{"title":"External Quality Assessment in Diagnostic Cytopathology: Current Programs, Challenges, and Perspectives.","authors":"Irena Srebotnik Kirbis, Margareta Strojan Fležar","doi":"10.1159/000546537","DOIUrl":"10.1159/000546537","url":null,"abstract":"<p><strong>Background: </strong>External quality assessment (EQA), including proficiency testing (PT), is a fundamental aspect of laboratory quality management and a key requirement for diagnostic laboratory accreditation.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-7"},"PeriodicalIF":1.6,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172187","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mohammed S I Mansour, Gennaro Acanfora, Giancarlo Troncone, Hans Brunnström, Elena Vigliar
{"title":"PD-L1 in Lung Cytology: The Path for Standardization.","authors":"Mohammed S I Mansour, Gennaro Acanfora, Giancarlo Troncone, Hans Brunnström, Elena Vigliar","doi":"10.1159/000546275","DOIUrl":"10.1159/000546275","url":null,"abstract":"<p><strong>Background: </strong>The advent of programmed cell death-1/programmed death-ligand 1 (PD-1/PD-L1) inhibitors has revolutionized lung cancer treatment, necessitating accurate PD-L1 immunohistochemical (IHC) assessment. While standardized for formalin-fixed paraffin-embedded histological samples, PD-L1 testing on cytology remains challenging. This review aims to address the complexities of PD-L1 IHC in cytology, focusing on validation guidelines, quality assessment, cytohistological correlation, and interobserver variability.</p><p><strong>Summary: </strong>This review synthesizes current guidelines and research on PD-L1 IHC in cytology; in particular, recent College of American Pathologists (CAP) guidelines emphasize the necessity for rigorous validation, particularly for non-formalin-fixed specimens. As far as cytohistological concordance studies are concerned, the review of 48 original articles revealed significant variability in PD-L1 expression, with concordance rates ranging from 54 to 100% at the 1% cutoff and 82-100% at the 50% cutoff. Finally, interobserver variability, particularly in the 1-49% PD-L1 expression range, further complicates accurate assessment. The review also discusses the challenges associated with quality assessment in cytology, including the lack of standardized control materials and external quality assessment (EQA) programs specifically tailored for cytological samples.</p><p><strong>Key messages: </strong>PD-L1 testing in cytology is feasible but faces substantial challenges compared to histological specimens. Validation of PD-L1 IHC protocols for cytological preparations, especially non-formalin-fixed samples, is essential. Concordance between cytological and histological PD-L1 expression is variable, highlighting the need for caution in interpretation. Interobserver variability, particularly in cases with intermediate PD-L1 expression (1-49%), affects diagnostic reproducibility. The development of standardized quality control materials and EQA programs for cytology is urgently needed to support consistent and reliable PD-L1 testing.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-16"},"PeriodicalIF":1.6,"publicationDate":"2025-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144075335","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Risk of Malignancy Ranges and Category Percentage Assignment in Cytopathology Reporting Systems: Are They Useful Quality Assurance Indicators?","authors":"Lester J Layfield, Zubair W Baloch","doi":"10.1159/000546228","DOIUrl":"10.1159/000546228","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-17"},"PeriodicalIF":1.6,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143960304","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Laura Lanteri, Elena Luppi, Alessia Cimadamore, Gladell P Paner, José A Jiménez Heffernan, Giuseppe Gasparre
{"title":"Oncocytic Tumors in the Kidney: A Tri-Focal Review - Integrated Pathological, Cytopathological, and Molecular Perspectives, Part 2.","authors":"Laura Lanteri, Elena Luppi, Alessia Cimadamore, Gladell P Paner, José A Jiménez Heffernan, Giuseppe Gasparre","doi":"10.1159/000545946","DOIUrl":"10.1159/000545946","url":null,"abstract":"<p><strong>Background: </strong>This second of two parts review is devoted to the practical aspects of fine needle aspiration biopsy diagnosis of renal oncocytoma and the interesting biology underlying the morphologic transformation of oncocytes.