Błońska Ewa, Knapp Piotr Andrzej
Klinika Ginekologii i Ginekologii Onkologicznej, Uniwersytecki Szpital Kliniczny w Białymstoku, Polska.
Ginekol Pol. 2013 Aug;84(8):691-5. doi: 10.17772/gp/1625.
Verification of uncertain PAP-smear results in a group of women covered by the cervical screening program in the Podlaski province. The main aim of the study was to identify CIN (Cervical Intraepithelial Neoplasia) lesions present, with varying degrees of severity in women with cytological diagnosis of ASCUS (atypical squamous cells of undetermined significance), LSIL (low grade squamous intraepithelial lesion), and ASC-H (atypical squamous cells - cannot exclude high grade squamous intraepithelial lesion).
The study evaluated 101 cervical smears taken from the vaginal part of the cervix in a group of screened women in the Podlaski province. Cytological evaluation was performed according the Bethesda System. We analyzed abnormal smears selected from a total of 7296 cytological examinations performed during 2012 at the University Center for Pathomorphological and Genetic - Molecular Diagnosis, Medical University in Białystok. The cytological results which were of interest to us included 19 cases with ASCUS, 59 with LSIL, and 23 with ASC-H, as well as with morphological features of the presence of Human Papilloma Virus (HPV). Staining was performed using CINtecPLUS test according to the manufacturer's instructions. CINtecPLUS is a immunocytochemical test based on specially designed monoclonal antibodies (E6H4TM) that let us identify protein p16ink4a within the cervical smear Additionally the diagnostic kit was provided with antibodies for diagnosing the presence of Ki-67 protein, a known marker of cell proliferation. The result was considered positive when staining of the nucleus and the cytoplasm appeared in red and brown, respectively. All abnormal results were eventually verified by histological examination of the tissue taken from cervical lesions by diagnostic-therapeutic procedure following colposcopic evaluation of cervical lesion topography
In the group of cytological smears with ASCUS, the diagnosis was positive in 5 cases (26.3%), negative in 14 (73.7%). In the group with the diagnosis of LSIL, the cytology results were positive in 32 cases (54.2%), negative in 27 (45.8%). In the cytological diagnosis of ASC-H there were 20 positive (87%) and 3 negative (13%) results.
Test CINtecPLUS could be a helpful tool in the final diagnosis of cervical abnormality in patients with the cytological diagnosis of ASCUS, LSIL and ASC-H. The combination of conventional cytological test and CINtecPLUS can help create a new procedure algorithm for cases with abnormal or ambiguous cytological screening results. It could be especially useful in a group of young women of childbearing age, when it is common to avoid a more radical treatment of cervical lesions.
对Podlaski省宫颈筛查项目覆盖的一组女性中不确定的巴氏涂片结果进行验证。本研究的主要目的是识别细胞学诊断为意义不明确的非典型鳞状细胞（ASCUS）、低级别鳞状上皮内病变（LSIL）和不能排除高级别鳞状上皮内病变的非典型鳞状细胞（ASC-H）的女性中存在的不同严重程度的宫颈上皮内瘤变（CIN）病变。
本研究评估了从Podlaski省一组接受筛查的女性宫颈阴道部采集的101份宫颈涂片。根据贝塞斯达系统进行细胞学评估。我们分析了从2012年在比亚韦斯托克医科大学病理形态学与遗传 - 分子诊断大学中心进行的总共7296次细胞学检查中选出的异常涂片。我们感兴趣的细胞学结果包括19例ASCUS、59例LSIL和23例ASC-H，以及具有人乳头瘤病毒（HPV）存在的形态学特征的病例。根据制造商的说明使用CINtecPLUS检测进行染色。CINtecPLUS是一种基于专门设计的单克隆抗体（E6H4TM）的免疫细胞化学检测，它使我们能够在宫颈涂片中识别p16ink4a蛋白。此外，诊断试剂盒还提供了用于诊断细胞增殖已知标志物Ki-67蛋白存在的抗体。当细胞核和细胞质的染色分别呈现红色和棕色时，结果被认为是阳性。所有异常结果最终通过在阴道镜评估宫颈病变形态后通过诊断 - 治疗程序从宫颈病变处获取的组织的组织学检查进行验证。
在ASCUS细胞学涂片组中，诊断阳性5例（26.3%），阴性14例（73.7%）。在诊断为LSIL的组中，细胞学结果阳性32例（54.2%），阴性27例（45.8%）。在ASC-H的细胞学诊断中，有20例阳性（87%）和3例阴性（13%）结果。
CINtecPLUS检测可能是对细胞学诊断为ASCUS、LSIL和ASC-H的患者宫颈异常进行最终诊断的有用工具。传统细胞学检测与CINtecPLUS的结合可以帮助为细胞学筛查结果异常或不明确的病例创建一种新的程序算法。这在一群育龄年轻女性中可能特别有用，因为在这个群体中通常避免对宫颈病变进行更激进的治疗。
