Acta Cytologica最新文献

Background: Quality assurance (QA) and quality control (QC) are fundamental to maintaining high standards in cytopathologic diagnostics. The recent adoption of digital cytology (DC) has led to transformative changes in cytopathology workflows, including primary diagnosis, telecytopathology-based consultations, and rapid on-site evaluations (ROSEs). These technological developments call for a conceptual shift and redefinition of QA and QC frameworks in the DC era. Summary: This review explores the evolving landscape of QA and QC in cytopathology, with a focus on the integration of DC into existing quality systems. We examine the role of DC as both a QC tool and a platform for implementing DC-specific QA/QC protocols. Practical applications discussed include leveraging DC for conventional QA/QC tasks, such as education and training of laboratory staff and cytopathologists, and facilitating digital proficiency testing through cloud-based platforms. Additionally, we review current international recommendations for the adoption of DC in cytopathology and propose strategies for the safe and efficient management of digital environments. Key Messages: (i) DC is reshaping the practice of cytopathology and requires updated QA/QC strategies. (ii) DC can enhance QA/QC activities through improved training, proficiency testing, and collaborative diagnostics. (iii) The development and implementation of DC-specific protocols are essential for ensuring accuracy and reliability in digital cytopathologic practice.

Background: The efficiency of the cytological test largely depends on the control and quality assurance of laboratory procedures, to avoid false results. The objectives of this descriptive review were to point out and discuss the main mechanisms for controlling and ensuring the quality of cytological diagnosis.

Summary: A critical revision was performed to identify the principal challenges involved in the processes of all the main issues related to the morphological alterations that characterize a true-related lesion in the daily routine of the Pap test examination. Principles of QC and QA are already being implemented worldwide, and the positive aspects and limitations of these are discussed as well as proposing alternatives when pertinent. Most of the articles evaluated highlighted the necessity of implementing audit mechanisms to control the performance of the professionals involved with the cytology evaluation.

Key message: Promising data from the new image-based technological arsenal appear to be a remarkable tool for improving cytological evaluation, reducing errors of interpretation and serving as a powerful arm for cytology teaching.

Background: External quality assessment (EQA), including proficiency testing (PT), is a fundamental aspect of laboratory quality management and a key requirement for diagnostic laboratory accreditation.

Summary: This review highlights significant gaps in comprehensive EQA/PT programs for diagnostic non-gynecological cytopathology that fully address all aspects of the diagnostic process, particularly in Europe.

Key messages: Current EQA/PT programs for diagnostic cytopathology are mostly regional, national, and only partially cover the examination process. The unique challenges of diagnostic cytopathology, including small and limited patient samples, non-standardized laboratory procedures, biomarker testing tailored to specific cytology samples, and the qualitative subjective nature of cytopathologic reporting, necessitate adapted approaches for effective and meaningful EQA.

Background: This invited review addresses the steps involved in ensuring quality in interventional cytopathology. These include an understanding of its historical perspective and presenting a snapshot of current training and clinical practice. It provides examples of documentation of the FNA procedure and also guidance on the use of local anaesthetics and management of antithrombotic medication.

Summary: The invited co-authors represent those actively involved in this field and bring a wide range of views that represents a step in the direction of producing up-to-date guidance for those aspiring to set up or to further improve their existing practice of interventional cytopathology.

Key messages: It is hoped that this collaborative effort will pave the way for standardization, ensuring quality in interventional cytopathology.

Background: Cervical screening is changing to the use of human papillomavirus (HPV) testing as the primary screening test. It is essential that the well-established and critically important systems for quality assurance based on laboratory audits of seemingly negative samples taken before HSIL and cervical cancer are maintained. They provide a means of verifying if the actual screening is effective for the intended purpose. Together with international proficiency panels, audits provide a simple and unambiguous way to evaluate if the screening is adequate. Detailed knowledge of how these systems work and how they are dependent on the genotyping of HPV, biobanking, and screening registries is vital to cytologists and pathologists involved in quality assurance work and follow-up of cervical lesions and cervical cancer. Interpretation and communication of outcome and results are equally important for successful quality assurance work and should ideally be done together with expertise in HPV.

