SurePath Specimens Research Articles

BD SurePath Direct to Slide (DTS) cervical cytology: Migrating the benefits of liquid-based cytology to low-resource settings.

The benefits of liquid-based cytology (LBC) in routine cervical cancer screening are often associated with the availability of instrumented platforms and economic considerations. A low-cost alternative to LBC in low-volume settings remains an unmet need. A multisite evaluation of the BD SurePath (SurePath) LBC Direct to Slide (DTS) method was conducted. The DTS preparations were evaluated across 3 sites. Cytology features for DTS preparation included predetermined thresholds for total cellularity, cell distribution, cellular preservation, and stain quality. Rare event detection was evaluated using SiHa cells spiked into pools from negative cytology specimens. Concordance between Bethesda classification results was evaluated for SurePath LBC and DTS methods using routinely collected SurePath specimens in a split-sample study design. The DTS specimens met criteria for total cellularity, cell distribution, cellular preservation, and stain quality in more than 98% of all cases. Rare event detection was observed with an average detection of 5 SiHa cells per 2mL of specimen. Concordant cervical cytology classifications were observed between SurePath LBC and DTS methods. The results demonstrate that the DTS process is suitable for routine cervical cytology evaluation. The procedure is reproducible and detected abnormal cervical cells in concordance with standard SurePath LBC preparation.

Comparison of Alinity m HPV and cobas HPV assays on cervical specimens in diverse storage media

ObjectiveTo assess the concordance of high-risk HPV (HR-HPV) testing with the Alinity assay on cervical samples collected with diverse collection/storage protocols (ThinPrep, SurePath, Cervicollect) and to assess inter-assay concordance of HR-HPV testing of cervical cell specimens with Alinity m HR HPV assay (Alinity) vs cobas® 4800 HPV assay (cobas). MethodsSpecimens were obtained from 560 women attending a Women's Health clinic. Two specimens were obtained from each woman with combinations of two of the three collection devices and aliquots were tested by the two assays. ResultsAlinity showed an agreement of 93.9%, Kappa = 0.89 (263/280) between ThinPrep and SurePath specimens; 97.5%, Kappa = 0.95 (347/356) and 92.9%, Kappa = 0.85 (104/112) between ThinPrep and SurePath aliquots taken before or after cytology processing, respectively. Cervi-Collect specimens showed an agreement of 94.6%, Kappa = 0.89 (265/280) with ThinPrep specimens. Compared to cobas, Alinity showed agreements of 94.3%, Kappa = 0.88 (395/419) and 91.8%, Kappa = 0.82 (257/280) between ThinPrep and SurePath specimens, respectively. Alinity and cobas detected genotypes 16/18 and other high-risk HPV types at similar rates and showed similar correlations with cytology grades. ConclusionsCompared to cobas, Alinity performed equally well for detecting HPV in cervical specimens obtained with ThinPrep and SurePath. The Cervi-Collect device compared well to the other collection methods. Alinity is a reliable assay for simultaneous detection of HPV-16/18 and other high-risk genotypes in cervical specimens.

The reporting rates of high-grade squamous intraepithelial lesions and their human papillomavirus testing and histologic follow-up results: A comparison between ThinPrep and SurePath preparations.

Liquid-based cytology (LBC) tests SurePath (SP) and ThinPrep (TP) have largely replaced conventional Papanicolaou (Pap) tests for cervical cytology screening due to higher sensitivity. However, comparison between SP and TP test sensitivity and efficacy in detecting squamous abnormalities is lacking. Our study aims to compare high-grade squamous intraepithelial lesion (HSIL) reporting rates, human papillomavirus (HPV) positivity rates, and histologic outcome between these two LBC methods. We performed a retrospective search of the period between January 2014 and June 2017, when both TP and SP were utilized at our institution, to identify HSIL cases and collect the HPV testing and histologic follow-up results for those cases. One hundred twenty-five HSILs were identified from the 15 382 TP specimens (0.81%) and 93 HSILs were identified from the 25 105 SP specimens (0.37%), a statistically significant difference (P < .0001). The corresponding HPV positivity rates were 95.6% and 89.7% in TP-HSILs and SP-HSILs, respectively, a statistically non-significant difference. Histologic follow-up showed HSILs or carcinomas were identified in 78% (49/63) of TP-HSILs and 79% (45/57) of SP-HSILs, with no statistically significant difference. TP demonstrated a higher HSIL detection rate than SP with no significant difference in follow-up HPV or histologic results.

