Belekar Shubhangi V, Kamal Meherbano, Warke Aishwarya S
Department of Pathology, GMC Nagpur, Maharashtra, India.
J Cytol. 2023 Oct-Dec;40(4):205-210. doi: 10.4103/joc.joc_174_22. Epub 2023 Oct 16.
The performance parameters of cervical cytology in any accredited cytology laboratory requires implementation of quality control exercise, which ensures acceptable performance by a laboratory. This study aims to assess the analytical aspect of quality control measures by evaluating the frequency and accuracy of epithelial abnormalities as detected in cervical Pap smears using histopathologic diagnosis as the gold standard.
A retrospective diagnostic test study from 2018 to 2020 was conducted. Out of the total 6000 Pap smears, histopathologic correlation was available in 150 cases in the form of colposcopic-directed biopsy (CDB) and loop electrosurgical excision procedure (LEEP) tissue in 105 cases. The quality control measures analyzed were Atypical Squamous Cell: Squamous Intraepithelial Lesion (ASC: SIL) ratio, cyto-histo correlation, and study parameters like sensitivity, specificity, positive predictive value, and negative predictive value of Pap smears as against CDB and LEEP.
4.5% smears were reported as inadequate, 92.3% as Negative for intraepithelial lesion or malignancy (NILM), followed by epithelial abnormality found in 3.21%. The ASC: SIL ratio was 1.3:1. Concordance rate against CDB was 100% in Squamous cell carcinoma (SCC), 82.35% in high-grade squamous intraepithelial lesion (HSIL), 82% in atypical squamous cells of undetermined significance (ASCUS), 65.6% in low-grade squamous intraepithelial lesion (LSIL), and 50% in Atypical Squamous Cell ,High grade Squamous Intraepithelial Lesion can not be ruled out (ASC-H). Total concordance rate was 84.15%. Sensitivity of Pap smear was 65% for LSIL and 82% for HSIL. Specificity, positive predictive value, and negative predictive value were 63.63%, 90%, and 75%, respectively. Concordance rate was 96% with LEEP.
Quality control measures give an insight of performance of any accredited cytology laboratory. This exercise needs to be conducted on a regular basis, so that relevant steps can be taken in case of major discrepancy.
任何经认可的细胞学实验室的宫颈细胞学检查性能参数都需要实施质量控制措施，以确保实验室的表现令人满意。本研究旨在通过以组织病理学诊断作为金标准，评估宫颈巴氏涂片检测到的上皮异常的频率和准确性，来评价质量控制措施的分析方面。
进行了一项2018年至2020年的回顾性诊断试验研究。在总共6000例巴氏涂片中，150例有组织病理学相关性，其中105例为阴道镜引导下活检（CDB）形式，45例为环形电切术（LEEP）组织形式。分析的质量控制措施包括非典型鳞状细胞：鳞状上皮内病变（ASC：SIL）比率、细胞-组织学相关性，以及巴氏涂片相对于CDB和LEEP的敏感性、特异性、阳性预测值和阴性预测值等研究参数。
4.5%的涂片报告为不合格，92.3%为上皮内病变或恶性病变阴性（NILM），其次3.21%发现上皮异常。ASC：SIL比率为1.3：1。鳞状细胞癌（SCC）与CDB的符合率为100%，高级别鳞状上皮内病变（HSIL）为82.35%，意义不明确的非典型鳞状细胞（ASCUS）为82%，低级别鳞状上皮内病变（LSIL）为65.6%，不能排除高级别鳞状上皮内病变的非典型鳞状细胞（ASC-H）为50%。总符合率为84.15%。巴氏涂片对LSIL的敏感性为65%，对HSIL的敏感性为82%。特异性、阳性预测值和阴性预测值分别为63.63%、90%和75%。与LEEP的符合率为96%。
质量控制措施能够洞察任何经认可的细胞学实验室的表现。这项工作需要定期开展，以便在出现重大差异时能够采取相关措施。
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