Summary: The internationally defined procedures for laboratory audit, similar to those used for cytology, require sensitivities before HSIL of >95% and before invasive cervical cancer of >90%. If also results on blinded proficiency panels and international criteria for analytic sensitivity, specificity, and reproducibility are achieved, the HPV screening test can be said to be adequate.

Key messages: Performance of HPV screening tests in a cervical screening program includes similar laboratory audits as hitherto used for cytology. Similarly, technical proficiency of a laboratory is established using blinded proficiency panels with defined contents of virus. Detailed knowledge of quality assurance work is necessary for cytologists and pathologists. Communication of outcome and results depends on collaboration between laboratories.

Background: Ancillary tests are increasingly important for primary cancer diagnosis, as well as predictive and prognostic information, and occasionally cytological samples are the only material readily available. Advanced ancillary testing, including immunohistochemistry (IHC), immunocytochemistry (ICC), in situ hybridization, and next-generation sequencing (NGS) should be carefully standardized and quality controlled in order to provide reliable results. The diversity of preanalytics in the cytological laboratory process poses challenges for quality management.

Summary: Paraffin-embedded cell blocks (CBs) from cytological samples that are collected in and fixed with formalin appear to be the easiest option for ancillary tests, the majority of which are developed for formalin-fixed and paraffin-embedded (FFPE) samples. They can be stained with the same IHC protocols and on-slide controls without additional validation. Fixation time of FFPE CB samples should be controlled since nucleic acid quality and quantity decrease in formalin in a time-dependent manner. Ethanol and methanol, the standard fixatives in cytology, alter the tertiary structure of proteins, thus impairing ICC staining. Depending on the antibody, staining signals can be weaker or even absent in alcohol-fixed cells. Nevertheless, air-dried or methanol-fixed cytospins, liquid-cytology samples, cell-free supernatants, and unstained or stained smears can successfully be used for ancillary testing, but this requires careful protocol optimization and validation. Appropriate on-slide controls are not easily available for ICC, but these can be prepared for example from cell lines or left-over patient samples. If polymerase chain reaction (PCR) or NGS-based testing is performed in-house, different cytological sample types can be validated for routine use.

Key messages: Ancillary tests like ICC need to be validated according to the up-to-date guidelines in order to use the optimal protocol for each sample and fixation type and to discover the possible limitations of the test. Appropriate controls that reflect the preanalytical conditions of the sample material ensure reliable and reproducible results. Cytological material suits well for molecular pathology and could be more widely exploited in diagnostics. European cytopathology laboratories need to recognize the requirements of the in vitro diagnostic (IVD) regulation especially in documenting validation, risk management, and clinical performance data of the laboratory-developed (in house) tests.

Background: Quality assurance (QA) is essential in cytopathology to ensure diagnostic accuracy. Common QA methods include peer reviews, 10% random reviews, and benchmarking against published standards. Benchmarking, which compares institutional data on specimen category assignment and risk of malignancy (ROM) with published body site reviews, helps evaluate performance and identify areas of improvement. Cytopathology reporting systems for various body sites categorize specimens based on ROM estimates. The diagnostic categories and ROM estimates in non-gynecologic cytopathology systems can serve as quality metrics to improve practices and maintain high standards of patient care.

Summary: A well-developed QA system in cytology is crucial for ensuring diagnostic accuracy and minimizing errors. By using tools like secondary reviews, retrospective analyses, and structured reporting systems, laboratories can improve practices, detect errors, and maintain high standards of patient care.

Key messages: The cytopathology reporting systems help provide categorical information that can guide clinicians, ensuring quality assurance (QA) and accuracy in diagnosis across various organ sites. Institutional data on category assignments and ROM can be compared with broader literature to assess accuracy and QA. Significant outliers in ROM for specific categories should trigger peer review and potential retraining to improve diagnostic accuracy.