Validation of cobas 4800 HPV assay in SurePath Papanicolaou specimens for cervical cancer screening

The cobas (Roche Diagnostics, Indianapolis, IN) HPV assay was approved by the US Food and Drug Administration for human papillomavirus (HPV) testing in SurePath (Becton Dickinson, Franklin Lakes, NJ) Papanicolaou specimens for cervical cancer prevention. To validate the cobas HPV assay in SurePath specimens in our institution, we compared its accuracy and clinical efficacy to that of the Cervista (Hologic, Marlborough, MA) HPV HR assay. This study used 138 Papanicolaou (Pap) cytology specimens collected in SurePath preservative fluid at our institution in 2018. After Pap cytology testing, the residual specimens were split for testing with the cobas and Cervista assays. Polymerase chain reaction (PCR)-based HPV testing (GP5+/GP6+) was performed on specimens with discrepant results. Clinical follow-up data were reviewed. The cobas HPV and Cervista HPV HR assays showed good concordance (89.1%), with a kappa value of 0.78 (95% CI: 0.675-0.885). Fifteen specimens showed discrepant results between the 2 assays. Of 7 cases with cobas+/Cervista- results, 5 (71%) were confirmed positive by PCR. Of 8 cases with cobas-/Cervista+ results, 4 (50%) were confirmed positive by PCR. cobas HPV and Cervista HPV HR showed the same HPV-positive rate in cases of pathologically diagnosed ASC-H, LSIL, or HSIL. The sensitivities and specificities for detecting high-risk HPV of cobas HPV (93.7%, 97.3%) and Cervista HPV HR (92.1%, 94.7%) were comparable. The cobas HPV assay had false-negative results in 4 cases (5.2%) including 1 false-negative case that failed to predict CIN3. The cobas HPV assay is valid in SurePath Pap cytology specimens for cervical cancer screening but has limitations of false-negative results with clinical implications.

Improving laboratory workflow through automated pre-processing of SurePath specimens for human papillomavirus testing with the Abbott RealTime assay.

Cervical specimens collected in liquid-based cytology (LBC) are used for cervical screening in the UK. The Abbott RealTime high-risk human papillomavirus (hrHPV) assay for the detection of 14 hrHPV types is approved by the English NHS Cervical Screening Programme (NHSCSP). As per manufacturer's instructions, pre-analytic processing of LBC involves a manual vortex and liquid transfer into a secondary tube. In high-throughput settings, hands-on time for pre-processing is considerable and poses the potential for human error. Implementation of hrHPV primary screening planned for 2019 accompanied by centralisation of services is a major change for the NHSCSP, increasing the demand for availability of automated pre-analytics. This study evaluated a custom-configured work-table setup of the Tecan Freedom EVO designed to automate pre-processing of BD SurePath LBC prior to HPV testing on the Abbott m2000. Automatically and manual pre-processed specimen results were compared (primary screening population n=307; triage population n=169). Excellent agreement of overall hrHPV results (98.1%; k: 0.95) was observed. On average, it takes approximately 1.5minutes hands-on-time per sample to process manually compared to 45minutes to aliquot 48 samples using the Freedom EVO 150. The Tecan worktable configuration designed to automate and control pre-analytics required for preparing SurePath LBC samples for HPV testing using Abbott RealTime resulted in assay performance comparable to that following the manufacturer validated manual process. It significantly reduces hands-on-time and allows for complete specimen identification tracking and documentation of process control.

Performance of the cobas HPV Test for the Triage of Atypical Squamous Cells of Undetermined Significance Cytology in Cervical Specimens Collected in SurePath.

Determine performance of the cobas human papillomavirus (HPV) test for triage of atypical squamous cells of undetermined significance (ASC-US) in SurePath. Women presenting for routine screening had cervical specimens collected in SurePath and specimen transport medium (STM); those with ASC-US cytology underwent colposcopy. Performance of cobas HPV in SurePath specimens that had undergone a preanalytic procedure to reverse possible cross-linking of HPV DNA was compared with Hybrid Capture 2 (hc2) specimens in STM. Among 856 women, HPV prevalence was 45.8%; HPV 16 and HPV 18 prevalences were lower than expected in the 21- to 29-year-old group in this highly vaccinated population. cobas HPV performance in SurePath was comparable to hc2 in STM. Sensitivity and specificity for detection of cervical intraepithelial neoplasia grade 3 or worse were 87.5% (95% confidence interval [CI], 71.9%-95.2%) and 55.5% (95% CI, 52.1%-58.9%) for cobas and 85.3% (95% CI, 69.9%-93.6%) and 54.7% (95% CI, 51.4%-57.9%) for hc2. Sensitivity was negatively affected by random biopsies performed at colposcopy; comparable sensitivities were achieved in the nonvaccinated and vaccinated populations with disease determined by directed biopsy only. Performance of cobas HPV for ASC-US triage in pretreated SurePath specimens meets criteria for validation. Preliminary data indicate reliable performance of HPV testing in a highly vaccinated population.

