Sprenger E, Schwarzmann P, Kirkpatrick M, Fox W, Heinzerling R H, Geyer J W, Knesel E A
Institute for Cytopathology, Clinics of the University of Kiel, Germany.
Acta Cytol. 1996 Jan-Feb;40(1):81-9. doi: 10.1159/000333588.
To compare cervical monolayers prepared by a density gradient technique to conventional smears.
The study evaluated 2,863 patient samples. After conventional smears were prepared, the residual samples (collected in preservative fluid) were processed by the monolayer preparation system, which disaggregates the cells, removes nonclinical debris and layers the diagnostic material onto a microscopic slide. Slides were screened in Germany and the United States in masked studies.
In the U.S. study, the false negative rate for the conventional smears was 9.4% when endocervical components were present and 16.7% when absent. The false negative rate for the monolayer preparation was 4.0% when endocervical components were present and 5.7% when absent. A comparison of the diagnostic results showed that the monolayer made possible the detection of 48 cases of low grade disease or higher that were not found on the conventional smear. The German study was independent but used the same samples. The results, although based upon the Papanicolaou classification, were similar.
Cervical samples that are preserved in a liquid suspension and prepared using the density gradient monolayer technology have many advantages over conventional cervical cytologic smear preparations. The quality of cell preservation and presentation is superior. Elimination of obscuring material, homogeneity of the sample and standardized quality work together to produce preparations that can be effectively and reliably screened by cytotechnologists. These preparations should greatly enhance the reliability of machine-based screening in the future.
比较采用密度梯度技术制备的宫颈单层细胞涂片与传统涂片。
该研究评估了2863份患者样本。制备传统涂片后，将剩余样本（收集于保存液中）通过单层细胞制备系统进行处理，该系统可使细胞解离，去除非诊断性碎片，并将诊断材料铺展在载玻片上。玻片在德国和美国进行双盲研究筛查。
在美国的研究中，当存在宫颈管成分时，传统涂片的假阴性率为9.4%，不存在时为16.7%。单层细胞制备的假阴性率，存在宫颈管成分时为4.0%，不存在时为5.7%。诊断结果比较显示，单层细胞涂片能够检测出48例传统涂片未发现的低级别及以上病变。德国的研究是独立进行的，但使用了相同的样本。结果虽然基于巴氏分类，但相似。
保存在液体悬液中并采用密度梯度单层技术制备的宫颈样本，相较于传统宫颈细胞学涂片制备具有诸多优势。细胞保存和呈现的质量更优。去除遮盖物、样本均一性以及标准化质量共同作用，产生能够被细胞技术人员有效且可靠筛查的涂片。这些涂片应能极大提高未来基于机器筛查的可靠性。
