SurePath Method Research Articles

Comparative analysis of cytomorphology of thyroid lesion on conventional cytology versus liquid-based cytology and categorize the lesions according to The Bethesda System for Reporting Thyroid Cytopathology.

Thyroid nodules are a common disorder of the thyroid. Most of these are benign and only 5%-30% are malignant. Fine-needle aspiration cytology (FNAC) plays a vital role in differentiating benign from malignant and hence directing toward timely intervention. Liquid-based cytology (LBC) has been recently started in sampling thyroid lesions and has shown good results. The aim of our study was to compare the cytomorphology of thyroid lesions by conventional smear (CS) and LBC method and categorize the lesions according to TBSRTC (The Bethesda System for Reporting Thyroid Cytopathology). A prospective study was conducted from January 2018 to June 2019 on 131 patients. Thyroid FNAC samples were taken to prepare 2-5 slides for conventional reporting and one sample for LBC preparation by SurePath method. Staining with hematoxylin and eosin, May-Grünwald-Giemsa, and Papanicolaou stain was done. Cases were reported by TBSRTC and compared. The nonneoplastic lesions constituted the major proportion on both CS (83.2%) and LBC (73.2%). The neoplastic lesions constituted only 9.9% of all the diagnosis both on CS and LBC smear. The kappa agreement between CS and LBC cytology as per The Bethesda System for Reporting Thyroid Cytopathology came out to be 0.715, which was statistically significant. Colloid appearance was statistically significant on comparison by both methods. The comparison of ill formed epithelioid granulomas was statistically significant in autoimmune thyroiditis cases. In malignancy cases, nuclear and cytoplasmic details were crisper on CS. Cytoplasm appeared fragile and fragmented on LBC smears.

Liquid-based cytology: Technical aspects.

Liquid-based cytology (LBC) is a monolayer slide preparation technology that has outperformed conventional Pap smears because of improved fixation, decreased obscuring factors, and standardized cell transfer. In LBC, samples are collected by completely immersing the sampling device into the company vial containing preservative fluid, whereby the cells are preserved and fixed simultaneously unlike conventional smears where the sample is smeared onto the glass slide and fixed separately. To date, two major liquid-based preparation methods are known – ThinPrep and SurePath. These two methods are different in their principles of cell harvesting but produce similar preparations. SurePath works on the principle of density gradient sedimentation. In this, a sample is vortexed and strained to break the mucus and large cell groups and then is treated through a density gradient centrifugation process to remove blood and debris. The cell pellet is resuspended and is allowed to sediment onto a glass slide. This is followed by staining on the PrepStain instrument. Government Medical College and Hospital, Nagpur, India, uses the SurePath method which was approved by FDA in the USA in 1999. Our institution uses Rovers Cervex-Brush to collect the cells from the transformation zone. This chapter describes the principle of SurePath and the processing of cervicovaginal specimen using the fully automated system in the laboratory.

CYTOLOGICAL, HPV GENOME, AND HISTOPATHOLOGICAL CORRELATION OF CERVICAL SMEARS IN FEMALES 30 YEARS AND ABOVE

Objectives: The objectives of the study were to evaluate the patterns of cervical smear cytology in relation to human papillomavirus (HPV) and to correlate with histopathological diagnosis in females of 30 years and above. Methods: The 2-year prospective study was done in the Department of Pathology in 100 patients who attended the Gynaecology OPD of Govt. Medical College, Patiala. The cervical brushings obtained were subjected to cytological examination by liquid-based cytology through SurePath method and for HPV evaluation by BD Onclarity HPV assay. The cytological findings were further correlated with histopathological examination. Results: Majority of the females were in the age group of 30−45 years (62%). There was high incidence of dysplasia and malignancy in those who were of parity 3, 4, and above. The most common presenting symptom was discharge per vaginum (DPV) seen in 28% of cases. Maximum cases on cytology were diagnosed as NILM (including inflammatory pathology, 49%) followed by LSIL as 14% and malignant as 13%. Overall HPV genome was detected in 54% of the samples, the cases diagnosed as dysplasia and malignancy showed 68.42% and 100% presence of HPV, respectively. This was found to be statistically significant (p<0.05). Conclusion: Pap smear along with HPV evaluation is an effective screening method for the detection of pre-invasive lesions and cancers of cervix that are potentially curable.