Detection of cervical precancerous lesions with Aptima HPV assays using SurePath preservative fluid specimens

SurePath specimens from women referred to colposcopy were treated with Aptima Transfer Solution (ATS) before testing in Aptima HPV (AHPV) and Aptima HPV 16, 18/45 (AHPV-GT) assays. Untreated SurePath specimens were tested with the cobas HPV test. PreservCyt specimens were assessed for cytology and tested with AHPV. High-grade cervical intraepithelial neoplasia lesions served as the reference standard. Excellent agreement (95.5%; k=0.91) was observed for ATS-treated SurePath specimens between Tigris and Panther systems and between the PreservCyt and ATS-treated SurePath specimens (91.1%, k=0.81) with the AHPV assay on Tigris. Agreement between the AHPV and cobas assays with SurePath specimens was substantial (89.9%, k=0.80). AHPV sensitivity for CIN2+(n=147) was 91.2% for SurePath and PreservCyt. Cobas HPV sensitivity was 93.9% for SurePath specimens. AHPV testing of SurePath specimens was more specific (59.4%) than cobas (54.7%) (p<0.001). Detection and genotyping showed similar absolute and relative risks. ATS-treated SurePath specimens tested with AHPV and AHPV-GT assays showed similar performance with greater specificity than cobas HPV on SurePath specimens. Similar overall results were seen using a CIN3 disease endpoint.

Multiple Human Papilloma Virus Infections and Their Impact on the Development of High-Risk Cervical Lesions

Objective: Individuals are often infected with multiple genotypes of human papillomavirus (HPV) simultaneously, but the role these infections play in the development of cervical disease is not well established. This study aimed to determine the association of multiple HPV infections with high-risk cervical lesions (hrCLs). Study Design: HPV genotyping was performed on 798 SurePath specimens collected between December 1, 2009, and April 30, 2011. The cases were classified as hrCL (n = 90) or non-hrCL (n = 708) based on cytology diagnoses. The association between hrCL and HPV infection patterns was analyzed. Results: Multiple HPV infections were frequently encountered (38.2%) in the cohort. Increased frequency of hrCLs was associated with a single high-risk HPV (hrHPV) infection. An additive or synergistic effect was not observed for hrCL in multiple HPV infections. The hrCL rates appeared to decrease in various patterns of multiple HPV infections, but the reduction was not statistically significant. Conclusions: Multiple HPV infections are common with no additive or synergistic effect on the development of hrCL. Conversely, reduced hrCL rates were observed in various patterns of multiple HPV infections compared to their single-genotype infection counterparts, suggestive of possible intergenotypic competition or more effective immune response triggered by multiple infections. Further studies in larger cohorts are needed.

Specimen Age Stability for Human Papilloma Virus DNA Testing Using BD SurePath.

Currently, the BD SurePath liquid-based Papanicolaou (Pap) test is approved by the U.S. Food and Drug Administration (FDA) only for Pap testing; however, these specimens are widely used for human papilloma virus (HPV) testing. We retested, at 21 days after the collection date, 50 BD SurePath specimens that had initially tested positive for high-risk HPV using the Roche Cobas 4800 assay to compare repeat results of aged specimens to original results and evaluate false-negative results. Of 50 specimens that initially tested positive for HPV DNA with the Roche Cobas 4800 assay (average, 7 days), 8 tested negative when retested at 21 days after the collection date (false-negative rate, 16.0%). Aged BD SurePath-preserved Pap test specimens older than 21 days from collection date may produce false-negative HPV DNA testing results when testing with assays such as Roche Cobas 4800, most likely due to degradation of DNA. Guidelines are needed to limit specimen age to less than 2 weeks to prevent false-negative test results and to improve diagnostic accuracy and patient care.

Sensitivity of high-risk HPV Hybrid Capture II (hrHPV HC2) test using SurePath(TM) specimens in the prediction of cervical high-grade squamous lesions.

