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SurePath™ Liquid-Based Pap Test

(AutoCyte Prep™ System) with Reflex to Human Papillomavirus (HPV) DNA Probe, High Risk

Test indication: The SurePath™ (formerly AutoCyte Prep™ system) liquid-based Pap test produces slides that are intended as replacements for conventional gynecologic. The Pap smear is use in the screening and detection of cervical cancer, precancerous lesions, atypical cells and all other cytologic categories as defined by the Bethesda System for Reporting Cervical Cytology.

Specimen required: Cervicovaginal/ endocervical sampling. Methodology: PrepStain™ Slide Processor, FocalPoint™ (computer assisted pap screening analysis), routine cytopathologic evaluation, Hybrid Capture® II DNA Test (Nucleic acid, hybridization assay with signal amplification)

Supplies: This test requires a SurePath™ special collection kit, which includes a SurePath™ preservative fluid collection vial and the sampling device(s). Kits may be ordered separately through PLA Client Services at (501) 225-7711. Also required is a PLA Cytology test request form and a permanent marker.

Collection procedure:
a) Obtain cervical specimen prior to bimanual examination. Use an un-lubricated speculum (saline or warm water may be used). Vaginal discharge or secretion, when present in large amounts, should be removed before obtaining the cervical sample so as not to disturb the epithelium (e.g. cellulose swab). Small amounts of blood will not interfere with the cytologic evaluation; however, large amounts of blood as present during menses may interfere with cytologic evaluation because cells may be obscured by blood. Use of liquid-based specimen collection minimizes the interference from these factors. If testing for sexually transmitted disease is indicated, the cervical cytology sample should be Cervex-Brush™ or the Pap Perfect® plastic spatula and Cytobrush® Plus GT or ROVER’S CERVEX-BRUSH™
b) To use the broom, insert the long central bristles into the cervical os until the lateral bristles bend against the ectocervix and rotate 360° in a clockwise direction five (5) times in the same direction while maintaining gentle pressure.
c) The device should be twisted slowly. While maintaining gentle pressure hold the stem between the thumb and the forefinger and rotate the brush five times in a clockwise direction. The direction must be consistent. Do not alter or vary the direction of the broom during sampling.
d) Transfer the entire sample by placing your thumb against the back of the brush pad, and simply disconnect the entire brush from the stem into the SurePath™ preservative vial.

a) To obtain an adequate sampling, scrape the ectocervix using the Pap Perfect® plastic spatula. Disconnect the spatula head into the SurePath™ Preservative vial.
b) Insert the Cytobrush® Plus GT into the cervix until only the bottom most fibers are exposed. Slowly rotate or turn one half turn in one direction. DO NOT OVER-ROTATE. Disconnect the brush head and place in the SurePath™ preservative vial.
c) Recap the vial and tighten. Record the patient’s first and last name, date of birth, specimen source and date collected on the vial. Record the patient’s information and medical history on the PLA Cytology test request form.
d) Place the vial and test request form in a biohazard specimen bag for transport to the laboratory. PLA Laboratories will not accept samples in expired SurePath™ preservative.

NOTE:
Samples received without the collection devices in the vial are reported in the Specimen Adequacy statement as: Satisfactory, but limited if cellularity is adequate. The specimen is processed and examined but limited due to the absence of the Cervex-Brush (broom-like device), cytobrush or spatula head in the specimen collection vial. Failure to follow recommended procedures for SurePath™ collection may compromise performance. Use of the SurePath™ Test without the Cervex-Brush is not FDA approved and is considered off label testing by TriPath Imaging. Specimen requirements: This test requires a SurePath™ special collection kit that must be ordered separately trough PLA Client Services at (501) 225-7711. Collect and transport in Path™ Liquid-Based Pap Test vial (AutoCyte Prep™ System).

Remarks: This test includes a Cytology, SurePath™ Liquid-Based Pap Test (AutoCyte Prep™, FocalPoint™ computer assisted screening analysis, Routine cytopathologic evaluation and a Human Papillomavirus (HPV) DNA Probe, recommended High Risk ONLY if the SurePath™ Liquid-Based Pap Test is interpreted as atypical squamous cells of undetermined significance (ASC-US).

Unacceptable conditions: Frozen, older than 28 days, samples not collected in a SurePath™ special collection kit provided by lab, Expired SurePath™ vials will not be processed.

Stability: Ambient: 1 month; Refrigerated: 1 month; Frozen: Unacceptable.

SurePath test reference interval: By Report.

Note: Store SurePath™ preservative fluid without cytologic samples at 15-30°C in this vials provided. Do not use SurePath™ solution beyond expiration date marked on the vial. Rotate stock of SurePathTM and use vials with closest expiration date first. No specimen will be accepted in expired solution.

Warning: SurePath™ preservative contains denatured ethanol which may be fatal if swallowed. Vapor is harmful if inhaled. May cause blindness. SurePath™ is flammable. Keep away from fire, heat, sparks, and flames. Other solutions must not be substituted for SurePath™ preservative.

CPT code(s): Refer to the earlier information given in Cytopathology section.

HPV DNA reference interval: High-risk HPV: Not detected.

Hybrid capture II Interpretative Data: Women with atypical squamous cells of undetermined significance (ASC-US) should be managed using a program of either repeat cervical cytology testing, immediate colposcopy or DNA testing for high-risk types of Human Papillomavirus (HPV). Testing for HPV DNA is the preferred approach when liquid-based cytology is used for screening. All women who test positive for high-risk HPV DNA should be referred for colposcopic evaluation. Women with ASC-US who test negative for high-risk HPV DNA can be followed up with repeat cytologic testing at 12 months (2001 ASCCP Guidelines –JAMA 2002; 287:2120-2129).

A positive high risk HPV test result indicates that the patient may be infected with one or more of the following HPV genotypes: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68; which are associated with cervical cancer and its precursor lesions. However, cross-reactions with other genotypes may occur. Results should be correlated with cytologic/histologic findings.

Note: A negative result does not rule out the presence of an HPV genotype absent from the test panel, a low level infection or specimen sampling error.

CPT code(s): CPT Codes vary based on testing.

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