Characterizing the Effect of Processing Technique and Solution Type on Cytomorphology Using Liquid-Based Cytology

Introduction: Liquid-based cytology (LBC) is increasingly used for nongynecologic applications. However, the cytological preparation of LBC specimens is influenced by the processing technique and the preservative used. In this study, the influence of the processing techniques and preservatives on cell morphology was examined mathematically and statistically. Methods: Cytological specimens were prepared using the ThinPrep (TP), SurePath (SP), and AutoSmear methods, with 5 different preservative solutions. The cytoplasmic and nuclear areas of Papanicolaou-stained specimens were measured for all samples. Results: The cytoplasmic and nuclear areas were smaller in cells prepared using the 2 LBC methods, compared to that prepared using the AutoSmear method, irrespective of the preservative used. The cytoplasmic and nuclear areas of cells prepared using the SP method were smaller than those of cells prepared using the TP method, irrespective of the preservative used. There were fewer differences among the cytoplasmic areas of cells prepared with different preservative solutions using the TP method; however, the cytoplasmic areas of cells prepared using the SP method changed with the preservative solution used. Conclusions: The most significant difference affecting the cytoplasmic and nuclear areas was the processing technique. The TP method increased the cytoplasmic and nuclear areas, while the methanol-based PreservCyt solution enabled the highest enlargement of the cell. LBC is a superior preparation technique for standardization of the specimens. Our results offer a better understanding of methods suitable for specimen preparation for developing precision AI-based diagnosis in cytology.

Comparative analyses between conventional Papanicolaou smear method and the liquid based SurePath method in body cavity fluid cytology

Comparative analyses between conventional Papanicolaou smear method and the liquid based SurePath method in body cavity fluid cytology

Liquid-Based Cytology Preparation Can Improve Cytological Assessment of Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Objective: This study investigated whether liquid-based cytology (LBC) can improve diagnostic values of cytological assessment of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA). Study Design: A cohort of 600 cases in West China Hospital was prospectively studied from June 2012 to September 2013. EBUS-TBNA was carried out in outpatients under local anesthesia and moderate sedation. The procedure was performed with an echobronchoscope (BF-UC160F-OL8, Olympus, Tokyo, Japan). Histological cores were stained with hematoxylin and eosin for further study. Additional immunohistological analysis was performed for establishing a reliable diagnosis when necessary. Aspirates were smeared on glass slides and separate aspirates were processed by the monolayer SurePath method. Results: In total, 480 malignant tumors and 120 benign lesions were confirmed by histological examination. The sensitivity of SurePath liquid-based preparations and conventional smears was 82.1 and 56%, and the specificity was 87.5 and 82.5%, respectively. The combined specificity was 100%. Positive predictive values of the two groups were 96.3 and 92.8%, whereas negative predictive values were 54.9 and 31.9%, respectively. The difference between the two groups was significant (p < 0.001). Conclusions: LBC preparation can improve cytological assessment of EBUS-TBNA. Histological study is necessary in cases in which the cytological diagnosis is obscure.

WT1 immunoenzyme staining using SurePath(™) processed urine cytology helps to detect kidney disease.

