COVID-19 greatly disrupted the global supply chain of nasopharyngeal swabs, and thus new products have come to market with little data to support their use. In this prospective study, 2 new 3D printed nasopharyngeal swab designs were evaluated against the standard, flocked nasopharyngeal swab for the diagnosis of COVID-19. Seventy adult patients (37 COVID-positive and 33 COVID-negative) underwent consecutive diagnostic reverse transcription polymerase chain reaction testing, with a flocked swab followed by one or two 3D printed swabs. The “Lattice Swab” (manufacturer Resolution Medical) demonstrated 93.3% sensitivity (95% CI, 77.9%–99.2%) and 96.8% specificity (83.3%–99.9%), yielding κ = 0.90 (0.85–0.96). The “Origin KXG” (manufacturer Origin Laboratories) demonstrated 83.9% sensitivity (66.3%–94.6%) and 100% specificity (88.8%–100.0%), yielding κ = 0.84 (0.77–0.91). Both 3D printed nasopharyngeal swab results have high concordance with the control swab results. The decision to use 3D printed nasopharyngeal swabs during the COVID-19 pandemic should be strongly considered by clinical and research laboratories.

COVID-19 极大地扰乱了鼻咽拭子的全球供应链，因此新产品上市时几乎没有数据支持其使用。在这项前瞻性研究中，根据标准植绒鼻咽拭子对 2 种新的 3D 打印鼻咽拭子设计进行了评估，以诊断 COVID-19。 70 名成年患者（37 名新冠病毒阳性和 33 名新冠病毒阴性）接受了连续的诊断性逆转录聚合酶链反应测试，先使用植绒拭子，然后使用一两个 3D 打印拭子。 “Lattice Swab”（制造商Resolution Medical）表现出 93.3% 的敏感性（95% CI，77.9%–99.2%）和 96.8% 的特异性（83.3%–99.9%），产生 κ = 0.90 (0.85–0.96)。 “Origin KXG”（制造商 Origin Laboratories）表现出 83.9% 的敏感性 (66.3%–94.6%) 和 100% 的特异性 (88.8%–100.0%)，产生 κ = 0.84 (0.77–0.91)。两种 3D 打印鼻咽拭子结果与对照拭子结果具有很高的一致性。临床和研究实验室应认真考虑在 COVID-19 大流行期间使用 3D 打印鼻咽拭子的决定。