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Surepath liquid based pap test

Manufactured by BD
Sourced in United States

SurePath liquid-based Pap test is a laboratory equipment product that is used for the collection, processing, and preparation of cervical cell samples for cytological examination. It is a standard technique for screening and detection of cervical cancer and precancerous changes.

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6 protocols using surepath liquid based pap test

1

Vaginal Epithelial Sampling Protocol

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Vaginal samples were collected by trained gynecologists. The procedure began by removing the cervical mucus with a sterile swab. Furthermore, endocervical and exocervical epithelia were gathered with a cervix examination brush (Rovers Cervex-Brush; Rovers Medical Devices B.V., Oss, The Netherlands). Additionally, the pH of the mucus samples was determined from the vaginal swab using a pH test strip (MColorpHast; Merck-Millipore, Burlington, MA, USA). The detachable head of the cervix examination brush was preserved in a liquid vial (BD SurePath™ liquid-based Pap test; BD Biosciences, San Jose, CA, USA) and transported under refrigeration conditions (4 °C). The samples were stored at −40 °C for 5 h until DNA extraction.
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2

Cervical Cancer Screening Protocol

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Four hundred and eighty women were screened for LSIL, including cervical intraepithelial neoplasia grade 1 (CIN1); HSIL, including CIN2/3; and ICC, through visual inspection with acetic acid (VIA) and Lugol according to WHO guidelines [31 ,32 (link)]. In addition, endocervical samples were collected for HPV testing and characterization. Specimens were collected using BD SurePath™ liquid-based Pap test and shipped to Clinica Universidad de Navarra (Pamplona, Spain), where they were stored at 4 °C until further use.
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3

Cervical Cytology Sample Preparation

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An automated liquid-based cytology, SurePath™ liquid-based Pap test (BD, USA), was employed for cytological sample preparation. After removing obscuring mucus from the cervix with a cotton swab, endocervical and ectocervical cells were collected with cytobrush. This cytobrush was immediately rinsed in a vial containing SurePath Preservative Fluid. Samples were transported at room temperature for analysis at the International Clinical Laboratories (ICL) in Addis Ababa using BD PrepMate™ and PrepStain™ Slide Processor. Vials containing samples were labeled and placed into the BD PrepMate™ Slide Processor in which a liquid-based filtration process removed mucus and debris, preserving cell morphology, and making a smear of even distribution. All slides were stained with the BD SurePath Kit Cytology Stain and examined by two pathologists [7 (link)] who were enrolled in the College of American Pathologists (CAP) proficiency program and received stained LBC slides every three months as well as participating in the external quality assurance scheme. LBC test results were recorded based on the Bethesda gynecologic cytology guideline [8 (link)].
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4

Cervical Exfoliated Cells Screening Protocol

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Another cervical exfoliated cells sample was collected by cyto-brush (QIAGEN, Valencia, CA) among women with HPV infection. ThinPrep 2000 (Hologic Inc.) and SurePath liquid-based Pap test (BD, USA) were used for the TCT test which was performed by Kingmed Center for Clinical Laboratory Corporation (Guangzhou, China). Cytological slides were read by three cytopathologist. Cervical cell samples were categorized according to the Bethesda System (2001)
[18 (link),19 (link)] as follows: normal; atypical squamous cells of unknown significance (ASCUS); low-grade squamous intraepithelial neoplasia (LSIL); and high-grade squamous intraepithelial lesion (HSIL) or worse (i.e., cases of squamous cell carcinoma were combined with HSIL cases for the purposes of analysis).
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5

Cervical Cytology Evaluation via Liquid-Based Pap Test

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The cytobrush containing cervical exfoliated cells was collected and stained, and then fixed in TCT cytological solution for 15 min. TCT was performed by a SurePath liquid-based Pap test (BD, United States), according to the manufacturer's instructions. Cervical cytology test results were classified by the Bethesda System (TBS; 2001) criteria as follows: negative for intraepithelial lesion or malignancy (NILM); atypical glandular cells (AGC); squamous intraepithelial lesions (SIL) of low (LSIL) or high (HSIL) grade; atypical squamous cells (ASC) of undetermined significance (ASC-US) or not possible exclude HSIL (ASC-H); and squamous cell carcinoma (SCC) (25 (link)). In this study, cervical cytology was dichotomized into normal (NILM) and abnormal (≥ASC). More detailed information is available in our previous study (22 (link)).
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6

Cervical Cell Collection and Screening

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Cervical exfoliated cells were collected by cytobrush (Qiagen China Co., Ltd, Shanghai, China) from ectocervix and endocervix of the uterus of every woman by cervical scrapings. These were then fixed in TCT cytological solution for 15 min. ThinPrep 2000 (Hologic Inc., USA) and a SurePath liquid-based Pap test (BD, USA) were used for the TCT test. ThinPrep smears were screened by two independent cytopathologists. The smears were stained using standard Pap methodology and classified using the The Bethesda System (TBS; 2001) criteria [19 (link),20 (link)] as follows: negative for intraepithelial lesion or malignancy (NILM); atypical squamous cells of unknown significance (ASCUS); atypical squamous cells-high grade (ASC-H); low-grade squamous intraepithelial neoplasia (LSIL); and high-grade squamous intraepithelial lesion (HSIL) or worse.
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