Damage and detachment of podocytes and loss into the urine have been implicated in the progression of kidney diseases. The purpose of this study was to investigate the potential role of urine cytology based on SurePath(™) combined with immunoenzyme staining using Wilms' tumour 1 (WT1) antibody as a podocyte marker in the discrimination of normality and non-renal urinary tract disease from kidney disease. Sixty-six patients with kidney disease, 45 patients with lower urinary tract disease and 30 healthy volunteers were examined. Urine cytology slides were prepared using the SurePath method and immunoenzyme stained with WT1 antibody, and the number of WT1-positive cells was counted. In kidney disease, WT1-positive cells were found in 33 (50%) of 66 samples. No WT1-positive cells were found in 45 patients with lower urinary tract disease or in 30 healthy volunteers. The positive rates for WT1 varied with disease type, but not significantly: immunoglobulin A (IgA) nephropathy, (14/23); membranous glomerulonephritis, (4/10); Henoch-Schönlein purpura nephritis, (3/5); diabetic glomerulopathy, (5/5); minor glomerular abnormality/minimal change nephrotic syndrome (0/4). The results suggest that WT1 immunoenzyme staining of urine cytology can be used to detect some types of kidney disease.

Evaluation of Endometrial Cytology Prepared with the Becton Dickinson SurePath™ Method: A Pilot Study by the Osaki Study Group

Objective: To evaluate the sensitivity and specificity of the BD SurePath™ liquid-based Papanicolaou test for assessing the cytology of intrauterine endometrial samples according to newly devised cytological diagnostic criteria and a novel descriptive reporting format. Materials and Methods: One hundred and twenty-two endometrial samples were analyzed. All samples were obtained directly from the intrauterine cavity using the Uterobrush or Honest Super Brush. The samples used for the histological examination and cytological tests were collected simultaneously. Our study group devised new cytological diagnostic criteria for examining endometrial samples: the Osaki Study Group method. In this study, histological diagnosis was considered to be the gold standard for cytological diagnosis. A novel descriptive reporting format was also used. Results: Satisfactory cytological specimens were obtained in all cases. The sensitivity and specificity of the SurePath endometrial cytological examination method were 96.4 and 100%, respectively. Conclusion: These results indicate that the SurePath method is acceptable for clinical use. Since the SurePath method seems to be easier and allows greater preparation standardization than the conventional method, coupling it with our newly devised cytological diagnostic criteria and descriptive reporting format might represent a reliable diagnostic method for assessing endometrial specimens.

A quality improvement comparative study for respiratory specimen processing, screening and reporting

The current laboratory procedures for respiratory specimen processing are the pick and smear technique for sputum specimens and a concentrated direct smear from a cell pellet for bronchial brush/wash. Both techniques each produce two slides to examine. This study aims to compare the screening productivity, cytological findings, diagnostic sensitivity and specificity of respiratory specimens using the current methods for processing with those of a liquid-based SurePath method (LBC-SPM) for the detection of abnormalities, and the possibility of reducing the number of unsatisfactory samples. Approximately 200 respiratory specimens will be prepared using both current and LBC-SPM and assessed using the following criteria: diagnoses, the presence of obscuring material and time taken to screen the slides. The expected quality improvement outcomes of this study using the LBC-SPM should reduce the screening time of the specimen due to the reduced number of slides and a smaller screening area. Furthermore, clearer, more visible preparations should decrease obscuring inflammatory and foreign material and thus possibly increase the sensitivity and specificity rate and decrease the unsatisfactory rate. Should these results show a statistically significant improvement in any of the quality improvement objectives, recommendations will be discussed and implemented according to management assessment and approval.

Comparison of conventional and liquid-based cytology, and human papillomavirus testing using SurePath preparation in Japan

We compared the detection rate of cervical neoplasias between a liquid-based cytology (LBC) method using SurePath and the conventional method. We also studied the feasibility of human papillomavirus (HPV) typing by linear array assay. Cytological specimens from 1551 Japanese women were prepared using the conventional and SurePath methods; the cytological and histological results from biopsy samples were compared. HPV typing using an HPV linear array assay was carried out on residual specimens using the SurePath method. The cytodiagnostic results showed a concordance rate of 85.3% (Κ= 0.46) between the two methods. The sensitivity of lesions histopathologically diagnosed as CIN1 or above was not significantly different between the two methods (P = 0.575-1.000). The receiver operating characteristic curve analysis of the detectability in CIN2 or above revealed no significant difference between the two methods (P = 0.096). Among the 44 patients who underwent HPV typing using a linear array assay, 33 samples were eligible for HPV testing and were stored at ambient temperature. In conclusion, the SurePath and conventional methods have equivalent abilities for detecting cervical lesions. After preparation for cytological diagnosis, use of the remaining cells from the SurePath specimens to perform HPV typing using the linear array method could be feasible.