High-risk HPV (hrHPV) testing is now considered standard of care in the detection and management of cervical high-grade squamous intraepithelial lesions (HSIL/CIN 2-3) and their precursors. Recently, there has been concern in the scientific literature and lay media about the lack of data regarding the false-negative rate (FNR) of HPV testing on SurePath(TM) cytology specimens. This is a critical issue, since guidelines on the management of Pap test abnormalities rely heavily on HPV status. We undertook this study to determine whether HPV testing on SurePath(TM) specimens is less sensitive compared to reports in the literature for ThinPrep®. We identified women with new diagnoses of CIN 2, CIN 3, and squamous cell carcinoma (SCC) on biopsy or excision in 2009-2013. For each patient, we recorded all SurePath(TM) cytology and hrHPV HC2 (high-risk HPV Hybrid Capture 2) test results from within 5 years prior to histologic diagnosis. Using the histologic diagnosis as the gold standard, we calculated the sensitivities of cytology and hrHPV HC2 tests for the detection of CIN 2, 3, and SCC. Our findings are based only on women who underwent biopsy or excision after having an abnormal cytology and/or positive HPV result. In our cohort, the sensitivity of testing in the 5 years prior to histologic diagnosis of CIN 2, 3, and SCC (combined as a single group) is 98.4% for SurePath(TM) cytology, 95.3% for hrHPV HC2, and 100% if both tests are used together. No conclusion can be drawn regarding testing for SCC alone, because there was only one case of SCC. Our results show that the false-negative rate of hrHPV HC2 testing on SurePath(TM) specimens for the detection of CIN 2 and CIN 3 is low and comparable to that of ThinPrep® specimens.

Analytical performance of cervista HPV 16/18 in SurePath pap specimens.

To evaluate the performance of Cervista HPV 16/18 in SurePath specimens, we compared the analytical sensitivity of Cervista HPV 16/18 with that of a previously validated PCR-based, commercially available HPV genotyping assay, EasyChip HPV Blot, in residual specimens collected after routine Pap tests at our cancer center. We retrospectively selected 79 consecutive Cervista HPV HR (high risk)-positive SurePath residual Pap specimens. The cytology results for these specimens comprised 42 negative, 22 ASC-US/ASC-H, 10 low-grade squamous intraepithelial lesions, and 5 high-grade squamous intraepithelial lesions. HPV 16/18 genotypes of the 79 specimens were analyzed by Cervista HPV 16/18 assay and EasyChip genotyping assay and compared with the patient's follow-up results. Of the 79 cases, 33 (42%) were positive for HPV16/18 by Cervista HPV 16/18 and 37 (47%) were positive by EasyChip. The overall agreement between the 2 assays, at 85% (67/79), was good (kappa = 0.698, 95% CI: 0.541-0.855). In the 65 patients with follow-up results, the sensitivity for predicting cervical intraepithelial neoplasia grade 2 or higher (CIN2+) was 77% for Cervista HPV 16/18 assay and 69% for EasyChip. The predictive values for CIN2+ in cases stratified by Pap results were highly consistent between the Cervista HPV16/18 and EasyChip assays; there was one false negative HPV16 result, in a specimen identified as NILM by EasyChip. Our findings support use of the Cervista HPV 16/18 assay for HPV16/18 genotyping in SurePath Pap specimens. However, further studies of larger cohorts with clinical follow-up data are required to verify the efficacy of Cervista HPV16/18 assay in SurePath Pap specimens.

Stability of Cervical Specimens in SurePath Medium for Human Papillomavirus Testing with the Roche cobas 4800 Assay

The stability of cervical specimens in SurePath preservative fluid for human papillomavirus (HPV) testing with Roche cobas 4800 was determined using a panel of 308 pooled specimens from a colposcopy referral population. The SurePath specimens appeared to be stable for up to 10 weeks at ambient temperature for HPV testing with cobas 4800.

Unexpected High Prevalence of HPV 90 Infection in an Underserved Population: Is It Really a Low-Risk Genotype?