</p><p><strong>Summary: </strong>In the first section, we describe the most useful cytologic variables for the recognition of oncocytoma since its first cytologic description 44 years ago. The usefulness of the recently introduced cytologic diagnostic category of \"low-risk oncocytic neoplasm\" is discussed, as well as the known problems of differential diagnosis. The second section deals with the molecular aspects of oncocytes, with special emphasis on correlating it with the peculiar morphology of oncocytic tumors and their less aggressive behavior. First, why does this accumulation of abnormal mitochondria occur, and second, what are the consequences? Regarding oxidative phosphorylation, oncocytes show a dysfunctional respiratory complex that makes them unable to respond adequately to the hypoxia so typical of the neoplastic environment.</p><p><strong>Key messages: </strong>The low-risk oncocytic neoplasm category is so relevant that they may limit the possibility of an accurate diagnosis in small specimens, such as FNA and core biopsies. However, this must be compatible with the possibility of making a useful diagnosis for the therapeutic management of the patient. Further, we discuss the genes and molecules responsible for mitochondrial dysfunction, and, finally, the molecular differences between sporadic oncocytomas and those associated with a hereditary context.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-12"},"PeriodicalIF":1.6,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143962313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alessia Cimadamore, Carmine Franzese, José A Jiménez Heffernan, Rodolfo Montironi, Jung Woo Kwon, Giuseppe Gasparre, Gladell P Paner
{"title":"Oncocytic Tumors in the Kidney: A Trifocal Review - Integrated Pathological, Cytopathological, and Molecular Perspectives (Part 1).","authors":"Alessia Cimadamore, Carmine Franzese, José A Jiménez Heffernan, Rodolfo Montironi, Jung Woo Kwon, Giuseppe Gasparre, Gladell P Paner","doi":"10.1159/000545812","DOIUrl":"10.1159/000545812","url":null,"abstract":"<p><strong>Background: </strong>We review the pathological, cytopathological, and molecular features centered on renal oncocytoma and its differential diagnosis. The recent expansion of entities under the category of renal tumors with oncocytic or eosinophilic cytoplasm has important implications on how cytologic diagnosis is clinically considered.</p><p><strong>Summary: </strong>In this first of two parts, we discussed the pathological spectrum of oncocytic or eosinophilic tumors of the kidney that includes oncocytoma; chromophobe renal cell carcinoma (ChRCC) - including its eosinophilic variant (eosinophilic ChRCC); hybrid oncocytic/chromophobe tumors, either sporadic or syndromic; oncocytic papillary RCC, acquired cystic disease-associated RCC; succinate dehydrogenase (SDH)-deficient RCC; and eosinophilic solid and cystic (ESC) RCC. We describe the histomorphological and immunohistochemical features of these tumors, including the newly accepted entities, and focus on the molecular alterations reported. A practical approach for differential diagnosis and broader correlation to available cytologic findings are provided, with more in-depth cytologic descriptions for oncocytoma and eosinophilic ChRCC included in part 2 of this review. Most of the oncocytic tumors have an indolent behavior, although few aggressive cases have been reported in patients with ESC RCC, eosinophilic vacuolated tumor, and SDH-deficient RCC.</p><p><strong>Key messages: </strong>In this era where surveillance management for low-grade oncocytic renal tumors is considered, precise diagnosis is important as it will have an impact on their subsequent management. Further, accurate diagnosis is important especially in renal tumors associated with hereditary neoplasms for monitoring and genetic counseling for their family members.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-9"},"PeriodicalIF":1.6,"publicationDate":"2025-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143954894","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Vincenzo Condello, Massimo Bongiovanni, C Christofer Juhlin
{"title":"Oncocytic Adrenal Tumors: A Tri-Focal Review with Integrated Cytopathological, Pathological, and Molecular Perspectives.","authors":"Vincenzo Condello, Massimo Bongiovanni, C Christofer Juhlin","doi":"10.1159/000545715","DOIUrl":"10.1159/000545715","url":null,"abstract":"<p><strong>Background: </strong>Oncocytic lesions of the adrenal gland pose several diagnostic challenges as they can be associated with both functional and non-functional adrenal disorders and may be either benign or malignant.