Longitudinal clinical evaluation of a novel antibody cocktail for detection of high-grade squamous intraepithelial lesions on cervical cytology specimens.

Abstract Context.—Although cervical cancer screening by cytology is successful, the test continues to show relatively poor operating characteristics. Cell cycle markers may enhance detection of high-grade squamous intraepithelial lesions. Objective.—To determine the clinical usefulness of ProExC, an immunocytochemical assay for cell cycle components, performed on routine cervical cytology samples. Design.—Cervical cytology samples were collected using the SurePath method. Residual cells remaining after preparation of the Papanicolaou-stained slide were used to make a second slide for ProExC staining using an indirect polymer-based immunoperoxidase method. Only adequately cellular slides were evaluated for the presence of nuclear staining within cytologically abnormal epithelial cells. Results were correlated with clinical follow-up. Results.—Six hundred twenty-four samples were satisfactorily cellular and stained. Correlation with clinical follow-up for subsequent cervical intraepithelial neoplasia 2+ on ...

Longitudinal Clinical Evaluation of a Novel Antibody Cocktail for Detection of High-Grade Squamous Intraepithelial Lesions on Cervical Cytology Specimens

Although cervical cancer screening by cytology is successful, the test continues to show relatively poor operating characteristics. Cell cycle markers may enhance detection of high-grade squamous intraepithelial lesions. To determine the clinical usefulness of ProExC, an immunocytochemical assay for cell cycle components, performed on routine cervical cytology samples. Cervical cytology samples were collected using the SurePath method. Residual cells remaining after preparation of the Papanicolaou-stained slide were used to make a second slide for ProExC staining using an indirect polymer-based immunoperoxidase method. Only adequately cellular slides were evaluated for the presence of nuclear staining within cytologically abnormal epithelial cells. Results were correlated with clinical follow-up. Six hundred twenty-four samples were satisfactorily cellular and stained. Correlation with clinical follow-up for subsequent cervical intraepithelial neoplasia 2+ on biopsy/high-grade squamous intraepithelial lesion on cytology (CIN 2+/HSIL) showed that 434 results were true negative, 78 true positive, 18 false-negative, and 94 false-positive, resulting in a sensitivity/specificity of 81%/82%. When ProExC results were combined with any level of cytologic atypia, sensitivity for CIN 2+/HSIL was 92% and specificity was 84%. ProExC shows promise as an aid in enhancing the sensitivity and specificity of cervical cytology for subsequent CIN 2+/HSIL and may be useful in identifying those cervical lesions most apt to progress.

Split Sample Comparison of a Liquid-Based Method and Conventional Smears in Thyroid Fine Needle Aspiration

To compare the efficacy of the SurePath (SP) vs. conventional smears (CS) in fine needle aspiration (FNA) of thyroid gland lesions.A total of 193 FNA cases with thyroid nodules were studied. Samples from ultrasound-guided FNA were split to prepare CS and SP slides. The diagnostic categories of unsatisfactory, benign, atypical and malignant were compared. Galectin-3 immunostaining was performed on SP slides.Some differences were found between the cytomorphology of CS and SP. SP slides showed more increased cellularity and more clustered tissue fragments. On SP slides, nuclear detail and nucleoli were more easily detected and nuclear irregularity was very useful for the diagnosis of papillary carcinoma. SP showed a trend toward a lower proportion of atypical category. The overall sensitivity of FNA in diagnosing thyroid neoplasm was 90.9% for CS and 93.9% for SP. Most lesions (73%) diagnosed as papillary carcinoma after surgery showed positive staining of galectin-3.The SP method showed easy evaluation of cytomorphologic features and consistent specimen quality and appeared to be more useful in diagnosing the suspicious cases. Moreover, it offered the possibility of adjunctive immunocytochemistry on the same sample.

