed to low levels of viral RNA in the body, a factor influenced by when the samples were collected, according to the study’s authors. The issue wasn’t necessarily the swabs failing to detect the virus, but rather the limited amount of virus present for detection.

Regarding the influence of the swabs themselves on test outcomes, the authors found that both swab types used by the laboratory had produced false negative results. While this might suggest that swab type didn’t impact the false negative rate, they contend that more data is needed to reach a definitive conclusion.

Optimizing Sample Collection

However, this does not negate the potential for improving sample collection and storage methods to enhance testing accuracy. A paper published in June 2021 proposed that reducing the volume of transport medium fluid (thereby minimizing sample dilution) and redesigning swabs to maximize virus capture while minimizing nasal discomfort could further optimize testing procedures.

Proving Swab Superiority

OPT Industries must demonstrate that their superior swab can effectively collect significant amounts of viral RNA in the early stages of illness and that this increased collection rate translates into a reduction in false negatives.

While OPT’s initial study (which has not undergone peer review) indicates that their swabs can collect more virus, it lacks sufficient data to definitively prove that these swabs improve the accuracy of COVID-19 tests performed on humans.

“We are currently collaborating with two clinical partners to conduct clinical research on this matter,” Ou explains. “The results of this study, combined with the findings of our current research, will be compiled into a manuscript for submission to a peer-reviewed publication.”

Market Potential and Future Outlook

If OPT Industries can validate the superiority of their 3D-printed swab, the key question becomes which market they will target. As vaccines became more widely available in early 2021, demand for COVID-19 tests nationwide decreased by approximately 46%, as reported by The Wall Street Journal.

As of July 2021, the U.S. is conducting an average of 504,048 new COVID-19 tests per day, a significant drop from the approximately 1,992,273 tests conducted daily in January. (Even with the emergence of the more transmissible Delta variant, the CDC advises that vaccinated individuals do not require routine testing.)

Focus on At-Home Testing

Ou remains optimistic about growth potential in the at-home testing sector – initially for COVID-19, but also noting that the company’s 3D-printed swabs could be utilized for any bodily fluid requiring swabbing.

“We are observing a shift in testing from point-of-care or hospital settings to home testing in the U.S. Therefore, our current focus is on establishing partnerships and collaborations with home testing kit companies,” he states.

The company has already secured “several” partnerships with home-testing companies, although a non-disclosure agreement (NDA) prevents Ou from disclosing their identities.

Competition in the At-Home Testing Market

The at-home testing market, in general (for both COVID-19 and other conditions), is attracting increasing interest from major players, including Amazon, which plans to offer at-home testing kits for COVID-19 and sexually transmitted infections.

OPT Industries may be well-positioned to capitalize on a potential resurgence in at-home swab demand, extending beyond the pandemic.