</p><p><strong>Summary: </strong>Oncocytic tumors are predominantly (>90%) composed of oncocytic cells, characterized by bulky, eosinophilic cytoplasm due to an abundance of mitochondria. Notably, the conventional histopathological criteria for diagnosing adrenal cortical carcinoma (ACC), such as the Weiss criteria, are not recommended for oncocytic tumors, and separate classification algorithms have been proposed for this entity. In addition to their unique cytopathology and histopathology, oncocytic adrenal cortical neoplasms share many driver gene alterations with conventional adrenal tumors, albeit at lower frequencies. However, these tumors also exhibit some distinct genetic changes, particularly deletions of mitochondrial DNA, which are consistent with patterns seen in oncocytic lesions of other endocrine organs. Interestingly, the presence of oncocytic features may correlate with prognosis in ACCs, making this morphological distinction clinically significant. Some studies suggest that oncocytic features could be linked to either a more favorable or unfavorable outcome, depending on other molecular markers. This highlights the importance of accurate diagnostic work-up for these lesions and underscores the critical role of endocrine pathologists in their management. While cytology is not part of the routine work-up for primary adrenal tumors, fine-needle aspiration cytology may still be useful in distinguishing primary adrenal tumors from metastases.</p><p><strong>Key messages: </strong>This review examines the histological and molecular characteristics of oncocytic adrenal cortical lesions, highlighting their clinically relevant differences from conventional adrenal tumors. It clarifies the limited role of cytology in diagnosing primary adrenal tumors while recognizing its usefulness in distinguishing adrenal metastases. Finally, it underscores the need for a tailored diagnostic approach to effectively manage this complex entity.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-11"},"PeriodicalIF":1.6,"publicationDate":"2025-04-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12101806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143794360","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Oncocytic Tumors in the Familial and Syndromic Contexts: A Tri-Focal Review - Integrated Cytopathological, Pathological, and Molecular Perspectives.","authors":"Maria Cristina Riascos, Vania Nosé","doi":"10.1159/000545321","DOIUrl":"10.1159/000545321","url":null,"abstract":"<p><strong>Background: </strong>Familial neoplastic syndromes are distinguished by the presence of specific neoplasms which serve as critical indicators for their suspicion and diagnosis. Among these, only a limited subset includes tumors with distinctive oncocytic features, highlights the necessity for pathologists and clinicians to pursue further investigation in affected patients and their families.</p><p><strong>Summary: </strong>Advances in genetic research and diagnostic pathology have highlighted the germline predispositions underlying these tumors, which manifest across multiple organ systems, including thyroid, parathyroid, renal, and adrenal glands. This review examines the clinical, pathological, and molecular features of oncocytic neoplasms in the context of hereditary syndromes such as Carney complex, Li-Fraumeni syndrome, DICER1 syndrome, Birt-Hogg-Dubé syndrome, hyperparathyroidism-jaw tumor syndrome, hereditary leiomyomatosis and renal cell carcinoma syndrome, tuberous sclerosis syndrome, Beckwith-Wiedemann syndrome, and SDH-deficient hereditary paraganglioma/pheochromocytoma syndrome. It emphasizes the importance of recognizing syndromic associations through histopathological clues, genetic testing, and family history to facilitate accurate diagnosis and tailored management.</p><p><strong>Key message: </strong>By integrating clinical insights with molecular data, this paper sheds light on the mechanisms driving oncocytic transformation and underscores the role of pathologists in identifying hereditary cancer syndromes.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-14"},"PeriodicalIF":1.6,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778662","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Shurong He, Jingxin Zhang, Mengge Wang, Feiliang Wang, Kan Gao, Rongming Chen, Songtao Hu, Jing Di, Dongge Liu, Mulan Jin
{"title":"Improving Diagnostic Accuracy of Indeterminate Thyroid Fine-Needle Aspiration Using Results of Ultrasound Examination, Cyclin D1 Immunostaining, and Molecular Testing.","authors":"Shurong He, Jingxin Zhang, Mengge Wang, Feiliang Wang, Kan Gao, Rongming Chen, Songtao Hu, Jing Di, Dongge Liu, Mulan Jin","doi":"10.1159/000545319","DOIUrl":"10.1159/000545319","url":null,"abstract":"<p><strong>Introduction: </strong>Fine-needle aspiration (FNA) is the standard procedure and routine method for diagnosing thyroid nodules. However, indeterminate cytological results diagnoses present considerable challenges in clinical management. This study aimed to evaluate cyclin D1 immunocytochemistry and the Chinese thyroid imaging reporting and data system (C-TIRADS) score, individually and in combination with a simple gene test for cytological diagnosis of Bethesda category III-Ⅴ.