Comparison of Two Preparation Methods for Endocervical Evaluation

To assess the validity of SurePath liquid-based preparation method for examination of endocervical brush specimens as a substitute for conventionally prepared cytology methods for evaluating the endocervical canal during colposcopic examination and biopsy.Paired SurePath liquid-based test slides and conventional smears were obtained using an endocervical brush in a split sample protocol before biopsy at the time of colposcopy. The level of agreement between cytologic results obtained was assessed. Accuracy and operating characteristics were evaluated compared to histologic follow-up.Agreement between cytology results for the methods was excellent. The overall kappa was 0.924 (p = 0.0000). There was exact agreement on interpretation between the methods in 283 of 299 cases (94.6%). Cytohistologic follow-up results correlation were: SurePath liquid-based Pap test results and conventional smear results agreed with histology results in 47.8% and 49.2% of cases, respectively. Allowing for a discrepancy within 1 level of severity of cytologic grade, agreements were 76.6% and 77.2%, respectively.This study demonstrates that the SurePath method is equivalent to conventional endocervical brush cytology preparation and performs well for detection of cervical intraepithelial lesions and cancer. SurePath is acceptable for endocervical evaluation as a substitute for endocervical curettage at colposcopic biopsy.

P‐26 CONVENTIONAL V THIN LAYER TECHNIQUES: A COMPARATIVE STUDY OF BRONCHIAL SPECIMENS USING CONVENTIONAL AND TWO LBC METHODS, THINPREP AND SUREPATH

The current, conventional method used is quick, easy and reasonably cheap but the nature of bronchial specimens themselves creates the need for a better preparation technique. Bronchial specimens often present with many obscuring features, such as blood and mucus, which can affect definitive diagnosis. In the study, the bronchial specimens underwent routine conventional preparation and that remaining was used to prepare an LBC slide. Both LBC methods were separately evaluated alongside the conventional method where, of the 44 specimens used, half were prepared using the conventional and ThinPrep and half with the conventional and SurePath. Evaluation forms were completed by pathologists who assessed all preparations. The results showed both LBC methods produced superior preparations that were better fixed, more cellular and had improved nuclear detail. They also removed a high percentage of background debris, were more diagnostically accurate and reduced the inadequate rate by a third. The conventional slides prepared from the same specimen as the SurePath had a lower average than those prepared with the ThinPrep. This indicated that the specimens used to evaluate the SurePath method were in fact inferior to those used for ThinPrep, with the SurePath slides showing only a slight improvement in overall quality. Despite LBC preparations reducing pathologist screening and reporting time, both methods are more labour intensive and less cost effective. The majority of laboratories are not in the financial situation to trial new methods that require extra training and more staff hours, and as such this study has highlighted an important question ‘Do the benefits of better quality preparation and diagnostic accuracy offset an increase in time and cost’.

Enhancing Recovery of Endocervical Component on Gynecologic Cytology Specimens Processed by Thin-Layer Technology

To address the causes and report the corrective measures required for resolving the initial problem of high rates of cervical vaginal cytology specimens reported as having no endocervical component on SurePath (AutoCyte, Inc., Burlington, North Carolina, U.S.A.) liquid-based, thin-layer technology at an academic center cytology laboratory. Analysis of 511 cases lacking endocervical/transformation zone component out of 9,221 SurePath thin-layer gynecologic specimens processed in a one-year period. The study encompassed a review of sample collection techniques by physicians and nurses, specimen processing, cytologic features of endocervical/squamous metaplastic cells processed by the SurePath method and statistical analysis of endocervical cell recovery rates after implementation of corrective measures. Absence of endocervical/transformation zone component varied from an initial 18% in the first month to an average of 5.3% after corrective actions were implemented. Current rates of SurePath thin-layer specimens having no endocervical component are lower than those for conventional smears. Since SurePath was only recently introduced to the market, there are no previously published data addressing how to optimize the recovery of endocervical component on liquid-based, thin-layer specimens processed by this methodology.