Background: Pediatric lung and mediastinal tumors constitute a rare and heterogeneous group of neoplasms, often of embryonal, germ cell, lymphoid, or mesenchymal derivation. Cytology (especially fine-needle aspiration) plays a critical role in the minimally invasive diagnosis of these masses, particularly in children, where surgical biopsy may carry a high risk.

Summary: This review synthesizes the cytomorphologic spectrum of pediatric thoracic tumors, emphasizing distinguishing features, common pitfalls, and the integration of ancillary studies (immunocytochemistry, molecular testing). Special focus is on pleuropulmonary blastoma, inflammatory myofibroblastic tumor, germ cell tumors, lymphomas, Langerhans cell histiocytosis, neurogenic tumors, and small round cell tumors. We propose a structured diagnostic algorithm that incorporates clinical, radiologic, and cytologic data, and review the emerging roles of next-generation sequencing, AI-assisted cytology, and liquid-based methods in pediatric thoracic cytopathology.

Conclusion: Accurate cytologic diagnosis in pediatric thoracic masses demands optimal sampling, careful morphologic assessment, and judicious use of ancillary techniques. Improved standardization, multicenter collaborations, and integration of digital/molecular tools hold promise to enhance diagnostic yield and guide therapy in this challenging realm.

Introduction: This study aimed to evaluate the impact of single and multiple human papillomavirus (HPV) positivity on cervical intraepithelial lesions, specifically focusing on whether the addition of high-risk HPV types to HPV-16 or HPV-18 affects the progression to high-grade lesions.

Methods: A retrospective analysis was conducted on 612 HPV-positive patients from Karadeniz Technical University Faculty of Medicine, Department of Obstetrics and Gynecology (2018-2023), who underwent Pap smear and HPV genotyping. Demographic, cytological, and histopathological data were collected, with HPV types categorized as HPV-16, HPV-18, and other high-risk types. Colposcopic biopsy results were used to assess the risk of cervical intraepithelial neoplasia.

Results: Among 612 HPV-positive patients, 137 had HPV-16 (17.4%), 39 had HPV-18 (4.9%), and 503 had other high-risk types (63.8%). HPV-16 and multiple high-risk HPV types exhibited a higher proportion of cytological abnormalities. Histopathological analysis showed that the presence of other high-risk HPV types alongside HPV-16 was associated with a lower risk of progression to high-grade lesions compared to HPV-16 alone. Specifically, HPV-16 combined with other high-risk types showed a significantly lower rate of cervical intraepithelial neoplasia.

Conclusion: The addition of other high-risk HPV types to HPV-16 may slow the progression to high-grade cervical lesions, contradicting the literature that suggests multiple HPV infections increase the risk. These findings contribute to the ongoing debate on the role of multiple HPV types in cervical lesion progression.

Key message: The presence of additional high-risk HPV types alongside HPV-16 may reduce the likelihood of progression to high-grade cervical lesions, suggesting a possible attenuating effect of multiple HPV infections rather than a synergistic risk.

Background: The historical journey of Hodgkin lymphoma (HL) has undergone a unique path since its inauguration as a malignant entity. Then it was further classified into classical HL (cHL) and nodular lymphocyte-predominant HL (NLPHL). Since then, the diagnosis was traditionally made on histological examination of tissue sections. The procurement of core, open, or excisional tissue biopsy used to be the backbone prerequisite to make the diagnosis. This dependence of diagnosis on histological sections has recently been challenged.

Summary: In this review, making the diagnosis of HL by aspiration cytology is offered. Emerging evidence supports that in specialized centers with appropriate tools (specifically immunophenotyping by immunohistochemical stains) the diagnosis of cHL can be made confidently on cytological specimens with high levels of accuracy. The recent improvements in flow cytometric technology further assists in supporting the diagnosis of cHL on cytology. New parameters are now being reported as flow cytometric features of cHL, potentially distinguishing it from close mimickers.

Key messages: The diagnosis of cHL can be achieved utilizing cytomorphology in combination with appropriate necessary ancillary studies. On the other hand, NLPHL still lags behind in these newer discoveries and its final diagnosis should still be made on histological tissue sections.