Shidham Vinod B, Pandit Ashwini W, Rao R Nagarjun, Basir Zainab, Shidham Anjani
Dept of Pathology, Medical College of Wisconsin, Milwaukee, WI, USA.
BMC Clin Pathol. 2007 Mar 7;7:2. doi: 10.1186/1472-6890-7-2.
Fine needle aspiration biopsy (FNAB) cytology has been a highly effective methodology for tissue diagnosis and for various ancillary studies including molecular tests. In addition to other benefits, FNAB predominantly retrieves the diagnostic loosely cohesive cells in the lesion as compared to the adjacent supporting stroma with relatively higher cohesiveness. However, FNAB procedure performed with currently available resources is highly skill dependent with inter-performer variability, which compromises its full potential as a diagnostic tool. In this study we report a device overcoming these limitations.
'Tissue Harvester with Functional Valve' (THFV) was evaluated as part of a phase 1 National Institute of Health (NIH) research grant under Small Business Technology Transfer (STTR) Program. Working prototypes of the device were prepared. Each of the four cytopathologists with previous cytopathology fellowship training and experience in performing FNAB evaluated 5 THFV and 5 hypodermic needles resulting in 40 specimens (20 with THFV, 20 with hypodermic needles). A piece of fresh cattle liver stuffed in latex glove was used as the specimen. Based on these results a finished design was finalized.
The smears and cell blocks prepared from the specimens obtained by THFV were superior in terms of cellularity to specimens obtained with hypodermic needles. The tissuecrit of specimens obtained with THFV ranged from 70 to 100 microl (mean 87, SD 10), compared to 17 to 30 microl (mean 24, SD 4) with conventional hypodermic needles (p < .0001, Student t-test). The technical ease [on a scale of 1 (easy) to 5 (difficult)] with THFV ranged from 1 to 2 as compared to 2 to 3 with hypodermic needles.
The specimen yield with the new THFV was significantly higher when compared to hypodermic needles. Also, the FNAB procedure with THFV was relatively easier in comparison with hypodermic needles. The final version of Shidham's THFV device would improve the FNAB specimen yield by eliminating the skill factor. The increased specimen yield by this device would also facilitate wider application of FNAB specimens for various ancillary tests, including molecular tests.
细针穿刺活检（FNAB）细胞学检查一直是一种高效的组织诊断方法，可用于包括分子检测在内的各种辅助研究。除其他优点外，与相邻的具有相对较高黏附性的支持性基质相比，FNAB主要获取病变中诊断性的松散黏附细胞。然而，使用现有资源进行的FNAB操作高度依赖技术，操作者之间存在差异，这限制了其作为诊断工具的全部潜力。在本研究中，我们报告了一种克服这些局限性的设备。
“带功能瓣膜的组织采集器”（THFV）作为美国国立卫生研究院（NIH）小企业技术转移（STTR）计划一期研究资助的一部分进行了评估。制备了该设备的工作原型。四位接受过细胞病理学进修培训且有FNAB操作经验的细胞病理学家每人评估了5个THFV和5个皮下注射针，共获得40个标本（20个用THFV采集，20个用皮下注射针采集）。将一块塞在乳胶手套中的新鲜牛肝用作标本。根据这些结果确定了最终设计。
与用皮下注射针获取的标本相比，用THFV获取的标本制成的涂片和细胞块在细胞数量方面更优。用THFV获取的标本的组织量为70至100微升（平均87，标准差10），而用传统皮下注射针获取的标本为17至30微升（平均24，标准差4）（p <.0001，学生t检验）。使用THFV的技术难度（从1分（容易）到5分（困难）评分）为1至2分，而使用皮下注射针为2至3分。
与皮下注射针相比，新型THFV的标本获取量显著更高。此外，使用THFV进行FNAB操作相对更容易。Shidham的THFV设备最终版本将通过消除技术因素提高FNAB标本获取量。该设备增加的标本获取量也将有助于更广泛地将FNAB标本用于各种辅助检测，包括分子检测。
