Clinical Diagnostic Study of a Novel Injection Molded Swab for SARS-Cov-2 Testing

Global demand for diagnostic tools has outpaced traditional manufacturing capabilities. Standard nasopharyngeal swabs are essential for RT-PCR testing. Prior research has shown that 3D printing can address short-term shortages. However, long-term scalability remains a challenge. Injection molding offers a more scalable alternative. No prior work had resolved the trade-offs between 3D printing and injection molding for swab production. This gap motivated the development of a new swab design. The need for a reliable alternative swab is critical for sustained testing efforts.

This study aimed to evaluate a new injection molded swab as an alternative to commercial swabs. The goal was to ensure consistent supply for diagnostic testing. The specific problem is the shortage of approved swabs due to high demand. The motivation is to maintain diagnostic accuracy while improving production efficiency. The study focused on clinical performance and patient safety. It compared the new swab to a widely used commercial model. The objective was to confirm diagnostic equivalence. The study also assessed user experience and safety outcomes.

The study used a clinical diagnostic design with paired swab comparisons. Forty confirmed COVID-19 patients and ten healthy controls were enrolled. Each participant provided two swabs from the same nostril. Swabs were tested using RT-PCR for SARS-CoV-2. The primary outcome was agreement with the Copan FLOQSwab. Cycle threshold values were measured for ORF1ab and E-gene targets. Pain levels were reported by participants post-sampling. Adverse events were monitored and recorded systematically.

The new swab showed 96.0% overall agreement with the commercial swab. Positive percent agreement was 94.9%. Cycle threshold values were nearly identical for both swabs. ORF1ab values were 28.05 vs. 28.03 (p=0.97). E-gene values were 29.72 vs. 29.37 (p=0.64). No significant difference in diagnostic accuracy was observed. Patient-reported pain levels were equivalent between swabs. No adverse events were recorded during the study period.

The new swab is a safe and accurate alternative to commercial models. The study supports its use in clinical settings. It matches the diagnostic performance of the Copan FLOQSwab. The findings suggest it can be used without compromising test accuracy. The swab’s design ensures consistent production quality. It addresses supply chain limitations effectively. The results confirm clinical equivalence and safety. The authors propose it as a viable long-term solution.