Biomedical subjects

Sarah J Day

Publications and source records attributed to Sarah J Day.

5 recordsLinked to original sources

PubMed2005

Test performance comparison of inform HPV and hybrid capture 2 high-risk HPV DNA tests using the SurePath liquid-based Pap test as the collection method.

No US Food and Drug Administration-approved method is available to test for human papillomavirus (HPV) DNA in the SurePath liquid-based Papanicolaou (Pap) test (TriPath Care Technologies, Burlington, NC). We compared the performance characteristics of Inform HPV (Ventana Medical Systems, Tucson, AZ) and Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD) using SurePath for collection. The study included samples from 102 women, aged 18 to 60 years, who underwent a SurePath Pap test immediately before colposcopy and cervical biopsy. Each SurePath specimen was processed additionally for Inform HPV and HC2. Performance characteristics were determined by using the cervical biopsy as the "gold standard." The SurePath, Inform HPV, and HC2 correctly identified high-grade squamous intraepithelial lesions (HSILs) in 15 (94%) of 16, 6 (38%) of 16, and 14 (93%) of 15 cases, respectively. When only SurePath samples with a diagnosis of atypical glandular and/or squamous cells were examined, Inform HPV and HC2 correctly identified HSIL in 19 (43%) of 44 and 45 (100%) of 45 cases, respectively. When SurePath is used for collection, Inform HPV lacks sufficient sensitivity to detect HSIL reliably.

Adolescent↗

PubMed2004

Additional collection devices used in conjunction with the SurePath Liquid-Based Pap Test broom device do not enhance diagnostic utility.

BACKGROUND: We have previously shown that use of an EC brush device in combination with the Rovers Cervex-Brush (SurePath broom) offered no significant improvement in EC recovery. Here we determine if use of additional collection devices enhance the diagnostic utility of the SurePath Pap for gynecologic cytology. METHODS: After informed consent, 37 women ages 18-56 receiving their routine cervical examinations were randomized into four experimental groups. Each group was first sampled with the SurePath broom then immediately re-sampled with an additional collection device or devices. Group 1: Rover endocervix brush (n = 8). Group 2: Medscand CytoBrush Plus GT (n = 7). Group 3: Rover spatula + endocervix brush (n = 11). Group 4: Medscand spatula + CytoBrush Plus GT (n = 11). RESULTS: Examination of SurePath broom-collected cytology yielded the following abnormal diagnoses: atypia (n = 2), LSIL (n = 5) and HSIL (n = 3). Comparison of these diagnoses to those obtained from paired samples using the additional collection devices showed that use of a second and or third device yielded no additional abnormal diagnoses. Importantly, use of additional devices did not improve upon the abnormal cell recovery of the SurePath broom and in 4/10 cases under-predicted or did not detect the SurePath broom-collected lesion as confirmed by cervical biopsy. Finally, in 36/37 cases, the SurePath broom successfully recovered ECs. Use of additional devices, in Group 3, augmented EC recovery to 37/37. CONCLUSIONS: Use of additional collection devices in conjunction with the SurePath broom did not enhance diagnostic utility of the SurePath Pap. A potential but not significant improvement in EC recovery might be seen with the use of three devices.

Journal Article↗

PubMed2003

Effectiveness of the SurePath liquid-based Pap test in automated screening and in detection of HSIL.

We have shown that SurePath when compared to conventional Paps fails to increase HSIL detection. In this study, assessment of test performance characteristics for the FocalPoint showed that sensitivity was 96% when manual screening was used as the "gold standard." When cervical biopsy, however, was used as the "gold standard" FocalPoint sensitivity decreased to 93%, which was the same as manual screening. Examination of the FocalPoint "no further review" cases showed that 4/296 were SIL. To understand better the implication of an SIL diagnosis, cervical biopsies generated from SurePath and conventional Paps were compared. Conventional Paps diagnosed as LSIL had a biopsy LSIL:HSIL ratio of 3.1/1, while SurePath Paps had a biopsy LSIL:HSIL ratio of 1.5/1. These results indicate that when cervical biopsy is used as the "gold standard," FocalPoint and manual screening of SurePath Paps have similar test performance but that the FocalPoint can fail to detect LSIL. Importantly, LSIL in a SurePath Pap is 1.6 times more likely to be HSIL on biopsy than LSIL in a conventional Pap.

False Negative Reactions↗

PubMed2002

Dual sampling of the endocervix and its impact on AutoCyte Prep endocervical adequacy.

We compared satisfactory for evaluation but limited by (limited by) and unsatisfactory gynecologic cytologic diagnoses for samples collected by conventional smearing with those generated with the AutoCyte Prep in a population with a historic squamous intraepithelial lesion (SIL) rate of less than 1%. Results from 18,819 AutoCyte Preps were compared with 53,835 conventional cervical smears. Furthermore, 23 women ages 18 to 65 years undergoing annual Papanicolaou tests underwent sequential sampling with the AutoCyte Prep and the Surgipath C-E brush. Comparison of the AutoCyte Prep with conventional cytologic diagnoses revealed the following: unsatisfactory rate, down 97%; limited by rate, down 67%; low-grade SIL rate, up 86%; cervical cancer rate, up 300%; and high-grade SIL rate, unchanged. Examination of unsatisfactory and limited by cases for the AutoCyte Prep showed that 88% were due to absence of endocervical cells (ECs). Dual sampling showed no improvement in EC recovery over the AutoCyte collection device. Compared with conventional Papanicolaou smears, the AutoCyte Prep significantly decreased the rate of unsatisfactory and limited by specimens while increasing low-grade SIL and cancer detection and EC recovery. The majority of limited by specimens with the AutoCyte Prep were due to absence of ECs, but use of a brush-type device for better endocervical sampling did not enhance EC recovery.

Adolescent↗

PubMedDate not supplied

New red blood cell lysing fixative for use in fine needle aspiration and fluid cytology.

OBJECTIVE: To describe a new red blood cell (RBC) lysing fixative, Devine's lysing solution (DLS), that increases the diagnostic utility of fine needle aspiration (FNA) and fluid cytology. STUDY DESIGN: Twenty bloody FNA cases were fixed with either DLS or 95% ethanol, and the ability to render a diagnosis on these materials was analyzed. DLS was compared to the red cell lysing fixative CytoRich Red (CRR) (TriPath Care Technologies, Burlington, North Carolina, U.S.A.) in its ability to lyse RBCs by mixing human RBCs with the U266 multiple myeloma cell line. DLS was compared to CRR in its ability to suitably preserve materials for Papanicolaou and immunocytochemical analysis. RESULTS: Comparison of DLS with 95% ethanol fixation in 20 bloody FNA cases prepared in duplicate showed that DLS reduced from 17 to 3 the number of cases that had RBCs obscuring > or = 25% of the diagnostic material. In 3 cases, DLS enabled the rendering of a definitive diagnosis of malignancy, which could not be made on the ethanol-fixed material. DLS was compared to CRR, and both fixatives were similarly effective at lysing RBCs, preserving the cellular morphology of diagnostic cells in FNA and fluid cytology, and preserving cells for use in immunocytochemistry. CONCLUSIONS: DLS increases the visualization of diagnostic cellular material when compared to ethanol fixation. DLS is comparable to CRR in RBC lysing ability, diagnostic cell preservation and preservation of materials for immunocytochemistry.

Artifacts↗