</p><p><strong>Methods: </strong>A consecutive cohort of 177 thyroid FNA specimens with indeterminate diagnosis and available histopathologic follow-up data was collected. The samples were evaluated by cyclin D1 immunocytochemistry and molecular testing for the BRAFV600E mutation or a small panel of markers (BRAF, NRAS, HRAS, KRAS, and TERT). Two experienced sonographers independently reviewed original sonographic images of each nodule and used C-TIRADS to classify the images, obtaining a consensus C-TIRADS score. Identification of the optimal cut-off points of cyclin D1 and C-TIRADS score for the diagnosis of malignancy was evaluated using the receiver operating characteristic (ROC) curves and the assessment of the area under the ROC curve (AUC). The specificity, sensitivity, positive predictive value (PPV) and negative predictive value (NPV) of all tests were evaluated with crosstabs. Logistic regression analysis and ROC curve analysis were used to evaluate the diagnostic accuracy of the three tests individually and in combination.</p><p><strong>Results: </strong>We enrolled 169 patients (177 thyroid nodules), including 140 malignancies, 15 low-risk neoplasms, and 22 benign lesions. All 177 specimens from the nodules were tested for BRAF V600E, while only 21 specimens adopted the 5-gene detection protocol. With cut-off values set at 10% for cyclin D1 immunocytochemistry and at a C-TIRADS score of 3, along with defining a positive diagnosis as the presence of a mutation in genetic testing, the PPVs for diagnosing thyroid malignancy using the three tests were 97.8%, 90.3%, and 98%, respectively; however, the NPVs were 50%, 24.2%, and 26.3%, respectively. The sensitivities were 87.7%, 83.9%, and 63.9%, and the specificities were 86.4%, 36.4% and 90.9%, respectively. Regarding AUC, cyclin D1 alone demonstrated greater diagnostic accuracy (AUC = 0.921, 95% CI = 0.857-0.985, p = 0.000) compared with the other two methods, which had AUC values of 0.775 (95% CI = 0.703-0.846, p = 0.000) and 0.587 (95% CI = 0.443-0.731, p = 0.235). The combination of two or three tests yielded higher accuracy (AUC = 0.929, 95% CI = 0.873-0.985, p = 0.000; AUC = 0.925, 95% CI = 0.860-0.989, p = 0.000; AUC = 0.937, 95% CI = 0.889-0.985, p = 0.000) compared with cyclin D1 immunocytochemistry alone (AUC = 0.921, 95% CI = 0.857-0.985, p = 0.000).</p><p><strong>Conclusion: </strong>The addition of cyclin D1 immunocytochemistry or a simple gene panel test, either alone or in combination, signi","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-13"},"PeriodicalIF":1.6,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alena Skálová, Martina Bradová, Arnaud Da Cruz Paula, William C Faquin
{"title":"Oncocytic Tumors in the Salivary Gland: Cytopathological, Pathological, and Molecular Features.","authors":"Alena Skálová, Martina Bradová, Arnaud Da Cruz Paula, William C Faquin","doi":"10.1159/000544802","DOIUrl":"10.1159/000544802","url":null,"abstract":"<p><strong>Background: </strong>Primary oncocytic salivary gland tumors and oncocytic subtypes of traditionally non-oncocytic salivary gland neoplasms are occasionally encountered in fine needle aspiration specimens, biopsies, and resections. Oncocytes are cells, either non-neoplastic or neoplastic, containing increased numbers of mitochondria resulting in cells with abundant eosinophilic cytoplasm and a low N/C ratio.</p><p><strong>Summary: </strong>A broad range of salivary gland tumors can be oncocytic including oncocytoma, Warthin tumor, mucoepidermoid carcinoma, salivary duct carcinoma, and others, especially those tumors where the oncocytic pattern represents a subtype of neoplasm; the oncocytic pattern can create a diagnostic challenge due to marked similarities in the oncocytic pattern of cells.</p><p><strong>Key messages: </strong>While their microscopic cytologic and histologic features may be similar, these tumors differ intrinsically at the molecular level. Ancillary studies such as immunologic (e.g., androgen receptor for salivary duct carcinoma) and molecular analysis, e.g., FISH for detecting the MAML2 or PLAG1/HMGA2 gene alterations in mucoepidermoid carcinoma and pleomorphic adenoma, respectively, can be used to classify these oncocytic tumors in difficult cases.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-12"},"PeriodicalIF":1.6,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060841/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Human Papillomavirus Primary Screening and Collaboration in Quality Assurance Work between Laboratories.","authors":"Henrik Edvardsson, Joakim Dillner","doi":"10.1159/000544988","DOIUrl":"10.1159/000544988","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Summary: </strong>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.</p><p><strong>Key messages: </strong>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.</p>","PeriodicalId":6959,"journal":{"name":"Acta Cytologica","volume":" ","pages":"1-6"},"PeriodicalIF":1.6,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143603140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}