The PrepStain ® System produces SurePath ® slides that are intended as replacements for conventional gynecologic Pap smears. Refer to the assay package inserts for instructions virus de papiloma humano es igual que sida using SurePath ® Preservative Fluid to prepare specimens for use with these assays. Air-drying artifact, obscuring, overlapping cellular material and debris are largely eliminated. The numbers of white blood cells are significantly reduced, allowing for easier visualization of epithelial cells, diagnostically relevant cells and infectious organisms.
The SurePath ® process begins with qualified medical personnel using a broom-type sampling device e. Rather than smearing cells collected by the sampling devices on a glass slide, the heads of the sampling devices detach from the handle and are placed into a vial of SurePath ® Preservative Fluid.
The vial is capped, labeled, and sent with appropriate paperwork to the laboratory for processing.
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The heads of the sampling devices are never removed from the preservative vial containing the collected sample. An enrichment step, consisting of centrifugal sedimentation through Density Reagent, partially removes non-diagnostic debris and excess inflammatory cells from the sample.
After centrifugation, the pelleted cells are resuspended, mixed and transferred to a PrepStain ® Settling Chamber mounted on a SurePath ® PreCoat slide. The cells are sedimented by gravity, then stained using a modified Papanicolaou staining procedure.
The slide is cleared with xylene or a xylene substitute and coverslipped. The cells, presented within a 13mm diameter circle, are examined under a microscope by trained cytotechnologists and pathologists with access to other relevant patient background information. Wooden spatulas should not be used with the PrepStain ® System.
PrepStain® System Product Insert - BD
Cytotechnologists and pathologists will be trained in morphology assessment on the SurePath ® slides. Training will include a proficiency examination.
Laboratory customers will be provided with the use of instructional slide and test sets. TriPath Imaging, Inc. Used supplies should be disposed of properly in accordance with institutional and governmental regulations.
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Reagents For In Vitro Diagnostic use. For laboratory use only. SurePath® Preservative Fluid contains an aqueous solution of denatured ethanol. The mixture contains small amounts of methanol and isopropanol. Do not ingest. PrepStain® Density Reagent contains sodium azide. On disposal, flush with a large volume of water to prevent buildup of azide.
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See website: www. Toxic if ingested. Do not breathe vapors.
Use with adequate ventilation. Avoid contact with skin and eyes. Highly flammable. The storage condition for SurePath ® Preservative Fluid without cytologic samples is up to 36 months from date of manufacture at room temperature 15° to 30° C.
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The storage limit for SurePath ® Preservative Fluid with cytologic samples is 6 months at refrigerated temperature 2° to 10° C or 4 weeks at room temperature 15° to 30° C. Operators should use appropriate hand, eye and clothing protection. However, universal precautions for safe handling of biological fluids should be practiced at all times. Healthcare providers may need to acquire a new specimen if the results do not correlate with the clinical history of the patient.
Furthermore, cytology addresses different clinical questions than sexually transmitted disease STD testing; therefore, aliquot removal may not be suitable for all clinical situations. Only one aliquot may be removed from the SurePath ® Preservative Fluid Collection Vial prior to performing the PapTest, regardless of the volume of the aliquot.
Procedure 1. In order to ensure a homogenous mixture, the SurePath ® Preservative Fluid Collection Vial must be vortexed for virus de papiloma humano es igual que sida and the 0. A polypropylene aerosol barrier pipette tip that is sized appropriately for the volume being withdrawn must be used for aliquot removal. Note: Serological pipettes should not be used. Good laboratory practices must be followed to avoid introducing contaminants into the SurePath ® Preservative Fluid collection vial or the aliquot.
Aliquot removal should be performed in an appropriate location outside an area where amplification is performed.
Visually check the aliquot material in the pipette for evidence of large gross particulates or semi-solids. Evidence of such material encountered while withdrawing the aliquot material should prompt return of all the material to the specimen vial and disqualify the specimen for ancillary testing prior to performing the Pap test.
Not all the materials listed below are required for preparing SurePath ® slides manually without using the PrepStain ® instrument.