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Univ.-Led Consortium Produces Covid-19 Test Swabs

NP swabs

Nasopharyngeal swab package (PrintedSwabs.org)

10 Apr. 2020. A group of academic researchers, manufacturers, and military labs created an FDA-approved nasal swab, now available in large quantities for Covid-19 testing. The millions of new nasopharyngeal swabs, developed by an ad hoc coalition led by a Harvard University biomedical engineering lab, are expected to relieve a chronic bottleneck that limits mass testing for the SARS-CoV-2 virus responsible for the burgeoning number of Covid-19 cases in the U.S.

A nasopharyngeal swab collects specimens of nasal secretions at the back of the throat. The swabs, used to collect samples for tests of respiratory diseases, are inserted by a clinician through the patient’s nose to the region where the throat meets the roof of the mouth. The clinician gently rotates the swab around the throat to collect the specimen, then removes and sends the swab in a sterile container for analysis, either in a remote lab or at the point of care.

With the sudden large demand for Covid-19 tests to diagnose individual patients and trace the spread of the disease, current stocks of nasopharyngeal swabs became quickly depleted. Harvard biomedical engineering professor Kit Parker organized a group of some 100 researchers at other academic labs, manufacturers, entrepreneurs, and military labs to solve the shortage. The group designed a solution, created prototypes for product testing, evaluated the prototypes in lab tests and clinical trials, and received FDA authorization in about three weeks.

The group’s solution is a 3-D printed nasopharyngeal swab that its developers say is comparable or superior to flocked swabs, considered the gold-standard for specimen collection, where multi-length fibers attach to the wand with adhesive. Parker and colleagues recruited the additive manufacturing company Desktop Metal in Burlington, Massachusetts as part of the core team. The team later enlisted six other manufacturers meeting industry standards — ISO 13485 — for medical devices to manufacture the swabs: Carbon, FormLabs, Envisiontec, Neurophotometrics, Origin.io, and OPT Industries.

Other participants in the project are Ramy Arnaout, professor of pathology at Harvard Medical School, and labs at Beth Israel Deaconess Medical Center, HP, Ohio State University, USF Health, Stanford University, and the Army’s Soldier Systems Center in Natick, Massachusetts.

The consortium says its manufacturers can produce 4 million swabs a week, and is taking orders for immediate fulfillment directly from hospitals on the project web site.

Science & Enterprise previously reported several times on Parker’s work, most recently in August 2019 on a device testing the functions of insulin-producing islet cells in the pancreas on a plastic chip made with common materials and manufacturing methods.

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