Human papillomavirus 90 (HPV 90) is a rarely reported genotype worldwide, with few data available to characterize its prevalence, distribution, and disease association. To investigate the prevalence, distribution, and disease association of HPV 90 infection in an underserved inner-city Latino population. Residual SurePath specimens were collected from 808 women referred for abnormal Papanicolaou tests. DNA microarray against HPV subtypes determined HPV genotypes, followed by confirmatory DNA sequencing assays. HPV 90 was detected in 32 women (4%) with an average age of 39 years (range, 23-42 years). Most women (31 of 32) had only HPV 90 infection, and one woman was coinfected with HPV 13. Two women had low-grade intraepithelial lesion and one woman had low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion; the rest of the women had negative concurrent cytology. Available concurrent biopsies in 2 of 3 instances with abnormal cytology confirmed HPV cytopathic effect, with no high-risk HPV detected by in situ hybridization. We demonstrated an unexpected, high infection rate of HPV 90 in an underserved population in the United States, with 9.4% having concurrent cytologic abnormalities. In the absence of other detectable HPV genotypes by DNA microarray, DNA sequencing, and in situ hybridization, we suspect HPV 90 may be a causative agent responsible for the concurrent cervical lesions. Because of potential shifts in HPV infection patterns in the postvaccine era, monitoring the emergence of previously underrecognized HPV genotypes is becoming increasingly important. To the best of our knowledge, this is the first study to characterize HPV 90 infection in an underserved, North American population.

Should LSIL‐H be a distinct cytology category?

The 2001 Bethesda System for gynecologic cervical cytology reporting classifies squamous intraepithelial lesions into low-grade (LSIL) and high-grade (HSIL) lesions. An intermediate term, "low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion (LSIL-H)," has been used in a small percentage of LSIL cases. To the authors' knowledge, little is known regarding the human papillomavirus (HPV) status in patients with LSIL-H. A total of 808 SurePath specimens obtained between December 2009 and April 2011 were tested for 40 HPV genotypes using DNA microarray, followed by a confirmatory DNA sequencing assay. The infection rate for high-risk HPV in women with LSIL-H (92%) was strikingly close to that for women with HSIL (91%), which was higher than that for those with LSIL (74%); atypical squamous cells, cannot rule out high-grade lesion (ASC-H) (78%); or LSIL and ASC-H combined (74%). HPV type 16, the most common carcinogenic HPV genotype, was detected in 36% of women with LSIL-H, which was significantly higher than that in women with LSIL and ASC-H combined (13.8%), but less than that in women with HSIL (44.6%). Patients with LSIL-H and HSIL had similar infection rates for low-risk/intermediate-risk HPV genotypes, which were lower than those in LSIL or LSIL and ASC-H combined. Women found to have LSIL-H on a Papanicolaou test appear to have a unique HPV distribution pattern that clearly differs from LSIL and is comparable to that for HSIL, suggesting an increased risk of high-grade lesions over that of women with LSIL. Recognizing LSIL-H as an independent diagnostic category may help in the early identification of the high-risk subgroup that may require a management algorithm comparable to that for patients with HSIL. Cancer (Cancer Cytopathol) 2012. © 2012 American Cancer Society.

Implementation of FocalPoint GS location‐guided imaging system

Recently, the Food and Drug Administration approved the use of the location-guided imaging system FocalPoint GS (FPGS), on SurePath Papanicolaou (Pap) tests for primary screening. The objective of the current study was to evaluate the impact of FPGS on the following: distribution of diagnostic categories; rate of high-risk human papillomavirus (HR-HPV)-positive ASC-US cases; and quality control (QC) data before and after FPGS implementation. A search of the laboratory information system was performed to identify all SurePath Pap tests processed in our laboratory for the first 19 months after FPGS implementation. We also retrieved all SurePath specimens from a 16-month period prior to FPGS implementation to serve as the control. During the period from Janaury 2008 to April 2009, the FocalPoint Slide Profiler was used. Implementation of FPGS resulted in a significantly higher percentage of LSIL and ASC-US interpretations, as well as a significant increase in the detection of candidiasis and bacterial vaginosis. The ASC-to-SIL ratio was 1.4 and 1.9 before and after FPGS implementation, respectively. There was a decrease in the HR-HPV positive rate in ASC-US cases, and a decrease in the estimated false-negative fraction after FPGS implementation. In conclusion, our study seems to demonstrate a favorable performance of FPGS in the routine clinical setting. FPGS may have the potential to be a promising screening tool for gynecologic cytology in a low-risk patient population.

