UCLA David Geffen School of Medicine, Department of Surgery, Division of General Surgery, Los Angeles, CA, USA.
UCLA, Department of Pathology and Laboratory Medicine, Los Angeles, CA, USA.
Diagn Microbiol Infect Dis. 2021 Mar;99(3):115257. doi: 10.1016/j.diagmicrobio.2020.115257. Epub 2020 Oct 22.
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，因此市场上出现了一些新产品，但几乎没有数据支持其使用。在这项前瞻性研究中，我们评估了两种新的 3D 打印鼻咽拭子设计与标准的植绒鼻咽拭子在 COVID-19 诊断方面的性能。70 名成年患者（37 名 COVID-19 阳性和 33 名 COVID-19 阴性）连续进行了逆转录聚合酶链反应检测，先使用植绒拭子，然后使用一个或两个 3D 打印拭子。“格子拭子”（制造商 Resolution Medical）的灵敏度为 93.3%（95%CI，77.9%-99.2%），特异性为 96.8%（83.3%-99.9%），κ 值为 0.90（0.85-0.96）。“Origin KXG”（制造商 Origin Laboratories）的灵敏度为 83.9%（66.3%-94.6%），特异性为 100%（88.8%-100.0%），κ 值为 0.84（0.77-0.91）。两种 3D 打印鼻咽拭子的结果与对照拭子的结果高度一致。临床和研究实验室在 COVID-19 大流行期间应强烈考虑使用 3D 打印鼻咽拭子。