Liquid‐based FNAC of the thyroid

The aims of this study were to analyze cytomorphological features of Tripath PREP (BD SurePath, Burlington, NC) preparations in thyroid nodules and to examine adequacy and accuracy of SurePath and frozen sections for both clinical outcome and histological diagnosis when applicable. Gathered during a period of 4 years, 712 SurePath specimens of the thyroid were included. Histological (n = 207) or clinical follow-up (n = 505) was available in all cases. During the same period, 253 frozen sections of surgical thyroid resection specimens were also assessed. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value were calculated. Sensitivity was 77% for SurePath and 29% for frozen section; specificity was 81% for SurePath and 100% for frozen section; accuracy was 80% for SurePath and 90% for frozen section. One hundred seventy-eight (25%) SurePath patients were considered unsatisfactory for diagnosis. In this study, sensitivity, specificity, and accuracy were comparable for SurePath and other reported results of liquid-based thyroid cytology. Presence of free colloid or pure cystic changes favored a benign diagnosis. Cellular smears with nuclear atypia of papillary carcinoma allowed an overt diagnosis of malignancy. The authors concluded that SurePath is a reliable technique for assessment of thyroid nodules and offers the advantage of easy identification of colloid and atypical nuclei. Supplementary frozen section analysis should be limited to an FNAC diagnosis of suspicious for papillary carcinoma.

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.

APTIMA assay on SurePath liquid-based cervical samples compared to endocervical swab samples facilitated by a real time database

Background:Liquid-based cytology (LBC) cervical samples are increasingly being used to test for pathogens, including: HPV, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) using nucleic acid amplification tests. Several reports have shown the accuracy of such testing on ThinPrep (TP) LBC samples. Fewer studies have evaluated SurePath (SP) LBC samples, which utilize a different specimen preservative. This study was undertaken to assess the performance of the Aptima Combo 2 Assay (AC2) for CT and GC on SP versus endocervical swab samples in our laboratory.Materials and Methods:The live pathology database of Montefiore Medical Center was searched for patients with AC2 endocervical swab specimens and SP Paps taken the same day. SP samples from CT-and/or GC-positive endocervical swab patients and randomly selected negative patients were studied. In each case, 1.5 ml of the residual SP vial sample, which was in SP preservative and stored at room temperature, was transferred within seven days of collection to APTIMA specimen transfer tubes without any sample or patient identifiers. Blind testing with the AC2 assay was performed on the Tigris DTS System (Gen-probe, San Diego, CA). Finalized SP results were compared with the previously reported endocervical swab results for the entire group and separately for patients 25 years and younger and patients over 25 years.Results:SP specimens from 300 patients were tested. This included 181 swab CT-positive, 12 swab GC-positive, 7 CT and GC positive and 100 randomly selected swab CT and GC negative patients. Using the endocervical swab results as the patient’s infection status, AC2 assay of the SP samples showed: CT sensitivity 89.3%, CT specificity 100.0%; GC sensitivity and specificity 100.0%. CT sensitivity for patients 25 years or younger was 93.1%, versus 80.7% for patients over 25 years, a statistically significant difference (P = 0.02).Conclusions:Our results show that AC2 assay of 1.5 ml SP samples transferred to APTIMA specimen transfer medium within seven days is sufficiently sensitive and specific to be used to screen for CT and GC. CT sensitivity may be somewhat reduced in samples from patients over 25 years. SP specimens retained in the original SP fixative for longer time intervals also may have decreased sensitivity, due to deterioration of RNA, but this was not assessed in this study. The ability to tap the live pathology database is a valuable tool that can useful to conduct clinical studies without a costly prospective clinical trial.

Cytological distinction between high-risk and low-risk human papillomavirus infections in SurePath liquid-based cell preparations

Aims:To investigate the correlation of various diagnostic cytological features in SurePath liquid-based cell preparations with high-risk human papillomavirus (HPV) infection.Methods:Case–control study. SurePath specimens from 510 cases that had been tested...

Cytologic features of endocervical glandular lesions: Comparison of SurePath, ThinPrep, and conventional smear specimen preparations

The cytologic features of endocervical neoplasia have been well-described for conventional and ThinPrep, but not for SurePath, methods. This study is designed to ascertain if cytological features are similar in SurePath specimens. Conventional, ThinPrep and SurePath specimens with either endocervical adenocarcinoma in situ or invasive endocervical adenocarcinoma were evaluated for architectural and cytological features previously described for endocervical neoplasia. A generalized linear model was used to assess the differences of ordinal multinomial data. Of 18 evaluated, the only features showing statistical differences were architectural: large groups of cells and single cells were more frequent in SurePath preparations and conventional smears. Feathering was more frequently noted in conventional smears. Individual cytological features were identical across all groups. Mitoses and apoptotic debris were seen with equal frequency in all preparations. The architectural and cytologic features of endocervical glandular neoplasia in liquid-based specimens show only subtle architectural differences when compared with conventional smears. Keeping these differences in mind, virtually the same criteria can be used to identify endocervical glandular lesions in all three specimen types.